Lucentis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ranibizumab

Available from:

Novartis Europharm Limited

ATC code:

S01LA04

INN (International Name):

ranibizumab

Therapeutic group:

Ophthalmologicals

Therapeutic area:

Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative; Choroidal Neovascularization

Therapeutic indications:

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

Product summary:

Revision: 43

Authorization status:

Authorised

Authorization date:

2007-01-22

Patient Information leaflet

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE ADULT PATIENT
LUCENTIS 10 MG/ML SOLUTION FOR INJECTION
ranibizumab
ADULTS
Please find information for babies born prematurely on the other side
of this leaflet.
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 Lucentis is and what it is used for
2.
What you need to know before you are given Lucentis
3.
How Lucentis is given
4.
Possible side effects
5.
How to store Lucentis
6.
Contents of the pack and other information
1.
WHAT LUCENTIS IS AND WHAT IT IS USED FOR
WHAT LUCENTIS IS
Lucentis is a solution which is injected into the eye. Lucentis
belongs to a group of medicines called
antineovascularisation agents. It contains the active substance called
ranibizumab.
WHAT LUCENTIS IS USED FOR
Lucentis 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 LUCENTIS WORKS
Lucentis specifically recognises and binds to a protein called human
vascular endothelial growth
factor A (VEGF-A) present in th

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lucentis 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 and a single dose of 0.02 ml containing 0.2 mg
ranibizumab to preterm infants.
*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 brownish-yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lucentis 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)
Lucentis is indicated in preterm infants for:
•
The treatment of retinopathy of prematurity (ROP) with zone I (stage
1+, 2+, 3 or 3+), zone II
(stage 3+) or AP-ROP (aggressive posterior ROP) disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lucentis must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
Posology
_Adults _
The recommended dose for Lucentis 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