INTRON A SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INTERFERON ALFA-2B

Available from:

MERCK CANADA INC

ATC code:

L03AB05

INN (International Name):

INTERFERON ALFA-2B

Dosage:

10000000UNIT

Pharmaceutical form:

SOLUTION

Composition:

INTERFERON ALFA-2B 10000000UNIT

Administration route:

INTRAMUSCULAR

Units in package:

0.5ML/1ML/2.5ML

Prescription type:

Prescription

Therapeutic area:

INTERFERONS

Product summary:

Active ingredient group (AIG) number: 0118647003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-04-12

Summary of Product characteristics

_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
........