GENOTROPIN POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SOMATROPIN

Available from:

PFIZER CANADA ULC

ATC code:

H01AC01

INN (International Name):

SOMATROPIN

Dosage:

5MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

SOMATROPIN 5MG

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PITUITARY

Product summary:

Active ingredient group (AIG) number: 0131827001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-02-07

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
GENOTROPIN
®
GOQUICK
TM
SOMATROPIN [RDNA ORIGIN] FOR INJECTION
Lyophilized Powder for reconstitution
5 mg, 5.3 mg, 12 mg pre-filled pen, GoQuick
and
PR
GENOTROPIN
®
MINIQUICK
TM
SOMATROPIN [RDNA ORIGIN] FOR INJECTION
Lyophilized Powder for reconstitution
0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8
mg, and 2.0 mg prefilled
syringe, MiniQuick
Human Growth Hormone
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Approval:
January 19, 1998
Date of Revision:
June 22, 2020
Submission Control No: 229726
®Pfizer Health AB
Pfizer Canada ULC, Licensee
© Pfizer Canada Inc 2020
_ _
_GENOTROPIN* (SOMATROPIN FOR INJECTION) Product Monograph _
_Page 2 of 92_
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
.................................................................................................
14
DRUG INTERACTIONS
..................................................................................................
36
DOSAGE AND ADMINISTRATION
..............................................................................
37
OVERDOSAGE
................................................................................................................
39
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 39
STORAGE AND
STABILITY............................