Country: Canada
Language: English
Source: Health Canada
INTERFERON ALFA-2B
MERCK CANADA INC
L03AB05
INTERFERON ALFA-2B
6000000UNIT
SOLUTION
INTERFERON ALFA-2B 6000000UNIT
INTRAMUSCULAR
0.5ML/3ML
Prescription
INTERFERONS
Active ingredient group (AIG) number: 0118647004; AHFS:
CANCELLED POST MARKET
2021-08-31
_INTRON A_ _®_ _ (interferon alfa-2b)_ _ _ _ _ _ _ _Page 1 of 41 _ PRODUCT MONOGRAPH INTRON A ® INTERFERON ALFA-2B LYOPHILIZED POWDER WITH DILUENT: 10 million IU interferon alfa-2b/vial READY-TO-USE SOLUTION (ALBUMIN (HUMAN) FREE): 10 million IU interferon alfa-2b/vial (10 million IU/mL) 18 million IU interferon alfa-2b/vial (6 million IU/mL) 25 million IU interferon alfa-2b/vial (10 million IU/mL) BIOLOGICAL RESPONSE MODIFIER Merck Canada Inc. Date of Revision: 16750 route Transcanadienne July 5, 2019 Kirkland, Quebec H9H 4M7 Submission Control No: 227164 _INTRON A_ _®_ _ (interferon alfa-2b)_ _ _ _ _ _ _ _Page 2 of 41 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 5 WARNINGS AND PRECAUTIONS ................................................................................. 6 ADVERSE REACTIONS ................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 16 DOSAGE AND ADMINISTRATION ............................................................................. 17 OVERDOSAGE ............................................................................................................... 24 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 25 STORAGE AND STABILITY ......................................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ........ Read the complete document