Bracco Diagnostics Inc

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2.1  Recommended Dose

The recommended dose of Lumason after reconstitution is 2 mL administered as an intravenous bolus injection during echocardiography. During a single examination, a second injection of 2 mL may be administered to prolong contrast enhancement. Follow each Lumason injection with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection.

2.2  LumaSon Reconstitution

Lumason is supplied within a kit containing the following:

a clear glass vial labeled as Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, 25 mg lipid-type A /60.7 mg powder and headspace filled with sulfur hexafluoride, a prefilled syringe with 5 mL Sodium Chloride 0.9% Injection, USP, (Diluent), a Mini-Spike.

Reconstitution steps:

Prior to Lumason reconstitution, inspect the kit and its components for signs of damage. Do not use the kit if the protective caps on the vial and prefilled syringe are not intact or if the kit shows other signs of damage. Perform all Lumason reconstitution steps under aseptic conditions. The Lumason vial and the prefilled syringe do not contain a bacteriostatic preservative. Lumason is reconstituted by injecting the prefilled syringe contents (5 mL Sodium Chloride 0.9% Injection, USP) into the Lumason vial using the following illustrated steps.

1. Connect the plunger rod to the prefilled syringe barrel by screwing it clockwise into the syringe (see Figure 1).

2. Open the Mini-Spike blister and remove the syringe tip cap (see Figure 2).

3. Open the Mini-Spike green cap and connect the syringe to the Mini-Spike by screwing it in clockwise (see Figure 3).

4. Remove the flip cap plastic protective cap from the vial, remove the Mini-Spike spike protection and position the spike in the center of the rubber stopper of the vial. Press firmly inward until the spike is fully inserted in the stopper (see Figure 4).

5. Empty the content of the syringe into the vial by pushing on the plunger rod (see Figure 5).

6. Shake vigorously for 20 seconds, mixing all the contents in the vial (see Figure 6). A homogeneous white milky liquid indicates formation of sulfur hexafluoride lipid microspheres.

7. Invert the system and slowly withdraw 2 mL of suspension into the syringe (see Figure 7).

8. Unscrew the syringe from the Mini-Spike (see Figure 8). Immediately connect the syringe to the dose administration line (20 G) and administer as directed under Administration section below.

Administration:

Administer Lumason as an intravenous bolus injection. The milky white Lumason suspension should be used immediately after reconstitution. If the suspension is not used immediately after reconstitution, the microspheres should be resuspended by a few seconds of hand agitation before the suspension is withdrawn into the syringe. Reconstituted suspension within a vial may be used for up to 3 hours from the time of its reconstitution, after the microspheres have been resuspended by hand agitation prior to withdrawal of the suspension into the syringe. Maintain the vial containing the reconstituted suspension at room temperature. Lumason is for single use only. Unused portions of the reconstituted suspension must be discarded after one use in accordance with regulations dealing with the disposal of such materials. Syringe and other materials used should also be properly disposed of after single use.

2.3  Imaging Guidelines

After baseline non-contrast echocardiography is complete, the mechanical index for the ultrasound device should be adjusted to 0.8 or lower. Ultrasound imaging is then continued following Lumason injection.

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After preparation with oxidant-free sodium pertechnetate Tc 99m injection the suggested dose range of technetium Tc 99m medronate injection in the average patient (70 kg) is 370 to 740 megabecquerels (10 to 20 millicuries) given intravenously. Imaging post injection is optimal at 1 to 4 hours.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Shielding should be utilized when preparing the technetium Tc 99m medronate injection.

Radiation Dosimetry

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average patient (70 kg) from an intravenous injection of a maximum dose of 740 megabecquerels (20 millicuries) of technetium Tc 99m medronate are shown in Table 4.

TABLE 4 Absorbed Radiation Dose Organ mGy/740 MBq rads/20 mCi Total Body  1.3 0.13 Bone Total  7.0 0.70 Red Marrow  5.6 0.56 Kidneys  8.0 0.80 Liver  0.6 0.06 Bladder Wall 2-hr. void 26.0 2.60                   4.8-hr. void 62.0 6.20 Ovaries       2-hr. void  2.4 0.24                   4.8-hr. void  3.4 0.34 Testes         2-hr. void  1.6 0.16                   4.8-hr. void  2.2 0.22

Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MlRD Pamphlet No. 11, 1975

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Central Nervous System

ADULTS: The recommended dose of ProHance (Gadoteridol) Injection is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min). In patients with normal renal function suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans, a supplementary dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose.

CHILDREN (2-18 years): The recommended dose of ProHance is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min). The safety and efficacy of doses > 0.1 mmol/kg, and sequential and/or repeat procedures has not been studied.

Extracranial/Extraspinal Tissues

ADULTS: The recommended dose of ProHance is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min).

CHILDREN: Safety and efficacy for extracranial/extra-spinal tissues has not been established.Dose adjustments in renal and liver impairment have not been studied.

To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL normal saline flush. The imaging procedure should be completed within 1 hour of the first injection of ProHance (Gadoteridol) Injection.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.

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Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) is for intravenous use only.

Directions For Use

Preparation of the Patient: For best results, the usual preliminary measures for cholecystography are recommended, particularly in cholecystectomized patients, i.e., a low residue diet on the day before examination and administration of castor oil the night before or neostigmine at the time of examination to dispel excess intestinal gas. Cholecystography is preferably carried out in the morning with the patient fasting.

Dose: The usual adult dose is 20 mL. For infants and children, the suggested dose is 0.3 to 0.6 mL/kg of body weight; the dosage for infants and children should not exceed 20 mL.

Note: The dose should not be repeated for 24 hours.

Administration: After warming to body temperature, Cholografin Meglumine should be given by slow intravenous injection, following the usual precautions of intravenous administration. It is important that the preparation be injected slowly over a period of 10 minutes. Use of a narrow bore hypodermic needle will ensure a slow rate of injection. During the injection, the patient should be watched for untoward reactions such as a feeling of warmth, flushing and occasionally nausea. Nausea indicates that the injection rate is too rapid.

Radiography: A scout film should be exposed routinely before the intravenous injection is made.

Position of the Patient: With the patient prone and the right side elevated, radiographs are made in the posterior-anterior projection. Some radiologists prefer the supine position with the left side elevated. Serial 10-minute exposures should be started 10 minutes after the injection is made and continued until optimal visualization of the biliary ducts is obtained. Wet films should be examined immediately by the radiologist. In some cases a 15-degree rotation or the upright position may prove helpful. Depending on the situation revealed by the roentgenograms in which the duct is first seen, the position of the subject should be changed to displace the shadow of the common bile duct from that of the spine. Tomography is a useful technique for enhancing bile duct visualization after administration of the radiopaque medium.

Examination of the gallbladder should be started about two hours after administration. The standard positions in routine examination of the gallbladder should be used unless otherwise indicated. There is no need for the patient to remain quiet awaiting the time for the gallbladder film to be exposed. Moderate activity on the part of the patient will, in most cases, preclude “stratification” of the contrast agent in the gallbladder. If the contrast medium should stratify in the gallbladder, decubitus as well as upright films should be obtained. Additional exposures may be made after the ingestion of a fatty meal.

If visualization is not achieved after two and one-half hours, the patient should be returned for a 24-hour film, whenever possible. Occasionally, delayed opacification of the gallbladder will occur in 24 hours.

In infants and children, gallbladder visualization may be expected to occur 30 minutes to four hours after administration.

Note: In the presence of liver disease (BSP retention greater than 30 to 40 percent), the contrast medium is not excreted efficiently by the liver and visualization is usually not achieved. Visualization is rarely achieved in the presence of a serum bilirubin of 3.0 mg per 100 mL if the elevated bilirubin level is due to mechanical obstruction or hepatocellular damage. In the presence of severe liver damage, the contrast agent is excreted by the kidneys.

Interpretation: When intravenous cholecystography and cholangiography are used as an aid in the differential diagnosis of acute abdominal conditions, visualization of the gallbladder is considered strong evidence against a diagnosis of acute cholecystitis, while nonvisualization of the gallbladder two and one-half hours after administration with visualization of the bile ducts is considered strong evidence in favor of a diagnosis of acute cholecystitis (if the bile ducts are only faintly visualized, gallbladder films four hours after administration may occasionally show visualization of the gallbladder). When neither the bile ducts nor the gallbladder is visualized, the study provides no definitive information with regard to determining the presence or absence of acute cholecystitis.

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In adults a solution that is approximately isotonic (ISOVUE-M 200) is recommended for examination of the lumbar region. For movement of the contrast medium to distant target areas the more concentrated ISOVUE-M 300 preparation should be used to compensate for dilution of ISOVUE-M (lopamidol Injection) with cerebrospinal fluid.

The usual recommended adult dose range for iopamidol is 2000-3000 mg iodine. Iopamidol formulated to contain more than 300 mgl/mL should not be used intrathecally in adults. The minimum dose needed to perform a procedure should always be used.

In pediatric patients, a solution that is approximately isotonic (ISOVUE-M 200) is recommended for all intrathecal procedures. In children, loss of contrast due to mixing on movement of the medium is less apt to occur because of their shorter spinal cord.

The usual recommended pediatric dose range for iopamidol is 1400-2400 mg iodine. Iopamidol formulated to contain more than 200 mgl/mL should not be used intrathecally in children. The minimum dose needed to perform a procedure should always be used. See pediatric dosage table for recommended dosage.

Anesthesia is not necessary. However, young children may require general anesthesia for technical reasons. Premedication with sedatives or tranquillizers is usually not needed. In patients with a history of seizure activity who are not on anticonvulsant therapy, premedication with barbiturates or phenytoin should be considered.

Lumbar puncture is usually made between L3 and L4; if pathology is suspected at this level, the interspace immediately above or below may be selected. A lateral cervical puncture may also be used.

Rate of Injection: To avoid excessive mixing with cerebrospinal fluid and consequent loss of contrast as well as premature cephalad dispersion, injection must be made slowly over one to two minutes; the needle may then be removed.

An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible five to seven days is recommended.

As with all radiopaque contrast agents, only the lowest dose of ISOVUE-M necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE-M; the combination of dose and ISOVUE-M concentration to be used should be carefully individualized, and factors such as age, body size, anticipated pathology and 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. Following are the usual recommended pediatric and adult doses of ISOVUE-M.

The pediatric doses listed below, intended as a guideline, are based on age rather than weight because the brain and CSF capacity is independent of weight. Variations will depend on such factors as height, suspected pathology, the patient’s condition, technique used, etc. (e.g. CT or standard radiology or movement of the contrast media directed distal to the site of injection).

Pediatric Dosage Table ISOVUE-M 200 (200 mgl/mL) Procedure AgeYears UsualRecommendedDose (mL) Lumbar, thoracic myelogram 2-7 7-9   8-12 8-11   13-18 10-12 Adult Dosage Table   Concentrationof Solution(mgI/mL) UsualRecommendedDose(mL) Lumbar myelogram 200 10 to 15 Thoracic myelogram 200 10 to 15 Cervical myelogram 200 10 to 15    (via lumbar injection) 300 10 Cervical myelogram 200 10    (via lateral cervical injection)     Total columnar myelography 300 10 CT cisternography 200 4 to 6    (via lumbar injection)    

Following subarachnoid injection, conventional radiography will continue to provide good diagnostic contrast for at least 30 minutes. At about one hour, diagnostic degree of contrast will not usually be available. However, sufficient contrast for CT myelography will be available for several hours. CT myelography following conventional myelography should be deferred for at least four hours to reduce the degree of contrast.

Aspiration of iopamidol is unnecessary following intrathecal administration (see CLINICAL PHARMACOLOGY).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.

It is desirable that solutions of radiopaque diagnostic agents for intrathecal use be at body temperature when injected. 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.

Patients should be well hydrated prior to and following ISOVUE-M (Iopamidol Injection) administration.

Suggestions for Usual Patient Management

Preprocedure

See WARNINGS regarding discontinuation of neuroleptic agents. Maintain normal diet up to 2 hours before procedure. Ensure hydration-fluids up to time of procedure.

During Procedure

Use minimum dose and concentration required for satisfactory contrast. Inject slowly over 1 to 2 minutes to avoid excessive mixing. Abrupt or active patient movement causes excessive mixing with CSF. Instruct patient to remain passive. Move patient slowly and only as necessary. To maintain as a bolus, move medium to distal area very slowly under fluoroscopic control. In all positioning techniques keep the patient’s head elevated above highest level of spine. Do not lower head of table more than 15° during thoraco-cervical procedures. In patients with excessive lordosis, consider lateral position for injection and movement of the medium cephalad. Avoid intracranial entry of a bolus. Avoid early and high cephalad dispersion of the medium. At completion of direct cervical or lumbo-cervical procedures, raise head of table steeply (45°) for about 2 minutes to restore medium to lower levels.

Postprocedure

Raise head of stretcher to at least 30° before moving patient onto it. Movement onto stretcher, and off the stretcher to bed, should be done slowly with patient completely passive, maintaining head up position. Before moving patient onto bed, raise head of bed 30° to 45° and maintain the patient in this position under close observation for 12 to 24 hours. Advise patient to remain still in bed, in head up position for the first 24 hours. Obtain visitors cooperation in keeping the patient quiet and in head up position, especially in first few hours. Encourage oral fluids and diet as tolerated. Antinauseants of the phenothiazine class should not be administered to the treat postprocedural nausea or vomiting (see WARNINGS). Since persistent nausea and vomiting may result in dehydration, prompt consideration of volume replacement by intravenous fluids is recommended.

Drug Incompatibilities

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.

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General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.

It is desirable that solutions of radiopaque diagnostic agents for intravascular use be at body temperature when injected. Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Sterile techniques must be used with any intravascular injection, and with catheters and guidewires.

Patients should be well hydrated prior to and following ISOVUE (lopamidol Injection) administration.

As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and 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.

Cerebral Arteriography

ISOVUE-300 (lopamidol Injection, 300 mgl/mL) should be used. The usual individual injection by carotid puncture or transfemoral catheterization is 8 to 12 mL, with total multiple doses ranging to 90 mL.

Peripheral Arteriography

ISOVUE-300 usually provides adequate visualization. For injection into the femoral artery or subclavian artery, 5 to 40 mL may be used; for injection into the aorta for a distal runoff, 25 to 50 mL may be used. Doses up to a total of 250 mL of ISOVUE-300 have been administered during peripheral arteriography.

Peripheral Venography (Phlebography)

ISOVUE-200 (lopamidol Injection, 200 mgl/mL) should be used. The usual dose is 25 to 150 mL per lower extremity. The combined total dose for multiple injections has not exceeded 350 mL.

Selective Visceral Arteriography and Aortography

ISOVUE-370 (lopamidol Injection, 370 mgl/mL) should be used. Doses up to 50 mL may be required for injection into the larger vessels such as the aorta or celiac artery; doses up to 10 mL may be required for injection into the renal arteries. Often, lower doses will be sufficient. The combined total dose for multiple injections has not exceeded 225 mL.

Pediatric Angiocardiography

ISOVUE-370 should be used. Pediatric angiocardiography may be performed by injection into a large peripheral vein or by direct catheterization of the heart.

The usual dose range for single injections is provided in the following table:

Single Injection Usual Dose Range Age mL < 2 years 10-15 2-9 years 15-30 10-18 years 20-50

The usual recommended dose for cumulative injections is provided in the following table:

Cumulative Injection Usual Recommended Dose Age mL < 2 years 40 2-4 years 50 5-9 years 100 10-18 years 125

Coronary Arteriography and Ventriculography

ISOVUE-370 should be used. The usual dose for selective coronary artery injections is 2 to 10 mL. The usual dose for ventriculography, or for nonselective opacification of multiple coronary arteries following injection at the aortic root is 25 to 50 mL. The total dose for combined procedures has not exceeded 200 mL. EKG monitoring is essential.

Excretory Urography

ISOVUE-250 ISOVUE-300 or ISOVUE-370 may be used. The usual adult dose for ISOVUE-250 is 50 to 100 mL, for ISOVUE-300 is 50 mL and for ISOVUE-370 is 40 mL administered by rapid intravenous injection.

Pediatric Excretory Urography

ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children for excretory urography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and 1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.

Computed Tomography

ISOVUE-250 or ISOVUE-300 may be used.

CECT OF THE HEAD: The suggested dose for ISOVUE-250 is 130 to 240 mL and for ISOVUE-300 is 100 to 200 mL by intravenous administration. Imaging may be performed immediately after completion of administration.

CECT OF THE BODY: The usual adult dose range for ISOVUE-250 is 130 to 240 mL and for ISOVUE-300 is 100 to 200 mL administered by rapid intravenous infusion or bolus injection. Equivalent doses of ISOVUE-370 based on organically bound iodine content may also be used. The total dose for either CECT procedure should not exceed 60 grams of iodine.

Pediatric Computed Tomography

ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children for contrast enhanced computed tomography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and 1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.

Drug Incompatibilities

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.

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2.1  Dosing and Imaging Instructions

2.1.1 MRI of the CNS

The recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.

2.1.2 MRA of Renal and Aorto-ilio-femoral Vessels

For MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.

2.2  Dosing Table

TABLE 1: WEIGHT-BASED DOSING VOLUMES FOR: CNS IMAGING (ADULTS AND PEDIATRICS ≥2 YEARS OF AGE) AND MRA IMAGING (ADULTS ONLY)     Volume Kilograms (Kg) Pounds (lb) Milliliters (mL) 5 11 1.0 10 22 2.0 15 33 3.0 20 44 4.0 25 55 5.0 30 66 6.0 35 77 7.0 40 88 8.0 45 99 9.0 50 110 10.0 55 121 11.0 60 132 12.0 65 143 13.0 70 154 14.0 75 165 15.0 80 176 16.0 85 187 17.0 90 198 18.0 95 209 19.0 100 220 20.0 105 231 21.0 110 242 22.0 115 253 23.0 120 264 24.0 125 275 25.0 130 286 26.0 135 297 27.0 140 308 28.0 145 319 29.0 150 330 30.0

2.3  Administration

Inspect the MultiHance bottle visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.

Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.

2.4  Directions for Proper Use of MultiHance Multipack

The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty syringes.

MultiHance Multipack injection should be drawn into the syringe and administered using sterile technique. Unused portions of the drug must be discarded.

When MultiHance Multipack injection is to be injected using plastic disposable syringes, the agent should be drawn into the syringe and used immediately.

The transferring of MultiHance (gadobenate dimeglumine) injection from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique. The container closure may be penetrated only one time, utilizing a suitable transfer device. Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operation. Any unused MultiHance Multipack injection must be discarded 8 hours after initial puncture of the bulk package. Temperature of container after the closure has been entered should not exceed 25°C (77°F).

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2.1  Dosing and Imaging Instructions

2.1.1 MRI of the CNS

The recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.

2.1.2 MRA of Renal and Aorto-ilio-femoral Vessels

For MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.

2.2  Dosing Table

TABLE 1: WEIGHT-BASED DOSING VOLUMES FOR: CNS IMAGING (ADULTS AND PEDIATRICS ≥2 YEARS OF AGE) AND MRA IMAGING (ADULTS ONLY)     Volume Kilograms (Kg) Pounds (lb) Milliliters (mL) 5 11 1.0 10 22 2.0 15 33 3.0 20 44 4.0 25 55 5.0 30 66 6.0 35 77 7.0 40 88 8.0 45 99 9.0 50 110 10.0 55 121 11.0 60 132 12.0 65 143 13.0 70 154 14.0 75 165 15.0 80 176 16.0 85 187 17.0 90 198 18.0 95 209 19.0 100 220 20.0 105 231 21.0 110 242 22.0 115 253 23.0 120 264 24.0 125 275 25.0 130 286 26.0 135 297 27.0 140 308 28.0 145 319 29.0 150 330 30.0

2.3  Administration

Inspect the MultiHance vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.

Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.

MultiHance vials are intended for single use only. Administer immediately after opening and discard any unused product.

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2.1 Infusion System

Use CardioGen-82 only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection. Follow instructions in the Infusion System User’s Guide for the set up and intravenous infusion of rubidium Rb 82 chloride injection dose(s).

2.2 Rubidium Rb 82 Chloride Injection Dosage

The recommended adult single dose of rubidium Rb 82 chloride injection is 1480 MBq (40 mCi) with a range of 1110-2220 MBq (30-60 mCi).

Do not exceed a single dose of 2220 MBq (60 mCi). Use the lowest dose necessary to obtain adequate cardiac visualization consistent with the dosing goal of as low as reasonably achievable (ALARA). Individualize the dose by considering factors such as body size, and the imaging equipment and technique. Administer the single dose at 50 mL/minute through a catheter inserted into a large peripheral vein; do not to exceed a total infusion volume of 100 mL.

Administer two separate single doses to complete rest and stress myocardial perfusion imaging as follows:

Administer a single (“rest”) rubidium Rb-82 chloride dose; Start imaging 60-90 seconds after completion of the infusion of the rest dose and acquire images for 5 minutes; if a longer circulation time is anticipated (e.g., in a patient with severe left ventricular dysfunction), start imaging 120 seconds after the rest dose.

For stress imaging:

Begin the study 10 minutes after completion of the resting dose infusion, to allow for sufficient Rb-82 decay; Administer a pharmacologic stress agent in accordance with its prescribing information; After an interval of 3 minutes, infuse a single (“stress”) rubidium Rb-82 chloride dose; Start imaging 60-90 seconds after completion of the stress Rb-82 chloride dose infusion and acquire images for 5 minutes; if a longer circulation time is anticipated start imaging 120 sec after the stress dose.

2.3 Drug Handling

Limit the use of radiopharmaceuticals to physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Wear waterproof gloves and effective shielding when handling rubidium Rb-82 chloride injection and the infusion system. Observe aseptic techniques in all drug handling. Use only additive-free Sodium Chloride Injection USP to elute the generator. Visually inspect the drug for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer eluate from the generator if there is any evidence of foreign matter.

2.4 Directions for Eluting Rubidium Rb 82 Chloride Injection

Allow at least 10 minutes between elutions for regeneration of Rb-82. Elute with additive-free Sodium Chloride Injection USP only. Additives (particularly calcium ions, to which strontium ions are chemically analogous), may cause the release of substantial amounts of Sr-82 and/or Sr-85 into the eluate regardless of the age or prior use of the generator. Discard the first 50 mL eluate each day the generator is first eluted. Employ proper safety precautions since the eluate contains radioactivity. Maintain an on-going record of all eluate volumes (washing, testing, dosing volumes), including a summary of the cumulative volume of eluate from the generator.

2.5 Eluate Testing Protocol

Use additive-free sodium chloride injection USP for all elutions. Apply aseptic technique throughout.

Before administering rubidium Rb 82 chloride injection to the first patient each day, perform the following test:

Strontium Alert Limits and Mandatory Eluate Testing:

Use an ionization chamber-type dose calibrator for eluate testing. Daily, before administering rubidium Rb 82 chloride injection to any patient, perform an eluate testing to determine Rb-82, Sr-82, and Sr-85 levels Perform additional daily eluate tests after detecting any of the following Alert Limits: 14 L total elution volume has passed through the generator column, or Sr-82 level reaches 0.002 µCi per mCi Rb-82, or Sr-85 level reaches 0.02 µCi per mCi Rb-82.

Perform the additional daily eluate tests at time points determined by the day’s elution volume; tests are performed every 750 mL.

  For example, if an Alert Limit were reached and the clinical site eluted less than 750 mL from the generator during the day, then no additional eluate tests would have been performed that day. If the same clinical site the next day eluted 1,500 mL from the generator, then the site would have performed three tests that day: 1) the required daily test that precedes any patient dosing, 2) a test at the 750 mL elution point, and 3) a test at the 1,500 mL elution point. If a generator’s Alert Limit is reached, the clinical site performs the additional daily tests (at intervals of 750 mL) each subsequent day the generator is used. The additional tests are necessary to promptly detect excessive Sr-82 and/or Sr-85 in eluates.

Rubidium Eluate Level Testing:

Set a dose calibrator for Rb-82 as recommended by the manufacturer or use the Co-60 setting and divide the reading obtained by 0.548. Obtain the reading from the instrument in millicuries. Elute the generator with 50 mL of Sodium Chloride Injection USP and discard the eluate (first elution). Allow at least 10 minutes for the regeneration of Rb-82, then elute the generator with 50 mL of Sodium Chloride Injection USP at a rate of 50 mL/min and collect the eluate in a stoppered glass vial (plastic containers are not suitable). Note the exact time of end of elution (E.O.E.). Using the dose calibrator, determine the activity of Rb-82 and note the time of the reading. Correct the reading for decay to the E.O.E. using the appropriate decay factor for Rb-82 (see Table 1).Note: If the reading is taken 2 1/2 minutes after end of elution, multiply the dose calibrator reading by 4 to correct for decay.Strontium Eluate Level Testing: Using the sample obtained for the Rb-82 activity determination, allow the sample to stand for at least one hour to allow for the complete decay of Rb-82. Measure the activity of the sample in a dose calibrator at the setting recommended by the manufacturer for Rb-82 and/or Sr-82. As an alternative, use the Co-60 setting and the reading obtained divided by 0.548. Set the instrument to read in microcuries and record the reading in the display. Calculate the ratio (R) of Sr-85/Sr-82 on the day (post-calibration) of the measurement using the ratio of Sr-85/Sr-82 on the day of calibration provided on the generator label and the Sr-85/Sr-82 Ratio Factor from Table 2. Determine R using the following equation: R = [Sr-85] / [Sr-82] on calibration date X Ratio Factor on the day (post-calibration) of measurement Use a correction factor (F) of 0.478 to compensate for the contribution of Sr-85 to the reading. Calculate the amount of Sr-82 in the sample using the following equation:Sr-82 (μCi) = dose calibration reading (μCi) / [1 + (R) (F)]Example: dose calibrator reading (μCi) = 0.8; Sr85/Sr82 ratio (R) =1.48; correction factor (F) = 0.478.Sr-82 (μCi) = 0.8 / [1 + (1.48)(0.478)] = 0.47 Determine if Sr-82 in the eluate exceeds an Alert or Expiration Limit by dividing the μCi of Sr-82 by the mCi of Rb-82 at End of Elution (see below for further instructions based on the Sr-82 level) Example: 0.47 μCi of Sr-82; 50 mCi of Rb-82 E.O.E. 0.47 μCi Sr-82 / 50 mCi Rb-82 = 0.0094 μCi/mCi Rb-82 (is above Alert Limit of 0.002; additional daily eluate testing must be performed) Determine if Sr-85 in the eluate exceeds an Alert or Expiration Limit by multiplying the result obtained in step 10 by (R) as calculated in step 7 (above). Example: 0.0094 x 1.48 = 0.014 μCi Sr-85/mCi Rb-82 (test result is below Alert and Expiration Limits) *Elution time TABLE 1Physical Decay Chart: Rb-82 half-life 75 seconds Seconds FractionRemaining Seconds FractionRemaining 0* 1.000 165 0.218 15 0.871 180 0.190 30 0.758 195 0.165 45 0.660 210 0.144 60 0.574 225 0.125 75 0.500 240 0.109 90 0.435 255 0.095 105 0.379 270 0.083 120 0.330 285 0.072 135 0.287 300 0.063 150 0.250     *Day of calibration TABLE 2Sr-85/Sr-82 Ratio Chart (Sr-85 T ½ = 65 days, Sr-82 ½ = 25 days) Days Ratio Factor Days Ratio Factor Days Ratio Factor 0* 1.00 15 1.29 30 1.67 1 1.02 16 1.31 31 1.70 2 1.03 17 1.34 32 1.73 3 1.05 18 1.36 33 1.76 4 1.07 19 1.38 34 1.79 5 1.09 20 1.41 35 1.82 6 1.11 21 1.43 36 1.85 7 1.13 22 1.46 37 1.88 8 1.15 23 1.48 38 1.91 9 1.17 24 1.51 39 1.95 10 1.19 25 1.53 40 1.98 11 1.21 26 1.56 41 2.01 12 1.23 27 1.58 42 2.05 13 1.25 28 1.61     14 1.27 29 1.64    

2.6 CardioGen-82 Expiration

Stop use of the CardioGen-82 generator once any one of the following Expiration Limits is reached.

A total elution volume of 17 L has passed through the generator column, or 42 days post calibration date, or An eluate Sr-82 level of 0.01 μCi /mCi Rb-82, or An eluate Sr-85 level of 0.1 μCi /mCi Rb-82.

2.7 Radiation Dosimetry

The estimated absorbed radiation doses for Rb-82, Sr-82, and Sr-85 from an intravenous injection rubidium Rb- 82 chloride are shown in Table 3.

Table 3 Adult Absorbed Radiation Dose Coefficient   Organa,b Rb-82 (Average for Rest and Stress) mrem/mCi (µSv/3.7 MBq)c Sr-82 mrem/µCi (µSv/3.7kBq)c Sr-85 mrem/µCi (µSv/3.7kBq)c   Effective Dosee .74f4 23.4 4.03 aRb-82 doses are averages of rest and stress dosimetry data (see Senthamizhchelvan et al. 1,2). To calculate organ doses (mrem) from Rb-82, multiply the dose coefficient for each organ by the administered activity in mCi. bSr-82 and Sr-85 doses are calculated using software package DCAL and ICRP dose coefficients. To calculate organ doses (mrem) attributable to Sr-82, and Sr-85, multiply the dose coefficients by the calculated amounts of strontium in µCi.3 cTo convert to SI units, insert the dose coefficient into the formula in parentheses, e.g. for adrenals 7.56 mrem/mCi = 7.56 µSv/37 MBq = 2.04 x 10-13 Sv/Bq . dCalculated from ICRP 66eCalculated from ICRP 60fStress phase only   Adrenals 7.56 10.6 5.03   Bone – Osteogenic cells 1.86 --- ---   Bone Surface ---- 107 9.81   Brain 0.60 8.29 2.96   Breast 0.82 7.03 1.72   Gall Bladder Wall 3.17 8.47 2.82   Heart Wall 16.5 8.18 2.67   Kidneys 20.04 9.18 2.50   Liver 4.20 8.10 2.50   Lower Large Intestine Wall 2.84 51.8 5.14   Lungsd 10.7 8.25 2.84   Muscles 1.29 8.14 2.66   Ovaries 1.41 10.2 4.29   Pancreas 8.85 9.10 3.46   Red Marrow 1.19 91.0 9.84   Skin 1.14 7.03 1.75   Small Intestine 4.76 9.62 4.03   Spleen 6.61 8.10 2.54   Stomach 8.14 7.84 2.26   Testes 0.82 7.25 1.70   Thymus 1.49 7.84 2.33   Thyroid 6.11 8.07 2.57   Upper Large Intestine 5.94 23.7 3.62   Urinary Bladder Wall 1.61 21.9 2.90   Uterus 3.72 9.14 3.32   Total Body 1.77 Not Calculated Not Calculated

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General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.

It is desirable that solutions of radiopaque diagnostic agents for intravascular use be at body temperature when injected. Sterile techniques must be used with any intravascular injection.

The transferring of ISOVUE from the ISOVUE Imaging Bulk Package container should be performed utilizing aseptic technique. The Imaging Bulk Package closure may be penetrated only one time, with a suitable sterile component of the automated contrast injection system or contrast management system approved or cleared for use with this Imaging Bulk Package.

Patients should be well hydrated prior to and following ISOVUE (Iopamidol Injection) administration.

As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and 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.

Computed Tomography

CECT OF THE HEAD: The suggested dose for ISOVUE-300 is 100 to 200 mL by intravenous administration. Imaging may be performed immediately after completion of administration. CECT OF THE BODY: The usual adult dose range for ISOVUE-300 is 100 to 200 mL administered by rapid intravenous infusion or bolus injection.

Equivalent doses of ISOVUE-370 based on organically bound iodine content may also be used.

The total dose for either CECT procedure should not exceed 60 grams of iodine.

Pediatric Computed Tomography

The dosage recommended for use in children for contrast enhanced computed tomography is 1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.

Drug Incompatibilities

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.

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As a convenience to the physician, the following guidelines which have proven satisfactory are provided (seePRECAUTIONS, General). Patients should be counseled prior to radiographic examination (seePRECAUTIONS, Information for the Patient).

Preparation of the patient: Hysterosalpingography should be performed three to five days after the cessation of the patient’s menstrual period as a precautionary measure. An enema and vaginal douche one hour before the examination are helpful, but not essential. The patient should empty her bladder before the examination. Since the procedure is remarkably free of pain when Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is used, the use of a narcotic or anesthesia is unnecessary.

Dosage: 3 to 4 mL of Sinografin, administered in fractional doses of approximately 1 mL, are usually adequate to visualize the uterus; an additional 3 to 4 mL will demonstrate the tubes. Total doses varying from 1.5 to 10 mL have been employed with satisfactory results.

Administration: The patient is placed in the lithotomy position and the vulva is cleansed with a suitable antiseptic solution. A Graves-type vaginal speculum is introduced, the cervix is exposed, and the vaginal vault is sponged with antiseptic solution.

A tenaculum is placed on the cervical lip, usually the anterior lip. A sterile sound may be passed to determine the position of the uterus and the direction of the cervical canal, and, when necessary, the cervical canal may be dilated. (Sounding the uterine cavity and dilatation of the canal are not usually required when a flexible cannula tip is used.)

A sterile syringe containing the Sinografin is attached by Luer-Lok to a uterine cannula. The two-way cannula valve is opened and all air bubbles in the cannula and syringe are expressed. About 1.5 to 2 mL of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) are required to fill the cannula. (If preferred, a tubal insufflator under controlled pressure with a salpingogram attachment may be used instead of the syringe.)

The cannula tip is inserted into the cervical canal so that the adjustable rubber acorn obturator fits snugly at the external os. Careful placement of the cannula is important to avoid trauma and pain. Squeezing the trigger of the cannula to provide simultaneous traction on the tenaculum and forward pressure on the cannula should give a nonleaking cervical seal. Sinografin flows freely so that only gentle pressure on the plunger is necessary; however, the medium should be used as promptly as possible following withdrawal into the syringe. The syringe should be rinsed as soon after the procedure as possible to prevent freezing of the plunger.

The connection at the external os is checked for leakage. If the acorn obturator is inadequate, an inflatable balloon-obturator may be used to seal the cervical canal. When the equipment has been positioned satisfactorily, the tenaculum and cannula may be fixed in position until the procedure is terminated.

Radiography: A scout film may be made before the medium is administered. After the initial fractional injection, a film should be made using a Bucky diaphragm. After each successive injection of 1 mL, a film is taken, developed immediately, and inspected in the dark room before the next fractional dose of Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is given, until the procedure is completed. Further injection and subsequent films can be made as required using posterior-anterior or oblique angles.

Clinical experience indicates that tubal patency, if present, will be demonstrable at the time of the injection and delayed films have not been required.

General

Diatrizoate Meglumine and lodipamide Meglumine Injection should be inspected visually for particulate matter and discoloration prior to instillation whenever solution and container permit. The solution may vary in color from essentially colorless to pale yellow. Solutions which may have become substantially darker should not be used.

In the event that crystallization occurs, the solution may be clarified by placing the vial in hot water and shaking gently for several minutes or until the solution is clear. If cloudiness persists, the preparation should not be used. Allow the solution to cool to body temperature before administering.

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2.1 Dosing and Imaging Instructions

MRI of the CNSAdults:

Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min) A supplementary dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose in patients with normal renal function suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans Immediately after injection, inject at least a 5 mL normal saline flush to ensure complete administration of contrast medium Imaging procedure should be completed within 1 hour of the first injection of ProHance

Pediatric Use (2-17 years):

Recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min) Safety and efficacy of doses > 0.1 mmol/kg, and sequential and/or repeat procedures have not been studied Follow injection by at least a 5 mL normal saline flush

MRI of Extracranial/Extraspinal TissuesAdults:

Recommended dose 0.1 mmol/kg (0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (> 60 mL/min) To ensure complete injection of the contrast medium, the injection should be followed by at least a 5 mL normal saline flush

Pediatric Use: Safety and efficacy for extracranial/extraspinal tissues have not been established.

2.2 Administration

Visually inspect ProHance for particulate matter and discoloration prior to use Do not administer the solution if it is discolored or particulate matter is present Concurrent medications or parenteral nutrition should not be physically mixed with contrast agents and should not be administered in the same intravenous line because of the potential for chemical incompatibility

2.3 Directions for Proper Use of Pharmacy Bulk Package

NOT FOR DIRECT INFUSION The pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedures when transferring ProHance from the pharmacy bulk package to individual syringes:

Use of this product is restricted to a suitable work area, such as a laminar flow hood, utilizing aseptic technique Prior to entering the vial, remove the seal and cleanse the rubber closure with a suitable antiseptic agent The container closure may be penetrated only one time, utilizing a suitable transfer device or dispensing set that allows measured dispensing of the contents Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use Withdrawal of container contents should be accomplished without delay. A maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations Any unused contents must be discarded by 8 hours after initial puncture of the bulk package Once drawn into syringe, administer transferred agent promptly

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General

This medium is not to be used for the preparation of solutions for parenteral administration. Oral or rectal administration only. Discard any unused portion after procedure.

The routine preparatory measures employed for barium studies are also appropriate for this agent.

For pediatric and severely cachectic patients the maintenance of an intravenous fluid line may be advisable.

Radiographic Examination of Segments of the Gastrointestinal Tract

Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient. For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk, or mineral oil. When used in infants, the solution may be given in a nursing bottle. Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals.

For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) in 3 parts water is recommended.

For Enemas or Enterostomy Instillations: Gastrografin should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

Tomography (Body Imaging)

A usual adult dose is 240 mL of a dilute Gastrografin solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

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Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended.

Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows. Best results are obtained when the bladder is filled with the contrast agent. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below.

Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full.

Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered.

Dilution Table USE DILUTED SOLUTIONS IMMEDIATELY 100 mL Bottle   Sterile Water or Sterile Saline Added % Diatrizoate Meglumine w/v % Organically Bound Iodine w/v Total Volume 0 mL 30.0 14.1 100 mL 25 mL 24.0 11.3 125 mL 50 mL 20.0 9.4 150 mL 67 mL 18.0 8.5 167 mL 300 mL Bottle   Sterile Water or Sterile Saline Added   0 mL 30.0 14.1 300 mL 50 mL 25.7 12.1 350 mL

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Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended.

Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows. Best results are obtained when the bladder is filled with the contrast agent.

Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin Dilute using a suitable sterile administration set. Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full.

Radiography: The commonly employed radiographic techniques should be used. A scout film is recommended before the contrast agent is administered.