RENFLEXIS infliximab 100 mg powder for injection vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Infliximab, Quantity: 100 mg

Dostępny od:

Samsung Bioepis AU Pty Ltd

INN (International Nazwa):

Infliximab

Forma farmaceutyczna:

Injection, powder for

Skład:

Excipient Ingredients: water for injections; sucrose; monobasic sodium phosphate monohydrate; polysorbate 80; dibasic sodium phosphate heptahydrate

Droga podania:

Intravenous Infusion

Sztuk w opakowaniu:

Pack of one

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

RENFLEXIS is indicated for the treatment of:,Rheumatoid Arthritis in adults RENFLEXIS, 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.,RENFLEXIS should be given in combination with methotrexate. Efficacy and safety in Rheumatoid Arthritis have been demonstrated only in combination with methotrexate,Ankylosing Spondylitis RENFLEXIS is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,Psoriatic arthritis RENFLEXIS 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.,RENFLEXIS may be administered in combination with methotrexate.,Psoriasis RENFLEXIS 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 to 17 years) RENFLEXIS 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 RENFLEXIS 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) RENFLEXIS is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Podsumowanie produktu:

Visual Identification: White lyophilised powder in a glass vial with rubber stopper and aluminum crimp protected by a plastic cap; Container Type: Vial; Container Material: Glass; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Licence status A

Data autoryzacji:

2016-11-28

Ulotka dla pacjenta

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Version 8.0
_RENFLEXIS_
_®_
_ - infliximab_
Page 1 / 7
RENFLEXIS
®
_Infliximab _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
RENFLEXIS.
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
RENFLEXIS against the benefits
this medicine 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 RENFLEXIS IS
USED FOR
RENFLEXIS contains the active
ingredient, infliximab.
RENFLEXIS is a biosimilar
medicine. Comparability in
safety, efficacy and quality
between RENFLEXIS and the
reference product has been
established.
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.
RENFLEXIS can block the
damage caused by too much
TNFα.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an
inflammatory disease of the
joints. RENFLEXIS 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. RENFLEXIS 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 whic

Charakterystyka produktu

_Product Information _
_RENFLEXIS_
_®_
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Version 12.0
Page 1 / 53
AUSTRALIAN PRODUCT INFORMATION
RENFLEXIS
® (INFLIXIMAB) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Infliximab
RENFLEXIS (infliximab) is a biosimilar medicine to Remicade
®
(infliximab). The
comparability of RENFLEXIS with Remicade
®
has been demonstrated with regard to
physicochemical characteristics and efficacy and safety outcomes (see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES - COMPARABILITY OF RENFLEXIS WITH
REMICADE
®
). The evidence for comparability supports the use of RENFLEXIS for
the listed
indications.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RENFLEXIS
®
100 mg Power for Injection
Each vial of RENFLEXIS contains infliximab 100 mg, a chimeric
human-murine IgG1
monoclonal antibody produced by recombinant DNA technology.
RENFLEXIS 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 RENFLEXIS contains infliximab 100 mg/10 mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
Powder for Injection
The powder is white, free of foreign particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS IN ADULTS
RENFLEXIS, 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.
RENFLEXIS should be given in combination with methotrexate. Efficacy
and safety in
Rheumatoid Arthritis have been demonstrated only in combination with
methotrexate.
_Product Information _
_RENFLEXIS_
_®_
_ _
Version 12.0
Page 2 / 53
ANKYLOSING SPONDYLITIS
RENFLEXIS is indicated for the reduction of signs and symptoms and
improvement in
physical function in patients with active disease.
PSORIATIC ARTHRITIS
RENFLEXIS is indica