TWYNSTA TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)

Διαθέσιμο από:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Φαρμακολογική κατηγορία (ATC):

C09DB04

INN (Διεθνής Όνομα):

TELMISARTAN AND AMLODIPINE

Δοσολογία:

40MG; 10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TELMISARTAN 40MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

14/28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0252947002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2011-08-03

Αρχείο Π.Χ.Π.

_ _
_Product Monograph _
_ _
_TWYNSTA (telmisartan/amlodipine) _
_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TWYNSTA
®
Telmisartan / Amlodipine (as Amlodipine Besylate) Tablets
Tablet, 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg, Oral
Angiotensin II AT1 Receptor Blocker / Calcium Channel Blocker
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
Date of Initial Authorization:
AUG 11, 2011
Date of Revision:
October 4, 2022
Submission Control Number: 264045
BICL CCDS# 0275-08
Twynsta
®
is a registered trademark used under license by Boehringer Ingelheim
(Canada) Ltd.
_ _
_Product Monograph _
_ _
_TWYNSTA (telmisartan/amlodipine) _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION
10/2022
7 WARNINGS AND PRECAUTIONS
10/2022
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
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......