Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Succinic acid
Polysorbate 80
Water for injections

For adjuvant, see section 2.
6.2   Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials 
6.4   Special precautions for storage

Store in a refrigerator (2 °C to 8 °C). Pre-filled syringes should be stored in the refrigerator horizontally to minimise the resuspension time.

Do not freeze. Discard if the vaccine has been frozen.

From a microbiological point of view, once removed from the refrigerator, the vaccine should be used immediately.

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods
Prevenar 20 should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

6.5     Nature and contents of container

0.5 mL suspension for injection in pre-filled syringe (Type I glass) with a tip cap (synthetic isoprene/bromobutyl blend rubber) and a plunger stopper (chlorobutyl rubber).

Pack sizes of 1, 10 pre-filled syringes, with or without needle.

Not all pack sizes may be marketed.


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6.6   Special precautions for disposal and other handling

During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension. Pre-filled syringes should be stored horizontally to minimise the resuspension time.

Preparation for administration


Step 1. Vaccine resuspension
Hold the pre-filled syringe horizontally between the thumb and the forefinger and shake vigorously until the contents of the syringe are a homogeneous white suspension. Do not use the vaccine if it cannot be resuspended.



Step 2. Visual inspection
Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found. If the vaccine is not a homogenous white suspension, repeat steps 1 and 2.


Step 3. Remove syringe cap
Remove the syringe cap from the Luer lock adapter by slowly turning the cap counter clockwise while holding the
Luer lock adapter.

Note: Care should be taken to ensure that the extended plunger rod is not depressed while removing the syringe cap.
Step 4. Attach a sterile needle
Attach a needle appropriate for intramuscular administration to the pre-filled syringe by holding the Luer lock adapter and turning the needle clockwise.

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