Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)
MICRO LABS LIMITED
S01EC03
DORZOLAMIDE
2%
SOLUTION
DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%
OPHTHALMIC
100
Prescription
Active ingredient group (AIG) number: 0128558001; AHFS:
APPROVED
2022-06-24
_DORZOLAMIDE (Dorzolamide Eye Drops)_ _ _ _Page 1 of 24_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DORZOLAMIDE Dorzolamide Eye Drops Sterile Ophthalmic Solution, 2% weight/volume Dorzolamide (as Dorzolamide hydrochloride), ophthalmic BP Elevated Intraocular Pressure Therapy (Topical Carbonic Anhydrase Inhibitor) Manufactured by: Micro Labs Limited Bangalore– 560001 INDIA Canadian Importer/Distributer: 13187811 Canada Inc. Mississauga, ON L4Z 1S1 Submission Control Number: 248994 Date of Initial Approval: June 14, 2022 _DORZOLAMIDE (Dorzolamide Eye Drops)_ Page 2 of 24 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................... 3 1 INDICATIONS................................................................................................................. 3 1.1 Pediatrics ......................................................................................................... 3 1.2 Geriatrics .......................................................................................................... 3 2 CONTRAINDICATIONS ................................................................................................... 3 3 DOSAGE AND ADMINISTRATION ................................................................................... 3 3.1 Recommended Dose and Dosage Adjustment .................................................... 3 3.2 Missed Dose ..................................................................................................... 4 4 OVERDOSAGE................................................................................................................ 4 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................... 4 6 WARNINGS AND PRECAUTIONS .................................................................................... 5 6.1 Special Populations ........................................................................................... 7 6.1.1 Pregnant Women ...................... Belgenin tamamını okuyun