DESMOPRESSIN SPRAY SPRAY, METERED DOSE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DESMOPRESSIN ACETATE

Available from:

AA PHARMA INC

ATC code:

H01BA02

INN (International Name):

DESMOPRESSIN

Dosage:

10MCG

Pharmaceutical form:

SPRAY, METERED DOSE

Composition:

DESMOPRESSIN ACETATE 10MCG

Administration route:

NASAL

Units in package:

2.5ML/5ML

Prescription type:

Prescription

Therapeutic area:

PITUITARY

Product summary:

Active ingredient group (AIG) number: 0112050001; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-07-18

Summary of Product characteristics

_DESM OPRESSIN SPRAY (desmopressin acetate) _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DESMOPRESSIN SPRAY
Desmopressin acetate
Nasal Spray Solution, 10 mcg/spray, Intranasal
USP
ATC code: H01BA02
Antidiuretic
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
AUG 18, 2000
Date of Revision:
MAR 29, 2022
Submission Control Number: 258711
_ _
_DESMOPRESSIN SPRAY (desmopressin acetate) _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
None
N/A
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
4.4
Administration.................................................................................