6 mg trastuzumab/kg body weight:
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 ml of 0.9 % sodium chloride solution. Do not use with glucose-containing solutions (see section 6.2). The bag should be gently inverted to mix the solution in order to avoid foaming. 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).
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Herceptin is for single-use only, as the product contains no preservatives. Any unused product or waste material should be disposed of in accordance with local requirements.
No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
7. MARKETING AUTHORISATION HOLDER
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/00/145/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28 August 2000
Date of latest renewal: 4 September 2010
10. DATE OF REVISION OF THE TEXT
23 June 2011
LEGAL STATUS
POM
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
|
