MYLAN-LOSARTAN HCTZ TABLET
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
10-09-2013
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Ingredient activ:
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Disponibil de la:
MYLAN PHARMACEUTICALS ULC
Codul ATC:
C09DA01
INN (nume internaţional):
LOSARTAN AND DIURETICS
Dozare:
100MG; 12.5MG
Forma farmaceutică:
TABLET
Compoziție:
LOSARTAN POTASSIUM 100MG; HYDROCHLOROTHIAZIDE 12.5MG
Calea de administrare:
ORAL
Unități în pachet:
30/100
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Rezumat produs:
Active ingredient group (AIG) number: 0233168003; AHFS:
Statutul autorizaţiei:
CANCELLED POST MARKET
Data de autorizare:
2018-05-10
Caracteristicilor produsului
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MYLAN-LOSARTAN HCTZ
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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
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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
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