Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DORZOLAMIDE HCL
SANTEN PHARMA MALAYSIA SDN. BHD.
DORZOLAMIDE HCL
5 ml
Santen Pharmaceutical Co., Ltd. Noto Plant
Santen PI Blue PRINTABLE COLOURS: Profile Technical Info NON PRINT: DESCRIPTION: GLAMS PART NUMBER: TECHNICAL DRAWING NO: 2D MATRIX: DATE: MARKET: MATERIAL CODE: SGK is a Matthews International Corporation COMMERCIAL ARTWORK 754776 Trusopt 2% (MY) 5 ml Leaflet CAW-5804-01 N/A DIMENSION: 387 X 240 mm PHARMA CODE: 7842 N/A 14-03-2023 MY ARTWORK VERSION NUMBER: SCHAWK JOB NO.: 108421419/403221570 03 CMO SPEC NUMBER: N/A CMO ITEM NUMBER: N/A LOCAL PRODUCT CIRCULAR Sterile Ophthalmic Solution (dorzolamide hydrochloride ophthalmic solution) I. THERAPEUTIC CLASS TRUSOPT (dorzolamide hydrochloride ophthalmic solution) is a novel carbonic anhydrase inhibitor formulated for topical ophthalmic use. Unlike oral carbonic anhydrase inhibitors, TRUSOPT, which is administered topically, exerts its effects directly in the eye. II. CHEMISTRY TRUSOPT Sterile Ophthalmic Solution contains dorzolamide hydrochloride, which is described chemically as: (4_S-trans_)-4- (ethylamino)-5,6-dihydro-6-methyl-4_H_-thieno[2,3-_b_] thiopyran-2- sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is 405 α 25° (C=1, water) = ~ -17°. Its empirical formula is C 10 H 16 N 2 O 4 S 3 . HCl and its structural formula is: Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, free flowing crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. III. COMPOSITION _Active Ingredient (all formulations):_ TRUSOPT Sterile Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. Each mL of TRUSOPT 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). _Inactive ingredients:_ _TRUSOPT Ophthalmic Solution:_ hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. IV. CLINICAL PHARMACOLOGY _IVa. Mech Lugege kogu dokumenti