Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Powder

Sucrose
Potassium dihydrogen phosphate
Solution

Sodium phosphate buffer
Sodium dihydrogen phosphate monohydrate
Disodium phosphate dihydrate
Sodium chloride
Water for injections

6.2    Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


Menveo_DR V4.0_notification_13.06.2019_clean                             Page 14 of 16 6.3    Shelf life

The expiry date of the vaccine is indicated on the labelling and packaging 
After reconstitution, the medicinal product should be used immediately. However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.

6.4    Special precautions for storage

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vials in the outer carton 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 a stopper ( butyl rubber with fluoropolymer coated surface) and solution in vial (type I glass) with a stopper (butyl rubber).

Pack size of one dose (2 vials) or five doses (10 vials).

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

Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).

The contents in the two different vials (MenA powder and MenCWY solution) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.

The components of the vaccine should be visually inspected before and after reconstitution.

Using a syringe and suitable needle (21G, 40 mm length or 21G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.

Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product. Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.

Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.

Prior to injection, change the needle for one suitable for the administration. Ensure that no air bubbles are present in the syringe before injecting the vaccine.

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