Ge Healthcare Inc.

Ge Healthcare Inc. Drugs

• Omnipaque
  

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  Omnipaque

  

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  DOSAGE AND ADMINISTRATION — Intrathecal

  The volume and concentration of OMNIPAQUE 180, OMNIPAQUE 240, or OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.

  OMNIPAQUE 180 at a concentration of 180 mgI/mL, OMNIPAQUE 240 at a concentration of 240 mgI/mL, or OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.

  OMNIPAQUE 180 at a concentration of 180 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in children by lumbar injection and is slightly hypertonic to CSF.

  A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults and a total dose of 2700 mg iodine or a concentration of 180 mgI/mL should not be exceeded in children in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.

  Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration. Seizure-prone patients should be maintained on anticonvulsant medication.

  Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.

  Rate of Injection

  To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.

  Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.

  The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.

  Adults

  The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1.2 gI to 3.06 gI as follows:

  Procedure Formulations Concentration(mgI/mL) Volume(mL) Dose(gI) Lumbar Myelography (via lumbar injection) OMNIPAQUE 180OMNIPAQUE 240 180240 10-17      7-12.5   1.8-3.061.7-3.0 Thoracic Myelography (via lumbar or cervical injection) OMNIPAQUE 240OMNIPAQUE 300 240300 6-12.56-10   1.7-3.01.8-3.0 Cervical Myelography (via lumbar injection) OMNIPAQUE 240OMNIPAQUE 300 240300 6-12.56-10   1.4-3.01.8-3.0 Cervical Myelography (via C1-2 injection) OMNIPAQUE 180OMNIPAQUE 240OMNIPAQUE 300 180240300 7-10  6-12.54-10   1.3-1.81.4-3.01.2-3.0 Total Columnar Myelography (via lumbar injection) OMNIPAQUE 240OMNIPAQUE 300 240300 6-12.56-10   1.4-3.01.8-3.0

  Pediatrics

  The usual recommended total doses for lumbar, thoracic, cervical, and/or total columnar myelography by lumbar puncture in children are 0.36 gI to 2.7 gI (see table below). Actual volumes administered depend largely on patient age and the following guidelines are recommended.

  Age Conc.(mgI/mL) Volume(mL) Dose(gI) 0 to < 3 mos 180 2-4 0.36-0.72 3 to < 36 mos. 180 4-8 0.72-1.44 3 to < 7 yrs. 180 5-10 0.9-1.8 7 to < 13 yrs. 180 5-12   0.9-2.16 13 to 18 yrs. 180 6-15 1.08-2.7  

  Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Spinal puncture must always be performed under sterile conditions.

  Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.

  Repeat Procedures

  If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.

  As with all radiopaque contrast agents, the lowest dose of OMNIPAQUE necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OMNIPAQUE. The combination of volume and concentration of OMNIPAQUE to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

  Sterile technique must be used in all vascular injections involving contrast media.

  Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile equipment. Sterile techniques must be used with any invasive procedure.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  It may be desirable that solutions of radiopaque diagnostic agents be used at body temperature when injected.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions of OMNIPAQUE should be used only if clear and within the normal colorless to pale yellow range. If particulate matter or discoloration is present, do not use.

  Dosage and Administration

  The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young children. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

  The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in children are as follows:

  Dosage and Administration

  Adults

  The usual adult volume as a single injection is 50 mL to 80 mL for the aorta, 30 mL to 60 mL for major branches including celiac and mesenteric arteries, and 5 mL to 15 mL for renal arteries. Repeated injections may be performed if indicated, but the total volume should not exceed 291 mL of OMNIPAQUE 300 or 250 mL of OMNIPAQUE 350 (87.5 gI).

  Pediatrics

  The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350 and should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350.

  Dosage and Administration

  OMNIPAQUE 300 is recommended for cerebral arteriography at the following volumes: common carotid artery (6 mL to 12 mL), internal carotid artery (8 mL to 10 mL), external carotid artery (6 mL to 9 mL), and vertebral artery (6 mL to 10 mL).

  Dosage and Administration

  The concentration and volume required will depend on the equipment and imaging technique used.

  OMNIPAQUE (iohexol) Injection

  The dosage recommended for use in adults for contrast enhanced computed tomography is as follows:

  Head Imaging by Injection: 70 mL to 150 mL (21 gI to 45 gI) of OMNIPAQUE 300 (300 mgI/mL)    80 mL (28 gI) of OMNIPAQUE 350 (350 mgI/mL) Head Imaging by Infusion: 120 mL to 250 mL (29 gI to 60 gI) of OMNIPAQUE 240 (240 mgI/mL) Body Imaging by Injection: 50 mL to 200 mL (15 gI to 60 gI) of OMNIPAQUE 300 (300 mgI/mL) 60 mL to 100 mL (21 gI to 35 gI) of OMNIPAQUE 350 (350 mgI/mL)

  The dosage recommended for use in children for contrast enhanced computed tomographic head imaging is 1.0 mL/kg to 2.0 mL/kg for OMNIPAQUE 240 or OMNIPAQUE 300. It should not be necessary to exceed a maximum dose of 28 gI with OMNIPAQUE 240 or 35 gI with OMNIPAQUE 300.

  Dosage and Administration

  The usual injection volume of OMNIPAQUE 350 for the intravenous digital technique is 30 mL to 50 mL of a 350 mgI/mL solution. This is administered as a bolus at 7.5 to 30 mL/second using a pressure injector. The volume and rate of injection will depend primarily on the type of equipment and technique used.

  Frequently three or more injections may be required, up to a total volume not to exceed 250 mL (87.5 gI).

  Dosage and Administration

  Mechanical or hand injection can be used to administer one or more bolus intra-arterial injections of OMNIPAQUE 140. The volume and rate of injection will depend on the type of equipment, technique used, and the vascular area to be visualized. The following volumes and rates of injection have been used with OMNIPAQUE 140.

  Arteries Volume/Injection(mL) Rate of Injection(mL/sec)   Aorta 20-45     8-20   Carotid 5-10 3-6   Femoral 9-20 3-6   Vertebral 4-10 2-8   Renal 6-12 3-6   Other Branches of the Aorta    (includes subclavian, axillary, innominate and iliac) 8-25   3-10

  Dosage and Administration

  The volume required will depend on the size, flow rate, and disease state of the injected vessel and on the size and condition of the patient, as well as the imaging technique used.

  The dosage recommended for use in peripheral angiography is as follows:

  Aortofemoral runoffs: 20 mL to 70 mL of OMNIPAQUE 350 (350 mgI/mL) 30 mL to 90 mL of OMNIPAQUE 300 (300 mgI/mL) Selective arteriograms: 10 mL to 30 mL of OMNIPAQUE 350 (350 mgI/mL) (femoral/iliac) 10 mL to 60 mL of OMNIPAQUE 300 (300 mgI/mL) Venography (per leg): 20 mL to 150 mL of OMNIPAQUE 240 (240 mgI/mL) 40 mL to 100 mL of OMNIPAQUE 300 (300 mgI/mL)

  Dosage and Administration

  Adults

  OMNIPAQUE 300 and OMNIPAQUE 350 at dosages from 200 mgI/kg body weight to 350 mgI/kg body weight have produced diagnostic opacification of the excretory system in patients with normal renal function.

  Pediatrics

  Excretory Urography

  OMNIPAQUE 300 at doses of 0.5 mL/kg to 3.0 mL/kg of body weight has produced diagnostic opacification of the excretory tract. The usual dose for children is 1.0 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

  See SECTION II, DOSAGE AND ADMINISTRATION—General.

  Dosage and Administration

  Adults

  The recommended dosage of undiluted OMNIPAQUE 350 at a concentration of 350 mgI/mL for oral pass-thru examination of the gastrointestinal tract in adults is 50 mL to 100 mL depending on the nature of the examination and the size of the patient.

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 6 mgI/mL to 9 mgI/mL for contrast enhanced computed tomography of the abdomen in adults is 500 mL to 1000 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). In conjunction with dilute oral administration, the recommended dosage of OMNIPAQUE 300 administered intravenously is 100 mL to 150 mL. The oral dose is administered about 20 to 40 minutes prior to the intravenous dose and image acquisition.

  Children

  The dosage of undiluted OMNIPAQUE 300 at a concentration of 300 mgI/mL, OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 180 at a concentration of 180 mgI/mL for oral pass-thru examination of the gastrointestinal tract in children is dependent on the nature of the examination and the size of the patient. Based on clinical experience, it is recommended that OMNIPAQUE 180 be used in children less than 3 months of age. OMNIPAQUE 180, OMNIPAQUE 240 or OMNIPAQUE 300 may be used in children 3 months of age and older. The following dosage guidelines are recommended:

  Age Volume of OMNIPAQUE When given rectally, larger volumes may be used. Less than 3 months 5    — 30 mL Three months to 3 years Up to 60 mL Four years to 10 years Up to 80 mL Greater than 10 years Up to 100 mL

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 9 mgI/mL to 21 mgI/mL for contrast enhanced computed tomography of the abdomen in children is 180 mL to 750 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). The total oral dose in grams of iodine should generally not exceed 5 gI for children under 3 years of age and 10 gI for children from 3 to 18 years of age. The oral dosage may be given all at once or over a period of 30 to 45 minutes if there is difficulty in consuming the required volume.

  In conjunction with dilute oral administration the recommended dosage of OMNIPAQUE 240 and OMNIPAQUE 300 is 2.0 mL/kg when administered intravenously with a range of 1.0 mL/kg to 2.0 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total intravenously administered dose should not exceed 3 mL/kg. The oral dose is administered about 30 to 60 minutes prior to the intravenous dose and image acquisition.

  OMNIPAQUE may be diluted with water or beverage as follows:

  To Achieve Add To One Liter of Contrast Medium at A Final Concentration(mgI/mL) of Stock Concentration of OMNIPAQUE(mgI/mL) Volume(mL) Water, Carbonated Beverage, Milk, or Juice(mL) 6 240 25 975 300 20 980 350 17 983 9 240 38 962 300 30 970 350 26 974 12 240 50 950 300 40 960 350 35 965 15 240 63 937 300 50 950 350 43 957 18 240 75 925 300 60 940 350 52 948 21 240 88 912 300 70 930 350 60 940

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

  Dosage and Administration

  OMNIPAQUE may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mgI/mL to 100 mgI/mL for voiding cystourethrography. The concentration may vary depending upon the patient's size and age and also with the technique and equipment used. Sufficient volume of contrast medium should be administered to adequately fill the bladder. The usual volume ranges from 50 mL to 300 mL of OMNIPAQUE at a concentration of 100 mgI/mL and 50 mL to 600 mL of OMNIPAQUE at a concentration of 50 mgI/mL.

  OMNIPAQUE may be diluted with Sterile Water for Injection as indicated in the table below:

  To Achieve Add To A Final Concentration Each 100 mL of OMNIPAQUE Sterile Water for Injection, USP (mL) (mgI/mL) OMNIPAQUE 240 OMNIPAQUE 300 OMNIPAQUE 350 100 140 200 250 90 167 233 289 80 200 275 338 70 243 330 400 60 300 400 483 50 380 500 600

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

  Dosage and Administration

  Arthrography is usually performed under local anesthesia. The amount of OMNIPAQUE injected is dependent on the size of the joint to be examined and the technique employed. Lower volumes of contrast medium are usually injected for knee and shoulder arthrography when double-contrast examinations using 15 mL to 100 mL of air are performed.

  The following concentrations and volumes are recommended for normal adult knee, shoulder, and temporomandibular joints but should serve as guidelines since joints may require more or less contrast medium for optimal visualization.

  KNEE OMNIPAQUE 240  5 mL to 15 mLOMNIPAQUE 300  5 mL to 15 mLOMNIPAQUE 350  5 mL to 10 mLSHOULDER OMNIPAQUE 300   10 mLOMNIPAQUE 240    3 mLTEMPOROMANDIBULAR OMNIPAQUE 300  0.5 mL to 1.0 mL Lower volumes recommended for double-contrastexaminations; higher volumes recommended for single-contrast examinations.

  Passive or active manipulation is used to disperse the medium throughout the joint space.

  Dosage and Administration

  The recommended dose of OMNIPAQUE 240 at a concentration of 240 mgI/mL is 10 mL to 50 mL but may vary depending on individual anatomy and/or disease state.

  Dosage and Administration

  The recommended dosage of OMNIPAQUE 240 is 15 mL to 20 mL and of OMNIPAQUE 300 is 15 mL to 20 mL but will vary depending on individual anatomy and/or disease state.

  Dosage and Administration

  The recommended dosage of OMNIPAQUE 240 is 50 mL but may vary depending on individual anatomy and/or disease state.

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• Cysview
  

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  Cysview

  

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  2.1 Recommended Dose

  The recommended dose for adults is 50 mL of reconstituted solution of Cysview [see Dosage and Administration (2.2)], instilled into the bladder via a urinary catheter [see Dosage and Administration (2.3)].

  2.2 Reconstitution of Cysview

  Cysview is supplied as a kit containing two vials: a clear glass vial labeled as Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, containing 100 mg hexaminolevulinate hydrochloride as a powder, and a vial labeled as DILUENT for Cysview, containing 50 mL of the diluent in a polypropylene vial.

  Perform all steps under aseptic conditions. Use gloves during the reconstitution procedure; skin exposure to hexaminolevulinate hydrochloride may increase the risk for sensitization to the drug.

  Use a 50 mL syringe with a Luer Lock tip throughout the reconstitution procedure to ensure that the correct concentration (2mg/mL) of the drug is obtained and that a stable syringe-catheter connection is made for the bladder instillation of Cysview.

  Figure 1.

  1. Remove the cap from the sterile 50 mL syringe and carefully retain it for subsequent reattachment to the syringe (step 4). Attach a needle to the syringe and withdraw 50 mL of the diluent ( Figure 1).

  Figure 2.

  2. Penetrate the stopper of the Cysview powder vial with the needle and inject 10 mL of the diluent from the syringe into the powder vial ( Figure 2).

  Figure 3.

  3. Without withdrawing the needle from the vial, hold the powder vial and syringe in a firm grip ( Figure 3) and gently shake to dissolve of the powder in the diluent. The powder normally dissolves almost immediately.

  Figure 4.

  4. Withdraw all of the dissolved solution from the powder vial (10 mL) into the 50 mL syringe ( Figure 4).

  Figure 5.

  5. Remove the needle from the powder vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap ( Figure 5). Gently mix the contents of the syringe. The reconstituted solution of Cysview is colorless to pale yellow and clear to slightly opalescent, and free from visible particles.

  Figure 6.

  6. Peel off the detachable portion of the label (starting at the corner marked with a black triangle) from the Cysview powder vial and affix it to the syringe containing the solution of Cysview ( Figure 6). Add two hours to the present time and write the resulting expiration time and date on the syringe label. Cysview is now reconstituted and ready for use. Instill the reconstituted solution of Cysview into the bladder. If unable to administer the solution shortly after reconstitution, the solution may be stored for up to 2 hours in a refrigerator at 2°-8°C (36°- 46°F) in the labeled syringe. If not used within 2 hours, discard the solution. [ see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16)]

  2.3 Bladder Instillation of Cysview

  For bladder instillation of the solution of Cysview, use straight, or intermittent, urethral catheters with a proximal funnel opening that will accommodate the Luer Lock adapter. Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), and silicone to instill the reconstituted Cysview. Do not use catheters coated or embedded with silver or antibiotics. In-dwelling bladder catheters (Foley catheters) may be used if the catheters are inserted shortly prior to Cysview administration and are removed following the Cysview instillation.

  Use the following steps for bladder instillation of Cysview:

  1. Using standard sterile catheterization technique, first insert the urethral catheter into the bladder of the patient and use the catheter to completely empty the patient's bladder before instillation of Cysview.

  Figure 7.

  2. To attach the syringe containing the solution of Cysview to the catheter, do the following: Remove the syringe cap from the 50 mL syringe that contains the solution of Cysview. Attach the Luer Lock end of the (provided) catheter adapter to the syringe. Insert the tapered end of the catheter adapter into the funnel opening of the catheter. See Figure 7, with the connection enlarged in the inset. 3. Slowly instill the solution of Cysview into the bladder through the catheter ( Figure 7), ensuring that the complete volume of the syringe (50 mL) is administered. 4. After the solution is instilled, remove the catheter and instruct the patient to retain the solution within the bladder for at least 1 hour; do not exceed 3 hours [ see Dosage and Administration (2.4)]. Patients may stand, sit and move about during the time period between instillation and start of the cystoscopic procedure. 5. Evacuate the solution of Cysview from the bladder as part of routine emptying of the bladder immediately prior to the initiation of the cystoscopic procedure (refer to the Karl Storz PDD Telescope Instruction manual). Also, the patient may void and completely empty the bladder prior to the procedure.

  Avoid skin contact with Cysview. If skin does come in contact with Cysview, wash immediately with soap and water and dry off. After voiding the bladder of Cysview, routinely wash the patient's perineal skin region with soap and water and dry.

  2.4 Use of the Karl Storz D-Light C Photodynamic Diagnostic (PDD) System

  Cysview imaging requires the use of the Karl Storz D-Light C PDD system, which consists of a light source, a camera and a telescope. The light source enables both white light cystoscopy and blue light (wavelength 360 – 450 nm) fluorescence cystoscopy. Familiarity with this system is essential before beginning the procedure and before instilling Cysview into the bladder. For system set up and general information for the safe use of the PDD system, refer to the Karl Storz instruction manual for the PDD system and the instruction manuals for each of the system components. The PDD System is not for use by healthcare providers with green-red color blindness.

  2.5 Cystoscopic Examination

  Training

  Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview. Carefully review the instruction manuals provided with the Karl Storz D-Light C Photodynamic Diagnosis (PDD) System. For additional training in the use of the PDD System, contact the manufacturer's representative.

  Preparation for Cystoscopy

  Initiate the cystoscopic examination within 30 minutes after evacuation of Cysview from the bladder, but no less than 1 or more than 3 hours after Cysview is instilled in the bladder. If the patient did not retain Cysview in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview into the bladder to the start of the cystoscopic examination. The efficacy of Cysview has not been established when the solution was retained for less than 1 hour.

  Cystoscopic Examination

  Empty the patient's bladder and then fill the bladder with a clear fluid (standard bladder irrigation fluid) in order to distend the bladder wall for cystoscopic visibility. Ensure adequate irrigation during examination of the bladder; blood, urine or floating particles in the bladder may interfere with visualization under both white light and blue light.

  First perform a complete cystoscopic examination of the entire bladder under white light (Mode 1) and then repeat the examination of the entire bladder surface under blue light (Mode 2) unless the white light cystoscopy reveals extensive mucosal inflammation. Do not perform the blue light cystoscopy if the white light cystoscopy reveals wide-spread mucosal inflammation. Abnormalities of the bladder mucosa during blue light cystoscopy are characterized by the detection of red, homogenous and intense fluorescence. The margins of the abnormal lesions are typically well-demarcated and in contrast to the normal urothelium, which appears blue. Register and document (map) the location and appearance (e.g. papillary) of suspicious lesions and abnormalities seen under either white or blue light.

  During the cystoscopic examination, be aware that:

  a red fluorescence is expected at the bladder outlet and the prostatic urethra; this fluorescence occurs in normal tissue and is usually less intense and more diffuse than the bladder mucosal fluorescence associated with malignant lesions. tangential light may give false fluorescence. To help avoid false fluorescence, hold the endoscope perpendicular and close to the bladder wall with the bladder distended. false positive fluorescence may result from scope trauma from a previous cystoscopic examination and/or bladder inflammation [see Warnings and Precautions (5.3)]. malignant lesions may not fluoresce following Cysview administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect T2 tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [see Warnings and Precautions (5.3)]. when performing the blue light cystocopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trial, the cumulative blue light exposure from bladder mapping did not exceed 12 minutes and checking for complete tumor resection under blue light did not exceed 8 minutes for any patient [see Clinical Studies (14)].

  Perform biopsy and/or resection of suspicious lesions by transurethral resection of the bladder (TURB) only after completing white and blue light cystoscopic examinations with bladder mapping. Using standard cystoscopic practices, obtain biopsies of abnormal areas identified during either white or blue light examination and perform resections. Always check for the completeness of the resections under both white light and blue light before finalizing the TURB procedure.

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• Omniscan
  

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  Omniscan

  

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  2.1 CNS (Central Nervous System)

  Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

  Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].

  2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

  Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].

  2.3 Dosage Chart

  BODYWEIGHT PEDIATRIC ADULTS 0.05 0.1 0.05 0.1 (mmol/kg) (mmol/kg) kg lb VOLUME (mL) VOLUME (mL) * The heaviest patient in clinical studies weighed 136 kg. 12 26 1.2 2.4 - - 14 31 1.4 2.8 - - 16 35 1.6 3.2 - - 18 40 1.8 3.6 - - 20 44 2 4 - - 22 48 2.2 4.4 - - 24 53 2.4 4.8 - - 26 57 2.6 5.2 - - 28 62 2.8 5.6 - - 30 66 3 6 - - 40 88 4 8 4 8 50 110 5 10 5 10 60 132 6 12 6 12 70 154 7 14 7 14 80 176 8 16 8 16 90 198 - - 9 18 100 220 - - 10 20 110 242 - - 11 22 120 264 - - 12 24 130* 286 - - 13 26

  2.4 Dosing Guidelines

  Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

  Do not use the solution if it is discolored or particulate matter is present.

  Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

  To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride, as provided in the Prefill Plus needle-free system. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

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• Visipaque
  

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  Visipaque

  

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  For Pediatric dosing see the end of this Dosage and Administration section.

  GENERAL

  The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.

  The maximum recommended total dose of iodine is 80 grams.

  If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.

  Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents (see WARNINGS and PRECAUTIONS).

  INTRA-ARTERIAL ADMINISTRATION

  VISIPAQUE 320mgI/mL is recommended for intra-arterial injection in the radiographic contrast evaluation of arterial lesions of the brain, the coronary arteries and left ventricle, and for intra-arterial injection in the radiographic contrast evaluation of peripheral arteries. VISIPAQUE is also recommended for intra-arterial digital subtraction angiography, as specified in the dosing chart below.

  Injection rates should be approximately equal to the flow rate in the vessel being injected. The volume required will depend on the size, flow rate, and disease state of the injected vessel, on the size and condition of the patient, and on the imaging technique used. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in the tables below.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL SINGLE DOSES FOR INJECTION INTO SELECTED ARTERIES ARTERIOGRAPHY IA-DSA* Maximum Total Dose Intra-Arterial Injection Sites 320 mgI/mL 270 mgI/mL 320 mgI/mL * IA-DSA= Intra-Arterial Digital Subtraction Angiography Carotid Arteries 10 - 14 mL 5 - 8 mL Usually Not to Exceed 175 mL Vertebral Arteries 10 - 12 mL 5 - 8 mL Right Coronary Artery 3 - 8 mL Usually Not to Exceed 200 mL Left Coronary Artery 3 - 10 mL Left Ventricle 20 - 45 mL Renal Arteries 8 - 18 mL 10 - 25 mL — Usually Not to Exceed 250 mL Aortography 30 - 70 mL 20 - 50 mL 10 - 50 mL Major Branches of Aorta 10 - 70 mL 5 - 30 mL 2 - 10 mL Aortofemoral Runoffs 20 - 90 mL — 6 - 15 mL Peripheral Arteries 15 - 30 mL — 3 - 15 mL

  INTRAVENOUS ADMINISTRATION

  Contrast Enhanced Computed Tomography (CECT)

  Intravenous administration of VISIPAQUE Injection (270mgI/mL and 320mgI/mL) is recommended for contrast enhancement in the evaluation of neoplastic and nonneoplastic lesions of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions), evaluations of renal function, and evaluations of the peripheral venous system. Selected dosing for different indications in adults and pediatric patients are shown in the following tables.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL VISIPAQUE DOSING FOR INTRAVENOUS CONTRAST ADMINISTRATION Study Type Comment 270 mgI/mL 320 mgI/mL Maximum Total Volume CECT of Head or Body Bolus 75 - 150 mL 75 - 150 mL 150 mL Infusion 100 - 150 mL 100 - 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 - 150 mL 250 mL

  PEDIATRIC DOSING

  The recommended dose in children over 1 year of age for the evaluation of:

  Intra-arterial Administration for Cerebral, Cardiac chambers and related major arteries, and Visceral Studies

  VISIPAQUE 320 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 4 mL/kg.

  Intravenous Administration for Contrast Enhanced Computerized Tomography or Excretory Urography

  VISIPAQUE 270 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 2 mL/kg.

  The safety and efficacy relationships of other doses, concentrations or procedures have not been established. (See Clinical Pharmacology–Special Populations, and Precautions–Pediatric Use sections.)

  The maximum total dose of iodine in the pediatric population has not been established.

  DRUG HANDLING

  As with all contrast agents because of the potential for chemical incompatibility, VISIPAQUE Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions or total nutritional admixtures.

  Sterile technique must be used in all procedures involving vascular injections of contrast agents.

  VISIPAQUE Injection may be administered at body temperature as well as at room temperature.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

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• Visipaque
  

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  Visipaque

  

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  For Pediatric dosing see the end of this DOSAGE AND ADMINISTRATION section.

  GENERAL

  The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.

  The maximum recommended total dose of iodine is 80 grams.

  If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.

  Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents (see WARNINGS and PRECAUTIONS).

  INTRA-ARTERIAL ADMINISTRATION

  VISIPAQUE 320mgI/mL is recommended for intra-arterial injection in the radiographic contrast evaluation of arterial lesions of the brain, the coronary arteries and left ventricle, and for intra-arterial injection in the radiographic contrast evaluation of peripheral arteries. VISIPAQUE is also recommended for intra-arterial digital subtraction angiography, as specified in the dosing chart below.

  Injection rates should be approximately equal to the flow rate in the vessel being injected. The volume required will depend on the size, flow rate, and disease state of the injected vessel, on the size and condition of the patient, and on the imaging technique used. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in the tables below.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL SINGLE DOSES FOR INJECTION INTO SELECTED ARTERIES ARTERIOGRAPHY IA-DSA* Maximum Total Dose Intra-Arterial Injection Sites 320 mgI/mL 270 mgI/mL 320 mgI/mL * IA-DSA= Intra-Arterial Digital Subtraction Angiography Carotid Arteries 10 - 14 mL 5 - 8 mL Usually Not to Exceed 175 mL Vertebral Arteries 10 - 12 mL 5 - 8 mL Right Coronary Artery 3 - 8 mL Usually Not to Exceed 200 mL Left Coronary Artery 3 - 10 mL Left Ventricle 20 - 45 mL Renal Arteries 8 - 18 mL 10 - 25 mL — Usually Not to Exceed 250 mL Aortography 30 - 70 mL 20 - 50 mL 10 - 50 mL Major Branches of Aorta 10 - 70 mL 5 - 30 mL 2 - 10 mL Aortofemoral Runoffs 20 - 90 mL — 6 - 15 mL Peripheral Arteries 15 - 30 mL — 3 - 15 mL

  INTRAVENOUS ADMINISTRATION

  Contrast Enhanced Computed Tomography (CECT)

  Intravenous administration of VISIPAQUE Injection (270mgI/mL and 320mgI/mL) is recommended for contrast enhancement in the evaluation of neoplastic and nonneoplastic lesions of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions), evaluations of renal function, and evaluations of the peripheral venous system. Selected dosing for different indications in adults and pediatric patients are shown in the following table.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL VISIPAQUE DOSING FOR INTRAVENOUS CONTRAST ADMINISTRATION Study Type Comment 270 mgI/mL 320 mgI/mL Maximum Total Volume CECT of Head or Body Bolus 75 - 150 mL 75 - 150 mL 150 mL Infusion 100 - 150 mL 100 - 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 - 150 mL 250 mL

  PEDIATRIC DOSING

  The recommended dose in children over 1 year of age for the evaluation of:

  Intra-arterial Administration for Cerebral, Cardiac chambers and related major arteries, and Visceral Studies

  VISIPAQUE 320 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 4 mL/kg.

  Intravenous Administration for Contrast Enhanced Computerized Tomography or Excretory Urography

  VISIPAQUE 270 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 2 mL/kg.

  The safety and efficacy relationships of other doses, concentrations or procedures have not been established. (See Clinical Pharmacology–Special Populations, and Precautions–Pediatric Use sections.)

  The maximum total dose of iodine in the pediatric population has not been established.

  DRUG HANDLING

  As with all contrast agents because of the potential for chemical incompatibility, VISIPAQUE Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions or total nutritional admixtures.

  Sterile technique must be used in all procedures involving vascular injections of contrast agents.

  VISIPAQUE Injection may be administered at body temperature as well as at room temperature.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

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• Acetaminophen
  

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  Acetaminophen

  

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  2.1 CNS (Central Nervous System)

  Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

  Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].

  2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

  Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].

  2.3 Dosage Chart

  BODY WEIGHT PEDIATRIC ADULTS kg lb 0.05 0.1 0.05 0.1 (mmol/kg) (mmol/kg) VOLUME (mL) VOLUME (mL) * The heaviest patient in clinical studies weighed 136 kg. 12 26 1.2 2.4 - - 14 31 1.4 2.8 - - 16 35 1.6 3.2 - - 18 40 1.8 3.6 - - 20 44 2 4 - - 22 48 2.2 4.4 - - 24 53 2.4 4.8 - - 26 57 2.6 5.2 - - 28 62 2.8 5.6 - - 30 66 3 6 - - 40 88 4 8 4 8 50 110 5 10 5 10 60 132 6 12 6 12 70 154 7 14 7 14 80 176 8 16 8 16 90 198 - - 9 18 100 220 - - 10 20 110 242 - - 11 22 120 264 - - 12 24 130* 286 - - 13 26

  2.4 Dosing Guidelines

  Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

  Do not use the solution if it is discolored or particulate matter is present.

  Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

  To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

  2.5 Directions for Proper Use of OMNISCAN Pharmacy Bulk Package

  Use only a suitable work area, such as a laminar flow hood, to withdraw OMNISCAN Injection doses from the Pharmacy Bulk Package. Penetrate the Pharmacy Bulk Package container closure only once using a suitable transfer device and aseptic technique. Once the closure is penetrated, withdraw the container contents without delay. If delay is unavoidable, complete the fluid transfer as soon as possible within a maximum time of 8 hours. Once the closure is penetrated, keep the Pharmacy Bulk Package container in the aseptic area and at room temperature (do not exceed 30ºC). Following withdrawal of any dose from the Pharmacy Bulk Package, immediately label the dose with the supplied peel-off label that identifies the dose contents as OMNISCAN and that OMNISCAN is not for intrathecal use. Use each individual dose of OMNISCAN Injection immediately following withdrawal from the Pharmacy Bulk Package container; discard any unused portion of the OMNISCAN Injection dose not used immediately. Discard any unused OMNISCAN doses remaining in the Pharmacy Bulk Package 8 hours after the penetration of the container closure.

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• Omniscan
  

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  Omniscan

  

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  2.1 CNS (Central Nervous System)

  Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

  Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].

  2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

  Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].

  2.3 Dosage Chart

  BODY WEIGHT PEDIATRIC ADULTS kg lb 0.05 0.1 0.05 0.1 (mmol/kg) (mmol/kg) VOLUME (mL) VOLUME (mL) * The heaviest patient in clinical studies weighed 136 kg. 12 26 1.2 2.4 - - 14 31 1.4 2.8 - - 16 35 1.6 3.2 - - 18 40 1.8 3.6 - - 20 44 2 4 - - 22 48 2.2 4.4 - - 24 53 2.4 4.8 - - 26 57 2.6 5.2 - - 28 62 2.8 5.6 - - 30 66 3 6 - - 40 88 4 8 4 8 50 110 5 10 5 10 60 132 6 12 6 12 70 154 7 14 7 14 80 176 8 16 8 16 90 198 - - 9 18 100 220 - - 10 20 110 242 - - 11 22 120 264 - - 12 24 130* 286 - - 13 26

  2.4 Dosing Guidelines

  Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

  Do not use the solution if it is discolored or particulate matter is present.

  Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

  To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride, as provided in the Prefill Plus needle-free system. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

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• Optison Perflutren Prot...
  

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  Optison Perflutren Protein-type A Microspheres

  

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  The recommended dose of OPTISON is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. See individualization of dose below.

  The injection rate should not exceed 1 mL per second. Follow the OPTISON injection with a flush of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. The maximum total dose should not exceed 5.0 mL in any 10 minute period. The maximum total dose should not exceed 8.7 mL in any one patient study.

  Individualization of Dose

  Image quality in cardiac ultrasound is a function of the acoustic window which is influenced by many variables including body habitus, intervening lung tissue, adequacy of transducer skin interface and other acoustic factors. These variables may influence the ultrasound contrast effect.

  If the contrast enhancement is inadequate after the dose of 0.5 mL, additional doses in increments of 0.5 mL up to 5.0 mL cumulatively in a 10 minute period may be injected intravenously up to a maximum total dose of 8.7 mL in any one patient study.

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• Lamotrigine
  

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  Lamotrigine

  

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  The volume and concentration of OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.

  OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.

  A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.

  Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration.

  Seizure-prone patients should be maintained on anticonvulsant medication.

  Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.

  Rate of Injection

  To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.

  Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.

  The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.

  Adults

  The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1.2 gI to 3.0 gI as follows:

  Procedure Formulations Concentration(mgI/mL) Volume(mL) Dose(gI) Thoracic Myelography (via lumbar injection) OMNIPAQUE 300 300 6-10 1.8-3.0 Cervical Myelography (via lumbar injection) OMNIPAQUE 300 300 6-10 1.8-3.0 Cervical Myelography (via C1-2 injection OMNIPAQUE 300 300 4-10 1.2-3.0 Total Columnar Myelography (via lumbar injection OMNIPAQUE 300 300 6-10 1.8-3.0

  Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

  Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.

  Repeat Procedures

  If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.

  As with all radiopaque contrast agents, the lowest dose of OMNIPAQUE necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OMNIPAQUE. The combination of volume and concentration of OMNIPAQUE to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

  Sterile technique must be used in all vascular injections involving contrast media.

  Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  It may be desirable that solutions of radiopaque diagnostic agents be used at body temperature when injected.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions of OMNIPAQUE should be used only if clear and within the normal colorless to pale yellow range. If particulate matter or discoloration is present, do not use.

  Dosage and Administration

  The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young children. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

  The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in children are as follows:

  Ventriculography

  Adults

  The usual adult volume for a single injection is 40 mL with a range of 30 mL to 60 mL. This may be repeated as necessary. When combined with selective coronary arteriography, the total administered volume should not exceed 250 mL (87.5 gI).

  Pediatrics

  The usual single injection dose of OMNIPAQUE 350 is 1.25 mL/kg of body weight with a range of 1.0 mL/kg to 1.5 mL/kg. For OMNIPAQUE 300 the usual single injection dose is 1.75 mL/kg with a range of 1.5 mL/kg to 2.0 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or up to a total volume of 291 mL of OMNIPAQUE 300.

  Selective Coronary Arteriography

  The usual adult volume for right or left coronary arteriography is 5 mL (range 3 mL to 14 mL) per injection.

  Aortic Root and Arch Study When Used Alone

  The usual adult single injection volume is 50 mL, with a range of 20 mL to 75 mL.

  Pulmonary Angiography

  Pediatrics

  The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350.

  Combined Angiocardiographic Procedures

  Multiple Procedures

  Adults

  The visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

  Large doses of OMNIPAQUE 350 were well tolerated in angiographic procedures requiring multiple injections.

  The maximum total volume for multiple procedures should not exceed 250 mL of 350 mgI/mL (87.5 gI).

  Pediatrics

  Visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

  The maximum total dose for multiple injection procedures should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or 6.0 mL/kg up to a total volume of 291 mL of OMNIPAQUE 300.

  Dosage and Administration

  Adults

  The usual adult volume as a single injection is 50 mL to 80 mL for the aorta, 30 mL to 60 mL for major branches including celiac and mesenteric arteries, and 5 mL to 15 mL for renal arteries. Repeated injections may be performed if indicated, but the total volume should not exceed 291 mL of OMNIPAQUE 300 or 250 mL of OMNIPAQUE 350 (87.5 gI).

  Pediatrics

  The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350 and should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350.

  Dosage and Administration

  OMNIPAQUE 300 is recommended for cerebral arteriography at the following volumes: common carotid artery (6 mL to 12 mL), internal carotid artery (8 mL to 10 mL), external carotid artery (6 mL to 9 mL), and vertebral artery (6 mL to 10 mL).

  Dosage and Administration

  The concentration and volume required will depend on the equipment and imaging technique used.

  Dosage and Administration

  The usual injection volume of OMNIPAQUE 350 for the intravenous digital technique is 30 mL to 50 mL of a 350 mgI/mL solution. This is administered as a bolus at 7.5 to 30 mL/second using a pressure injector. The volume and rate of injection will depend primarily on the type of equipment and technique used.

  Frequently three or more injections may be required, up to a total volume not to exceed 250 mL (87.5 gI).

  Dosage and Administration

  The volume required will depend on the size, flow rate, and disease state of the injected vessel and on the size and condition of the patient, as well as the imaging technique used.

  The dosage recommended for use in peripheral angiography is as follows:

  Aortofemoral runoffs: 20 mL to 70 mL of OMNIPAQUE 350 (350 mgI/mL)30 mL to 90 mL of OMNIPAQUE 300 (300 mgI/mL) Selective arteriograms: (femoral/iliac) 10 mL to 30 mL of OMNIPAQUE 350 (350 mgI/mL)10 mL to 60 mL of OMNIPAQUE 300 (300 mgI/mL) Venography (per leg): 40 mL to 100 mL of OMNIPAQUE 300 (300 mgI/mL)

  Dosage and Administration

  Adults

  OMNIPAQUE 300 and OMNIPAQUE 350 at dosages from 200 mgI/kg body weight to 350 mgI/kg body weight have produced diagnostic opacification of the excretory system in patients with normal renal function.

  See SECTION II, DOSAGE AND ADMINISTRATION—General.

  Dosage and Administration

  Adults

  The recommended dosage of undiluted OMNIPAQUE 350 at a concentration of 350 mgI/mL for oral pass-thru examination of the gastrointestinal tract in adults is 50 mL to 100 mL depending on the nature of the examination and the size of the patient.

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 6 mgI/mL to 9 mgI/mL for contrast enhanced computed tomography of the abdomen in adults is 500 mL to 1000 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). In conjunction with dilute oral administration, the recommended dosage of OMNIPAQUE 300 administered intravenously is 100 mL to 150 mL. The oral dose is administered about 20 to 40 minutes prior to the intravenous dose and image acquisition.

  Children

  The dosage of undiluted OMNIPAQUE 300 at a concentration of 300 mgI/mL, is dependent on the nature of the examination and the size of the patient. Based on clinical experience, it is recommended that OMNIPAQUE 180 (available in single use vials), be used in children less than 3 months of age. OMNIPAQUE 300 may be used in children 3 months of age and older. The following dosage guidelines are recommended:

  Age Volume of OMNIPAQUE Less than 3 months 5 — 30 mL Three months to 3 years Up to 60 mL Four years to 10 years Up to 80 mL Greater than 10 years Up to 100 mL

  When given rectally, larger volumes may be used.

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 9 mgI/mL to 21 mgI/mL for contrast enhanced computed tomography of the abdomen in children is 180 mL to 750 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). The total oral dose in grams of iodine should generally not exceed 5 gI for children under 3 years of age and 10 gI for children from 3 to 18 years of age. The oral dosage may be given all at once or over a period of 30 to 45 minutes if there is difficulty in consuming the required volume.

  In conjunction with dilute oral administration the recommended dosage of OMNIPAQUE 300 is 2.0 mL/kg when administered intravenously with a range of 1.0 mL/kg to 2.0 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total intravenously administered dose should not exceed 3 mL/kg. The oral dose is administered about 30 to 60 minutes prior to the intravenous dose and image acquisition.

  OMNIPAQUE may be diluted with water or beverage as follows:

  To Achieve Add To One Liter of Contrast Medium at A Final Concentration(mgI/mL) of Stock Concentration of OMNIPAQUE(mgI/mL) Volume(mL) Water, Carbonated Beverage, Milk, or Juice(mL) 6 300 20 980 350 17 983 9 300 30 970 350 26 974 12 300 40 960 350 35 965 15 300 50 950 350 43 957 18 300 60 940 350 52 948 21 300 70 930 350 60 940

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

  Dosage and Administration

  OMNIPAQUE may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mgI/mL to 100 mgI/mL for voiding cystourethrography. The concentration may vary depending upon the patient's size and age and also with the technique and equipment used. Sufficient volume of contrast medium should be administered to adequately fill the bladder. The usual volume ranges from 50 mL to 300 mL of OMNIPAQUE at a concentration of 100 mgI/mL and 50 mL to 600 mL of OMNIPAQUE at a concentration of 50 mgI/mL.

  OMNIPAQUE may be diluted with Sterile Water for Injection as indicated in the table below:

  To Achieve Add To A Final Concentration Each 100 mL of OMNIPAQUE Sterile Water for Injection, USP (mL) (mgI/mL) OMNIPAQUE 300 OMNIPAQUE 350 100 200 250 90 233 289 80 275 338 70 330 400 60 400 483 50 500 600

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

  Dosage and Administration

  Arthrography is usually performed under local anesthesia. The amount of OMNIPAQUE injected is dependent on the size of the joint to be examined and the technique employed. Lower volumes of contrast medium are usually injected for knee and shoulder arthrography when double-contrast examinations using 15 mL to 100 mL of air are performed.

  The following concentrations and volumes are recommended for normal adult knee, shoulder, and temporomandibular joints but should serve as guidelines since joints may require more or less contrast medium for optimal visualization.

  KNEE Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations. OMNIPAQUE 300 5 mL to 15 mL OMNIPAQUE 350 5 mL to 10 mL SHOULDER OMNIPAQUE 300 10 mL TEMPOROMANDIBULAR OMNIPAQUE 300 0.5 mL to 1.0 mL

  Passive or active manipulation is used to disperse the medium throughout the joint space.

  Dosage and Administration

  The recommended dosage of OMNIPAQUE 300 is 15 mL to 20 mL but will vary depending on individual anatomy and/or disease state.

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• Omnipaque
  

  ×

  Omnipaque

  

  ---

  The volume and concentration of OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.

  OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.

  A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.

  Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration. Seizure-prone patients should be maintained on anticonvulsant medication.

  Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.

  Rate of Injection

  To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.

  Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.

  The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.

  Adults

  The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1.2 gI to 3.0 gI as follows:

  Procedure Formulations Concentration(mgI/mL) Volume(mL) Dose(gI) Thoracic Myelography (via lumbar injection) OMNIPAQUE 300 300 6-10 1.8-3.0 Cervical Myelography (via lumbar injection) OMNIPAQUE 300 300 6-10 1.8-3.0 Cervical Myelography (via C1-2 injection OMNIPAQUE 300 300 4-10 1.2-3.0 Total Columnar Myelography (via lumbar injection OMNIPAQUE 300 300 6-10 1.8-3.0

  Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

  Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.

  Repeat Procedures

  If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.

  As with all radiopaque contrast agents, the lowest dose of OMNIPAQUE necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OMNIPAQUE. The combination of volume and concentration of OMNIPAQUE to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

  Sterile technique must be used in all vascular injections involving contrast media.

  Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  It may be desirable that solutions of radiopaque diagnostic agents be used at body temperature when injected.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions of OMNIPAQUE should be used only if clear and within the normal colorless to pale yellow range. If particulate matter or discoloration is present, do not use.

  Dosage and Administration

  The individual dose or volume is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults, but must be considered in infants and young children. The volume of each individual injection is a more important consideration than the total dosage used. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

  The recommended single injection volume of OMNIPAQUE 350 for angiocardiographic procedures in adults and the recommended single injection volumes of OMNIPAQUE 350 and OMNIPAQUE 300 for angiographic procedures in children are as follows:

  Ventriculography

  Adults

  The usual adult volume for a single injection is 40 mL with a range of 30 mL to 60 mL. This may be repeated as necessary. When combined with selective coronary arteriography, the total administered volume should not exceed 250 mL (87.5 gI).

  Pediatrics

  The usual single injection dose of OMNIPAQUE 350 is 1.25 mL/kg of body weight with a range of 1.0 mL/kg to 1.5 mL/kg. For OMNIPAQUE 300 the usual single injection dose is 1.75 mL/kg with a range of 1.5 mL/kg to 2.0 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or up to a total volume of 291 mL of OMNIPAQUE 300.

  Selective Coronary Arteriography

  The usual adult volume for right or left coronary arteriography is 5 mL (range 3 mL to 14 mL) per injection.

  Aortic Root and Arch Study When Used Alone

  The usual adult single injection volume is 50 mL, with a range of 20 mL to 75 mL.

  Pulmonary Angiography

  Pediatrics

  The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350.

  Combined Angiocardiographic Procedures

  Multiple Procedures

  Adults

  The visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

  Large doses of OMNIPAQUE 350 were well tolerated in angiographic procedures requiring multiple injections.

  The maximum total volume for multiple procedures should not exceed 250 mL of 350 mgI/mL (87.5 gI).

  Pediatrics

  Visualization of multiple vascular systems and target organs is possible during a single radiographic examination of the patient.

  The maximum total dose for multiple injection procedures should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350 or 6.0 mL/kg up to a total volume of 291 mL of OMNIPAQUE 300.

  Dosage and Administration

  Adults

  The usual adult volume as a single injection is 50 mL to 80 mL for the aorta, 30 mL to 60 mL for major branches including celiac and mesenteric arteries, and 5 mL to 15 mL for renal arteries. Repeated injections may be performed if indicated, but the total volume should not exceed 291 mL of OMNIPAQUE 300 or 250 mL of OMNIPAQUE 350 (87.5 gI)

  Pediatrics

  The usual single injection dose is 1.0 mL/kg of OMNIPAQUE 350 and should not exceed 5.0 mL/kg up to a total volume of 250 mL of OMNIPAQUE 350.

  Dosage and Administration

  OMNIPAQUE 300 is recommended for cerebral arteriography at the following volumes: common carotid artery (6 mL to 12 mL), internal carotid artery (8 mL to 10 mL), external carotid artery (6 mL to 9 mL), and vertebral artery (6 mL to 10 mL).

  Dosage and Administration

  The concentration and volume required will depend on the equipment and imaging technique used.

  Dosage and Administration

  The usual injection volume of OMNIPAQUE 350 for the intravenous digital technique is 30 mL to 50 mL of a 350 mgI/mL solution. This is administered as a bolus at 7.5 to 30 mL/second using a pressure injector. The volume and rate of injection will depend primarily on the type of equipment and technique used.

  Frequently three or more injections may be required, up to a total volume not to exceed 250 mL (87.5 gI).

  Dosage and Administration

  The volume required will depend on the size, flow rate, and disease state of the injected vessel and on the size and condition of the patient, as well as the imaging technique used.

  The dosage recommended for use in peripheral angiography is as follows:

  Aortofemoral runoffs: 20 mL to 70 mL of OMNIPAQUE 350 (350 mgI/mL)30 mL to 90 mL of OMNIPAQUE 300 (300 mgI/mL) Selective arteriograms: (femoral/iliac) 10 mL to 30 mL of OMNIPAQUE 350 (350 mgI/mL)10 mL to 60 mL of OMNIPAQUE 300 (300 mgI/mL) Venography (per leg): 40 mL to 100 mL of OMNIPAQUE 300 (300 mgI/mL)

  Dosage and Administration

  Adults

  OMNIPAQUE 300 and OMNIPAQUE 350 at dosages from 200 mgI/kg body weight to 350 mgI/kg body weight have produced diagnostic opacification of the excretory system in patients with normal renal function.

  See SECTION II, DOSAGE AND ADMINISTRATION—General.

  Dosage and Administration

  Adults

  The recommended dosage of undiluted OMNIPAQUE 350 at a concentration of 350 mgI/mL for oral pass-thru examination of the gastrointestinal tract in adults is 50 mL to 100 mL depending on the nature of the examination and the size of the patient.

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 6 mgI/mL to 9 mgI/mL for contrast enhanced computed tomography of the abdomen in adults is 500 mL to 1000 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). In conjunction with dilute oral administration, the recommended dosage of OMNIPAQUE 300 administered intravenously is 100 mL to 150 mL. The oral dose is administered about 20 to 40 minutes prior to the intravenous dose and image acquisition.

  Children

  The dosage of undiluted OMNIPAQUE 300 at a concentration of 300 mgI/mL, is dependent on the nature of the examination and the size of the patient. Based on clinical experience, it is recommended that OMNIPAQUE 180 (available in single use vials), be used in children less than 3 months of age. OMNIPAQUE 300 may be used in children 3 months of age and older. The following dosage guidelines are recommended:

  Age Volume of OMNIPAQUE Less than 3 months 5 — 30 mL Three months to 3 years Up to 60 mL Four years to 10 years Up to 80 mL Greater than 10 years Up to 100 mL

  When given rectally, larger volumes may be used.

  The recommended oral dosage of OMNIPAQUE diluted to concentrations of 9 mgI/mL to 21 mgI/mL for contrast enhanced computed tomography of the abdomen in children is 180 mL to 750 mL. Smaller administered volumes are needed as the concentration of the final solution is increased (see Table below). The total oral dose in grams of iodine should generally not exceed 5 gI for children under 3 years of age and 10 gI for children from 3 to 18 years of age. The oral dosage may be given all at once or over a period of 30 to 45 minutes if there is difficulty in consuming the required volume.

  In conjunction with dilute oral administration the recommended dosage of OMNIPAQUE 300 is 2.0 mL/kg when administered intravenously with a range of 1.0 mL/kg to 2.0 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total intravenously administered dose should not exceed 3 mL/kg. The oral dose is administered about 30 to 60 minutes prior to the intravenous dose and image acquisition.

  OMNIPAQUE may be diluted with water or beverage as follows:

  Add To Stock Concentration of OMNIPAQUE(mgI/mL) Volume(mL) Water, Carbonated Beverage, Milk, or Juice(mL) 300 20 980 350 17 983 300 30 970 350 26 974 300 40 960 350 35 965 300 50 950 350 43 957 300 60 940 350 52 948 300 70 930 350 60 940

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure.

  Dosage and Administration

  OMNIPAQUE may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mgII/mL to 100 mgI/mL for voiding cystourethrography. The concentration may vary depending upon the patient's size and age and also with the technique and equipment used. Sufficient volume of contrast medium should be administered to adequately fill the bladder. The usual volume ranges from 50 mL to 300 mL of OMNIPAQUE at a concentration of 100 mgI/mL and 50 mL to 600 mL of OMNIPAQUE at a concentration of 50 mgI/mL.

  OMNIPAQUE may be diluted with Sterile Water for Injection as indicated in the table below:

  To Achieve Add To A Final Concentration Each 100 mL of OMNIPAQUE Sterile Water for Injection, USP (mL) (mgI/mL) OMNIPAQUE 300 OMNIPAQUE 350 100 200 250 90 233 289 80 275 338 70 330 400 60 400 483 50 500 600

  Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after theprocedure.

  Dosage and Administration

  Arthrography is usually performed under local anesthesia. The amount of OMNIPAQUE injected is dependent on the size of the joint to be examined and the technique employed. Lower volumes of contrast medium are usually injected for knee and shoulder arthrography when double-contrast examinations using 15 mL to 100 mL of air are performed.

  The following concentrations and volumes are recommended for normal adult knee, shoulder, and temporomandibular joints but should serve as guidelines since joints may require more or less contrast medium for optimal visualization.

  KNEE Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations. OMNIPAQUE 300 5 mL to 15 mL OMNIPAQUE 350 5 mL to 10 mL SHOULDER OMNIPAQUE 300 10 mL TEMPOROMANDIBULAR OMNIPAQUE 300 0.5 mL to 1.0 mL

  Passive or active manipulation is used to disperse the medium throughout the joint space.

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