TWYNSTA TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)

Tilgængelig fra:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kode:

C09DB04

INN (International Name):

TELMISARTAN AND AMLODIPINE

Dosering:

80MG; 10MG

Lægemiddelform:

TABLET

Sammensætning:

TELMISARTAN 80MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

14/28

Recept type:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0252947004; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2011-08-03

Produktets egenskaber

_ _
_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
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......