MYLAN-LOSARTAN HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Dostępny od:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C09DA01

INN (International Nazwa):

LOSARTAN AND DIURETICS

Dawkowanie:

100MG; 12.5MG

Forma farmaceutyczna:

TABLET

Skład:

LOSARTAN POTASSIUM 100MG; HYDROCHLOROTHIAZIDE 12.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0233168003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2018-05-10

Charakterystyka produktu

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MYLAN-LOSARTAN HCTZ
Page 1 of 42
PRODUCT MONOGRAPH
Pr
MYLAN-LOSARTAN HCTZ
losartan potassium and hydrochlorothiazide tablets
50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg
Manufacturer’s standard
Angiotensin II Receptor Antagonist and Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
August 09, 2013
SUBMISSION CONTROL NUMBER: 166901
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MYLAN-LOSARTAN HCTZ
Page 2 of 42
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
4
ADVERSE REACTIONS
.............................................................................................
8
DRUG INTERACTIONS
...........................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................
16
OVERDOSAGE
..........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................... 18
STORAGE AND STABILITY
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................. 23
PHARMACEUTICAL INFORMATION
................................................................. 2