DURATOCIN SOLUTION
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
28-04-2020
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Aktiv ingrediens:
CARBETOCIN
Tilgjengelig fra:
FERRING INC
ATC-kode:
H01BB03
INN (International Name):
CARBETOCIN
Dosering :
100MCG
Legemiddelform:
SOLUTION
Sammensetning:
CARBETOCIN 100MCG
Administreringsrute:
INTRAVENOUS
Enheter i pakken:
5X100MCG
Resept typen:
Prescription
Terapeutisk område:
OXYTOCICS
Produkt oppsummering:
Active ingredient group (AIG) number: 0132909001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2021-05-18
Preparatomtale
DURATOCIN (carbetocin injection)
Page 1 of 28
PRODUCT MONOGRAPH
Pr
DURATOCIN
®
(Carbetocin Injection)
1 mL ampoule – 100 mcg/mL Injection
For Intravenous Use Only
Uterotonic Agent
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, ON
M2J 5C1
Date of Revision:
April 28, 2020
Submission Control No: 236432
DURATOCIN (carbetocin injection)
Page 2 of 28
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................................................................................................16
TOXICOLOGY
........
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