AURO-CYCLOBENZAPRINE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CYCLOBENZAPRINE HYDROCHLORIDE

Saadav alates:

AURO PHARMA INC

ATC kood:

M03BX08

INN (Rahvusvaheline Nimetus):

CYCLOBENZAPRINE

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

CYCLOBENZAPRINE HYDROCHLORIDE 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/500/1000

Retsepti tüüp:

Prescription

Terapeutiline ala:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0112363001; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2010-04-30

Toote omadused

AURO-CYCLOBENZAPRINE PRODUCT MONOGRAPH PAGE 1 OF 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CYCLOBENZAPRINE
cyclobenzaprine hydrochloride tablets
Tablets, 10 mg, Oral
USP
Skeletal Muscle Relaxant
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Initial Authorization:
July 28, 2017
Date of Revision:
March 17, 2023
Submission Control No: 268216
AURO-CYCLOBENZAPRINE PRODUCT MONOGRAPH PAGE 2 OF 22
RECENT MAJOR LABEL CHANGES
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................................................. 5
5 OVERDOSAGE
...................................................................................................................
5
6 DOSAGE FORMS, STRENGTHS, COMPOSI