ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Abatacept, Quantity: 125.875 mg

Fáanlegur frá:

Bristol-Myers Squibb Australia Pty Ltd

INN (Alþjóðlegt nafn):

Abatacept

Lyfjaform:

Injection

Samsetning:

Excipient Ingredients: sucrose; water for injections; monobasic sodium phosphate; poloxamer; nitrogen; dibasic sodium phosphate

Stjórnsýsluleið:

Subcutaneous

Einingar í pakka:

1mL Prefilled syringe with Autoinjector (4 per pack)

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.,ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.,ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.),ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without non-biologic DMARDs.,ORENCIA should not be administered concurrently with other biological DMARDs (eg, TNF inhibitors, rituximab, or anakinra).

Vörulýsing:

Visual Identification: Clear to slightly opalescent, colourless to pale yellow solution; Container Type: Syringe; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2015-06-17

Upplýsingar fylgiseðill

ORENCIA
®
(OR-EN-SEE-AH)
_Abatacept (ab-ah-ta-sept) (rch) Powder for intravenous infusion;
Abatacept (rch) solution for Injection_
_(pre-filled syringe, pre-filled autoinjector)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ORENCIA. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving ORENCIA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
YOU SHOULD READ THIS LEAFLET
CAREFULLY AND KEEP IT IN A SAFE PLACE
TO REFER TO IT LATER.
WHAT ORENCIA IS
USED FOR
ORENCIA contains abatacept; a
medicine which is used to treat:
•
moderate to severe rheumatoid
arthritis in adults;
•
severe, active and progressive
rheumatoid arthritis,
•
psoriatic arthritis in adults, and
•
polyarticular juvenile idiopathic
arthritis.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is a disease that
causes pain and joint inflammation
(tenderness and swelling). It can also
cause joint damage.
You may be given ORENCIA and
methotrexate to:
•
Reduce the signs and symptoms
of your disease.
•
Slow down the damage to your
bones and joints.
•
Improve your physical function
and your ability to do normal
daily activities.
PSORIATIC ARTHRITIS
Psoriatic arthritis is an inflammatory
disease of the joints, usually
accompanied by psoriasis, an
inflammatory disease of the skin. If
you have active psoriatic arthritis you
will first be given other medicines. If
you do not respond well enough to
these medicines, you may be given
ORENCIA.
POLYARTICULAR JUVENILE IDIOPATHIC
ARTHRITIS
ORENCIA infused intravenously is
also used to treat moderate to severe
polyarticular juvenile idiopathic
arthritis in children and adolescents 6
years of age and older who have had
an inadequate response to one or
more disease-modifying anti-
rheumatic drugs.
It is not recommended to use the

Vara einkenni

AU_PI_Orencia_V19.0
1
AUSTRALIAN PRODUCT INFORMATION
ORENCIA
® (ABATACEPT)
1
NAME OF THE MEDICINE
abatacept
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abatacept is a fusion protein produced by recombinant DNA technology
in Chinese hamster ovary
cells.
LYOPHILIZED POWDER FOR IV INFUSION
Each vial contains 250 mg abatacept.
EXCIPIENT WITH KNOWN EFFECT
Each vial contains 8.625 mg sodium.
SOLUTION FOR SUBCUTANEOUS ADMINISTRATION
Each 1 mL pre-filled syringe or autoinjector contains 125 mg
abatacept.
EXCIPIENT WITH KNOWN EFFECT
Each syringe or autoinjector contains 0.322 mg sodium.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
LYOPHILIZED POWDER FOR IV INFUSION
ORENCIA is a sterile, white, preservative-free, lyophilized powder for
parenteral administration.
Following reconstitution with 10 mL of sterile water for injection,
the solution of ORENCIA is clear,
colourless to pale yellow, with a pH range of 7.2 to 7.8.
SOLUTION FOR SUBCUTANEOUS ADMINISTRATION
ORENCIA, solution for injection, pre-filled syringe or autoinjector is
supplied as a sterile, preservative-
free, ready-to-use solution for subcutaneous injection. The
subcutaneous solution is clear, colourless to
pale yellow with a pH of 6.8 to 7.4.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ORENCIA in combination with methotrexate is indicated for the
treatment of moderate to severe active
rheumatoid arthritis in adult patients who have had an insufficient
response or intolerance to other
disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate
or tumour necrosis factor
(TNF) blocking agents. A reduction in the progression of joint damage
and improvement in physical
function have been demonstrated during combination treatment with
ORENCIA and methotrexate.
ORENCIA in combination with methotrexate is also indicated in the
treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated with
methotrexate.
ORENCIA is indicated for reducing signs and symptoms in paediatri