Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1     List of excipients
2-Phenoxyethanol, ethanol, formaldehyde and Hanks Medium 199*, water for injections, polysorbate 80,
hydrochloric acid and sodium hydroxide for pH adjustment.
* Hanks 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components, including potassium.

6.2     Incompatibilities
In the absence of compatibility studies, this pharmaceutical product 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.
Keep in the original packaging, protected 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 (chlorobutyl or bromobutyl), with attached needle, without needle or with two separate needles. Box of 1, 10 or 20.
All pack sizes may not be marketed.

6.6     Special precautions for disposal and other handling
Shake before injection, until a homogenous suspension is obtained.
The vaccine must be visually inspected before administration to verify the absence of foreign particles.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. MANUFACTURER:

SANOFI PASTEUR
14 ESPACE HENRY VALLÉE
69007 LYON FRANCE