Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)
ALCON CANADA INC
S01ED51
TIMOLOL, COMBINATIONS
2.0%; 0.5%
SOLUTION
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2.0%; TIMOLOL (TIMOLOL MALEATE) 0.5%
OPHTHALMIC
5ML/10ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0237301001; AHFS:
CANCELLED PRE MARKET
2021-06-25
_Product Monograph – _ _ _ _Page 1 of 28_ _ _ _DORZOLAMIDE-TIMOLOL _ _ _ PRODUCT MONOGRAPH PR DORZOLAMIDE-TIMOLOL Dorzolamide (as Dorzolamide Hydrochloride USP) 2.0% and Timolol (as Timolol Maleate USP) 0.5% w/v Sterile Ophthalmic Solution Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent) Alcon Canada Inc. 2665 Meadowpine Blvd. Mississauga, ON L5N 8C7 Date of Preparation: October 1, 2010 SUBMISSION CONTROL NO: 131041 _Product Monograph – _ _ _ _Page 2 of 28_ _ _ _DORZOLAMIDE-TIMOLOL _ _ _ 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 DRUG INTERACTIONS...................................................................................................... 8 DOSAGE AND ADMINISTRATION ............................................................................... 10 OVERDOSAGE ................................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 11 STORAGE AND STABILITY............................................................................................ 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 14 PART II: SCIENTIFIC INFORMATION ........................................................................... 15 PHARMACEUTICAL INFORMATIO Đọc toàn bộ tài liệu