ontrol male monkeys. Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which occurred at all doses eva luated.
No pre- and post-natal development animal studies have been conducted with panitumumab. All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Sodium acetate trihydrate
Acetic acid, glacial (for pH-adjustment)
Water for injections.
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
3 years.
Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C to 8°C. Do not freeze diluted solution.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
6.5 Nature and contents of container
Single-use vial (type I glass) with an elastomeric stopper, aluminium seal and flip-off plastic cap.
One vial contains: 100 mg of panitumumab in 5 ml, 200 mg panitumumab in 10 ml, or 400 mg panitumumab in 20 ml of concentrate for solution for infusion.
Pack of 1 vial containing 5 ml.
Pack of 1 vial containing 10 ml.
Pack of 1 vial containing 20 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Vectibix should be diluted in 0.9% sodium chloride injection by healthcare professional using aseptic technique. Do not shake or vigorously agitate the vial. Do not administer Vectibix if discolouration is observed. Withdraw the necessary amount of Vectibix for a dose of 6 mg/kg. Dilute in a total volume of 100 ml. The final concentration should not exceed 10 mg/ml. Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection (see section 4.2). The diluted solution should be mixed by gentle inversion, do not shake.
No incompatibilities have been observed between Vectibix and 0.9% sodium chloride injection in polyvinyl chloride bags or polyolefin bags.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/07/423/001
EU/1/07/423/002
EU/1/07/423/003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3 December 2007
Date of last renewal: 17 March 2011
10. DATE OF REVISION OF THE TEXT
10 November 2011
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
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