Pharmaceutical particulars : מידע רוקחי

6.        PHARMACEUTICAL PARTICULARS

6.1       List of excipients

Powder:
Lactose (anhydrous)
Amino acids (containing phenylalanine)
Sorbitol
Mannitol
Medium 199 (containing phenylalanine, para-aminobenzoic acid, sodium and potassium) 

Solvent:
Water for injections

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.
The vaccine should be injected promptly after reconstitution. If this is not possible, it must be stored at 2°C – 8°C and used within 8 hours of reconstitution.

6.4       Special precautions for storage

Store and transport refrigerated (2°C – 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, see section 6.3.
6.5       Nature and contents of container

Powder in vial (Type I glass) with rubber stopper in the following pack sizes: 10 or 100.

0.5 ml of solution in ampoule or pre-filled syringe (Type I glass) with a stopper with or without needles in the following pack sizes: 10 or 100.

Not all pack sizes may be marketed.

6.6       Special precautions for disposal and handling
The solvent and the reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to reconstitution or administration.
In the event of either being observed, do not use the solvent or the reconstituted vaccine.

Solvent in ampoule
The vaccine must be reconstituted by adding the entire contents of the supplied ampoule of solvent to the vial containing the powder.

The mixture should be well shaken until the powder is completely dissolved in the solvent.

Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.

Withdraw the entire contents of the vial.

A new needle should be used to administer the vaccine.

Solvent in pre-filled syringe
The vaccine must be reconstituted by adding the entire contents of the supplied pre- filled syringe of solvent to the vial containing the powder.
To attach the needle to the syringe, carefully read the instructions given with pictures 1 and 2. However, the syringe provided with PRIORIX might be slightly different (without screw thread) than the syringe illustrated.

In that case, the needle should be attached without screwing.

Always hold the syringe by the barrel , not by the syringe plunger or the Luer Lock Adaptor (LLA), and maintain the needle in the axis of the syringe (as illustrated in picture 2). Failure to do this may cause the LLA to become distorted and leak.

During assembly of the syringe, if the LLA comes off, a new vaccine dose (new syringe and vial) should be used.


1. Unscrew the syringe cap by twisting it anticlockwise (as illustrated in picture 1).
Whether the LLA is rotating or not, please follow the below steps:

2. Attach the needle to the syringe by gently connecting the needle hub into the LLA and rotate a quarter turn clockwise until you feel it lock ( as illustrated in picture 2).
3. Remove the needle protector, which may be stiff.

4. Add the solvent to the powder. The mixture should be well shaken until the powder is completely dissolved in the solvent.

Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.

5. Withdraw the entire contents of the vial .

6. A new needle should be used to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle by repeating step 2 above.



Contacts with disinfectants should be avoided (see section 4.4).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.