Remsima 100mg powder for concentrate for solution for infusion vials

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Infliximab

Disponibil de la:

Napp Pharmaceuticals Ltd

Codul ATC:

L04AB02

INN (nume internaţional):

Infliximab

Dozare:

100mg

Forma farmaceutică:

Powder for solution for infusion

Calea de administrare:

Intravenous

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

VMP not recommended to prescribe - brands not bioequivalent

Rezumat produs:

BNF: 10010300; GTIN: 5012854024519

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
REMSIMA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Infliximab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
•
If you have any further questions, ask your doctor.
•
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. 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 Remsima will be given
4.
Possible side effects
5.
How to store Remsima
6.
Contents of the pack and other information
1.
WHAT REMSIMA IS AND WHAT IT IS USED FOR
Remsima contains the active substance called infliximab. Infliximab is
a type of protein of human and
mouse origin.
Remsima belongs to a group of medicines called ‘TNF blockers’. It
is used in adults for the following
inflammatory diseases:
•
Rheumatoid arthritis
•
Psoriatic arthritis
•
Ankylosing spondylitis (Bechterew’s disease)
•
Psoriasis.
Remsima is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Remsima works by blocking the action of a protein called ‘tumour
necrosis factor alpha’ (TNF
α
). This
protein is involved in inflammatory processes of the body and blocking
it can reduce the inflammation
in your body.
RHEUMATOID ARTHRITIS
Rh

Caracteristicilor produsului

OBJECT 1
REMSIMA 100 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 30-May-2018 | Napp
Pharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Remsima 100 mg powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
One vial contains 100 mg of infliximab*. After reconstitution each mL
contains 10 mg of infliximab.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in murine hybridoma cells
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion
The powder is white.
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).
Adult 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, active Crohn's disease, in adult
patients who have not responded despite a full
and adequate course of therapy