SUPREFACT SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BUSERELIN (BUSERELIN ACETATE)

Saatavilla:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC-koodi:

L02AE01

INN (Kansainvälinen yleisnimi):

BUSERELIN

Annos:

1MG

Lääkemuoto:

SOLUTION

Koostumus:

BUSERELIN (BUSERELIN ACETATE) 1MG

Antoreitti:

SUBCUTANEOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0117891001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-06-04

Valmisteyhteenveto

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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
_ _
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
...........