Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Hib powder:
Lactose

DTPa-IPV suspension:
Sodium chloride
Medium 199 (as stabilizer containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances) Water for injections


For adjuvants, 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 vaccine is indicated on the label and packaging.


After reconstitution, the vaccine should be injected immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 8 hours at 2°C to 8°C (in a refrigerator).

6.4    Special precautions for storage

Store in a refrigerator (2°C to 8°C).
Do not freeze.

Store in the original package, in order to protect from light.

For storage conditions after reconstitution of the medicinal product, please section 6.3.
6.5    Nature and contents of container

Powder in a vial (type I glass) containing 1 dose with a stopper (butyl rubber) and 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.

The tip cap and rubber plunger stopper of the pre-filled syringe and the stopper of the vial are made with synthetic rubber.

Pack sizes of 1 and 10 doses, with or without needles.

6.6    Special precautions for disposal and other handling

Upon storage of the DTPa-IPV suspension, a white deposit and clear supernatant can be observed in the syringe. This is not a sign of deterioration.

The pre-filled syringe should be well shaken to obtain a homogeneous suspension. The DTPa-IPV suspension in the pre-filled syringe, the Hib powder in the vial and the reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either is observed, the vaccine should be discarded.

The vaccine is reconstituted by adding the entire contents of the pre-filled syringe of DTPa-IPV suspension to the vial containing the Hib powder. The mixture should then be injected immediately.
The full reconstitution instructions are:

1.   Shake the pre-filled syringe containing the DTPa-IPV suspension
2.   Attach a needle to the pre-filled syringe of DTPa-IPV and inject the contents of the syringe into the
Hib vial.
3. With the needle still inserted, shake the Hib vial vigorously and examine for complete dissolution.
4. Withdraw the entire mixture back into the syringe.
5. Replace the needle with an appropriate size needle for injection and administer the vaccine.
6. If the vaccine is not administered immediately, shake the solution vigorously again before injection.


Instructions for the pre-filled syringe



Luer Lock Adaptor   Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by twisting it anticlockwise.
Plunger
Barrel
Cap



To attach the needle, connect the hub to the Luer Lock
Needle hub            Adaptor and rotate a quarter turn clockwise until you feel it lock.
Reconstitute the vaccine as described above.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.



Disposal


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