Sylvant
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
17-07-2023
Valmisteyhteenveto
(SPC)
17-07-2023
Julkisesta arviointikertomuksesta
(PAR)
13-07-2018
Aktiivinen ainesosa:
siltuximab
Saatavilla:
Recordati Netherlands B.V.
ATC-koodi:
L04AC11
INN (Kansainvälinen yleisnimi):
siltuximab
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Giant Lymph Node Hyperplasia
Käyttöaiheet:
Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.,
Tuoteyhteenveto:
Revision: 13
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-05-22
Pakkausseloste
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYLVANT 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
siltuximab
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SYLVANT is and what it is used for
2.
What you need to know before you are given SYLVANT
3.
How SYLVANT is given
4.
Possible side effects
5.
How to store SYLVANT
6.
Contents of the pack and other information
1.
WHAT SYLVANT IS AND WHAT IT IS USED FOR
WHAT SYLVANT IS
SYLVANT is a medicine that contains the active substance siltuximab.
Siltuximab is a monoclonal antibody (a specialised type of protein)
that binds selectively to an antigen
(a target protein) in the body called interleukin-6 (IL-6).
WHAT SYLVANT IS USED FOR
SYLVANT is used to treat multicentric Castleman’s disease (MCD) in
adult patients who do not have
human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8)
infection.
Multicentric Castleman’s disease causes benign tumours
(non-cancerous growths) to develop in the
lymph nodes in the body. Symptoms of this disease may include feeling
tired, sweating at night,
having a tingling feeling, and loss of appetite.
HOW SYLVANT WORKS
Patients with MCD produce too much IL-6 and this is thought to
contribute to the abnormal growth of
certain cells in lymph nodes. By binding to IL-6, siltuximab blocks
its activity and stops abnormal cell
growth. This helps reduce the size of the affected lymph nodes,
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
SYLVANT 100 mg powder for concentrate for solution for infusion
SYLVANT 400 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYLVANT 100 mg powder for concentrate for solution for infusion
Each single-use vial contains 100 mg siltuximab powder for concentrate
for solution for infusion.
After reconstitution the solution contains 20 mg siltuximab per mL.
SYLVANT 400 mg powder for concentrate for solution for infusion
Each single-use vial contains 400 mg siltuximab powder for concentrate
for solution for infusion.
After reconstitution the solution contains 20 mg siltuximab per mL.
Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ)
monoclonal antibody
produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
The product is a freeze-dried white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SYLVANT is indicated for the treatment of adult patients with
multicentric Castleman’s disease
(MCD) who are human immunodeficiency virus (HIV) negative and human
herpesvirus-8 (HHV-8)
negative.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be administered by qualified healthcare
professionals and under
appropriate medical supervision.
Posology
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an
intravenous infusion
administered every 3 weeks until treatment failure.
_Treatment criteria_
Haematology laboratory tests should be performed prior to each dose of
SYLVANT therapy for the
first 12 months and every third d
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