Enbrel

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

etanercept

Beschikbaar vanaf:

Wyeth Pharmaceuticals

INN (Algemene Internationale Benaming):

etanercept

Dosering:

50mg/ml

farmaceutische vorm:

solution for s/c injection

Prescription-type:

Prescription

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
187
1.
NAME OF THE MEDICINAL PRODUCT
Enbrel 50 mg solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 50 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion
protein produced by recombinant
DNA technology in a Chinese hamster ovary (CHO) mammalian expression
system. Etanercept is a
dimer of a chimeric protein genetically engineered by fusing the
extracellular ligand binding domain
of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc
domain of human IgG1. This Fc
component contains the hinge, CH
2
and CH
3
regions, but not the CH
1
region of IgG1. Etanercept
contains 934 amino acids and has an apparent molecular weight of
approximately 150 kilodaltons. The
specific activity of etanercept is 1.7 x 10
6
units/mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, and colourless or pale yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
R
h
eumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment
of moderate to severe active
rheumatoid arthritis in adults when the response to disease-modifying
antirheumatic drugs, including
methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults
not previously treated with methotrexate.
Enbrel, alone or in combination with methotrexate, has been shown to
reduce the rate of progression
of joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative)
and extended oligoarthritis in
children and adolescents from the age of 2 years who have had an
inadequate response to, or who