Țară: Canada
Limbă: engleză
Sursă: Health Canada
TELMISARTAN
MYLAN PHARMACEUTICALS ULC
C09CA07
TELMISARTAN
80MG
TABLET
TELMISARTAN 80MG
ORAL
28/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0138223002; AHFS:
CANCELLED POST MARKET
2018-08-15
_ MYLAN-TELMISARTAN Product Monograph _ _Page 1 of 33 _ PRODUCT MONOGRAPH PR MYLAN-TELMISARTAN Telmisartan Tablets 40 mg and 80 mg USP Angiotensin II AT 1 Receptor Blocker Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control No.: 162814 Date of Revision: May 27, 2013 _ MYLAN-TELMISARTAN Product Monograph _ _Page 2 of 33 _ 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 ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 15 DOSAGE AND ADMINISTRATION .......................................................................... 18 OVERDOSAGE ................................................................................................................ 18 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 19 STORAGE AND STABILITY ......................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 22 PART II: SCIENTIFIC INFORMATION .................................................................... 24 PHARMACEUTICAL INFORMATION ......................................................................... 24 CLINICAL TRIALS ....................................................................................................... 25 DETAILED PHARMACOLOGY .................................. Citiți documentul complet