Raptiva
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-08-2009
Charakterystyka produktu
(SPC)
04-08-2009
Sprawozdanie z oceny publicznego
(PAR)
04-08-2009
Składnik aktywny:
efalizumab
Dostępny od:
Serono Europe Limited
Kod ATC:
L04AA21
INN (International Nazwa):
efalizumab
Grupa terapeutyczna:
Immunosuppressants
Dziedzina terapeutyczna:
Psoriasis
Wskazania:
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 - Clinical Efficacy).
Podsumowanie produktu:
Revision: 8
Status autoryzacji:
Withdrawn
Data autoryzacji:
2004-09-20
Ulotka dla pacjenta
Medicinal product no longer authorised
23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAPTIVA
100 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
EFALIZUMAB
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions,ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Raptiva is and what it is used for
2.
Before you use Raptiva
3.
How to use Raptiva
4.
Possible side effects
5
How to store Raptiva
6.
Further information
1.
WHAT RAPTIVA IS AND WHAT IT IS USED FOR
Raptiva is a systemic psoriasis medicine. Systemic therapies are
medicines taken orally or
administered by injection and thus will be present in and affect the
whole body.
Raptiva is a medicine containing efalizumab, made by means of
biotechnology. It is produced by
genetically engineered mammalian cells. Efalizumab is a monoclonal
antibody. Monoclonal antibodies
are proteins that recognise and bind to other specific proteins of the
human body. Efalizumab reduces
inflammation of the psoriatic lesions which results in improvement of
the affected areas of the skin.
THERAPEUTIC INDICATIONS
Treatment of adult patients with moderate to severe chronic plaque
psoriasis who have failed to
respond to, or who have a contraindication to, or are intolerant to
other systemic therapies including
ciclosporin, methotrexate and PUVA.
This restriction of the indication of Raptiva is based on the present
efficacy data and limited long-term
experience with Raptiva.
2.
BEFORE YOU USE RAPTIVA
Ask your doctor or pharmacist for advice before taking any medicine.
DO NOT USE RAPTIVA:
-
If you are allergic (hypersensitive) to efalizumab or a
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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
Raptiva 100 mg/ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains a retrievable amount of 125 mg of efalizumab.
Reconstitution with the solvent yields a solution containing
efalizumab at 100 mg/ml.
Efalizumab is a recombinant humanized monoclonal antibody produced in
genetically engineered
Chinese Hamster Ovary (CHO) cells. Efalizumab is an IgG1 kappa
immunoglobulin, containing
human constant region sequences and murine light- and heavy-chain
complementary determining
region sequences.
Excipients: 2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg
histidine hydrochloride monohydrate,
102.7 mg sucrose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white to off white cake.
The solvent is a clear, colourless liquid.
The pH of the reconstituted solution is 5.9 – 6.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with moderate to severe chronic plaque
psoriasis who have failed to
respond to, or who have a contraindication to, or are intolerant to
other systemic therapies including
ciclosporin, methotrexate and PUVA (see section 5.1 – Clinical
Efficacy).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Raptiva should be initiated by a physician specialised
in dermatology.
An initial single dose of 0.7 mg/kg body weight is given followed by
weekly injections of 1.0 mg/kg
body weight (maximum single dose should not exceed a total of 200 mg).
The volume to be injected
should be calculated as follows:
Dose
Volume to be injected per
10 kg body weight
Single initial dose: 0.7 mg/kg
0.07 ml
Subsequent doses: 1 mg/kg
0.1 ml
The duration of therapy is 12 weeks. Therapy may be continued only in
patients who responded to
treatment (PGA good or better). For discontinuation guidance
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