Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Suspension for injection:
-    Formaldehyde
-    Phenoxyethanol
-    Ethanol anhydrous
-    Medium 199 Hanks without phenol red [complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other substances (such as glucose)] -    Acetic acid glacial and/or sodium hydroxide for pH adjustment
-    Water for injections

Freeze-dried substance:
-     Trometamol
-     Sucrose
-     Concentrated hydrochloric acid for pH adjustment

For adsorbent: see section 2.
6.2   Incompatibilities

In the absence of compatibility studies, this medicinal 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.

The vaccine must be injected immediately after reconstitution.
6.4   Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze.
For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5   Nature and content of container
Freeze-dried substance:
Single dose vial (glass) with stopper (chlorobutyl elastomer) and detachable cap (aluminium/polypropylene).

Suspension for injection
Single dose prefilled syringe (glass) with plunger (bromobutyl or chlorobutyl), attached needle and needle shield (elastomer).

Single dose prefilled syringe (glass) with plunger (bromobutyl or chlorobutyl) and tip cap (elastomer), without needle.
Single dose prefilled syringe (glass) with plunger (bromobutyl or chlorobutyl) and tip cap (elastomer), with 1 separate needle (for each syringe).

Single dose prefilled syringe (glass) with plunger (bromobutyl or chlorobutyl) and tip cap (elastomer), with 2 separate needles (for each syringe).

Packs of 1 or 10 or 20.

Not all pack sizes and presentations may be marketed.
6.6   Special precautions for disposal and other handling

For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one quarter turn.

•  Shake the pre-filled syringe containing the suspension until the contents become homogeneous.
•  Inject this suspension into the vial with the powder
•  Gently shake the vial until complete dissolution of the powder, achieving a whitish-turbid appearance
• Withdraw immediately the reconstituted vaccine into the syringe
• Gently shake the loaded syringe and promptly deliver the injection.
• Should the reconstituted vaccine separate into a transparent phase and gel-like phase, then remix by shaking the syringe vigorously before administration.
The whitish cloudy aspect of the reconstituted vaccine is normal.

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