Kineret
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
21-03-2024
Karatteristiċi tal-prodott
(SPC)
21-03-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
22-12-2021
Ingredjent attiv:
anakinra
Disponibbli minn:
Swedish Orphan Biovitrum AB (publ)
Kodiċi ATC:
L04AC03
INN (Isem Internazzjonali):
anakinra
Grupp terapewtiku:
Immunosuppressants
Żona terapewtika:
Arthritis, Rheumatoid; COVID-19 virus infection
Indikazzjonijiet terapewtiċi:
Rheumatoid Arthritis (RA)Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone.COVID-19Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ≥ 6 ng/ml.Periodic fever syndromesKineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:Cryopyrin-Associated Periodic Syndromes (CAPS)Kineret is indicated for the treatment of CAPS, including:Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)Muckle-Wells Syndrome (MWS)Familial Cold Autoinflammatory Syndrome (FCAS)Familial Mediterranean Fever (FMF)Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate.Still’s DiseaseKineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
Sommarju tal-prodott:
Revision: 34
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2002-03-08
Fuljett ta 'informazzjoni
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
KINERET 100 MG/0.67 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Anakinra
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kineret is and what it is used for
2.
What you need to know before you use Kineret
3.
How to use Kineret
4.
Possible side effects
5.
How to store Kineret
6.
Contents of the pack and other information
1.
WHAT KINERET IS AND WHAT IT IS USED FOR
Kineret contains the active substance anakinra. This is a type of
cytokine (an immunosuppressive
agent) that is used to treat:
-
Rheumatoid Arthritis (RA)
-
COVID-19 in patients who have pneumonia, need extra oxygen and are at
risk of lung failure
-
Periodic fever syndromes:
-
Cryopyrin-Associated Periodic Syndromes (CAPS)
o
Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called
Chronic
Infantile Neurological, Cutaneous, Articular Syndrome (CINCA),
o
Muckle-Wells Syndrome (MWS),
o
Familial Cold Autoinflammatory Syndrome (FCAS)
-
Familial Mediterranean Fever (FMF)
-
Still’s disease including Systemic Juvenile Idiopathic Arthritis
(SJIA) and Adult-Onset Still’s
Disease (AOSD)
Cytokines are proteins made by your body that co-ordinate
communication between cells and help
control cell activity. In RA, CAPS, FMF, Still’s disease, and in
COVID-19 pneumonia, your body
produces too much of a cytokine called interleukin-1. This results in
harmful effects leading to
inflammation, causing the symptoms of the disease. Normally, your body
produces a protein that
b
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each graduated pre-filled syringe contains 100 mg of anakinra* per
0.67 ml (150 mg/ml).
* Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in
_Escherichia coli _cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless-to-white solution for injection that may contain
some product-related translucent-
to-white amorphous particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis (RA)
Kineret is indicated in adults for the treatment of the signs and
symptoms of RA in combination with
methotrexate, with an inadequate response to methotrexate alone.
COVID-19
Kineret is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adult patients with
pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who
are at risk of progressing
to severe respiratory failure determined by plasma concentration of
soluble urokinase plasminogen
activator receptor (suPAR) ≥ 6 ng/ml (see sections 4.2, 4.4 and
5.1).
Periodic fever syndromes
Kineret is indicated for the treatment of the following
autoinflammatory periodic fever syndromes in
adults, adolescents, children and infants aged 8 months and older with
a body weight of 10 kg or
above:
_Cryopyrin-Associated Periodic Syndromes (CAPS) _
Kineret is indicated for the treatment of CAPS, including:
-
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic
Infantile Neurological,
Cutaneous, Articular Syndrome (CINCA)
-
Muckle-Wells Syndrome (MWS)
-
Familial Cold Autoinflammatory Syndrome (FCAS)
_Familial Mediterranean Fever (FMF) _
Kineret is indicated for the treatment of Familial Mediterranean Fever
(FMF). Kineret should be given
in combination with colchicine, if appropriate.
Still’s Disease
Kineret is indicated in a
Aqra d-dokument sħiħ
