PROCYSBI CAPSULE (DELAYED RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CYSTEAMINE (CYSTEAMINE BITARTRATE)

Beschikbaar vanaf:

HORIZON THERAPEUTICS IRELAND DAC

ATC-code:

A16AA04

INN (Algemene Internationale Benaming):

MERCAPTAMINE

Dosering:

75MG

farmaceutische vorm:

CAPSULE (DELAYED RELEASE)

Samenstelling:

CYSTEAMINE (CYSTEAMINE BITARTRATE) 75MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0159170003; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2017-06-13

Productkenmerken

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_PROCYSBI_
_®_
_ cysteamine delayed-release capsules _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROCYSBI
®
Cysteamine delayed-release capsules
25 mg and 75 mg cysteamine (as cysteamine bitartrate, also called
mercaptamine bitartrate)
ATC code: A16AA04
Amino Acids and Derivatives
Horizon Therapeutics Ireland DAC
Connaught House, 1
st
Floor
1 Burlington
Road
Dublin 4, D04 C5Y6
Ireland
Imported and distributed by:
Horizon Therapeutics Canada
9131 Keele St., Unit 4A
Vaughan, Ontario L4K 0G7
Canada
Date of Revision:
July 22, 2021
Submission
Control No: 240671
_ _
_PROCYSBI_
_®_
_ cysteamine delayed-release capsules _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................3
WARNINGS AND PRECAUTIONS
.............................................................................4
ADVERSE
REACTIONS..............................................................................................7
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
.........................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
18
STORAGE AND STABILITY
....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 22
PART II: SCIENTIFIC INFORMATION
...................................................................