CYSTADANE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BETAINE

Available from:

RECORDATI RARE DISEASES CANADA INC

ATC code:

A16AA06

INN (International Name):

BETAINE

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BETAINE 1G

Administration route:

ORAL

Units in package:

180G

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0134220001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-04-07

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
Cystadane
®
betaine anhydrous powder for oral solution
1 gram/1.7 cc scoop
Professed Standard
Anti-Homocysteine Agent
Recordati Rare Diseases Canada Inc.
3080 Yonge Street, Suite 6060
Toronto, ON
M4N 3N1
Distributed by:
Recordati Rare Diseases Canada Inc.
Oakville, ON
L6M 2W2
Date of Revision:
April 10, 2018
Submission Control No: 213241
_Cystadane_
_®_
_ Product Monograph _
_Page 2 of 19_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
........................................................