ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection needle guard

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Abatacept, Quantity: 125.875 mg

Διαθέσιμο από:

Bristol-Myers Squibb Australia Pty Ltd

INN (Διεθνής Όνομα):

Abatacept

Φαρμακοτεχνική μορφή:

Injection

Σύνθεση:

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

Οδός χορήγησης:

Subcutaneous

Μονάδες σε πακέτο:

1mL Prefilled syringe with needle guard (4 per pack)

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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).

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2012-01-04

Αρχείο Π.Χ.Π.

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