IXIFI

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

INFLIXIMAB

Διαθέσιμο από:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

L04AB02

Φαρμακοτεχνική μορφή:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Σύνθεση:

INFLIXIMAB 100 MG

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PFIZER MANUFACTURING BELGIUM NV, BELGIUM

Θεραπευτική περιοχή:

INFLIXIMAB

Θεραπευτικές ενδείξεις:

Rheumatoid arthritis:IXIFI, 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.* Ankylosing spondylitis:IXIFI is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* Psoriatic arthritis:IXIFI is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.* IXIFI should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease.* Psoriasis:IXIFI is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA)* Adult Crohn’s diseaseIXIFI 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).* Ulcerative colitis• IXIFI is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Ημερομηνία της άδειας:

2019-11-27

Φύλλο οδηγιών χρήσης

PP-IFX-ISR-0000
8
7
9
7
DURING TREATMENT WITH IXIFI
®
•
Tell
your
physician
straight away if you get
new or worsening signs
of
heart
failure
during
treatment with IXIFI
®
Signs
include
shortness
of breath, swelling of the
feet
or
changes
in
your
heartbeat.
|| PREGNANCY AND VACCINATIONS ||
•
If you received IXIFI
®
during
your pregnancy, your baby
may have a higher risk for
getting an infection.
In case you have received
this
medicine
while
you
were
pregnant,
it
is
important that you inform
the medical staff about it
before your baby receives
any
vaccine.
Your
baby
must
not
receive
a
“live
vaccine” within the first 6
months
after
birth,
and
BCG
vaccine
(intended
to
prevent tuberculosis) within
the
first
12
months
after
birth,
unless
your
doctor
recommends
otherwise.
In
case
of
pregnancy,
keep this card for at least
12
months
after
birth.
At any visit to a healthcare
professional, please make
sure to bring a list of all
other
medicines
that
you
are using.
Keep this card with you for
4
months
after
receiving
your last dose of IXIFI
®
.
Side
effects
may
occur
a
long
time
after
receiving
your last dose.
REPORTING OF SUSPECTED
ADVERSE REACTIONS
Adverse
events
can
be
reported
directly
to
the
Ministry of Health using the
adverse
events
reporting
portal
which
is
available
on the home page of the
Ministry of Health website:
www.health.gov.il
or
by
this link: https://sideeffects.
health.gov.il/
Side
effects
can
also
be
reported to Pfizer by email:
[e-mail]
This
card
was
approved
according to the guidelines
of the Ministry of Health on
December 2022
IXIFI
® 100
MG
INFLIXIMAB
PATIENT SAFETY
INFORMATION
CARD
SHOW THIS CARD
TO ANY PHYSICIAN
INVOLVED IN YOUR
TREATMENT
PFIZER PHARMACEUTICALS ISRAEL LTD.
9 Shenkar St., Herzliya Pituach, Israel.
Tel: [phone], Fax: [phone]
1
2
3
4
5
6
PATIENT SAFETY
INFORMATION CARD
IXIFI
®
100 MG
(INFLIXIMAB)
Show this card to any
physician involved in your
treatment
This
Patient
Safety
Information
Card
contains
important safety information
that you need to be

Αρχείο Π.Χ.Π.

IXIFI, LPD, Israel CC 14 Mar 2023
1
2022-0083057
1. NAME OF THE MEDICINAL PRODUCT
Ixifi
®
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 Chinese Hamster Ovary (CHO) 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
4. CLINICAL PARTICULARS
The marketing of Ixifi is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that
the patient should be aware of before and during treatment. Please
explain to the patient the need
to review the card before starting treatment.
4.1 THERAPEUTIC INDICATIONS
Rheumatoid arthritis:
Ixifi
®
, 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.
Ankylosing spondylitis:
Ixifi
®
is indicated for treatment of severe, active ankylosing spondylitis,
in adult patients who have responded
inadequately to conventional therapy.
Psoriatic arthritis:
Ixifi
®
is indicated for treatment of active and progressive psoriatic
arthritis in adult patients when the response
to previous DMARD therapy has been inadequate.
* Ixifi
®
should be administered:

in combination with methotrexate

or alone in patients who show intolerance to methotrexate or for whom
methotrexa