Remicade 100mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Infliximab

Available from:

Merck Sharp & Dohme Ltd

ATC code:

L04AB02

INN (International Name):

Infliximab

Dosage:

100mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

VMP not recommended to prescribe - brands not bioequivalent

Product summary:

BNF: 10010300; GTIN: 5012376024769

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
REMICADE® 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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 Remicade.
•
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 Remicade is and what it is used for
2.
What you need to know before you use Remicade
3.
How Remicade will be given
4.
Possible side effects
5.
How to store Remicade
6.
Contents of the pack and other information
1.
WHAT REMICADE IS AND WHAT IT IS USED FOR
Remicade 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.
Remicade 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.
Remicade is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Remicade 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 first be given other medicines. If these medicines d

Summary of Product characteristics

OBJECT 1
REMICADE 100MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 30-May-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Remicade® 100 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains 100 mg of infliximab. Infliximab is a chimeric
human-murine IgG1 monoclonal
antibody produced in murine hybridoma cells by recombinant DNA
technology. After reconstitution each
ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion (powder for
concentrate).
The powder is a freeze-dried white pellet.
4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis
Remicade, 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
Remicade 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 with conventional treatment (including
antibiotics, drainage and
immunosuppressive therapy).
Paediatric Crohn's disease
Remicade is indicated for treatment of severe, active Crohn's disease,
in children a