INTRON A LIQUID

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

INTERFERON ALFA-2B

Saadav alates:

MERCK CANADA INC

ATC kood:

L03AB05

INN (Rahvusvaheline Nimetus):

INTERFERON ALFA-2B

Annus:

50000000UNIT

Ravimvorm:

LIQUID

Koostis:

INTERFERON ALFA-2B 50000000UNIT

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

1.2ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

INTERFERONS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0118647007; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2018-12-14

Toote omadused

_INTRON A_
_®_
_ (interferon alfa-2b)_
_ _
_ _
_ _
_Page 1 of 46 _
PRODUCT MONOGRAPH
INTRON A
®
INTERFERON ALFA-2B
LYOPHILIZED POWDER WITH DILUENT:
10 million IU interferon alfa-2b/vial
18 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)
SOLUTION FOR INJECTION (ALBUMIN (HUMAN) FREE), MULTI-DOSE PEN:
18 million IU interferon alfa-2b/pen (15 million IU/mL)
30 million IU interferon alfa-2b/pen (25 million IU/mL)
60 million IU interferon alfa-2b/pen (50 million IU/mL)
BIOLOGICAL RESPONSE MODIFIER
Merck Canada Inc.
Date of Revision:
16750 route Transcanadienne
December 14, 2016
Kirkland, Quebec H9H 4M7
Submission Control No: 204348
Date of Approval:
April 25, 2017
_INTRON A_
_®_
_ (interferon alfa-2b)_
_ _
_ _
_ _
_Page 2 of 46 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
6
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...................................................................