Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
DORZOLAMIDE AS HYDROCHLORIDE
RAFA LABORATORIES LTD
S01EC03
OPHTHALMIC SOLUTION
DORZOLAMIDE AS HYDROCHLORIDE 20 MG/ML
OCULAR
Required
FAREVA MIRABEL, FRANCE
DORZOLAMIDE
DORZOLAMIDE
For the treatment of eleveated intraocular pressure in patients with ocular hypertension, open-angle glaucoma and in some patients secondary glaucoma.
2022-07-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only Trusopt Eye drops Active ingredient: Dorzolamide (as hydrochloride) 20 mg/ml For the list of the additional ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. Read this entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is the medicine intended for? The medicine is intended for lowering raised pressure in the eye and for treating glaucoma. Therapeutic Group: carbonic anhydrase inhibitors. 2. Before using the medicine Do not use the medicine if: • You are sensitive (allergic) to the active ingredient or to any of the additional ingredients the medicine contains (for the list of the additional ingredients, see section 6). • If you have a severe impairment of kidney function or kidney problems, or if you have a history of kidney stones. Special warnings regarding the use of this medicine: Before (and during) treatment with the medicine, tell your doctor if: • You suffer or have suffered in the past from any medical problem, including eye problems and/or eye surgeries. • You suffer from any allergy to medicines. • You suffer or have suffered in the past from liver problems. • You suffer or have suffered in the past from impaired kidney function - see also the "Do not use the medicine if" section. Additional warnings • If you are sensitive to any food or medicine, including sulfonamide-derived medicines, inform your doctor before using this medicine. • If while using the medicine an eye allergic reaction, eye irritation or any other new eye problems such as redness of t Belgenin tamamını okuyun
DL-TRUSOPT- 22 March 2023 _02 1. NAME OF THE MEDICINAL PRODUCT TRUSOPT ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide. Excipient with known effect: One ml of eye drops solution contains 0.075 mg benzalkonium chloride and one drop contains about 0.002 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, ophthalmic solution Clear, colourless to nearly colourless, slightly viscous, solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of elevated intraocular pressure in patients with ocular hypertension, open-angle glaucoma and in some patients secondary glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose is one drop of TRUSOPT Ophthalmic Solution in the affected eye(s) three times daily. TRUSOPT may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. Patients should be informed of the correct handling of the containers. _Pediatric use _ Safety and effectiveness in pediatric patients have not been established. INSTRUCTIONS FOR USE -see at the end of this SPC. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 ml/min) or with hyperchloraemic acidosis. Because dorzolamide and its metabolites are Belgenin tamamını okuyun