Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)
MYLAN PHARMACEUTICALS ULC
S01ED51
TIMOLOL, COMBINATIONS
20MG; 5MG
SOLUTION
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG; TIMOLOL (TIMOLOL MALEATE) 5MG
OPHTHALMIC
10ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0237301001; AHFS:
CANCELLED PRE MARKET
2016-11-02
_ _ Mylan-Dorzolamide/Timolol_ _ Page 1 of 27 PRODUCT MONOGRAPH Pr MYLAN-DORZOLAMIDE/TIMOLOL Dorzolamide (as Dorzolamide hydrochloride) and Timolol (as Timolol maleate) Each mL contains Dorzolamide 20 mg and Timolol 5 mg Sterile Ophthalmic Solution Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent) Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Revision: September 19, 2014 Submission Control No: 177775 _ _ Mylan-Dorzolamide/Timolol_ _ Page 2 of 27 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................................ 3 SUMMARY PRODUCT INFORMATION .............................................................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................................................... 3 CONTRAINDICATIONS ........................................................................................................................................ 3 WARNINGS AND PRECAUTIONS ....................................................................................................................... 4 ADVERSE REACTIONS ......................................................................................................................................... 7 DOSAGE AND ADMINISTRATION.................................................................................................................... 10 OVERDOSAGE ..................................................................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY .................................................................................................. 11 STORAGE AND STABILITY ............................................................................................................................... 13 DOSAG Đọc toàn bộ tài liệu