PUREGON SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FOLLITROPIN BETA

Available from:

MERCK CANADA INC

ATC code:

G03GA06

INN (International Name):

FOLLITROPIN BETA

Dosage:

100UNIT

Pharmaceutical form:

SOLUTION

Composition:

FOLLITROPIN BETA 100UNIT

Administration route:

INTRAMUSCULAR

Units in package:

1X0.5 ML/5X0.5ML/10X0.5ML

Prescription type:

Prescription

Therapeutic area:

GONADOTROPINS AND ANTIGONADOTROPINS

Product summary:

Active ingredient group (AIG) number: 0141201003; AHFS:

Authorization status:

MARKETED

Authorization date:

2010-04-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PUREGON
®
(follitropin beta)
Solution for injection in cartridges (recFSH)
300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL solution for
injection
Solution for injection in vials (recFSH)
100 IU/0.5 mL solution for injection
House Standard
Human Gonadotropin
MERCK CANADA INC.
Date of Initial Approval
16750 route Transcanadienne
September 2, 2011
Kirkland QC Canada H9H 4M7
http://www.merck.ca
Date of Revision:
SUBMISSION CONTROL NO: 237449
_PUREGON_

_ (follitropin beta)_
Page 2 of 36
TABLE OF CONTENTS
: Tools - Reference - Table of Contents - Generate]
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........