Cyltezo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

adalimumab

Available from:

Boehringer Ingelheim International GmbH

ATC code:

L04AB04

INN (International Name):

adalimumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing

Therapeutic indications:

Please refer to section 4.1 of the Summary of product characteristics in the product information document.,

Product summary:

Revision: 2

Authorization status:

Withdrawn

Authorization date:

2017-11-10

Patient Information leaflet

68
B. PACKAGE LEAFLET
69
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CYLTEZO 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Adalimumab
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 that
you need to be aware of before you are given Cyltezo and during
treatment with Cyltezo. Keep this
Patient Alert Card with you.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cyltezo is and what it is used for
2.
What you need to know before you use Cyltezo
3.
How to use Cyltezo
4.
Possible side effects
5.
How to store Cyltezo
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT CYLTEZO IS AND WHAT IT IS USED FOR
Cyltezo contains the active substance adalimumab, a medicine that acts
on your body’s immune (defence)
system.
Cyltezo is intended for the treatment of the inflammatory diseases
described below:

Rheumatoid arthritis,

Polyarticular juvenile idiopathic arthritis,

Enthesitis-related arthritis,

Ankylosing spondylitis,

Axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis,

Psoriatic arthritis,

Psoriasis,

Hidradenitis suppurativa,

Crohn’s disease,

Ulcerative colitis and

Non-infectious uveitis
The active ingredient in Cyltezo, adalimu

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Cyltezo 40 mg solution for injection in pre-filled syringe
Cyltezo 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyltezo 40 mg solution for injection in pre-filled syringe
Each 0.8 mL single dose pre-filled syringe contains 40 mg of
adalimumab.
Cyltezo 40 mg solution for injection in pre-filled pen
Each 0.8 mL single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to slightly opalescent solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Cyltezo in combination with methotrexate, is indicated for:

the treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response to
disease-modifying anti-rheumatic drugs including methotrexate has been
inadequate.

the treatment of severe, active and progressive rheumatoid arthritis
in adults not previously treated with
methotrexate.
Cyltezo can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment
with methotrexate is inappropriate.
Cyltezo reduces the rate of progression of joint damage as measured by
X-ray and improves physical
function, when given in combination with methotrexate.
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis _
Adalimumab in combination with methotrexate is indicated for the
treatment of active polyarticular juvenile
idiopathic arthritis, in patients from the age of 2 years who have had
an inadequate response to one or more
disease-modifying anti