国: カナダ
言語: 英語
ソース: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)
VANC PHARMACEUTICALS INC
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 POST MARKET
2019-08-07
PRODUCT MONOGRAPH PR VAN-DORZOLAMIDE-TIMOLOL Dorzolamide and timolol eye drops BP 2 0 mg/ml, 5 m g/ml (as dorzolamide hydrochloride and timolol maleate) Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic Blocking Agent) MANUFACTURER AND DISTRIBUTOR: Vanc Pharmaceuticals Inc. Unit-210, 2639 Viking Way, Richmond, BC V6V 3B7 www.vancpharm.com DATE OF PREPARATION: 27 JANUARY 2016 SUBMISSION CONTROL NO: 190791 _VAN-Dorzolamide-Timolol _ _Page 2 of 26_ 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 ................................................................................9 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY..........................................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................13 PART II: SCIENTIFIC INFORMATION .................................................................................14 PHARMACEUTICAL INFORMATION........................................................................... 完全なドキュメントを読む