TEVETEN PLUS TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

EPROSARTAN (EPROSARTAN MESYLATE); HYDROCHLOROTHIAZIDE

Διαθέσιμο από:

BGP PHARMA ULC

Φαρμακολογική κατηγορία (ATC):

C09DA02

INN (Διεθνής Όνομα):

EPROSARTAN AND DIURETICS

Δοσολογία:

600MG; 12.5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

EPROSARTAN (EPROSARTAN MESYLATE) 600MG; HYDROCHLOROTHIAZIDE 12.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

7/28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0250121001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2023-09-18

Αρχείο Π.Χ.Π.

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_TEVETEN_
_®_
_ PLUS, eprosartan mesylate / hydrochlorothiazide Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVETEN® PLUS
eprosartan mesylate / hydrochlorothiazide
Tablets, 600 mg eprosartan / 12.5 mg hydrochlorothiazide, Oral
Angiotensin II Receptor (AT1) Antagonist and Diuretic
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUN 08, 2004
Date of Revision:
SEP 26, 2022
Submission Control Number: 263867
_ _
_ _
_ _
_TEVETEN_
_®_
_ PLUS, eprosartan mesylate / hydrochlorothiazide Product Monograph _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2020
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
02/2021
7 WARNINGS AND PRECAUTIONS, Respiratory
09/2022
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
4.1
Dosing Considerations
............................