Eucept 25 mg 0.5 mL Solution for Injection in Pre-filled Syringe

Country: Malaysia

Language: English

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

Active ingredient:

ETANERCEPT __

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

ETANERCEPT __

Units in package:

4 x 1 Pre-Filled Syringes

Manufactured by:

LG CHEM LTD

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
EUCEPT 25 MG / 0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EUCEPT 50 MG / ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EUCEPT 50 MG / ML AUTOINJECTOR IN PRE-FILLED SYRINGE
EUCEPT IS A BIOSIMILAR OF ENBREL
®
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS, ACTIVE MOIETIES
Etanercept (INN)
Etanercept is a human tumor necrosis factor receptor (TNFR) p75 Fc
fusion protein produced by
recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian
cell expression
system.
Etanercept is a dimer
of a chimeric
protein
genetically engineered
by fusing the
extracellular ligand binding domain of human tumor necrosis factor
receptor-2 (TNFR2/p75) to
the Fc domain of human IgG1. The Fc component of etanercept contains
the hinge, CH2 and CH3
regions, but not the CH1 region of IgG1.
Solubility: Etanercept is soluble in water.
Molecular weight: (apparent) 150 kilodaltons.
PHYSICAL CHARACTERISTICS
_Solution for injection in pre-filled syringe or Autoinjector _
_ _
The solution for injection in the pre-filled syringe or autoinjector
syringe is colourless to light yellow,
clear to opalescent solution for injection, with a pH of 6.0~6.6. It
is sterile and does not contain
preservatives.
3.
PHARMACEUTICAL FORM
All Eucept dosage forms are intended for subcutaneous injection.
Solution for injection in pre-filled syringe or autoinjector
COMPOSITION AND PHARMACEUTICAL CHARACTERISTICS
Eucept 25 mg / 0.5 mL Solution for Injection in Pre-filled Syringe
Each pre-filled syringe contains 25 mg of etanercept (active
ingredient).
Eucept 50 mg / mL Solution for Injection in Pre-filled Syringe
Each pre-filled syringe contains 50 mg of etanercept (active
ingredient).
Eucept 50 mg / mL Autoinjector in Pre-filled Syringe
Each autoinjector syringe contains 50 mg of etanercept (active
ingredient).
_For full list of ingredients see section 6.1 List of Excipients _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Treatment of signs and symptoms and i