Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder:

Trometamol
Sucrose
Solvent:

Sodium chloride
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 product is indicated on the packaging materials.
After reconstitution:

After reconstitution, the vaccine should be used promptly. Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution. If not used within 8 hours, do not administer the vaccine.

6.4   Special precautions for storage

Store in a refrigerator (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 a vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a stopper (butyl rubber). Pack sizes of 1 and 10 with or without needles.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe 
Nimenrix must be reconstituted by adding the entire content of the pre-filled syringe of solvent to the vial containing the powder.
To attach the needle to the syringe, refer to the below picture. However, the syringe provided with Nimenrix might be slightly different (without screw thread) than the syringe described in the picture. In that case, the needle should be attached without screwing.

1.    Holding the syringe barrel in one hand
(avoid holding the syringe plunger),
unscrew the syringe cap by twisting it anticlockwise.

Syringe plunger
Syringe barrel

Syringe cap


2.    To attach the needle to the syringe,
twist the needle clockwise into the syringe until you feel it lock (See picture).

3.    Remove the needle protector, which on occasion can be a little stiff.

Needle protector



4.    Add the solvent to the powder. After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in the solvent.
The reconstituted vaccine is a clear colourless solution.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
After reconstitution, the vaccine should be used promptly.

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.