Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
BRINZOLAMIDE
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
S01EC04
OPHTHALMIC SUSPENSION
BRINZOLAMIDE 10 MG/ML
OCULAR
Required
AZAD PHARMA AG, SWITZERLAND
BRINZOLAMIDE
Brinzolamide S.K. is indicated to decrease elevated intraocular pressure in: ocular hypertension open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contra-indicated or as adjunctive therapy to beta-blockers.
2020-01-08
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. BRINZOLAMIDE S.K. EYE DROPS (SUSPENSION) ACTIVE INGREDIENT: EACH 1 ML CONTAINS: brinzolamide 10 mg (1%) The inactive ingredients are listed in section 6 - “Further Information”. Also see “Important information about some of the ingredients of the medicine” in Section 2. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. This medicine is not intended for use in infants, children and adolescents under the age of 18, since there is no data about the safety and efficacy of the preparation in this population. 1. WHAT IS THE MEDICINE INTENDED FOR? Brinzolamide S.K. eye drops are used to decrease intraocular pressure in patients with ocular hypertension or in open-angle glaucoma patients, in patients who are unresponsive to beta-blockers, who cannot take beta-blockers or as adjunctive therapy to beta- blockers. THERAPEUTIC GROUP: Carbonic anhydrase inhibitors – intraocular pressure-reducing medicines. Intraocular pressure that is too high can damage your vision. 2. BEFORE USING THE MEDICINE SPECIAL WARNINGS REGARDING USE OF THE MEDICINE ! BEFORE TREATMENT WITH BRINZOLAMIDE S.K., TELL THE DOCTOR IF: • You suffer from liver or kidney problems. • You suffer from dryness of the eyes or cornea problems. • You are taking other sulfonamides. • You have a certain form of glaucoma in which the pressure inside the eye rises due to deposits that block fluid drainage (pseudoexfoliative glaucoma or pigmentary glaucoma) or a certain form of glaucoma in which the pressure in the eye increases (sometimes rapidly) due to the eye protruding forward and blocking fluid d Կարդացեք ամբողջական փաստաթուղթը
1/7 BRINZOLAMIDE SK EYE DROPS, SUSPENSION Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT BRINZOLAMIDE SK 10 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of suspension contains 10 mg brinzolamide. Excipient with known effect: Each ml of suspension contains 0.15 mg benzalkonium chloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white homogenous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BRINZOLAMIDE SK is indicated to decrease elevated intraocular pressure in: • ocular hypertension • open-angle glaucoma as monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers (see also section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology When used as monotherapy or adjunctive therapy, the dose is one drop of BRINZOLAMIDE SK in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. _Special populations _ _Elderly population _ No dose adjustment in elderly patients is necessary. _Hepatic and renal impairment _ BRINZOLAMIDE SK has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. BRINZOLAMIDE SK has not been studied in patients with severe renal impairment (creatinine clearance < 30 ml/min) or in patients with hyperchloraemic acidosis. Since brinzolamide and its main metabolite are excreted predominantly by the kidney, BRINZOLAMIDE SK is therefore contra-indicated in such patients (see also section 4.3). _Paediatric population _ The safety and efficacy of BRINZOLAMIDE SK in infants, children and adolescents aged 0 to 17 years have not been established. Currently available data are described in sections 4.8 and 5.1. BRINZOLAMIDE SK is not recommended for use in infants, children and adolescents. Method of administration For ocular use. Nasola Կարդացեք ամբողջական փաստաթուղթը