NIMENRIXâ¢ - GlaxoSmithKline

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Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ............................................ 3 SUMMARY PRODUCT INFORMATION ........................................................... 3 DESCRIPTION....................................................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................. 4 CONTRAINDICATIONS ...................................................................................... 4 WARNINGS AND PRECAUTIONS ..................................................................... 4 ADVERSE REACTIONS ....................................................................................... 6 DRUG INTERACTIONS ..................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................. 12 OVERDOSAGE ................................................................................................... 12 ACTION AND CLINICAL PHARMACOLOGY ............................................... 12 STORAGE AND STABILITY ............................................................................. 13 SPECIAL HANDLING INSTRUCTIONS .......................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 14 PART II: SCIENTIFIC INFORMATION .................................................................. 16 PHARMACEUTICAL INFORMATION ............................................................. 16 CLINICAL TRIALS ............................................................................................. 16 TOXICOLOGY .................................................................................................... 24 REFERENCES ..................................................................................................... 25 PART III: CONSUMER INFORMATION................................................................. 27 October 22, 2014 Page 2 of 29
NIMENRIX ® Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Intramuscular Injection Dosage Form / Strength Powder and diluent for solution for injection/ Neisseria meningitidis serogroup A polysaccharide 1 5 micrograms Neisseria meningitidis serogroup C polysaccharide 1 5 micrograms Neisseria meningitidis serogroup W-135 polysaccharide 1 5 micrograms Neisseria meningitidis serogroup Y polysaccharide 1 5 micrograms 1 conjugated to tetanus toxoid carrier protein 44 micrograms Clinically Relevant Nonmedicinal Ingredients Sucrose Trometamol Sodium chloride For a complete listing see Dosage Forms, Composition and Packaging section. DESCRIPTION NIMENRIX ® (meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) is a tetravalent meningococcal polysaccharide conjugated vaccine consisting of Neisseria meningitidis capsular polysaccharides A, C, W-135 and Y each coupled to tetanus toxoid as a carrier protein. The Neisseria meningitidis serogroups A and C polysaccharides are conjugated with an adipic dihydrazide (AH) spacer and indirectly conjugated to the tetanus toxoid whereas the W-135 and Y polysaccharides are conjugated directly to tetanus toxoid. The vaccine does not contain any preservatives or adjuvants. October 22, 2014 Page 3 of 29
Page 1: PRODUCT MONOGRAPH NIMENRIX ® Menin
Page 5 and 6: Febrile Illness As with other vacci
Page 7 and 8: Table 1 Study MenACWY-TT-039: Perce
Page 9 and 10: Adolescents aged 10-25 years In Stu
Page 11 and 12: Post-Market Adverse Drug Reactions
Page 13 and 14: when measured by assays using eithe
Page 15 and 16: Composition After reconstitution, 1
Page 17 and 18: Table 4 Study demographics and tria
Page 19 and 20: Table 6 Study MenACWY-TT-081: Perce
Page 21 and 22: The response to the four meningococ
Page 23 and 24: Table 9 Immune response (rSBA) 1 mo
Page 25 and 26: REFERENCES 1. Baxter, R., Baine, Y.
Page 27 and 28: IMPORTANT: PLEASE READ PART III: CO
Page 29: IMPORTANT: PLEASE READ MORE INFORMA

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