Country: Kanada
Tungumál: enska
Heimild: Health Canada
RABIES IMMUNOGLOBULIN (HUMAN)
SANOFI PASTEUR LIMITED
J06BB05
RABIES IMMUNOGLOBULIN
150UNIT
SOLUTION
RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT
INTRAMUSCULAR
2ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0110666002; AHFS:
CANCELLED POST MARKET
2022-03-31
SANOFI PASTEUR SECTION 1.3.1 194 – IMOGAM ® RABIES PASTEURIZED PRODUCT MONOGRAPH Product Monograph Template – Schedule D Page 1 of 21 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION IMOGAM ® RABIES PASTEURIZED RABIES IMMUNE GLOBULIN, PASTEURIZED (HUMAN) Solution for Injection (150 IU/mL) 2.0 mL vials and 10.0 mL vials Passive Immunizing Agent for the Prevention of Rabies ATC: Code J06BB05 Manufactured by: DATE OF REVISION: SANOFI PASTEUR SA November 2015 Lyon, France Distributed by: DATE OF APPROVAL: SANOFI PASTEUR LIMITED December 9, 2015 Toronto, Ontario, Canada SUBMISSION CONTROL NO: 177025 SANOFI PASTEUR SECTION 1.3.1 194 – IMOGAM ® RABIES PASTEURIZED PRODUCT MONOGRAPH Product Monograph Template – Schedule D Page 2 of 21 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................... 3 SUMMARY PRODUCT INFORMATION ...................................................................................... 3 DESCRIPTION ................................................................................................................................. 3 INDICATIONS AND CLINICAL USE ........................................................................................... 3 CONTRAINDICATIONS ................................................................................................................. 8 WARNINGS AND PRECAUTIONS ............................................................................................... 8 ADVERSE REACTIONS ................................................................................................................. 9 DRUG INTERACTIONS ................................................................................................................ 10 DOSAGE AND ADMINISTRATION............................................................................................ 10 OVERDOSAGE .............................................................................................................................. 12 Lestu allt skjalið