LUTREPULSE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GONADORELIN ACETATE

Available from:

FERRING INC

ATC code:

H01CA01

INN (International Name):

GONADORELIN

Dosage:

3.2MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

GONADORELIN ACETATE 3.2MG

Administration route:

INTRAVENOUS

Units in package:

10ML VIAL

Prescription type:

Prescription

Therapeutic area:

GONADOTROPINS AND ANTIGONADOTROPINS

Product summary:

Active ingredient group (AIG) number: 0121867001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-08-27

Summary of Product characteristics

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PRODUCT MONOGRAPH
Pr
LUTREPULSE
®
Gonadorelin Acetate for Injection
3.2 mg/vial
(0.9% Sodium Chloride for Injection (USP) (diluent)
Subcutaneous (SC) Use Only
Ovulatory Agent
Ferring Inc.
200 Yorkland Blvd.
Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
May 17, 2016
Submission Control No: 187199
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_LUTREPULSE_
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_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
..........................................................................................................26
TOXICOLOGY
.....................................................................................