Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of excipients
2-phenoxyethanol
Ethanol anhydrous
Formaldehyde
Medium 199 Hanks *
Water for injections
Polysorbate 80
Hydrochloric acid and sodium hydroxide for pH adjustment *Medium 199 Hanks (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components.

6.2.   Incompatibilities

In the absence of compatibility studies, the 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.
6.4.   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze. If frozen, the vaccine should be discarded.
Store in the original package in order to protect from light.

6.5.   Nature and contents of container
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger-stopper (bromochlorobutyl or chlorobutyl or bromobutyl) and attached needle and needle-shield.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger-stopper (bromochlorobutyl or chlorobutyl or bromobutyl), without needle.
Packs of 1, 5, 10 and 20 syringes.
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger-stopper (bromochlorobutyl or chlorobutyl or bromobutyl), with 1 or 2 separate needles (for each syringe).
Packs of 1 and 10 syringes.
Not all pack sizes and presentations may be marketed.

6.6.   Special precautions for disposal and other handling 
For needle free syringes, the needle should be pushed firmly on to the end of the pre-filled syringe and rotated through 90 degrees.
Shake before injection to obtain a homogeneous suspension. The vaccine should be visually inspected before administration for any foreign particulate matter.

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

7.     MANUFACTURER:

SANOFI PASTEUR France ,2
14 Espace Henry Vallée 69007 Lyon, France