Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1.    List of excipients
Powder*:
Maltose.
20% human albumin solution.
Basal Medium Eagle: mixture of mineral salts (including potassium), vitamins, dextrose and amino acids (including L- phenylalanine).
Hydrochloric acid and sodium hydroxide for pH adjustment.
Water for injections.
* Composition of the powder before the freeze-drying step.
Solvent:
Sodium chloride.
Water for injections.

6.2.    Incompatibilities
Rabies immunoglobulins or any other product and the rabies vaccine should never be combined in the same syringe or administered at the same site.

6.3.    Shelf life
The expiry date of the product is indicated on the packaging materials.
After first opening / reconstitution, the product must be used immediately.

6.4.    Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original 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 a vial (Type I glass) fitted with a stopper (chlorobutyl) and a cap + 0.5 mL of solvent in a pre-filled syringe (Type I glass) fitted with a plunger-stopper with attached needle and needle cap. Box of 1 or 10.


6.6.    Special precautions for disposal and other handling
Handling instructions:
• Remove the cap of the vial of lyophilised powder.
• Screw the plunger rod onto the syringe, if supplied separately.
• Inject the solvent into the vial of lyophilised powder.
• Gently stir the vial until a homogeneous suspension of powder is obtained.
• The reconstituted vaccine is a clear, homogeneous, particle-free liquid.
• Remove and discard the syringe used for reconstitution of the vaccine.
• Use a new syringe with a new needle to withdraw the reconstituted vaccine.
• Replace the needle used to withdraw the vaccine with a new needle for intramuscular injection.
• The length of the needle used to administer the vaccine must be adapted to the patient.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.