国: スウェーデン
言語: スウェーデン語
ソース: Läkemedelsverket (Medical Products Agency)
brinzolamid; timololmaleat
AZAD Pharma GmbH
S01ED51
brinzolamide; timololmaleat
10 mg/ml + 5 mg/ml
Ögondroppar, suspension
mannitol Hjälpämne; brinzolamid 10 mg Aktiv substans; timololmaleat 6,83 mg Aktiv substans; bensalkoniumklorid Hjälpämne
Receptbelagt
Förpacknings: Droppbehållare, 3 x 5 ml; Droppbehållare, 6 x 5 ml; Droppbehållare, 5 ml
Godkänd
2020-02-24
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Brinzolamide/Timolol AZAD 10 mg/ml + 5 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 10 mg brinzolamide and timolol maleate corresponding to 5 mg timolol. Excipient with known effect: One ml of suspension contains 0.10 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension (eye drops) White to off-white uniform suspension, pH 7.2 (approximately). _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Use in adults, including the elderly The dose is one drop of /.../ in the conjunctival sac of the affected eye(s) twice daily. When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4). If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye (s) twice daily. When substituting another ophthalmic antiglaucoma medicinal product with /.../, the other medicinal product should be discontinued and /.../ should be started the following day. Special populations _Paediatric population _ The safety and efficacy of /.../ in children and adolescents aged 0 to 18 years have not yet been established. No data are available. _Hepatic and renal impairment _ No studies have been conducted with /.../ or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment. No dosage adjustment is necessary in patients with hepatic impairment or in patients with mild to moderate renal impairment. 3 /.../ has not been studied in patients with severe renal impairment (creatinine clearance <30 m 完全なドキュメントを読む