البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
TIMOLOL (TIMOLOL MALEATE); LATANOPROST
MINT PHARMACEUTICALS INC
S01ED51
TIMOLOL, COMBINATIONS
5MG; 50MCG
SOLUTION
TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG
OPHTHALMIC
5ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0248501002; AHFS:
APPROVED
2015-08-11
PRODUCT MONOGRAPH PR MINT-LATANOPROST/TIMOLOL Latanoprost and timolol ophthalmic solution, 50 µg/mL/5 mg/mL (as timolol maleate) Elevated Intraocular Pressure Therapy Prostaglandin F 2α Analogue and Beta-adrenergic Receptor Blocker Mint Pharmaceuticals Inc. 1093 Meyerside Drive, Unit 1 Mississauga, Ontario Canada L5T 1J6 Control No. 176298 Date of Preparation: 10 August 2015 2 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....................................................................................................8 DRUG INTERACTIONS ..................................................................................................12 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSE ......................................................................................................................13 ACTION AND CLINICAL PHARMACOLOGY .............................................................14 STORAGE AND STABILITY ..........................................................................................15 DOSAGE FORMS, COMPOSITION AND PACKAGING..............................................15 PART II: SCIENTIFIC INFORMATION ...............................................................................16 PHARMACEUTICAL INFORMATION ..........................................................................16 CLINICAL TRIALS ..................................................................................................... اقرأ الوثيقة كاملة