Taltz

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

ixekizumab

Διαθέσιμο από:

Eli Lilly and Company (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

L04AC

INN (Διεθνής Όνομα):

ixekizumab

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

Psoriasis

Θεραπευτικές ενδείξεις:

Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.

Περίληψη προϊόντος:

Revision: 17

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-04-25

Φύλλο οδηγιών χρήσης

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TALTZ 80 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ixekizumab
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.
-
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 Taltz is and what it is used for
2.
What you need to know before you use Taltz
3.
How to use Taltz
4.
Possible side effects
5.
How to store Taltz
6.
Contents of the pack and other information
1.
WHAT TALTZ IS AND WHAT IT IS USED FOR
Taltz contains the active substance ixekizumab.
Taltz is intended for the treatment of the inflammatory diseases
described below:
•
Plaque psoriasis in adults
•
Plaque psoriasis in children from the age of 6 and with a body weight
of at least 25 kg
_ _
and in
adolescents
•
Psoriatic arthritis in adults
_ _
•
Radiographic Axial Spondyloarthritis in adults
_ _
•
Non-radiographic Axial
_S_
pondyloarthritis in adults
_ _
Ixekizumab belongs to a group of medicines called interleukin (IL)
inhibitors. This medicine
works by blocking the activity of a protein called IL-17A, which
promotes psoriasis and
inflammatory disease of the joints and the spine.
Plaque psoriasis
Taltz is used to treat a skin condition called “plaque psoriasis”
in adults and in children from the age
of 6 years and with a body weight of at least 25 kg
_ _
and in adolescents with moderate to severe
disease. Taltz reduces the signs and symptoms of the disease.
Using Taltz will benefit you by improvements of skin clearance and
reducing your symptoms
such as scaling, itching and pain.
Psoriatic arth

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Taltz 80 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Ixekizumab is produced in CHO cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear and colourless to slightly yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are candidates
for systemic therapy.
Paediatric plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque
psoriasis in children from the age
of 6 years and with a body weight of at least 25 kg and adolescents
who are candidates for
systemic therapy.
Psoriatic arthritis
Taltz, alone or in combination with methotrexate, is indicated for the
treatment of active psoriatic
arthritis in adult patients who have responded inadequately to, or who
are intolerant to one or more
disease-modifying anti-rheumatic drug (DMARD) therapies (see section
5.1).
Axial spondyloarthritis
_ _
_Ankylosing spondylitis (radiographic axial spondyloarthritis) _
Taltz is indicated for the treatment of adult patients with active
ankylosing spondylitis who have
responded inadequately to conventional therapy.
_ _
_Non-radiographic axial spondyloarthritis _
Taltz is indicated for the treatment of adult patients with active
non-radiographic axial
spondyloarthritis with objective signs of inflammation as indicated by
elevated C-reactive protein
(CRP) and/or magnetic resonance imaging (MRI) who have responded
inadequately to nonsteroidal
anti-inflammatory drugs (NSAIDs).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use under the guidance and
supervision of a physician
experienced in the diagnosis and treatment of conditions for which it
is indicated.
Posology
_Plaque p