PREVENAR 13 (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein) Pharmaceutical Particulars

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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 medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Prevenar 13 is stable at temperatures up to 25°C for four days. At the end of this period Prevenar 13 should be used or discarded. These data are intended to guide health care professionals in case of temporary temperature excursions.

6.5 Nature and contents of container

0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (latex-free chlorobutyl rubber) and protective-tip cap (latex-free isoprene bromobutyl rubber).

Pack sizes of 1, 10 and 50, with or without needle.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

During storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.

The vaccine should be shaken well to obtain a homogeneous white suspension prior to expelling air from the syringe, and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. Do not use if the content appears otherwise.

No special requirements for disposal.

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