Yesafili

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

aflibercept

זמין מ:

Viatris Limited

קוד ATC:

S01LA05

INN (שם בינלאומי):

aflibercept

קבוצה תרפויטית:

Ophthalmologicals

איזור תרפויטי:

Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications

סממני תרפויטית:

Yesafili is indicated for adults for the treatment ofneovascular (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).

leaflet_short:

Revision: 1

מצב אישור:

Authorised

תאריך אישור:

2023-09-15

עלון מידע

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
YESAFILI 40 MG/ML SOLUTION FOR INJECTION IN A VIAL
aflibercept
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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 Yesafili is and what it is used for
2.
What you need to know before you are given Yesafili
3.
How you will be given Yesafili
4.
Possible side effects
5.
How to store Yesafili
6.
Contents of the pack and other information
1.
WHAT YESAFILI IS AND WHAT IT IS USED FOR
Yesafili 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 Yesafili, 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.
In patients with CRVO, a blockage occurs in the main blood vessel that
transports blood away from the
retina. VEGF levels are elevated in response causing the

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Yesafili 40 mg/mL solution for injection in a vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 40 mg aflibercept*.
One vial contains an extractable volume of at least 0.1 mL, equivalent
to at least 4 mg aflibercept. This
provides a usable amount to deliver a single dose of 0.05 mL
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).
Clear, colourless to pale yellow and iso-osmotic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yesafili 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
Yesafili is for intravitreal injection only.
Yesafili must only be administered by a qualified physician
experienced in administering
intravitreal injections.
Posology
_wet AMD _
The recommended dose for Yesafili is 2 mg aflibercept, equivalent to
0.05 mL.
Yesafili treatment is initiated with one injection per month for three
consecutive doses. The
treatment interval is then extended to two months.
3
Based on th