Ilumetri

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

tildrakizumab

Διαθέσιμο από:

Almirall S.A

Φαρμακολογική κατηγορία (ATC):

L04AC

INN (Διεθνής Όνομα):

tildrakizumab

Θεραπευτική ομάδα:

Immunosuppressants, Interleukin inhibitors,

Θεραπευτική περιοχή:

Psoriasis

Θεραπευτικές ενδείξεις:

Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Περίληψη προϊόντος:

Revision: 10

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-09-17

Φύλλο οδηγιών χρήσης

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
ILUMETRI 100
MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
tildrakizumab
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 Ilumetri is and what it is used for
2.
What you need to know before you use Ilumetri
3.
How to use Ilumetri
4.
Possible side effects
5.
How to store Ilumetri
6.
Contents of the pack and other information
1. WHAT ILUMETRI IS AND WHAT IT IS USED FOR
Ilumetri contains the active substance tildrakizumab. Tildrakizumab
belongs to a group of medicines
called interleukin (IL) inhibitors.
This medicine works by blocking the activity of a protein called
IL-23, a substance found in the body
which is involved in normal inflammatory and immune responses and
which is present at increased levels
in diseases such as psoriasis.
Ilumetri is used to treat a skin condition called plaque psoriasis, in
adults with moderate to severe disease.
Using Ilumetri will benefit you by improvements of skin clearance and
reducing your symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ILUMETRI
DO NOT USE ILUMETRI:
-
If you are allergic to
tildrakizumab or any of the other ingredients of this medicine (listed
in
section 6).
-
If you have an infection which your doctor thinks is important, for
example, active tuberculosis
which is an infectious disease affecting mainly the lungs.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Ilumetri:
-
If you experience allergic reactions with symptoms such as che

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ilumetri 100 mg solution for injection in pre-filled syringe
Ilumetri 200 mg solution for injection in pre-filled syringe
Ilumetri 100 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ilumetri 100 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Ilumetri 200 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 200 mg of tildrakizumab in 2 mL.
Ilumetri 100 mg solution for injection in pre-filled pen
Each pre-filled pen contains 100 mg of tildrakizumab in 1 mL.
Tildrakizumab is a humanised IgG1/k 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
Solution for injection (injection)
The solution is clear to slightly opalescent and colourless to
slightly yellow. The solution pH is in the
range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ilumetri is indicated for the treatment of adults with moderate to
severe plaque psoriasis who are
candidates for systemic therapy.
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 plaque psoriasis.
Posology
The recommended dose is 100 mg by subcutaneous injection at weeks 0,
and 4 and every 12 weeks
thereafter.
At the physician’s discretion, in patients with high disease burden
or in patients above 90 kg of body
weight a dose of 200 mg may provide greater efficacy.
3
Consideration should be given to discontinuing treatment in patients
who have shown no response after
28 weeks of treatment. Some patients with initial partial response may
subsequently improve with
continued treatment beyond 28 weeks.
Missed dose
If a dose is missed, the dose should be administ