Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS


6.1       List of excipients
Powder:
Lactose
Sorbitol E420
L-Histidine hydrochloride
L-Alanine
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Calcium chloride
Magnesium sulphate
Solvent:
Sodium chloride
Water for injections

6.2       Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
6.3       Shelf life

The expiry date of the product is indicated on the packaging materials.
After reconstitution, the medicinal product must be used immediately.

6.4       Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial of powder and the syringe of solvent in the outer carton in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see Section 6.3.

6.5       Nature and contents of container

Powder in vial (type I glass), with a stopper (chlorbutyl) and a flip-off cap (chlorbutyl) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and an attached needle and needle- shield (polyisoprene) – pack size of 1, 10 or 20.


Powder in vial (type I glass), with a stopper (chlorbutyl) and a flip-off cap (chlorbutyl) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and a tip-cap (styrene - butadiene) – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
Powder in vial (type I glass), with a stopper (chlorbutyl) and a flip-off cap (chlorbutyl) + 0.5 mL of solvent in a pre-filled syringe (type I glass), with a plunger-stopper (halobutyl) and a tip cap (styrene - butadiene) with 1 or 2 separate needles attached in the blister – pack size of 1 or 10. The tip caps of the prefilled syringes contain a natural rubber latex derivative.
Not all pack sizes may be marketed.

6.6     Special precautions for disposal

For syringe without attached needle only: after removing the syringe tip cap, a needle should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90°).
The vaccine is reconstituted by adding the solvent provided in the pre-filled syringe to the vial of powder.
The vial is shaken and, after complete dissolution, the suspension obtained is withdrawn into the same syringe for injection.
Before administration, the reconstituted vaccine should be vigorously shaken.
Use immediately after reconstitution.
After reconstitution the suspension is beige to pink beige, more or less opalescent.
Contact with disinfectants is to be avoided since they may inactivate the virus.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.