PROPAFENONE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PROPAFENONE HYDROCHLORIDE

Διαθέσιμο από:

SANIS HEALTH INC

Φαρμακολογική κατηγορία (ATC):

C01BC03

INN (Διεθνής Όνομα):

PROPAFENONE

Δοσολογία:

150MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PROPAFENONE HYDROCHLORIDE 150MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CLASS IC ANTIARRYTHMICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0116258001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-02-08

Αρχείο Π.Χ.Π.

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_PROPAFENONE propafenone hydrochloride Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
PR
PROPAFENONE
Propafenone Hydrochloride Tablets
Film-coated tablets, 150 mg and 300 mg, Oral
Antiarrhythmic Agent
ATC-Code: C01BC03
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
April 18, 2017
Date of Revision:
June 08, 2022
Submission Control Number: 264304
_ _
_PROPAFENONE propafenone hydrochloride _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2022
7 WARNINGS AND PRECAUTIONS
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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