Orencia 250mg powder for concentrate for solution for infusion vials

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Abatacept

Dostupno od:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC koda:

L04AA24

INN (International ime):

Abatacept

Doziranje:

250mg

Farmaceutski oblik:

Powder for solution for infusion

Administracija rute:

Intravenous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 10010300; GTIN: 5012712003779

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORENCIA 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
abatacept
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ORENCIA is and what it is used for
2.
What you need to know before you are given ORENCIA
3.
How to use ORENCIA
4.
Possible side effects
5
How to store ORENCIA
6.
Contents of the pack and other information
1.
WHAT ORENCIA IS AND WHAT IT IS USED FOR
ORENCIA contains the active substance abatacept, a protein produced in
cell cultures. ORENCIA
lessens the immune system's attack on normal tissues by interfering
with the immune cells (called T
lymphocytes) that contribute to the development of rheumatoid
arthritis. ORENCIA selectively
modulates the activation of T cells involved in the immune systems’
inflammatory response.
ORENCIA is used to treat Rheumatoid arthritis and Psoriatic Arthritis
in adults.
Rheumatoid Arthritis
Rheumatoid arthritis is a long-term progressive systemic disease that,
if untreated, can lead to serious
consequences, such as joint destruction, increased disability and
impairment of daily activities. In
people with rheumatoid arthritis the body's own immune system attacks
normal body tissues, leading
to pain and swelling of the joints. This can cause joint damage.
Rheumatoid arthritis (RA) affects
everyone differently. In most people, joint symptoms develop gradually
over several years. However,
in some, RA may progress rapidly and yet other people may have RA for
a limited period of time and
then enter a period of remission. RA is usually a chronic (long-term),
progressive disease. This means,
even if you’re on treatment, whether or not yo

Svojstava lijeka

OBJECT 1
ORENCIA 250 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Aug-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
ORENCIA 250 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains 250 mg of abatacept.
Each mL contains 25 mg of abatacept, after reconstitution.
Abatacept is a fusion protein produced by recombinant DNA technology
in Chinese hamster ovary cells.
Excipient with known effect: sodium: 0.375 mmol (8.625 mg) per vial
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
The powder is a white to off-white whole or fragmented cake.
4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis
ORENCIA, in combination with methotrexate, is indicated for:
▪ the treatment of moderate to severe active rheumatoid arthritis
(RA) in adult patients who responded
inadequately to previous therapy with one or more disease-modifying
anti-rheumatic drugs (DMARDs)
including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha
inhibitor.
▪ the treatment of highly active and progressive disease in adult
patients with rheumatoid arthritis not
previously treated with methotrexate.
A reduction in the progression of joint damage and improvement of
physical function have been
demonstrated during combination treatment with abatacept and
methotrexate.
Psoriatic Arthritis
ORENCIA, alone or in combination with methotrexate (MTX), is indicated
for the treatment of active
psoriatic arthritis (PsA) in adult patients when the response to
previous DMARD therapy including MTX
has been inadequate, and for whom additional systemic therapy for
psoriatic skin lesions is not required.
Polyarticular juvenile idiopathic arthritis
ORENCIA in combination with methotrexate is indicated for the
treatment of moderate to severe active
polyarticular juvenile idiopathic arthritis (JIA) in paediatric
patients 6 y