ENBREL POWDER AND SOLVENT

Country: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

ETANERCEPT

Доступно од:

PFIZER PHARMACEUTICALS ISRAEL LTD

АТЦ код:

L04AB01

Фармацеутски облик:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Састав:

ETANERCEPT 25 MG/VIAL

Пут администрације:

S.C

Тип рецептора:

Required

Произведен од:

PFIZER INC, USA

Терапеутска група:

ETANERCEPT

Терапеутска област:

ETANERCEPT

Терапеутске индикације:

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.*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).

Датум одобрења:

2023-08-31

Информативни летак

Enbrel powder and solvent, PIL, CC 291023
1
2022-0078193, 2022-0078593, 2022-0078596
PATIENT LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) –
1986
The medicine is dispensed with a
doctor’s prescription only.
ENBREL
®
POWDER AND SOLVENT
POWDER AND SOLVENT FOR SOLUTION FOR SUBCUTANEOUS
INJECTION
EACH VIAL WITH POWDER CONTAINS:
etanercept 25 mg
Inactive ingredients and allergens: see 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 preparation Enbrel powder and solvent
also has 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 powder and solvent. Carefully read the patient
safety
information card and patient 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 ARTHRITIS in adults for whom
treatment with
disease modifying anti-rheumatic drugs (DMARDS) has been inadequate.
•
AXIAL SPONDYLOARTHRITIS:
o
Active and severe NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS in adults
who
do not respond adequately to treatment with non-steroidal
anti-inflammatory
drugs.
o
Severe and active ANKYLOSING

Карактеристике производа

Enbrel powder and solvent, LPD, CC 170124
2023-0088170
1
1.
NAME OF THE MEDICINAL PRODUCT
ENBREL POWDER AND SOLVENT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 25 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
Powder and solvent for solution for injection (powder for injection).
The powder is white. The solvent is a clear, colourless liquid.
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.
PATIENT SAFETY INFORMATION CARD
The marketing of Enbrel powder and solvent is subject to a risk
management plan (RMP)
including a 'Patient safety information card'. The 'Patient safety
information card', emphasizes
important safety information that the patient should be aware of
before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
Enbrel powder and solvent, LPD, CC 170124
2023-0088170
2
Treatment of psoriatic