ACCENTRIX 10MGML SOLUTION FOR INJECTION

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

Ranibizumab

Tilgjengelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

Ranibizumab

Enheter i pakken:

1Units Units

Produsert av:

NOVARTIS PHARMA STEIN AG

Informasjon til brukeren

Not Applicable

Preparatomtale

Novartis
Page 2
Malaysian Package Leaflet
28-Feb-2022
Accentrix
ACCENTRIX

Antineovascularization agents
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for injection.
Accentrix is supplied in a vial.
Sterile, clear, colorless to pale yellow and preservative-free aqueous
solution.
ACTIVE SUBSTANCE
One mL contains 10 mg ranibizumab.
Each vial contains 2.3 mg of ranibizumab in 0.23 mL solution.
Ranibizumab is a humanized monoclonal antibody fragment produced in
_Escherichia coli _
cells
by recombinant DNA technology.
EXCIPIENTS
alpha, alpha-trehalose dihydrate, histidine hydrochloride,
monohydrate, histidine, polysorbate
20, water for injections.
INDICATIONS
Accentrix 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 (RVO)
•
The treatment of visual impairment due to choroidal neovascularization
(CNV)
Accentrix 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.
Novartis
Page 3
Malaysian Package Leaflet
28-Feb-2022
Accentrix
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Single-use vial (adults and preterm infants) for intravitreal use
only. Use of more than one
injection from a vial can lead to product contamination and subsequent
ocular infection.
Accentrix must be administered by a qualified ophthalmologist
experienced in intravitreal
injections.
POSOLOGY
_ADULTS _
The recommended dose for Accentrix 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