Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium chloride (NaCl)
Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O)
Water for injections

For adjuvants, see section 2.
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.
Cervarix should be administered as soon as possible after being removed from the refrigerator.

However, for the monodose containers, the stability has been demonstrated when stored outside the refrigerator for up to 3 days at temperatures between 8°C and 25°C or for up to 1 day at temperatures between 25°C and 37°C.
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.

6.5     Nature and contents of container
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles in pack sizes of 1 and 10.

0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.

Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling
A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe or the vial. This does not constitute a sign of deterioration.

The content of the syringe or the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
In the event of either being observed, discard the vaccine.

The vaccine should be well shaken before use.

Instructions for administration of the vaccine presented in pre-filled syringe 

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.


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



4. Administer the vaccine.

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