Vabysmo

Երկիր: Եվրոպական Միություն

Լեզու: անգլերեն

Աղբյուրը: EMA (European Medicines Agency)

Ակտիվ բաղադրիչ:

Faricimab

Հասանելի է:

Roche Registration GmbH

ATC կոդը:

S01L

INN (Միջազգային անվանումը):

faricimab

Թերապեւտիկ խումբ:

Ophthalmologicals

Թերապեւտիկ տարածք:

Wet Macular Degeneration; Macular Edema; Diabetes Complications

Թերապեւտիկ ցուցումներ:

Vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (nAMD),visual impairment due to diabetic macular oedema (DME).

Ապրանքի ամփոփագիր:

Revision: 1

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2022-09-15

Տեղեկատվական թերթիկ

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VABYSMO 120 MG/ML SOLUTION FOR INJECTION
faricimab
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 START USING 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 Vabysmo is and what it is used for
2.
What you need to know before you receive Vabysmo
3.
How to use Vabysmo
4.
Possible side effects
5.
How to store Vabysmo
6.
Contents of the pack and other information
1.
WHAT VABYSMO IS AND WHAT IT IS USED FOR
WHAT VABYSMO IS AND WHAT IT IS USED FOR
Vabysmo contains the active substance faricimab, which belongs to a
group of medicines called
antineovascularisation agents.
Vabysmo is injected into the eye by your doctor to treat eye disorders
in adults called:
•
neovascular (wet) age-related macular degeneration (nAMD),
•
visual impairment due to diabetic macular oedema (DME).
These disorders affect the macula, the central part of the retina (the
light-sensitive layer at the back of
the eye) that is responsible for fine, central vision. nAMD is caused
by the growth of abnormal blood
vessels which leak blood and fluid into the macula, and DME is caused
by leaky blood vessels that
cause swelling of the macula.
HOW VABYSMO WORKS
Vabysmo specifically recognises and blocks the activity of proteins
known as angiopoietin-2 and
vascular endothelial growth factor A. When these proteins are present
at higher levels than normal,
they can cause growth of abnormal blood vessels and/or damage to
normal vessels, with leakage into
the macula, causing sw

Ապրանքի հատկությունները

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
Vabysmo 120 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Faricimab is a humanised antibody produced in mammalian Chinese
Hamster Ovary (CHO) cell
culture by recombinant DNA technology.
One mL of solution contains 120 mg of faricimab.
Each vial contains 28.8 mg faricimab in 0.24 mL solution. This
provides a usable amount to deliver a
single dose of 0.05 mL solution containing 6 mg of faricimab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear to opalescent, colourless to brownish-yellow solution, with a pH
of 5.5 and an osmolality of
270-370 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vabysmo is indicated for the treatment of adult patients with:
•
neovascular (wet) age-related macular degeneration (nAMD),
•
visual impairment due to diabetic macular oedema (DME).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product must be administered by a qualified physician
experienced in intravitreal
injections. Each vial should only be used for the treatment of a
single eye.
Posology
_Neovascular (wet) age-related macular degeneration_
(
_nAMD)_
_ _
The recommended dose is 6 mg (0.05 mL solution) administered by
intravitreal injection every 4
weeks (monthly) for the first 4 doses.
Thereafter, an assessment of disease activity based on anatomic and/or
visual outcomes is
recommended 20 and/or 24 weeks after treatment initiation so that
treatment can be individualised. In
patients without disease activity, administration of faricimab every
16 weeks (4 months) should be
considered. In patients with disease activity, treatment every 8 weeks
(2 months) or 12 weeks (3
months) should be consid