NEISVAC (meningococcal group C polysaccharide conjugate vaccine adsorbed) Pharmaceutical Particulars

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6.1 List of excipients

Sodium chloride

Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

42 months

6.4 Special precautions for storage

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

Keep the syringe in the outer carton in order to protect from light.

Within the indicated shelf life of 42 months the product may be stored at room temperature (up to +25°C) for a maximum single period of 9 months. During this period, the product may be returned to the refrigerator at 2-8°C. If stored at room temperature (up to +25°C) the starting date and the revised 9 months expiry date should be stated on the product package. The revised expiry date for storage at room temperature must not exceed the expiry date set in accordance with the total shelf life of 42 months.

6.5 Nature and contents of container

NeisVac-C is presented as a 0.5 ml suspension in pre-filled syringe (type I glass) with a cap (bromobutyl rubber) and a plunger stopper (bromobutyl rubber) in packs of 1 or 10 or 20.

Each pre-filled syringe is packed in a blister. The opening in the blister seal is intended and allows for the equilibration of moisture during the recommended warm-up prior to the administration of the vaccine. Open the blister by removing the lid to take out the syringe. Do not press the syringe through the blister.

The pack of 1 may include up to two needles of different sizes. All needles are sterile and for single use only.

The primary packaging is latex-free.

Not all pack sizes may be marketed.

6.6 Instructions for use, handling, and disposal

Upon storage, a white deposit and clear supernatant can be observed. The vaccine should be well shaken in order to obtain a homogeneous suspension and inspected for foreign particulate matter and discoloration prior to administration. Do not administer if particulate matter or discoloration is found and contact Pfizer Customer Service.

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

It is recommended to use the smaller one (0.50 x 16 mm) of the needles that may be included in the single packs for injection in children and the larger needle (0.60 x 25 mm) for vaccination in adults.