DURATOCIN Solution for injection Ref.[27961] Active ingredients: Carbetocin

Source: Health Products and Food Branch (CA)  Revision Year: 2018 

Product name

DURATOCIN (Carbetocin Injection).

1mL vial – 100 mcg/mL Injection.

Summary product information

Route of AdministrationDosage Form/StrengthClinically Relevant Nonmedicinal Ingredients
Intravenous100 mcg/mL solutionL-methionine, mannitol, sodium hydroxide, succinic acid, water for injection

Dosage forms, composition and packaging

DURATOCIN (carbetocin injection) is available in 1 mL vials as a sterile solution. Each vial contains 100 mcg carbetocin. Boxes contain 5 vials each.

Each vial contains 100 mcg (0.1 mg) of carbetocin, 1 mg L-methionine, 1.19 mg succinic acid 47 mg mannitol, sodium hydroxide for pH adjustment and water for injections q.s to 1 mL. Vials are colourless glass vial with bromobutyl rubber stoppers and aluminium crimp cap.

Marketing Informations Authorization Dates
Authorization holder:

Ferring Inc., 200 Yorkland Boulevard, Suite 500, North York, ON, M2J 5C1

Submission control number:

207085

Date of revision:

February 28, 2018

Drugs

Drug Countries
DURATOCIN Canada, Ecuador, Hong Kong, New Zealand, Singapore

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