Lucentis 1.65mg0.165ml solution for injection pre-filled syringes

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Ranibizumab

Disponible depuis:

Novartis Pharmaceuticals UK Ltd

Code ATC:

S01LA04

DCI (Dénomination commune internationale):

Ranibizumab

Dosage:

10mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Intravitreal

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: ; GTIN: 5010678912067

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUCENTIS
® 10 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ranibizumab
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). 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 the eye. In excess, VEGF-A causes
abnormal blood vessel growth and
swelling in the eye which can lead to impairment of vision in diseases
like AMD, PM, CNV, DME or
RVO. By bindi

Résumé des caractéristiques du produit

OBJECT 1
LUCENTIS 10 MG/ML SOLUTION FOR INJECTION IN PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 18-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Lucentis
®
10 mg/ml solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
One ml contains 10 mg ranibizumab*. One pre-filled syringe contains
0.165 ml, equivalent to 1.65 mg
ranibizumab. The extractable volume of one pre-filled syringe is 0.1
ml. This provides a usable amount to
deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.
*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
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)
4.2 Posology and method of administration
Lucentis must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
Posology
The recommended dose for Lucentis 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 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 continued treatment. In patients with wet AMD, DME and
RVO, initially, three or more
consecutive, monthly injections may be needed.
Thereafter, monit