SUPREFACT SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUSERELIN (BUSERELIN ACETATE)

Available from:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC code:

L02AE01

INN (International Name):

BUSERELIN

Dosage:

100MCG

Pharmaceutical form:

SOLUTION

Composition:

BUSERELIN (BUSERELIN ACETATE) 100MCG

Administration route:

NASAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0117891004; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-06-04

Summary of Product characteristics

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_Page 1 of 57_
PRODUCT MONOGRAPH
Pr
SUPREFACT
®
Buserelin Acetate
Injection 1 mg/mL
Nasal Solution 1 mg/mL
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Luteinizing Hormone-Releasing Hormone (LHRH) Analogue
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CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Distributed by
Xediton Pharmaceuticals Inc.
2000 Argentia Rd, Mississauga
Ontario L5N 1W1
Tel: 1-888-XEDITON
Date of Revision: June 2, 2020
Submission Control No.: 237854
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_Page 2 of 57_
TABLE OF CONTENTS
I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
10
DRUG INTERACTIONS
...................................................................................................
17
DOSAGE AND ADMINISTRATION
...............................................................................
18
OVERDOSAGE
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
...........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
24
PHARMACEUTICAL INFORMATION
...........................................................................
24
CLINICAL TRIALS
...........