REMICADE infliximab 100mg powder for injection vial

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Infliximab, Quantity: 100 mg

Disponibbli minn:

Janssen-Cilag Pty Ltd

Għamla farmaċewtika:

Injection, powder for

Kompożizzjoni:

Excipient Ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose

Rotta amministrattiva:

Intravenous Infusion

Indikazzjonijiet terapewtiċi:

Rheumatoid Arthritis in Adults: Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: patients with active disease despite treatment with methotrexate; patients with active disease who have not previously received methotrexate. Remicade should be given in combination with methotrexate. Efficacy and safety in Rheumatoid Arthritis have been demonstrated only in combination with methotrexate. Ankylosing Spondylitis: Remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. Psoriatic arthritis: Remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (DMARD) therapy. Remicade may be administered in combination with methotrexate. Psoriasis: Remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. Safety and efficacy beyond 12 months have not been established. Crohn's Disease in Adults and in Children and adolescents (6-17 years): Remicade is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. Refractory Fistulising Crohn's Disease: Remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. Ulcerative colitis in Adults and in Children and adolescents (6 to 17 years); Remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Sommarju tal-prodott:

Visual Identification: White solid, with no evidence of meltback; free of foreign particles.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2000-08-02

Fuljett ta 'informazzjoni

REMICADE(220427) ACMI
1
REMICADE
®
_Infliximab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REMICADE. It does
not contain all 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 using REMICADE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT REMICADE IS
USED FOR
REMICADE contains the active
ingredient, infliximab. Infliximab is a
monoclonal antibody that is produced
from human and mouse proteins by
recombinant technology. Monoclonal
antibodies are proteins that recognise
and bind to certain special proteins in
the body.
Infliximab acts by binding to a
special protein in the body called
tumour necrosis factor alpha (TNFα).
In people with diseases such as
Crohn's disease, ulcerative colitis,
rheumatoid arthritis, ankylosing
spondylitis, psoriatic arthritis and
psoriasis, the body produces too
much TNFα, which can cause the
body's immune system to attack
normal healthy parts of the body.
REMICADE can block the damage
caused by too much TNFα.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an
inflammatory disease of the joints.
REMICADE is used to reduce the
signs and symptoms of rheumatoid
arthritis and to prevent damage to the
joints. You will also be given a
disease-modifying medicine called
methotrexate.
ANKYLOSING SPONDYLITIS
Ankylosing spondylitis is an
inflammatory disease of the spine.
REMICADE can reduce the signs
and symptoms of ankylosing
spondylitis, thereby improving
physical function.
PSORIATIC ARTHRITIS
Psoriatic arthritis is an inflammatory
disease of the joints in which
psoriasis usually occurs in
association with arthritis. Often the
fingers and toes are affected,
although it may occur in other parts
of the body. REMICADE is used to
reduce the signs and symptoms of
psoriati

Karatteristiċi tal-prodott

CCDS200821
Page 1
REMICADE(220413) API
AUSTRALIAN PRODUCT INFORMATION
REMICADE
® (INFLIXIMAB)
POWDER FOR INJECTION
1. NAME OF THE MEDICINE
Infliximab
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
REMICADE 100 mg Powder for Injection
Each vial of REMICADE contains 100 mg of infliximab, a chimeric
human-murine IgG1 monoclonal
antibody produced in murine hybridoma cells by recombinant DNA
technology.
REMICADE Powder for Injection is to be reconstituted with sterile
Water for Injections and further
diluted in 0.9% sodium chloride solution for infusion. After
reconstitution, each vial of REMICADE
contains infliximab 100 mg/10 mL.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Powder for Injection
The powder is a white solid, with no evidence of meltback; free of
foreign particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS IN ADULTS
REMICADE, in combination with methotrexate, is indicated for the
reduction of signs and symptoms
and prevention of structural joint damage (erosions and joint space
narrowing) in:
־
patients with active disease despite treatment with methotrexate
־
patients with active disease who have not previously received
methotrexate.
REMICADE should be given in combination with methotrexate. Efficacy
and safety in Rheumatoid
Arthritis have been demonstrated only in combination with
methotrexate.
ANKYLOSING SPONDYLITIS
REMICADE is indicated for the reduction of signs and symptoms and
improvement in physical
function in patients with active disease.
PSORIATIC ARTHRITIS
REMICADE is indicated for the treatment of the signs and symptoms, as
well as for the improvement
in physical function in adult patients with active and progressive
psoriatic arthritis who have
responded inadequately to disease-modifying anti-rheumatic drug
(DMARD) therapy.
CCDS200821
Page 2
REMICADE (220413) API
REMICADE may be administered in combination with methotrexate.
PSORIASIS
REMICADE is indicated for the treatment of adult patients with
moderate to severe