País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
Aflibercept
BAYER (SOUTH EAST ASIA) PTE LTD
S01LA05
2.0mg/50mcl
INJECTION, SOLUTION
Aflibercept 2.0mg/50mcl
INTRAVITREOUS
Prescription Only
Vetter Pharma-Fertigung GmbH & Co. KG (mfg of pfs, In-process testing,QC testing, visual inspection)
ACTIVE
2013-07-18
Page 1 of 25 EYLEA PFS & VIAL _CCDS 6_20 June 2014 1. NAME OF THE MEDICINAL PRODUCT EYLEA, 40mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One milliliter solution for injection contains 40 mg aflibercept. Each single-dose, pre-filled syringe provides a usable amount to deliver a single dose of 50 microliters containing 2 mg aflibercept. Each vial provides a usable amount to deliver a single dose of 50 microliters containing 2 mg aflibercept. For a full list of excipients see section "List of excipients". 3. PHARMACEUTICAL FORM Solution for injection. Clear, colorless to pale yellow, iso-osmotic solution, pH 6.2. 4. CLINICAL PARTICULARS 4.1 INDICATION(S) EYLEA is indicated for the treatment of neovascular (wet) age-related macular degeneration (wet AMD) (see section 5.1 “Pharmacodynamic properties”). macular edema secondary to central retinal vein occlusion (CRVO). 4.2 DOSAGE AND METHOD OF ADMINISTRATION EYLEA is for intravitreal injection only. It must only be administered by a qualified physician experienced in administering intravitreal injections. 4.2.1 DOSAGE REGIMEN _4.2.1.1 _ _NEOVASCULAR (WET) AGE-RELATED DEGENERATION (WET AMD) _ The recommended dose for EYLEA is 2 mg aflibercept, equivalent to 50 microlitres. EYLEA treatment is initiated with one injection per month for three consecutive months, followed by one injection every 2 months. There is no requirement for monitoring between injections. Page 2 of 25 EYLEA PFS & VIAL _CCDS 6_20 June 2014 After the first 12 months of treatment with EYLEA, the treatment interval may be extended based on visual and anatomic outcomes. In this case the schedule for monitoring should be determined by the treating phy Leer el documento completo
Page 1 of 42 1. NAME OF THE MEDICINAL PRODUCT EYLEA, 40mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One milliliter solution for injection contains 40 mg aflibercept. Each single-dose, pre-filled syringe or vial provides a usable amount to deliver a single dose of 50 microliters containing 2 mg aflibercept. For the full list of excipients see section "List of excipients". 3. PHARMACEUTICAL FORM Solution for injection. Clear, colorless to pale yellow, iso-osmotic solution, pH 6.2. 4. CLINICAL PARTICULARS 4.1 INDICATION(S) EYLEA is indicated for the treatment of • neovascular (wet) age-related macular degeneration (wet AMD) (see section 5.1 “Pharmacodynamic properties”). • macular edema secondary to retinal vein occlusion (branch RVO or central RVO). • diabetic macular edema (DME). • myopic choroidal neovascularization (myopic CNV) 4.2 DOSAGE AND METHOD OF ADMINISTRATION EYLEA is for intravitreal injection only. It must only be administered by a qualified physician experienced in administering intravitreal injections. 4.2.1 DOSAGE REGIMEN _4.2.1.1 _ _NEOVASCULAR (WET) AGE-RELATED DEGENERATION (WET AMD) _ The recommended dose for EYLEA is 2 mg aflibercept, equivalent to 50 microlitres. EYLEA treatment is initiated with one injection per month for three consecutive doses, followed by one injection every two months. Based on the physician’s judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at two months or further extended, such as with using a treat-and-extend Page 2 of 42 dosing regimen, where treatment injection intervals are increased in 2- or 4-weekly increments to maintain stable visual and/or anatomic outcomes.. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly. There is no requirement for monitoring between injections. Based on the physician’s judgement the schedule of monitoring visits may be more frequent than the injections visits. Treatment intervals greater than 4 months (16 Leer el documento completo