Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

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

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/vaccine is indicated on packaging materials.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C – 8°C). If it is not used within 24 hours, it should be discarded..

6.4    Special precautions for storage

Store and transport refrigerated (2°C – 8°C).
Do not freeze.

Store in the original packaging 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) with a stopper (butyl rubber).
0.5 ml of solvent in an ampoule (type I glass).
Pack sizes of 1, 10, 20 or 50.

Powder in a vial (type I glass) with a stopper (butyl rubber).
0.5 ml of solvent in a pre-filled syringe (type I glass) with plunger stopper (butyl rubber) with or without separate needles in the following pack sizes:1, 10, 20 or 50.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, the vaccine should be discarded.

Solvent in ampoule:

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance before administration. In the event of either being observed, do not administer the vaccine.

The vaccine is 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.


The colour of the reconstituted vaccine may vary from clear peach to fuchsia pink due to minor variations of its pH. This is normal and does not impair the performance of the vaccine. In the event of other variation being observed, do not administer the vaccine.


Withdraw the entire contents of the vial.
A new needle should be used to administer the vaccine.


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

Solvent in a pre-filled syringe:

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance before administration. In the event of either being observed, do not administer the vaccine.

The vaccine is reconstituted by adding the entire contents of the 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-Tetra might be slightly different (without screw thread) than the syringe illustrated.
In that case, the needle should be attached without screwing.

Needle hub
Needle
Needle protector



Luer Lock Adaptor

Syringe

Syringe plunger
Syringe barrel
Syringe cap

Picture 1                                          Picture 2

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.
The colour of the reconstituted vaccine may vary from clear peach to fuchsia pink due to minor variations of its pH. This is normal and does not impair the performance of the vaccine. In the event of other variation being observed, do not administer the vaccine.

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.

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