Pharmaceutical particulars : מידע רוקחי

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

Vial
The expiry date of the product is indicated on the packaging materials.

Diluted solution

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 – 8°C. The diluted solution must not be frozen.

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 after dilution of the medicinal product, see section 6.3.

6.5    Nature and contents of container

Type I glass vial with an elastomeric stopper, aluminum seal and flip-off plastic cap.
One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.

Pack of 1 vial.


6.6   Special precautions for disposal and other handling

Vectibix is intended for single-use only. Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution should be colorless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. The final concentration should not exceed 10 mg/mL. Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2). The diluted solution should be mixed by gentle inversion, do not shake.

Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter.

No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.

Discard the vial and any liquid remaining in the vial after the single-use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MARKETING AUTHORIZATION HOLDER
Amgen Europe B.V.
Minervum 7061
NL-4817 ZK Breda
The Netherlands