CERVIDIL INSERT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DINOPROSTONE

Available from:

FERRING INC

ATC code:

G02AD02

INN (International Name):

DINOPROSTONE

Dosage:

10MG

Pharmaceutical form:

INSERT

Composition:

DINOPROSTONE 10MG

Administration route:

VAGINAL

Units in package:

1

Prescription type:

Prescription

Therapeutic area:

OXYTOCICS

Product summary:

Active ingredient group (AIG) number: 0111999003; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-04-07

Summary of Product characteristics

CERV IDIL dinoprostone_ _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CERVIDIL®
Dinoprostone Vaginal Insert
Insert, 10 mg, For Vaginal Use
Prostaglandin
Ferring Inc.
200 Yorkland Blvd., Suite500
Toronto, Ontario
M2J 5C1
Date of Initial Authorization:
Apr 01, 1997
Date of Revision:
Aug 15, 2022
Submission Control Number: 263036
_ _
CERV IDIL dinoprostone_ _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
4 DOSAGE AND ADMINISTRATION
08/2022
7 WARNINGS AND PRECAUTIONS, General
08/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
.........................................................................................