What Herceptin contains
- The active substance is trastuzumab. Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 ml of water for injection. The resulting solution contains approximately 21 mg/ml trastuzumab.
- The other ingredient(s) are L-histidine hydrochloride, L-histidine, ?,?-trehalose dihydrate, polysorbate 20.
What Herceptin looks like and contents of the pack
Herceptin is a powder for concentrate for solution for infusion, that is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab. The powder is a white to pale yellow pellet. Each carton contains 1 vial of powder..
Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Welwyn Garden City
Roche Pharma AG
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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This leaflet was last approved in
The following information is intended for medical or healthcare professionals only
Always keep this medicine in the closed original pack at a temperature of 2ºC ? 8 ºC in a refrigerator. A vial of Herceptin reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC ? 8 ºC after reconstitution and must not be frozen.
Appropriate aseptic technique should be used. Each vial of Herceptin is reconstituted with 7.2 ml of water for injections (not supplied). Use of other reconstitution solvents should be avoided. This yields a 7.4 ml solution for single-dose use, containing approximately 21 mg/ml trastuzumab. A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Herceptin should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial.
Instructions for Reconstitution:
1) Using a sterile syringe, slowly inject 7.2 ml of water for injections in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised 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 Herceptin results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Determine the volume of the solution required:
- based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Volume (ml) = Body weight(kg) xdose(4mg/kg for loading or2mg/kg for maintenance)21 (mg/ml, concentration of reconstituted solution)
- based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Volume (ml) = Body weight(kg) xdose(8mg/kg for loading or 6 mg/kg for maintenance)21 (mg/ml, concentration of reconstituted solution)
The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 ml of 0.9 % sodium chloride solution. Do not use with glucose-containing solutions. The bag should be gently inverted to mix the solution in order to avoid foaming. Parenteral solutions should be inspected visually for particulates and discoloration prior to administration. Once the infusion is prepared it should be administered immediately. If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).