Remsima 120mg solution for injection in pre-filled syringe

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Infliximab

Inapatikana kutoka:

CELLTRION HEALTHCARE MALAYSIA SDN. BHD.

INN (Jina la Kimataifa):

Infliximab

Vitengo katika mfuko:

1 x 1mL Pre-Filled Syringes; 2 x 1mL Pre-Filled Syringes; 1 x 1mL Pre-Filled Syringes; 2 x 1mL Pre-Filled Syringes

Viwandani na:

CELLTRION, Inc.

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
REMSIMA
® 120MG SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE (PFS)
Infliximab (120mg)
1
WHAT IS IN THIS LEAFLET
1.
What Remsima is used for
2.
How Remsima works
_3._
_ _
Before you use Remsima
_ _
4.
How to use Remsima
5.
While you are using Remsima
6.
Side effects
_7._
_ _
Storage and Disposal of Remsima
_ _
8.
Product Description
9.
Manufacturer and Batch Releaser
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT REMSIMA IS USED FOR
Remsima
is
used
in
adults
for
the
following inflammatory diseases:
•
Rheumatoid arthritis
•
Ankylosing spondylitis
•
Psoriatic arthritis
•
Psoriasis
•
Crohn’s disease
•
Fistulizing Crohn’s disease
•
Ulcerative colitis.
HOW REMSIMA WORKS
Remsima contains the active substance
infliximab. Infliximab is a monoclonal
antibody which belongs to a group of
medicines called ‘TNF blockers’.
Remsima works by selectively attaching
to tumour necrosis factor (TNF) alpha
and blocking its action, thereby reducing
the inflammation in your body.
BEFORE YOU USE REMSIMA_ _
-
_When you must not use it _
YOU MUST NOT BE GIVEN REMSIMA IF
•
you are allergic to infliximab or any
of
the
other
ingredients
of
this
medicine,
•
you are allergic to proteins that come
from mice,
•
you
have
tuberculosis
(TB)
or
another
serious
infection
such
as
pneumonia
or
sepsis
(serious
bacterial infection of the blood),
•
you
have
heart
failure
that
is
moderate or severe.
Do not use Remsima if any of the above
applies to you. If you are not sure, talk to
your
doctor
before
you
are
given
Remsima.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children and
adolescents under 18 years of age.
-
_Before you start to use it _
PREGNANCY AND BREAST-FEEDING
•
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor for advice before taking this
medicine. Remsima should only be
used
during
pregnancy
or
while
breast-feeding if your doctor feels it
is necessary for you.

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
Remsima 120 mg solution for injection in pre-filled syringe
Remsima 120 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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*.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in murine hybridoma
cells by recombinant DNA technology.
Excipient(s) with known effect Sorbitol 45 mg per 1 mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to opalescent, colourless to pale brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Infliximab is a “Disease-Controlling Anti-Rheumatic Therapy”
(DCART) indicated for:
-
the reduction of signs and symptoms
-
prevention of structural joint damage (erosions and joint space
narrowing)
-
improvement in physical function
in patients with active disease despite treatment with MTX, and
patients with active disease not
previously treated with methotrexate.
Ankylosing spondylitis
Infliximab is indicated for:
-
reduction of signs and symptoms
-
improvement in physical function
-
improvement in quality life
in patients with active disease.
Psoriatic arthritis
Infliximab is indicated for:
-
the reduction of signs and symptoms of arthritis
-
improvement in physical function
2
-
reduction in psoriasis as measured by PASI (an index which combines
symptom evaluation and
body surface area)
in patients with active psoriatic arthritis.
Psoriasis
Infliximab is indicated for treatment of moderate to severe plague
psoriasis in adults who failed to
respond to or who have a contraindication to, or are intolerant to
other systemic therapy including
cyclosporine, methotrexate or PUVA.
Crohn’s disease
Infliximab is indicated for treatment of moderate to se