Ranivisio

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

ranibizumab

Tilgængelig fra:

Midas Pharma GmbH

ATC-kode:

S01LA04

INN (International Name):

ranibizumab

Terapeutisk gruppe:

Ophthalmologicals

Terapeutisk område:

Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications

Terapeutiske indikationer:

Ranivisio 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)

Produkt oversigt:

Revision: 4

Autorisation status:

Authorised

Autorisation dato:

2022-08-25

Indlægsseddel

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT
RANIVISIO
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 Ranivisio is and what it is used for
2.
What you need to know before you are given Ranivisio
3.
How Ranivisio is given
4.
Possible side effects
5.
How to store Ranivisio
6.
Contents of the pack and other information
1.
WHAT RANIVISIO
IS AND WHAT IT IS USED FOR
WHAT RANIVISIO
IS
Ranivisio
is a solution which is injected into the eye. Ranivisio
belongs to a group of medicines called
antineovascularisation agents. It contains the active substance called
ranibizumab.
WHAT RANIVISIO
IS USED FOR
Ranivisio
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 (RV

Produktets egenskaber

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
Ranivisio 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
Ranivisio 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
Ranivisio
must be administered by a qualified ophthalmologist experienced in
intravitreal injections.
Posology
_Adults_
_ _
The recommended dose for Ranivisio
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 diseas