DURATOCIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CARBETOCIN

Commercializzato da:

FERRING INC

Codice ATC:

H01BB03

INN (Nome Internazionale):

CARBETOCIN

Dosaggio:

100MCG

Forma farmaceutica:

SOLUTION

Composizione:

CARBETOCIN 100MCG

Via di somministrazione:

INTRAVENOUS

Confezione:

5X100MCG

Tipo di ricetta:

Prescription

Area terapeutica:

OXYTOCICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0132909001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2021-05-18

Scheda tecnica

DURATOCIN (carbetocin injection)
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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
........