Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
Brinzolamide; Timolol Maleate 6.8mg/mL eqv Timolol (as free base)
NOVARTIS (SINGAPORE) PTE LTD
S01ED51
10mg/mL
SUSPENSION, STERILE
Brinzolamide 10mg/mL; Timolol Maleate 6.8mg/mL eqv Timolol (as free base) 5mg/mL
OPHTHALMIC
Prescription Only
S.A. Alcon Couvreur N.V
ACTIVE
2010-05-19
KAPVORM 140 x 504 / 140 x 22 mm AANTAL KLEUREN : 1 VC 13-11-2008 EET RECTO-verso Azarga 5 ml - 24m code 45834-0 BELGIUM V3 Quark 6 PMS ZWART À 100 % 1. NAME OF THE MEDICINAL PRODUCT AZARGA ® 10 mg/ml + 5 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). For excipients : see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. 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 Use in adults, including the elderly The dose is one drop of AZARGA ® eye drops, suspension in the conjunctival sac of the affected eye(s) twice daily. Nasolacrimal occlusion or gently closing the eyelid after instilla- tion is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. 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 agent with AZARGA ® eye drops, suspension, the other agent should be dis- continued and AZARGA ® eye drops, suspension should be start- ed the following day. Paediatric patients AZARGA ® eye drops, suspension is not recommended for use in children below 18 years due to a lack of data on safety and effi- cacy. Use in hepatic and renal impairment No studies have been conducted with AZARGA ® eye drops, sus- pension or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment. No dosage adjustment is neces- sary in patients with hepatic imp Soma hati kamili
Azarga May 2022.SIN Page 1 of 14 1. NAME OF THE MEDICINAL PRODUCT AZARGA ® (10 mg/mL brinzolamide + 5 mg/mL timolol) eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). Preservative: 1 mL of suspension contains 0.1 mg benzalkonium chloride. For the full list of excipients: see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension. White to off-white uniform suspension. 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 AZARGA ® eye drops in the conjunctival sac of the affected eye(s) twice daily. 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. If more than 1 topical ophthalmic medicinal product is used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with AZARGA ® eye drops, the other agent should be discontinued and AZARGA eye drops should be started the following day. Use in paediatric patients AZARGA ® eye drops is not recommended for use in children below 18 years due to a lack of data on safety and efficacy. Use in geriatric patients No overall differences in safety and effectiveness have been observed between elderly and other adult populations. Use in patients with hepatic or renal impairment No studies have been conducted with AZARGA ® eye drops 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. Azarga May 2022.SIN Page 2 of 14 AZARGA ® eye drops has not been studied in patients with s Soma hati kamili