KINERET 100 MG SOLUTION FOR INJECTION

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ANAKINRA

Dostopno od:

MEGAPHARM LTD

Koda artikla:

L04AC03

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

ANAKINRA 150 MG/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

SOBI SWEDISH ORPHAN BIOVITRUM AB

Terapevtska skupina:

ANAKINRA

Terapevtsko območje:

ANAKINRA

Terapevtske indikacije:

Kineret 100 mg solution for injection is indicated in adults for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, in patients with an inadequate response to methotrexate alone.Kineret 100 mg solution for injection 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 Cryopyrin-Associated Periodic Syndromes (CAPS), including:- Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)- Muckle-Wells Syndrome (MWS)- Familial Cold Autoinflammatory Syndrome (FCAS) Kineret 100 mg solution for injection is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret 100 mg solution for injection should be given in combination with colchicine, if appropriate.

Datum dovoljenje:

2016-03-31

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a physician’s prescription only
KINERET 100 MG SOLUTION FOR INJECTION
Pre-filled syringes
Solution for Subcutaneous Injection
Each pre-filled syringe contains:
Anakinra 100 mg per 0.67 ml (150 mg/ml)
For a list of inactive and allergenic ingredients in the medicine, see
section 6 ”Additional Information“.
Read this leaflet carefully in its entirety before using the
medicine. This leaflet contains concise information about the
medicine. If you have further questions, consult your physician or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them even if it seems to you that their
illness is similar.
1. What is this medicine intended for?
Kineret 100 mg solution for injection is indicated for the treatment
of
the signs and symptoms of Rheumatoid Arthritis (RA) in combination
with methotrexate, in adult patients with an inadequate response to
methotrexate alone.
Kineret 100 mg solution for injection is indicated for adults and
children aged 8 months and older with a body weight of 10 kg or
above for the treatment of Cryopyrin-Associated Periodic Syndromes
)CAPS(, a group of rare autoinflammatory diseases, including:
-
Chronic Infantile Neurological, Cutaneous, Articular Syndrome
)CINCA(, also called Neonatal-Onset Multisystem Inflammatory
Disease (NOMID).
-
Muckle-Wells Syndrome )MWS(.
-
Familial Cold Autoinflammatory Syndrome )FCAS(.
Kineret 100 mg solution for injection is indicated for the treatment
of Familial Mediterranean Fever (FMF). Kineret should be given in
combination with colchicine, if appropriate.
Kineret 100 mg solution for injection is a cytokine that belongs
to the immunosuppressant group of medicines and is used for the
treatment of Rheumatoid Arthritis and for the treatment of Cryopyrin-
Associated Periodic Syndromes )CAPS(. This is a group of rare,
autoinflammatory diseases including: Familial Cold Autoinf

Lastnosti izdelka

1.
NAME OF THE MEDICINAL PRODUCT
Kineret 100 mg solution for injection.
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
Kineret 100 mg solution for injection is indicated in adults for the
treatment of the signs and
symptoms of Rheumatoid Arthritis (RA) in combination with
methotrexate, in patients with an
inadequate response to methotrexate alone.
Kineret 100 mg solution for injection 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 Cryopyrin-
Associated Periodic Syndromes (CAPS), including:
-
Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic
Infantile
Neurological, Cutaneous, Articular Syndrome (CINCA)
-
Muckle-Wells Syndrome (MWS)
-
Familial Cold Autoinflammatory Syndrome (FCAS)
Kineret 100 mg solution for injection is indicated for the treatment
of Familial Mediterranean
Fever (FMF). Kineret 100 mg solution for injection should be given in
combination with
colchicine, if appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kineret 100 mg solution for injection treatment should be initiated
and supervised by specialist
physicians experienced in the diagnosis and treatment of Rheumatoid
Arthritis, FMF and CAPS,
respectively.
Posology
RA: Adults
The recommended dose of Kineret 100 mg solution for injection is 100
mg administered once a
day by subcutaneous injection. The dose should be administered at
approximately the same time
each day.
CAPS: Adults, adolescents, children and infants aged 8 months and
older with