Lucentis 10mgml Solution for Injection

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

Ranibizumab

Հասանելի է:

NOVARTIS (SINGAPORE) PTE LTD

ATC կոդը:

S01LA04

Դոզան:

3mg

Դեղագործական ձեւ:

INJECTION, SOLUTION

Կազմը:

Ranibizumab 2.3mg

Կառավարման երթուղին:

INTRAOCULAR

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Novartis Pharma Stein AG

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2008-02-15

Տեղեկատվական թերթիկ

LUCENTIS


Anti-neovascularisation agent  
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Solution for injection. 
Lucentis is supplied in a vial. 
Sterile, clear, colourless to pale yellow
and preservative-free aqueous solution for injection. 
ACTIVE SUBSTANCE 
One mL contains 10 mg ranibizumab. Each vial contains 2.3 mg of
ranibizumab in 0.23 mL 
solution. 
One mL contains 10mg ranibizumab. Each vial contains 3.0 mg of
ranibizumab in 0.3 mL 
solution. 
Ranibizumab is a humanized monoclonal antibody fragment produced
in _Escherichia coli _
cells by recombinant DNA technology. 
Not all presentations may be available locally 
ACTIVE MOIETY 
Ranibizumab 
EXCIPIENTS 
alpha, alpha-trehalose dihydrate, histidine
hydrochloride, monohydrate, histidine, polysorbate 
20, water for injections 
INDICATIONS 
Lucentis is indicated for: 
  the treatment of neovascular (wet) age-related macular
degeneration (AMD) 
  the treatment of visual impairment due to
diabetic macular edema (DME).  
  the treatment of visual impairment due
to macular edema secondary to retinal vein 
occlusion (branch RVO or central RVO).  
  the treatment of visual impairment due to choroidal
neovascularisation (CNV) 
secondary to pathologic myopia (PM) 

DOSAGE AND ADMINISTRATION 
DOSAGE 
Single-use vial for intravitreal use only. Use of more than one
injection from a vial can lead to 
contamination and subsequent infection. 
Lucentis must be administered by a
qualified ophthalmologist experienced in intravitreal 
injections. The recommended dose for Lucentis is 0.5 mg (0.05 mL)
or 0.3mg (0.03mL) given 
monthly given as a single intravitreal injection. The interval
between two doses should not be 
shorter than 1 month. 
The recommended maximal dose (0.5mg) should not be exceeded. One
eye only should be 
injected on each occasion and post-injection monitoring is
re

Ապրանքի հատկությունները

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Lucentis
®
Jan2023.SIN
LUCENTIS

Anti-neovascularisation agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for injection.
Lucentis is supplied in a vial or a pre-filled syringe.
VIAL
Sterile, clear, colourless to pale brownish-yellow and
preservative-free aqueous
solution for injection.
PRE-FILLED SYRINGE
Sterile, clear, colorless to pale brownish-yellow and
preservative-free aqueous solution.
ACTIVE SUBSTANCE
VIAL
One mL contains 10 mg ranibizumab. 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 humanized monoclonal antibody fragment produced in
_Escherichia coli_
_ _
cells by recombinant DNA technology.
Not all presentations may be available locally
EXCIPIENTS
alpha, alpha-trehalose dihydrate, 1-histidine hydrochloride,
l-histidine free base,
polysorbate 20, water for injection
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 edema
(DME).
•
the treatment of proliferative diabetic retinopathy (PDR)
•
the treatment of visual impairment due to macular edema secondary to
retinal
vein occlusion (branch RVO or central RVO).
•
the treatment of visual impairment due to choroidal neovascularization
(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.
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DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Single-use vial (adults and preterm infants) or single-use pre-filled
syringe (adults only) 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. The recommended dose for Lucentis