Byooviz

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

ranibizumab

Beschikbaar vanaf:

Samsung Bioepis NL B.V.

ATC-code:

S01LA04

INN (Algemene Internationale Benaming):

ranibizumab

Therapeutische categorie:

Ophthalmologicals

Therapeutisch gebied:

Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative

therapeutische indicaties:

Byooviz is indicated in adults for:The treatment of neovascular (wet) age-related macular degeneration (AMD)The treatment of visual impairment due to diabetic macular oedema (DME)The treatment of proliferative diabetic retinopathy (PDR)The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)The treatment of visual impairment due to choroidal neovascularisation (CNV)

Product samenvatting:

Revision: 6

Autorisatie-status:

Authorised

Autorisatie datum:

2021-08-18

Bijsluiter

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT
BYOOVIZ 10 MG/ML SOLUTION FOR INJECTION
ranibizumab
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.
ADULTS
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 Byooviz is and what it is used for
2.
What you need to know before you are given Byooviz
3.
How Byooviz is given
4.
Possible side effects
5.
How to store Byooviz
6.
Contents of the pack and other information
1.
WHAT BYOOVIZ IS AND WHAT IT IS USED FOR
WHAT BYOOVIZ IS
Byooviz is a solution which is injected into the eye. Byooviz belongs
to a group of medicines called
antineovascularisation agents. It contains the active substance called
ranibizumab.
WHAT BYOOVIZ IS USED FOR
Byooviz is used in adults to treat several eye diseases causing vision
impairment.
These diseases result from damage to the retina (light-sensitive layer
at the back of the eye) caused by:
-
Growth of leaky, abnormal blood vessels. This is observed in diseases
such as age-related
macular degeneration (AMD) and proliferative diabetic retinopathy
(PDR, a disease caused by
diabetes). It may also be associated with choroidal neovascularisation
(CNV) due to pathologic
myopia (PM), angioid streaks, central serous chorioretinopathy or
inflammatory CNV.
-
Macular oedema (swelling of the centre of the retina). This swelling
can be caused by diabetes
(a disease called diabetic macular oedema (DME)) or by the blockage of
retinal veins of the
retina (a disease called retinal vein occlusion (RVO)).
HOW BYOOVIZ WORKS

Productkenmerken

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
Byooviz 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of
ranibizumab in 0.23 ml solution.
This provides a usable amount to deliver a single dose of 0.05 ml
containing 0.5 mg ranibizumab to
adult patients.
*Ranibizumab is a humanised monoclonal antibody fragment produced in
_Escherichia coli _
cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Byooviz is indicated in adults for:
•
The treatment of neovascular (wet) age-related macular degeneration
(AMD)
•
The treatment of visual impairment due to diabetic macular oedema
(DME)
•
The treatment of proliferative diabetic retinopathy (PDR)
•
The treatment of visual impairment due to macular oedema secondary to
retinal vein occlusion
(branch RVO or central RVO)
•
The treatment of visual impairment due to choroidal neovascularisation
(CNV)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Byooviz must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
Posology
_Adults _
The recommended dose for Byooviz in adults is 0.5 mg given as a single
intravitreal injection. This
corresponds to an injection volume of 0.05 ml. The interval between
two doses injected into the same
eye should be at least four weeks.
Treatment in adults is initiated with one injection per month until
maximum visual acuity is achieved
and/or there are no signs of disease activity i.e. no change in visual
acuity and in other signs and
symptoms of the disease under co