Enbrel solution for s/c injection

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

etanercept

Disponibbli minn:

Wyeth Pharmaceuticals

Kodiċi ATC:

L04AB01

INN (Isem Internazzjonali):

etanercept

Dożaġġ:

50mg/ml

Għamla farmaċewtika:

solution for s/c injection

Unitajiet fil-pakkett:

(4) pre-filled glass pen-syringes 1ml and (4) alcohol swabs

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2017-09-26

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Enbrel
®
50 mg solution for injection in pre-filled syringe.
Enbrel
®
50 mg solution for injection in pre-filled pen.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: etanercept 50.0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear or opalescent from colourless to yellow liquid.
Small transparent to white amorphous particles are permissible.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Rheumatoid arthritis _
In combination with methotrexate, Enbrel
®
is prescribed to adults for the treatment of
moderate and severe active rheumatoid arthritis when response to
disease-modifying anti-
rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
Enbrel
®
may
be
prescribed
as
monotherapy
in
case
of
inefficacy
or
intolerance
of
methotrexate.
Enbrel
®
is indicated for the treatment of severe active and progressive
rheumatoid arthritis in
adults who have not been previously treated with methotrexate.
_Juvenile_ _idiopathic_ _polyarthritis_
Treatment
of
active
juvenile
idiopathic
polyarthritis
(seropositive
and
seronegative)
in
children and adolescents aged 12 years and older with a body weight of
more than 62.5 kg
(for Enbrel
®
in the pharmaceutical form of a solution for subcutaneous injection),
who have
had an ineffective response or intolerance to methotrexate.
Treatment of extended oligoarthritis in children and adolescents aged
12 years and older with
a body weight of more than 62.5 kg (for Enbrel
®
in the pharmaceutical form of a “solution for
subcutaneous
injection”),
who
have
had
an
ineffective
response
or
intolerance
to
methotrexate.
Treatment of psoriatic arthritis in adolescents aged 12 years and
older with a body weight of
more than 62.5 kg (for Enbrel
®
in the pharmaceutical form of a “solution for subcutaneous
injection”), who have had an ineffective response or intolerance to
methotrexate.
Treatment of arthritis associated with enthesitis in adolescents aged
12