Vsiqq solution for injection

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

Brolucizumab

Pieejams no:

Novartis Pharma Stein AG Technical Operations Schweiz

ATĶ kods:

S01LA06

SNN (starptautisko nepatentēto nosaukumu):

Brolucizumab

Deva:

120mg/ml

Zāļu forma:

solution for injection

Vienības iepakojumā:

glass vial and filter needle

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2021-07-16

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VSIQQ 120 MG/ML SOLUTION FOR INJECTION
brolucizumab
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 Vsiqq is and what it is used for
2.
What you need to know before you are given Vsiqq
3.
How Vsiqq is given
4.
Possible side effects
5.
How to store Vsiqq
6.
Contents of the pack and other information
1.
WHAT VSIQQ IS AND WHAT IT IS USED FOR
WHAT VSIQQ IS
Vsiqq contains the active substance brolucizumab, which belongs to a
group of medicines called
antineovascularisation agents. Vsiqq is injected into the eye by your
doctor to treat an eye disorder
called neovascular (wet) age-related macular degeneration (AMD).
WHAT VSIQQ IS USED FOR
Vsiqq is used to treat neovascular wet AMD in adults, which occurs
when abnormal blood vessels
form and grow underneath the macula. The macula, which is at the back
of the eye, is responsible for
clear vision. The abnormal blood vessels may leak fluid or blood into
the eye and interfere with the
macula’s function, resulting in decreased vision.
HOW VSIQQ WORKS
A substance called vascular endothelial growth factor A (VEGF-A)
causes the growth of blood vessels
in the eye. By attaching to VEGF-A, Vsiqq blocks its effect and so
reduces the growth of abnormal
blood vessels in AMD, which in turn reduces the leakage of fluid or
blood in the eye.
Vsiqq may slow down disease progression and thereby maintain, or even
improve, your vision.
Abnormal blood vessels
that leak fluid or bloo

Produkta apraksts

1
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
Vsiqq 120 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution for injection contains 120 mg of brolucizumab*.
* Brolucizumab is a humanised monoclonal single-chain Fv (scFv)
antibody fragment produced in
_Escherichia coli_
cells by recombinant DNA technology.
Vsiqq 120 mg/ml solution for injection
Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This
provides a usable amount to deliver
a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to slightly opalescent, colourless to slightly brownish-yellow
aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vsiqq is indicated in adults for the treatment of neovascular (wet)
age-related macular degeneration
(AMD).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vsiqq must be administered by a qualified ophthalmologist experienced
in intravitreal injections.
Posology
The recommended dose is 6 mg brolucizumab (0.05 ml solution)
administered by intravitreal injection
every 4 weeks (monthly) for the first 3 doses. Thereafter, the
physician may individualise treatment
intervals based on disease activity as assessed by visual acuity
and/or anatomical parameters. A
disease activity assessment is suggested 16 weeks (4 months) after
treatment start. In patients without
disease activity, treatment every 12 weeks (3 months) should be
considered. In patients with disease
activity, treatment every 8 weeks (2 months) should be considered. The
physician may further
individualise treatment intervals based on disease activity.
If visual and anatomical outcomes indicate that th