Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
MYLAN PHARMACEUTICALS ULC
C09DA01
LOSARTAN AND DIURETICS
100MG; 25MG
TABLET
LOSARTAN POTASSIUM 100MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
100
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0233168002; AHFS:
CANCELLED POST MARKET
2018-05-10
________________________________________________________________________________________________________ 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 ________________________________________________________________________________________________________ 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 Izlasiet visu dokumentu