REMSIMA infliximab 120 mg solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Infliximab, Quantity: 120 mg

Available from:

Celltrion Healthcare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections

Administration route:

Subcutaneous

Units in package:

6 pre filled syringes, 2 pre filled syringes, 1 pre filled syringe, 4 pre filled syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid Arthritis in adults REMSIMA 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.,REMSIMA should be given in combination with methotrexate. Efficacy and safety in Rheumatoid Arthritis have been demonstrated only in combination with methotrexate.,Ankylosing Spondylitis REMSIMA is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,Psoriatic arthritis REMSIMA 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. REMSIMA may be administered in combination with methotrexate.,Psoriasis REMSIMA 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 REMSIMA 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 REMSIMA is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,Ulcerative colitis in Adults REMSIMAis indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Product summary:

Visual Identification: Colourless to pale brown, clear to opalescent solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-11-12

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
Celltrion Healthcare Australia Pty Ltd
Infliximab 120mg solution for injection
REMSIMA® (PFS) CMI – v0621
Page 1 of 20
REMSIMA
®
120MG SUBCUTANEOUS INJECTION
Contains the active ingredients:
infliximab (RMC) 120mg Solution for injection in pre-filled syringe
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers
some common questions
about REMSIMA
®
for
subcutaneous (under the
skin) injection. 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 REMSIMA
®
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
REMSIMA
®
IS USED
FOR
REMSIMA
®
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.
REMSIMA
®
can block the
damage caused by too
much TNFα.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is
an inflammatory disease
of the joints. REMSIMA
®
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. REMSIMA
®
can reduce the signs and
symptoms of ankylosing
spondylitis, thereby
improving physical
fu

Summary of Product characteristics

Supersedes: v0821
Page 1 of 67
Version: v0522
AUSTRALIAN PRODUCT INFORMATION –
REMSIMA
®
(INFLIXIMAB (RMC))
1
NAME OF THE MEDICINE
Infliximab
REMSIMA
®
(infliximab) is an approved biosimilar to the reference product
REMICADE
®
(infliximab).
Comparability
in
safety,
efficacy
and
quality
between
REMSIMA
®
and
REMICADE
®
has been established
_._
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remsima
®
100 mg powder for injection vial:
Each vial contains infliximab 100 mg. After reconstitution each ml
contains 10 mg of
infliximab.
Remsima
®
120 mg solution for injection in pre-filled syringe:
Each 1 mL single dose pre-filled syringe contains 120 mg of
infliximab*.
Remsima
®
120 mg solution for injection in pre-filled pen:
Each 1 mL single dose pre-filled pen contains 120 mg of infliximab*.
Excipient(s) with known effect
Sorbitol 45 mg per 1 mL
3
PHARMACEUTICAL FORM
Remsima
®
100 mg vial - Powder for Injection.
Remsima
®
120 mg pre-filled syringe/pen – Solution for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REMSIMA
® 100 MG POWDER FOR INJECTION (INTRAVENOUS FORMULATION)
RHEUMATOID ARTHRITIS IN ADULTS
REMSIMA
®
, 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.
REMSIMA
®
should be given in combination with methotrexate. Efficacy and safety
in
Supersedes: v0821
Page 2 of 67
Version: v0522
Rheumatoid Arthritis have been demonstrated only in combination with
methotrexate.
ANKYLOSING SPONDYLITIS
REMSIMA
®
is indicated for the reduction of signs and symptoms and improvement
in
physical function in patients with active disease.
PSORIATIC ARTHRITIS
REMSIMA
®
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
w