REMSIMA SOLUTION FOR SUBCUTANEOUS INJECTION 120 MGML IN PRE-FILLED SYRINGE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Infliximab

Available from:

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

ATC code:

L04AB02

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Infliximab 120mg/ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

VETTER Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2020-12-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMSIMA 120 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Infliximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Your doctor will also give you a Patient Alert Card, which contains
important safety
information you need to be aware of before and during your treatment
with Remsima.
•
When starting a new card, keep this card as a reference for 4 months
after your last dose of
Remsima.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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 Remsima is and what it is used for
2.
What you need to know before you use Remsima
3.
How to use Remsima
4.
Possible side effects
5.
How to store Remsima
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT REMSIMA IS AND WHAT IT IS USED FOR
Remsima contains the active substance infliximab. Infliximab is a
monoclonal antibody - a type of
protein that attaches to a specific target in the body called TNF
(tumour necrosis factor) alpha.
Remsima belongs to a group of medicines called ‘TNF blockers’. It
is used in adults for the following
inflammatory diseases:
•
Rheumatoid arthritis
•
Psoriasis
•
Ankylosing spondylitis
•
Psoriatic arthritis
•
Crohn’s disease
•
Ulcerative colitis
Remsima works by selectively attaching to TNF alpha and blocking its
action. TNF alpha is involved
in inflammatory processes of the body so blocking it can reduce the
inflammation in your body.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints
_. _
If you have active rheumatoid arthritis
you will

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Remsima 120 mg solution for subcutaneous injection in pre-filled
syringe
Remsima 120 mg solution for subcutaneous injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Remsima 120 mg solution for subcutaneous injection in pre-filled
syringe
Each 1 mL single dose pre-filled syringe contains 120 mg of
infliximab*.
Remsima 120 mg solution for subcutaneous 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
Remsima, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as
well as the improvement in physical function in:
•
adult patients with active disease when the response to
disease-modifying antirheumatic drugs
(DMARDs), including methotrexate, has been inadequate.
•
adult patients with severe, active and progressive disease not
previously treated with
methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured by
X-ray, has been demonstrated (see section 5.1).
Crohn’s disease
Remsima is indicated for:
•
treatment of moderately to severely active Crohn’s disease, in adult
patients who have not
responded despite a full and adequate course of therapy with a
corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such
therapies.
•
treatment of fistulising Crohn’s disease in adult patients who have
not responded despite a full
and adequate course of therapy with conventional treatment (including
antibiotics, drainage and
immunosuppressive