Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose ( ml) contains: Neisseria meningitidis group A polysaccharide1 5 micrograms Neisseria meningitidis group C polysaccharide1 5 micrograms Neisseria meningitidis group W-135 polysaccharide1 5 micrograms Neisseria meningitidis group Y polysaccharide1 5 micrograms 1conjugated to tetanus toxoid carrier protein 44 micrograms For the full list of excipients, see section 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder or cake is white.
A single dose administered at 6 months was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 4, and 6 months (see section 5.1). The clinical relevance of this observation is unknown. If …
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