Lucentis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ranibizumab 10 mg/mL

Available from:

Novartis New Zealand Ltd

INN (International Name):

Ranibizumab 10 mg/mL

Dosage:

10 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ranibizumab 10 mg/mL Excipient: Histidine Histidine hydrochloride Polysorbate 20 Trehalose dihydrate Water for injection

Units in package:

Vial, single dose, (0.23 mL) +filtration needle + inj needle + syringe, 0.23 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Roche Singapore Technical Operations

Therapeutic indications:

Lucentis® is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Product summary:

Package - Contents - Shelf Life: Syringe, glass, - 0.165 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours unopened stored at or below 25°C. blister tray is unopened - Vial, single dose, (0.23 mL) with or without admin kit - 0.23 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours unopened stored at or below 25°C protect from light. blister unopened

Authorization date:

2006-03-20

Patient Information leaflet

Lucentis

1
LUCENTIS

_Ranibizumab (rbe) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lucentis.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Lucentis
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LUCENTIS IS USED
FOR
Lucentis is used to treat problems
with your vision due to damage to
the retina (light-sensitive layer at the
back of the eye) caused by growth of
leaky, abnormal blood vessels
(choroidal neovascularisation, CNV),
in diseases that may cause decreased
vision such as:
•
Wet age related macular
degeneration (wet AMD)
•
Diabetic macular edema (DME),
or edema due to retinal vein
occlusion (RVO) where fluid
accumulates into the back of the
eye
•
Proliferative diabetic retinopathy
(PDR)
•
CNV secondary to pathologic
myopia (PM)
•
CNV due to other causes, such
as angioid streaks, post-
inflammatory
retinochoroidopathy, central
serous chorioretinopathy, and
inflammatory CNV
Lucentis contains the active
substance ranibizumab, which is part
of an antibody. Antibodies are
proteins which specifically recognise
and bind to other unique proteins in
the body. Ranibizumab binds
selectively to a protein called human
vascular endothelial growth factor A
(VEGF-A), which is present in the
re

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 36
1 PRODUCT NAME
LUCENTIS® Ranibizumab 10 mg/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
One mL contains 10 mg ranibizumab.
VIAL
Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution.
PRE-FILLED SYRINGE
Each pre-filled syringe contains 1.65 mg of ranibizumab in 0.165 mL
solution.
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 List of excipients.
3 PHARMACEUTICAL FORM
Solution for injection.
Lucentis is supplied in a vial or a pre-filled syringe.
VIAL
Sterile, clear, colourless to pale yellow to brown and
preservative-free aqueous solution.
PRE-FILLED SYRINGE
Sterile, clear, colourless to pale yellow to brown and
preservative-free aqueous solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Lucentis® is indicated 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 choroidal
neovascularization,
•
the treatment of visual impairment due to choroidal neovascularisation
(CNV) secondary to
pathologic myopia (PM)
•
the treatment of visual impairment due to macular oedema secondary to
retinal vein
occlusion (branch RVO or central RVO).
4.2
Dose and method of administration
Dosage regimen
Single-use vial for intravitreal use only. Use of more than one
injection from a vial can lead to
product contamination and subsequent ocular infection.
Lucentis must be administered by a qualified ophthalmologist
experienced in intravitreal injections.
NEW ZEALAND DATA SHEET
Page 2 of 36
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 not be shorter than one