Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1        List of excipients

Powder: Anhydrous lactose, mannitol, amino acids for injection, sorbitol.

Traces: Neomycin sulphate
Solvent: Water for injection

6.2        Incompatibilities


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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 expiry date refers to the last day of that month.

After reconstitution, it is recommended that the vaccine be injected as soon as possible.
However, it has been demonstrated that the reconstituted vaccine may be kept for up to 90 minutes at room temperature (25°C) and up to 8 hours in the refrigerator (2°C to 8°C). If not used within the recommended in- use storage timeframes and conditions, the reconstituted vaccine must be discarded.


6.4    Special precautions for storage
Store in a refrigerator (2°C to 8°C).
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 a single-dose glass vial (type I glass) with a stopper (bromobutyl rubber).
0.5 ml of solvent in a pre-filled syringe (type I glass) with plunger stopper (bromobutyl rubber) , with or without separate needles, or 0.5 ml of solvent in an ampoule (type I glass).

Pack sizes :1,10

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


Instructions for reconstitution of the vaccine with solvent presented in ampoules 
The solvent and 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 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.

The colour of the reconstituted vaccine may vary from clear peach to 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.

Instructions for reconstitution of the vaccine with solvent presented in a pre-filled syringe The solvent and 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 must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.

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To attach the needle to the syringe, carefully read the instructions given with pictures 1 and 2. However, the syringe provided with Varilrix 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                                           Picture
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 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.