Trudexa
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-02-2008
Charakterystyka produktu
(SPC)
15-02-2008
Sprawozdanie z oceny publicznego
(PAR)
15-02-2008
Składnik aktywny:
adalimumab
Dostępny od:
Abbott Laboratories Ltd.
Kod ATC:
L04AA17
INN (International Nazwa):
adalimumab
Grupa terapeutyczna:
Immunosuppressants
Dziedzina terapeutyczna:
Spondylitis, Ankylosing; Arthritis, Rheumatoid; Arthritis, Psoriatic; Crohn Disease
Wskazania:
Rheumatoid arthritisTrudexa in combination with methotrexate, is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.Psoriatic arthritisTrudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.Ankylosing spondylitisTrudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Crohn's diseaseTrudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Trudexa should be given in combination with cortiocosteroids. Trudexa can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Withdrawn
Data autoryzacji:
2003-09-01
Ulotka dla pacjenta
Medicinal Product no longer authorised
119
PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE
PACKAGE LEAFLET)
TRUDEXA PATIENT ALERT CARD
This alert card contains important safety
information that you need to be aware of before
you are given Trudexa and during treatment with
Trudexa.
•
Show this card to any doctor involved in your
treatment.
INFECTIONS
Trudexa increases the risk of getting infections.
Infections may progress more rapidly and be
more severe. This includes tuberculosis.
_Prior to Trudexa treatment:_
•
You should not be treated with Trudexa if
you have a severe infection.
•
You should be screened for tuberculosis. It is
very important that you tell your doctor if you
have ever had tuberculosis, or if you have
been in close contact with someone who has
had tuberculosis. Please record the dates of
the last screening for tuberculosis below:
Tuberculin test: _______________
Chest X-ray:
_______________
_During Trudexa treatment: _
•
If you develop symptoms suggestive of
infections, such as fever, persistent cough,
weight loss, or listlessness, seek medical
attention immediately.
HEART FAILURE
_Prior to Trudexa treatment: _
•
Trudexa should not be used if you have
moderate to severe heart failure.
_During Trudexa treatment: _
•
If you develop symptoms of heart failure
(shortness of breath or swelling of the feet)
seek medical attention immediately.
DATES OF TRUDEXA TREATMENT:
1 st injection: _______________________
Following injections:
_______________________
_______________________
_______________________
_______________________
•
See the Trudexa package leaflet for more
information.
•
Please make sure you also have a list of all
your other medicines with you at any visit to
a health care professional.
Patient’s Name: _____________________
Doctor’s Name: _____________________
Doctor’s Phone: _____________________
•
Keep this card with you for 5 months after the
last Trudexa dose, since side effects may
occur a long time after your last dose of
Trudexa.
Medicinal Pro
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Charakterystyka produktu
Medicinal Product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Trudexa 40 mg solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody expressed in
Chinese Hamster Ovary cells.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Trudexa in combination with methotrexate, is indicated for:
the treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the
response to disease-modifying anti-rheumatic drugs including
methotrexate has been
inadequate.
the treatment of severe, active and progressive rheumatoid arthritis
in adults not previously
treated with methotrexate.
Trudexa can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Trudexa has been shown to reduce the rate of progression of joint
damage as measured by X-ray and
to improve physical function, when given in combination with
methotrexate.
Psoriatic arthritis
Trudexa is indicated for the treatment of active and progressive
psoriatic arthritis in adults when the
response to previous disease-modifying anti-rheumatic drug therapy has
been inadequate.
Ankylosing spondylitis
Trudexa is indicated for the treatment of adults with severe active
ankylosing spondylitis who have
had an inadequate response to conventional therapy.
Crohn’s disease
Trudexa is indicated for treatment of severe, active Crohn’s
disease, in patients who have not
responded despite a full and adequate course of therapy with a
corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such therapies.
For induction treatment, Trudexa should be given in combination with
cortiocosteroids. Trudexa can
be given as monoth
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