Land: Kanada
Tungumál: enska
Heimild: Health Canada
LATANOPROST; TIMOLOL (TIMOLOL MALEATE)
SANDOZ CANADA INCORPORATED
S01ED51
TIMOLOL, COMBINATIONS
50MCG; 5MG
SOLUTION
LATANOPROST 50MCG; TIMOLOL (TIMOLOL MALEATE) 5MG
OPHTHALMIC
2.5ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0248501002; AHFS:
CANCELLED POST MARKET
2019-04-26
_Sandoz Latanoprost/Timolol _ _Page 1 of 31_ PRODUCT MONOGRAPH PR SANDOZ LATANOPROST/TIMOLOL Latanoprost and timolol ophthalmic solution, 50 mcg/mL / 5 mg/mL (as timolol maleate) Elevated Intraocular Pressure Therapy Prostaglandin F 2α A nalogue and Beta-adrenergic Receptor Blocker Sandoz Canada Inc. Date of Preparation: 145 Jules-Léger December 28, 2017 2017 Boucherville, QC, Canada J4B 7K8 Submission Control No: 211248 _ _ _Sandoz Latanoprost/Timolol _ _Page 2 of 31_ 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 ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................14 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................15 STORAGE AND STABILITY ..........................................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................16 PART II: SCIENTIFIC INFORMATION ...............................................................................18 PHARMACEUTICAL INFORMATION ..........................................................................18 CLINICAL TRIALS ........... Lestu allt skjalið