Eylea 2mg50microlitres solution for injection vials

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aflibercept

제공처:

Bayer Plc

ATC 코드:

L01XX44

INN (국제 이름):

Aflibercept

복용량:

40mg/1ml

약제 형태:

Solution for injection

관리 경로:

Intravitreal

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 11080200; GTIN: 5010605333040

환자 정보 전단

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
EYLEA 40 MG/ML SOLUTION FOR INJECTION IN A VIAL
Aflibercept
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Eylea is and what it is used for
2.
What you need to know before you are given Eylea
3.
How you will be given Eylea
4.
Possible side effects
5.
How to store Eylea
6.
Contents of the pack and other information
1.
WHAT EYLEA IS AND WHAT IT IS USED FOR
Eylea is a solution which is injected into the eye to treat eye
conditions in adults called
-
neovascular (wet) age-related macular degeneration (wet AMD),
-
impaired vision due to macular oedema secondary to retinal vein
occlusion (branch RVO
(BRVO) or central RVO (CRVO)),
-
impaired vision due to diabetic macular oedema (DME),
-
impaired vision due to myopic choroidal neovascularisation (myopic
CNV).
Aflibercept, the active substance in Eylea, blocks the activity of a
group of factors, known as Vascular
Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor
(PlGF).
In patients with wet AMD and myopic CNV, these factors, in excess are
involved in the abnormal
formation of new blood vessels in the eye. These new blood vessels can
cause the leak of blood
components into the eye and eventual damage to tissues in the eye
responsible for vision.
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In patients with CRV

제품 특성 요약

OBJECT 1
EYLEA 40MG/ML SOLUTION FOR INJECTION IN A VIAL
Summary of Product Characteristics Updated 26-Oct-2017 | Bayer plc
1. Name of the medicinal product
Eylea 40 mg/ml solution for injection in a vial.
2. Qualitative and quantitative composition
1 ml solution for injection contains 40 mg aflibercept*.
Each vial contains 100 microlitres, equivalent to 4 mg aflibercept.
This provides a usable amount to
deliver a single dose of 50 microlitres containing 2 mg aflibercept.
*Fusion protein consisting of portions of human VEGF (Vascular
Endothelial Growth Factor) receptors 1
and 2 extracellular domains fused to the Fc portion of human IgG1 and
produced in Chinese hamster
ovary (CHO) K1 cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection)
The solution is a clear, colourless to pale yellow and iso-osmotic
solution.
4. Clinical particulars
4.1 Therapeutic indications
Eylea is indicated for adults for the treatment of
• neovascular (wet) age-related macular degeneration (AMD) (see
section 5.1),
• visual impairment due to macular oedema secondary to retinal vein
occlusion (branch RVO or central
RVO) (see section 5.1),
• visual impairment due to diabetic macular oedema (DME) (see
section 5.1),
• visual impairment due to myopic choroidal neovascularisation
(myopic CNV) (see section 5.1).
4.2 Posology and method of administration
Eylea is for intravitreal injection only.
Eylea must only be administered by a qualified physician experienced
in administering intravitreal
injections.
Posology
_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. There is no requirement for monitoring
between injections.
After the first 12 months of treatment with Eylea, and based on visual
and/or anatomic outcomes, the
treatment interval may be extended, such as with a treat-and-ex