ENBREL 50 MG SOLUTION FOR INJECTION

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

ETANERCEPT

Доступна с:

PFIZER PHARMACEUTICALS ISRAEL LTD

код АТС:

L04AB01

Фармацевтическая форма:

SOLUTION FOR INJECTION

состав:

ETANERCEPT 50 MG/ML

Администрация маршрут:

S.C

Тип рецепта:

Required

Производитель:

PFIZER INC, USA

Терапевтическая группа:

ETANERCEPT

Терапевтические области:

ETANERCEPT

Терапевтические показания :

* Rheumatoid arthritis:- Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate.. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. - Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.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.* Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease. * Plaque psoriasis Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.* Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.* 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 have proved intolerant of, methotrexate. - Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.Enbrel has not been studied in children aged less than 2 years.* Axial spondyloarthritis- Ankylosing spondylitis(AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.- Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).

Дата Авторизация:

2015-01-31

тонкая брошюра

Enbrel 25 mg and 50 mg PFS, PIL, CC 291023
1
2022-0078193, 2022-0078596
PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) –
1986
The medicine is dispensed with a doctor’s prescription only.
ENBREL
®
25 MG SOLUTION FOR INJECTION
ENBREL
®
50 MG SOLUTION FOR INJECTION
Ready-to-use solution for subcutaneous injection
ACTIVE INGREDIENT AND ITS QUANTITY:
Enbrel 25 mg solution for injection: etanercept 50 mg/ml
Enbrel 50 mg solution for injection: etanercept 50 mg/ml
Inactive ingredients and allergens: see section 2 under "Important
information about
some of this medicine’s ingredients
" and section 6
“Further Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about this medicine. If you have any further
questions, contact
your doctor or pharmacist.
This medicine has been prescribed for you/your child. Do not pass it
on to others. It
may harm them even if it seems to you that their medical condition is
similar to yours.
In addition to the leaflet, the preparations Enbrel 25 mg solution for
injection and
Enbrel 50 mg solution for injection also have a patient safety
information card. This
card contains important safety information that you need to know and
that you
should follow before you start treatment and during treatment with
Enbrel 25 mg
solution for injection or Enbrel 50 mg solution for injection.
Carefully read the
patient safety information card and patient information leaflet before
you start using
this medicine. Keep the card in case you need to read it again.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Enbrel is intended for the treatment of adults for the following
indications:
•
Active RHEUMATOID ARTHRITIS in adults for whom treatment with disease
modifying
anti-rheumatic drugs (DMARDS), including methotrexate, has been
inadequate;
Enbrel
can be used in combination with methotrexate in patients who do not
respond adequately to treatment with methotrexate alone.
•
Active and progressive PSORIATIC ART

Характеристики продукта

Enbrel PFS and PFP, LPD, CC 170124
2023-0088170
1
1.
NAME OF THE MEDICINAL PRODUCT
ENBREL 25 MG SOLUTION FOR INJECTION, IN PRE-FILLED SYRINGE
ENBREL 50 MG SOLUTION FOR INJECTION, IN PRE-FILLED SYRINGE OR
PRE-FILLED PEN.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of Enbrel 25 mg solution for injection -
contains 25 mg of etanercept.
Each pre-filled syringe of Enbrel 50 mg solution for injection -
contains 50 mg of etanercept.
Each pre-filled pen of Enbrel 50 mg solution for injection -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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, and colourless to pale yellow or pale brown.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Enbrel is indicated for the treatment of active
rhematoid
arthritis in adults when the response to disease-modifying
antirheumatic drugs
(DMARDs)
including methotrexate (unless contraindicated
)
has been inadequate.
Enbrel can be
used in combination with methotrexate
in
patients who do not respond adequately
to methotrexate
alone.
Reducing signs and symptoms and inhibiting the progression of
structural damage in patients
with
moderately to
severely
active rheumatoid arthritis
.
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
have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12
years who have had an inadequate response to, or who
have proved intolerant of, methotrexate.
PATIENT