Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation Drugs

• Trasylol
  

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  Trasylol

  

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  Trasylol® given prophylactically in both Regimen A and Regimen B (half Regimen A) to patients undergoing CABG surgery significantly reduced the donor blood transfusion requirement relative to placebo treatment. In low risk patients there is no difference in efficacy between regimen A and B. Therefore, the dosage used (A vs. B) is at the discretion of the practitioner.

  Trasylol® is supplied as a solution containing 10,000 KIU/mL, which is equal to 1.4 mg/mL. All intravenous doses of Trasylol® should be administered through a central line. DO NOT ADMINISTER ANY OTHER DRUG USING THE SAME LINE. Both regimens include a 1 mL initial (test) dose, a loading dose, a dose to be added while recirculating the priming fluid of the cardiopulmonary bypass circuit (“pump prime” dose), and a constant infusion dose. To avoid physical incompatibility of Trasylol® and heparin when adding to the pump prime solution, each agent must be added during recirculation of the pump prime to assure adequate dilution prior to admixture with the other component. Regimens A and B, both incorporating a 1 mL initial (test) dose, are described in the table below:

  INITIAL (TEST) DOSE LOADING DOSE “PUMP PRIME” DOSE CONSTANT INFUSION DOSE TRASYLOL® REGIMEN A 1 mL(1.4 mg, or 10,000 KIU) 200 mL (280 mg, or 2.0 million KIU) 200 mL 280 mg, or 2.0 million KIU) 50 mL/hr (70 mg/hr, or 500,000 KIU/hr) TRASYLOL® REGIMEN B 1 mL(1.4 mg, or 10,000 KIU) 100 mL (140 mg, or 1.0 million KIU) 100 mL (140 mg, or 1.0 million KIU) 25 mL/hr (35 mg/hr, or 250,000 KIU/hr)

  The 1 ml initial (test) dose should be administered intravenously at least 10 minutes before the loading dose. With the patient in a supine position, the loading dose is given slowly over 20-30 minutes, after induction of anesthesia but prior to sternotomy. In patients with known previous exposure to Trasylol®, the loading dose should be given just prior to cannulation. When the loading dose is complete, it is followed by the constant infusion dose, which is continued until surgery is complete and the patient leaves the operating room. The “pump prime” dose is added to the recirculating priming fluid of the cardiopulmonary bypass circuit, by replacement of an aliquot of the priming fluid, prior to the institution of cardiopulmonary bypass. Total doses of more than 7 million KIU have not been studied in controlled trials.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discard any unused portion.

  Renal and Hepatic Impairment:

  Trasylol® administration is associated with a risk for renal dysfunction (see WARNINGS: Renal Dysfunction). Changes in aprotinin pharmacokinetics with age or impaired renal function are not great enough to require any dose adjustment. Pharmacokinetic data from patients with pre-existing hepatic disease treated with Trasylol® are not available.

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• Viadur
  

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  Viadur

  

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  The recommended dose of Viadur® is one implant for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal therapy.

  Viadur® must be removed after 12 months of therapy. At the time an implant is removed, another implant may be inserted to continue therapy. (See INSERTION AND REMOVAL PROCEDURES.)

  Insertion and Removal Procedures

  Viadur® is supplied in a box containing one sterile Viadur® implant in a sealed vial, one Viadur® sterile implanter, one sealed container of lidocaine HCl USP 2%, 10 mL, and one sterile Viadur® Kit. The Viadur® Kit is designed to provide a sterile field and supplies to facilitate the insertion and/or subsequent removal of the implant.

  In addition to the Viadur® Kit, sterile gloves are required for the insertion procedure and subsequent removal of the implant.

  Insertion Procedure

  Under aseptic conditions, an implanter is used to place the implant under the skin.

  The implant is inserted using the procedure outlined below.

  Identifying the Insertion Site

  Have the patient lie on his back on the examination table, with his left arm (if the patient is left-handed, the right arm) flexed at the elbow and externally rotated so that his hand is out to his side.

  Using a pen and ruler, mark a site on the inner, upper arm approximately 8-10 cm above the elbow crease in the groove between the biceps and triceps muscles. Make sure that the site is unaffected by movement of the muscles.

  Preparing the Sterile Field

  To establish a sterile field, carefully open the sterile Viadur® Kit. The sterile kit contains:

  1 scalpel

  1 forceps

  1 syringe

  1 package povidone-iodine swabs

  1 package wound closure strips

  1-22 Ga x 1.5” needle

  1-25 Ga x 1.5” needle

  6 gauze sponges

  2 alcohol prep swabs

  1 package skin protectant

  1 bandage

  1 fenestrated drape

  1 marking pen

  1 ruler

  1 mosquito clamp

  The implant tray contains:

  1 sealed vial, which contains the Viadur® implant

  1 sterile implanter

  1 sealed container of lidocaine HCl USP 2%, 10 mL

  To open the vial, remove the metal band from the bottle and pull up the stopper. Carefully drop the implant from the bottle onto the sterile field. Then, carefully drop the implanter and the container of lidocaine onto the sterile field.

  Using sterile technique, remove the protective cap from the implant by pulling the cap straight off. DO NOT TWIST CAP OFF AS IT MAY UNSCREW THE DIFFUSION MODERATOR, CAUSE ITS REMOVAL, OR OTHERWISE DAMAGE THE IMPLANT. SHOULD DAMAGE OCCUR, DO NOT INSERT THE IMPLANT AS PRODUCT FUNCTION CAN BE IMPAIRED.

  Loading the Implanter

  The implanter is packaged in the correct configuration for implant loading and insertion. Make sure the cannula is fully extended as shown, and the actuator is in its most forward position. Using sterile forceps, slide the implant into the end of the cannula and push until it stops. When properly loaded, the implant should not protrude more than 1 mm past the bottom of the beveled edge.

  Inserting the Implant

  Using aseptic technique, cleanse the insertion site, then drape the patient's arm. After determining the absence of known allergies to the anesthetic agent, infiltrate the site with lidocaine. Advance the needle to infiltrate the intended 5 cm track for the implant insertion. Determine that anesthesia is adequate. Make an incision of approximately 5 mm with the scalpel, just through the dermis. Grasp the handle of the implanter and extend the index finger to rest on the back of the actuator as shown. Insert the cannula tip into the incision with the bevel up and advance it subcutaneously along the intended track. To ensure subcutaneous placement, the Viadur® implanter should visibly raise the skin at all times during insertion. The implanter should not enter muscle tissue, but be well within the subcutaneous space. Advance the implanter to the depth indicator on the cannula, which indicates the recommended insertion length. Holding the implanter handle in position, use the index finger to slide the actuator slowly back until it stops. (This retracts the actuator cannula into the handle, leaving the implant beneath the skin.). Do not pull back on the implanter handle while sliding the actuator back, as this may lead to incorrect positioning of the implant and subsequent extrusion. Withdraw the implanter from the incision. Release of the implant can be checked by palpation. It is important to keep the implanter steady and not to push the implant into the tissue. After placement, sterile gauze may be used to apply pressure briefly to the insertion site to ensure hemostasis. Cleanse the insertion area. Press the edges of the incision together, and tightly close the incision with one or two surgical closure strips. Cover with an adhesive bandage. Observe the patient for a few minutes for signs of bleeding from the incision before he is discharged. Instruct the patient to keep the area clean and dry for 24 hours, and to avoid heavy lifting and strenuous physical activity for 48 hours. The surgical closure strip can be removed as soon as the incision has healed, ie, normally in 3 days.

  Removal Procedure

  Viadur® must be removed following 12 months of therapy.

  The position of the patient and the sterile technique are the same as for insertion.

  To remove Viadur® use the Viadur® Kit or the following sterile items:

    1 scalpel   1 forceps   1 syringe   1 package povidone-iodine swabs   1 package wound closure strips   1-22 Ga x 1.5” needle   1-25 Ga x 1.5” needle   1 sealed container of lidocaine HCl USP 2%, 10 mL   6 gauze sponges   2 alcohol prep swabs   1 package skin protectant   1 bandage   1 fenestrated drape   1 marking pen   1 ruler   1 mosquito clamp

  Preparing the Site

  Inspect the site, palpating the location of the implant. Mark the position of the implant with marking pen. Cleanse with povidone-iodine swab. Drape the area with a fenestrated drape.

  Suggestion:

  If unable to locate by palpation, radiological imaging may be helpful.

  After determining the absence of known allergies to the anesthetic agent, apply a small amount of local anesthetic under the end of the implant nearest the original incision site. Then advance the needle to infiltrate the tissue along the track.

  Removing the Implant

  Determine that anesthesia is adequate. Apply pressure to one end of the implant to elevate the other end. Make an incision of approximately 5 mm at the elevated end of the implant. Do not make a large incision.

  Continue to apply pressure to the end of the implant to encourage expulsion. Push the implant gently towards the incision with the fingers. When the tip is visible or near the incision, grasp it with a clamp and remove.

  If necessary, cut through any fibrous encapsulation with the scalpel to free the implant. Properly dispose of removed implant immediately, before opening the vial containing the new implant.

  If inserting a new Viadur®, return to section describing INSERTION PROCEDURE.

  The new Viadur® implant may be placed through the same incision site. Alternatively, the contralateral arm may be used.

  Cleanse insertion site area. Apply pressure to each end of the incision to close the wound. Apply one or two surgical closure strips to close the wound tightly, and cover with an adhesive bandage. Observe the patient for a few minutes for signs of bleeding from the incision before he is discharged. Instruct the patient to keep the area clean and dry for 24 hours, and to avoid strenuous physical activity for 48 hours.

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