Country: Holland
Tungumál: hollenska
Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BRINZOLAMIDE
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 HAFNARFJÖRDUR (IJSLAND)
S01EC04
BRINZOLAMIDE
Oogdruppels, suspensie
BENZALKONIUMCHLORIDE ; CARBOMEER 974P ; DINATRIUMEDETAAT 2-WATER ; MANNITOL (D-) (E 421) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Oculair gebruik
Brinzolamide
Hulpstoffen: BENZALKONIUMCHLORIDE; CARBOMEER 974P; DINATRIUMEDETAAT 2-WATER; MANNITOL (D-) (E 421); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2015-12-28
Brinzolamide, NL/H/2973/001, January 2020 1 PACKAGE LEAFLET: INFORMATION FOR THE USER BRINZOLAMIDE ACTAVIS 10 MG/ML OOGDRUPPELS, SUSPENSIE Brinzolamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What /…/ is and what it is used for 2. What you need to know before you use /…/ 3. How to use /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR /…/ CONTAINS BRINZOLAMIDE WHICH BELONGS TO A GROUP OF MEDICINES called carbonic anhydrase inhibitors. It reduces pressure within the eye. /…/ IS USED TO TREAT HIGH PRESSURE IN THE EYE. This pressure can lead to an illness called GLAUCOMA. If the pressure in the eye is too high, it can damage your sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE /…/ DO NOT USE /…/: - IF YOU HAVE SEVERE KIDNEY PROBLEMS. - IF YOU ARE ALLERGIC to brinzolamide or any of the other ingredients of this medicine (listed in section 6). - IF YOU ARE ALLERGIC TO MEDICINES CALLED SULPHONAMIDES. Examples include medicines used to treat diabetes and infections and also diuretics (water tablets). /…/ may cause the same allergy. - IF YOU HAVE TOO MUCH ACIDITY IN YOUR BLOOD (a condition called hyperchloraemic acidosis). If you have further questions, ask your doctor for advice. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using /…/ - IF YOU HAVE KIDNEY OR LIVER PROBLEMS. - IF YOU HAVE DRY EYES OR CORNEA PROBLEMS. - IF YOU ARE TAKING OTHER SULPHONAMIDE MED Lestu allt skjalið
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Brinzolamide Actavis 10 mg/ml oogdruppels, suspensie 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS /…/ 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 or prostaglandin analogues (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 /…/ 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 _ 2 Brinzolamide has not been studied in patients with hepatic impairment and is therefore not recommended in such patients. Brinzolamide 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, /…/ is therefore contra- indicated in such patients (see also section 4.3). _ _ _ _ _Paediatric population _ The safety and efficacy of brinzolamide in infants, children and adolescents aged 0 to 17 years has not been established. Currently available data are described in sections 4.8 and 5.1. /.../ is not recommended for use in infants, children and adolescents. Method of administration For ocular use. Nasolacrimal occlusion or gently closing the eyelid after ins Lestu allt skjalið