Vivitra

Vivitra Caution For Usage

trastuzumab

Manufacturer:

Zydus Cadila

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Caution For Usage
Reconstitution: Single-dose lyophilized product in vial: Each vial containing 150 mg of Vivitra Drug Product is reconstituted with 7.2 mL of Water for Injection to yield a solution at a concentration of 21 mg/mL.
Multi-dose lyophilized product in vial: Each vial containing 440 mg of Vivitra Drug Product is reconstituted with 20 mL of bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol as a preservative to yield a solution at a concentration of 21 mg/mL.
Special Instruction for Use, Handling and Disposal: Appropriate aseptic technique should be used.
The 440 mg vial of (Vivitra) is reconstituted with 20 mL Bacteriostatic Water for Injection, containing 1.1% benzyl alcohol, as supplied. This yields a solution for multiple use containing 21 mg/ml Trastuzumab. Use of other reconstitution solvents should be avoided.
The 150 mg vial of (Vivitra) is reconstituted with 7.2 mL of sterile water for injection.
Vivitra should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted Vivitra may result in problems with the amount of trastuzumab that can be withdrawn from the vial.
Instructions for Reconstitution-400 mg vial: 1. Using a sterile syringe, slowly inject 20 ml of Bacteriostatic Water for Injection into the Vivitra 440 mg vial containing the lyophilized trastuzumab, directing the stream into the lyophilized cake.
2. Swirl vial gently to aid reconstitution. DO NOT SHAKE.
Instructions for Reconstitution-150 mg vial: 1. Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection into the Vivitra 150 mg vial containing the lyophilized trastuzumab, directing the stream into the lyophilized cake.
2. Swirl vial gently to aid reconstitution. DO NOT SHAKE.
Slight foaming of the product upon reconstitution is not unusual. Allow the vial to stand undisturbed for approximately 5 minutes. The reconstituted Vivitra results in a colourless to pale yellow transparent solution and should be essentially free of visible particles.
Instruction for dilution: Determine the volume of the solution required: For loading dose (4 mg/kg body weight) or maintenance dose (2 mg/kg body weight): See Equation 1.

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For loading dose (8 mg/kg body weight) or a subsequent 3 weekly dose (6 mg/kg body weight): See Equation 2.

Click on icon to see table/diagram/image

The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 ml of 0.9% sodium chloride. Dextrose (5%) solution should not be used (see Incompatibilities as follows). The bag should be gently inverted to mix the solution in order to avoid foaming. Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. Once the infusion is prepared it should be administered immediately.
Special Precautions for Disposal: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via waste water and disposal through household waste should be avoided.
Incompatibilities: No incompatibilities between trastuzumab and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Dextrose (5%) solution should not be used since it causes aggregation of the protein.
Vivitra should not be mixed or diluted with other drugs.
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