Kineret 100mg0.67ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anakinra

Available from:

Swedish Orphan Biovitrum Ltd

ATC code:

L04AC03

INN (International Name):

Anakinra

Dosage:

150mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 7350046070042 07350031442090

Patient Information leaflet

1
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)
•
Cryopyrin-Associated Periodic Syndromes (CAPS) which includes the
following auto-
inflammatory diseases:
-
Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also called
Chronic Infantile
Neurological, Cutaneous, Articular Syndrome (CINCA),
-
Muckle-Wells Syndrome (MWS),
-
Familial Cold Autoinflammatory Syndrome (FCAS)
Cytokines are proteins made by your body that co-ordinate
communication between cells and help
control cell activity. In Rheumatoid Arthritis and in CAPS, 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
blocks the harmful effects of
interleukin-1. The active substance of Kineret is anakinra, this works
in the same way as your natural
interleukin-1 blocking protein. Anakinra is produced by DNA technology
using the micro-organism _E. _
_coli._
For Rheumatoid Arthr

Summary of Product characteristics

OBJECT 1
KINERET 100 MG SOLUTION FOR INJECTION IN A PRE-
FILLED SYRINGE
Summary of Product Characteristics Updated 05-Jan-2018 | Swedish
Orphan Biovitrum Ltd
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
Kineret is indicated in adults for the treatment of the signs and
symptoms of Rheumatoid Arthritis (RA) in
combination with methotrexate, with an inadequate response to
methotrexate alone.
Kineret 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)
4.2 Posology and method of administration
Kineret treatment should be initiated and supervised by specialist
physicians experienced in the diagnosis
and treatment of rheumatoid arthritis and CAPS, respectively.
Posology
RA: Adults
The recommended dose of Kineret 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 a body weight of 10 kg or
above
_Starting dose: _
The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by
subcutaneous injection. The
therapeuti