TWYNSTA TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TELMISARTAN; AMLODIPINE (AMLODIPINE BESYLATE)

Dostopno od:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Koda artikla:

C09DB04

INN (mednarodno ime):

TELMISARTAN AND AMLODIPINE

Odmerek:

40MG; 10MG

Farmacevtska oblika:

TABLET

Sestava:

TELMISARTAN 40MG; AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Pot uporabe:

ORAL

Enote v paketu:

14/28

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-08-03

Lastnosti izdelka

_ _
_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
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......