देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Dorzolamide hydrochloride 22.26 mg/mL equivalent to 20 mg/mL Dorzolamide free base; Timolol maleate 6.83 mg/mL equivalent to 5 mg/mL Timolol free base
Mundipharma New Zealand Ltd
Dorzolamide hydrochloride 22.26 mg/mL (equivalent to 20 mg/mL Dorzolamide free base)
20mg/mL, 5mg/mL
Eye drops, solution
Active: Dorzolamide hydrochloride 22.26 mg/mL equivalent to 20 mg/mL Dorzolamide free base Timolol maleate 6.83 mg/mL equivalent to 5 mg/mL Timolol free base Excipient: Benzalkonium chloride Hyetellose Mannitol Sodium citrate Sodium hydroxide Water for injection
Bottle, plastic, 'professional sample pack', 5 mL
Prescription
Prescription
F.I.S. Fabbrica Italiana Sintetici SpA
COSOPT is indicated for the treatment of elevated intraocular pressure (IOP) in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma · or other secondary open-angle glaucoma's and who are: · insufficiently responsive to topical beta blocker monotherapy · currently receiving concomitant antiglaucoma therapies such as dorzolamide HCl and timolol maleate
Package - Contents - Shelf Life: Bottle, plastic, 'professional sample pack' - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, Occumeter Plus - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light
1997-07-04
NAME OF MEDICINE COSOPT ® _dorzolamide hydrochloride and timolol maleate _ 20 mg/5 mg ophthalmic solution PRESENTATION A clear, colourless to nearly colourless, slightly viscous solution available in a translucent plastic dispensing bottle (Occumeter) with a yellow cap. Each mL contains 20 mg of dorzolamide (22.26 mg dorzolamide HCl) and 5 mg of timolol (6.83 mg of timolol maleate). THERAPEUTIC CLASS COSOPT Ophthalmic Solution (dorzolamide hydrochloride and timolol maleate, MSD) is the first combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. INDICATIONS COSOPT is indicated for the treatment of elevated intraocular pressure (IOP) in patients with: • ocular hypertension • open-angle glaucoma • pseudoexfoliative glaucoma • or other secondary open-angle glaucoma’s and who are: • insufficiently responsive to topical beta blocker monotherapy • currently receiving concomitant antiglaucoma therapies such as dorzolamide HCI and timolol maleate DOSAGE AND ADMINISTRATION The dose is one drop of COSOPT in the affected eye(s) two times daily. When substituting COSOPT for another ophthalmic antiglaucoma agent(s), discontinue the other agent(s) after proper dosing on one day, and start COSOPT on the next day. If another topical ophthalmic agent is being used, COSOPT and the other agent should be administered at least ten minutes apart. Safety and efficacy in paediatric patients below the age of 2 years have not been established. (For information regarding use in paediatric patients ≥2 years of age see Warnings and Precautions, _Paediatric Use_). CONTRAINDICATIONS COSOPT is contraindicated in patients with: • reactive airway disease, bronchial asthma or other obstructive lung disorders पूरा दस्तावेज़ पढ़ें