Flixabi 100mg powder for concentrate for solution for infusion vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Infliximab

Διαθέσιμο από:

Biogen Idec Ltd

Φαρμακολογική κατηγορία (ATC):

L04AB02

INN (Διεθνής Όνομα):

Infliximab

Δοσολογία:

100mg

Φαρμακοτεχνική μορφή:

Powder for solution for infusion

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

VMP not recommended to prescribe - brands not bioequivalent

Περίληψη προϊόντος:

BNF: 10010300; GTIN: 5713219481526

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXABI 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 Flixabi.
•
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 Flixabi is and what it is used for
2.
What you need to know before you use Flixabi
3.
How Flixabi will be given
4.
Possible side effects
5.
How to store Flixabi
6.
Contents of the pack and other information
1.
WHAT FLIXABI IS AND WHAT IT IS USED FOR
Flixabi contains the active substance called infliximab. Infliximab is
a type of protein of human and mouse
origin.
Flixabi 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.
Flixabi is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Flixabi 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

Αρχείο Π.Χ.Π.

OBJECT 1
FLIXABI 100 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 11-Apr-2018 | Biogen Idec
Ltd
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
Flixabi 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 Chinese Hamster Ovary
(CHO) 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
White powder.
4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis
Flixabi, 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
Flixabi 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 co