Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

1-dose and 2-dose containers
Sodium chloride
Water for injections

4-dose container
2-phenoxyethanol
Water for injections
Sodium chloride
For adsorbent, 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.

2-dose vial
After first opening of the 2-dose vial, immediate use is recommended. If not used immediately, the vaccine should be stored in a refrigerator (2 °C – 8 °C). If not used within 6 hours it should be discarded.

4-dose vial
After first opening of the 4-dose vial, the vaccine may be stored for a maximum of 28 days in a refrigerator (2 °C – 8 °C). If not used within 28 days it should be discarded.

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.
Multidose vial
For storage conditions after first opening of the medicinal product, see section 6.3.
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6.5    Nature and contents of container

Pre-filled syringe
0.5 ml of suspension in a pre-filled syringe (type I glass) for 1 dose with a plunger stopper (butyl rubber) with or without needles. Pack size of 1, 10 or 50.

Vial
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber). Pack size of 1, 10 or 100.

Multidose vial
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber). Pack size of 100.
2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (Chlorobutyl rubber). Pack size of
10 or 100.

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

Pre-filled syringe
A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe. This does not constitute a sign of deterioration.

The content of the pre-filled syringe 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 allowed to reach room temperature before use.

The vaccine should be well shaken before use.
Instructions for administration of the vaccine

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



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Vial
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial. This does not constitute a sign of deterioration.

The content of 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 allowed to reach room temperature before use.

The vaccine should be well shaken before use.
Multidose vial
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial. This does not constitute a sign of deterioration.

The content of 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 allowed to reach room temperature before use.

The vaccine should be well shaken before use.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.

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