LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ranibizumab, Quantity: 1.65 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

Ranibizumab

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20; water for injections

Administration route:

Intravitreal-Within The Vitreous Cavity Of The Eye

Units in package:

1 x prefilled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lucentis (ranibizumab) 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 choroidal neovascularisation.,- 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 (RVO)

Product summary:

Visual Identification: Clear, colourless to pale yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-11-05

Patient Information leaflet

LUCENTIS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I RECEIVING LUCENTIS?
Lucentis contains the active ingredient ranibizumab (rbe). It is used
to treat adults in 1) Wet age related macular degeneration (wet
AMD), 2) Diabetic macular oedema (DME), 3) Oedema due to retinal vein
occlusion (RVO) where fluid accumulates into the back of
the eye, 4) Proliferative diabetic retinopathy (PDR), 5) CNV secondary
to pathologic myopia (PM), 6) CNV due to other causes and
7) in babies born prematurely Retinopathy of Prematurity (ROP).
For more information, see Section 1. Why am I receiving Lucentis? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN LUCENTIS?
Do not use if you have ever had an allergic reaction to ranibizumab or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Lucentis? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lucentis and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN LUCENTIS?
•
Lucentis is given by an ophthalmologist (eye doctor) as an injection
into the eye under a local anaesthetic.
•
In adult patients, the usual dose is 0.05mL. In pre-term infants, the
usual dose is 0.02 mL.. Alternatively, a dose of 0.01 mL can
be given in pre-term infants.
More instructions can be found in Section 4. How will I be given
Lucentis? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM GIVEN LUCENTIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you v

Summary of Product characteristics

1
Use of this medicinal product in paediatric ROP patients is subject to
additional monitoring in
Australia. This will allow quick identification of new safety
information. Healthcare professionals are
asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – LUCENTIS

(RANIBIZUMAB) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ranibizumab (rbe)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lucentis is supplied in a vial or a pre-filled syringe.
Vial
Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution for
intravitreal injection.
Pre-filled syringe
Each pre-filled syringe contains 1.65 mg of ranibizumab in 0.165mL
solution.
Ranibizumab is a humanised monoclonal antibody fragment produced in
_Escherichia coli_
cells by
recombinant DNA technology.
May contain potential allergens: traces of milk and residue of
tetracycline (antibiotic) from the
manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
Vial
:
The solution is sterile, clear, colourless to pale yellow to brown,
aqueous and preservative free.
Pre-filled syringe
:
The solution is sterile, clear, colourless to pale yellow to brown,
aqueous and
preservative free.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Lucentis (ranibizumab) 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),
•
treatment of proliferative diabetic retinopathy (PDR),
•
the treatment of visual impairment due to choroidal
neovascularisation,
•
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
(RVO).
▼

2
Lucentis is indicated in preterm infants for:
•
the treatment of retinopathy of prematurity (ROP) with zone I (stage
1+, 2+, 3 or 3+),