Transcription of PRODUCT MONOGRAPH - Pfizer Canada
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PRODUCT MONOGRAPH - Pfizer Canada
PRODUCT MONOGRAPH . Prevnar* 13. Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein). Suspension for Intramuscular Injection Active Immunizing Agent * Wyeth LLC Date of Initial Approval: December 21, 2009. Pfizer Canada ULC, Licensee 17,300 Trans- Canada Highway Kirkland, Quebec H9J 2M5. Control No. 219617 Date of Revision: August 8, 2019.. Pfizer Canada ULC 2019. Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine) PRODUCT MONOGRAPH Page 1 of 61. TABLE OF CONTENTS. PART I: HEALTH PROFESSIONAL SUMMARY PRODUCT INFORMATION ..3. INDICATIONS AND CLINICAL CONTRAINDICATIONS ..4. WARNINGS AND ADVERSE DRUG INTERACTIONS ..17. DOSAGE AND ADMINISTRATION ..18. OVERDOSAGE ..21. ACTION AND CLINICAL PHARMACOLOGY ..21. STORAGE AND SPECIAL HANDLING INSTRUCTIONS ..23. DOSAGE FORMS, COMPOSITION AND PACKAGING ..23. PART II: SCIENTIFIC INFORMATION ..24.
Prevnar® 13 (Pneumococcal 13-valent Conjugate Vaccine) Product Monograph Page 7of 61 3. Adults 18Years and Older Safety was assessed in 7 clinical studies including 91,593 adults ranging in ages from 18 to 101 years. Prevnar 13 was administered to 48,806 adults; 2,616 adults were aged 50-64 years and 45,291 adults were 65 years and older.
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