KINERET anakinra 100mg/0.67mL solution for injection prefilled syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Anakinra, Quantity: 100 mg

Disponibil de la:

Swedish Orphan Biovitrum Pty Ltd

Forma farmaceutică:

Injection, solution

Compoziție:

Excipient Ingredients: polysorbate 80; sodium citrate dihydrate; water for injections; disodium edetate; sodium chloride

Calea de administrare:

Subcutaneous

Unități în pachet:

4 x 7 syringes

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

KINERET (anakinra) is indicated: -for the treatment of active adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more other Disease Modifying Anti Rheumatic Drugs (DMARDs). KINERET should be given in combination with methotrexate. - in adult and paediatric patients 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), and Familial Cold Autoinflammatory Syndrome (FCAS). - for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years and above who have failed to respond adequately to non-biological DMARDs

Rezumat produs:

Visual Identification: Clear, colourless-to-whitish liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2003-06-17

Prospect

KINERET®
1
KINERET
®
_anakinra _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KINERET. It does
not contain all the available
information. It does not take the
place of talking to your health
professional (i.e. doctor, nurse,
pharmacist).
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using KINERET
against the benefits he/she expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
HEALTH PROFESSIONAL.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START USING KINERET AND
KEEP IT WITH THE MEDICINE.
You may need to read it again.
WHAT KINERET IS
USED FOR
KINERET contains the active
substance anakinra and is used to
treat the signs and symptoms
associated with:
•
active Rheumatoid Arthritis (RA)
in adults in combination with
methotrexate;
•
Cryopyrin-Associated Periodic
Syndromes (CAPS), including
Neonatal-Onset Multisystem
Inflammatory Disease (NOMID) /
Chronic Infantile Neurological,
Cutaneous, Articular Syndrome
(CINCA), Muckle-Wells
Syndrome (MWS), and Familial
Cold Autoinflammatory
Syndrome (FCAS) in adults and
children (aged 8 months and
older);
•
active Systemic Juvenile
Idiopathic Arthritis (SJIA) in
patients aged 2 years and above.
In people with RA, CAPS and SJIA,
the body produces too much of the
protein interleukin-1. Too much
interleukin-1 causes inflammation
contributing to the symptoms of the
diseases. The body blocks this
inflammation by producing an
interleukin-1-receptor antagonist (IL-
1Ra). In patients with RA, CAPS and
SJIA, the amount of IL-1Ra that the
body produces is not enough to
counteract the increased amount of
interleukin-1. KINERET, which
contains anakinra (a man-made
protein similar to IL-1Ra), can block
the action of interleukin-1 and reduce
the signs and symptoms of the
disease.
The time it takes to see an
improvement in symptoms varies
from person to person; your doctor
will monitor your response to
KINERET.
In people with RA, KINERET is
given in combina

Caracteristicilor produsului

AUSTRALIAN PRODUCT INFORMATION –
KINERET
® ANAKINRA
KINERET
®
PI, vA12-0
Page 1 of 18
1. NAME OF THE MEDICINE
Anakinra (rbe).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 0.67 mL (100 mg) of anakinra.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
KINERET is a sterile, clear, colourless-to-white, preservative-free
solution for injection in a
pre-filled syringe. It may contain some small translucent-to-white
particles of protein.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KINERET (anakinra) is indicated
•
for the treatment of active adult rheumatoid arthritis (RA) in
patients who have had
inadequate response to one or more other Disease Modifying Anti
Rheumatic Drugs
(DMARDs). KINERET should be given in combination with methotrexate.
•
in adult and paediatric patients 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), and Familial Cold Autoinflammatory Syndrome (FCAS).
•
for the treatment of active Systemic Juvenile Idiopathic Arthritis
(SJIA) in patients
2 years and above who have failed to respond adequately to
non-biological DMARDs._ _
4.2 DOSE AND METHOD OF ADMINISTRATION
RA
The recommended dose of KINERET in adults and the elderly is 100
mg/day administered
by subcutaneous injection. The dose should be administered at
approximately the same
time every day.
Alternating the injection site is recommended to avoid discomfort at
the site of injection.
Concurrent
treatment
with
KINERET
and
TNF-alpha
antagonists
is
contraindicated
(see section 4.3 CONTRAINDICATIONS).
CAPS
_Starting dose: _
The
recommended
starting
dose
for
both
adults
and
children
is
1-2
mg/kg/day
by
subcutaneous (SC) injection. The therapeutic response is primarily
reflected by reduction in
clinical symptoms such a