Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
OLOPATADINE (OLOPATADINE HYDROCHLORIDE)
TEVA CANADA LIMITED
S01GX09
OLOPATADINE
0.1%
SOLUTION
OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.1%
OPHTHALMIC
5ML
Prescription
ANTIALLERGIC AGENTS
Active ingredient group (AIG) number: 0132394001; AHFS:
CANCELLED POST MARKET
2021-07-30
_ _ ACT OLOPATADINE 0.1% _ _ _Page 1_ PRODUCT MONOGRAPH Pr ACT_ _OLOPATADINE 0.1% Olopatadine Hydrochloride Ophthalmic Solution, USP Sterile 0.1% w/v olopatadine (as olopatadine hydrochloride) Anti-allergy Agent Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Date of Revision: June 15, 2020 Submission Control Number: 239279 _ _ ACT OLOPATADINE 0.1% _ _ _Page 2_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS ......................................................................................... 3 ADVERSE REACTIONS ........................................................................................................... 5 DRUG INTERACTIONS ........................................................................................................... 5 DOSAGE AND ADMINISTRATION ....................................................................................... 6 OVERDOSAGE ......................................................................................................................... 6 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 6 STORAGE AND STABILITY ................................................................................................... 7 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 7 PART II: SCIENTIFIC INFORMATION ................................................................................. 9 PHARMACEUTICAL INFORMATION ................................................................................... 9 CLINICAL TRIALS . Belgenin tamamını okuyun