Solymbic

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

adalimumab

זמין מ:

Amgen Europe B.V.

קוד ATC:

L04AB04

INN (שם בינלאומי):

adalimumab

קבוצה תרפויטית:

Immunosuppressants

איזור תרפויטי:

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

סממני תרפויטית:

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

leaflet_short:

Revision: 2

מצב אישור:

Withdrawn

תאריך אישור:

2017-03-22

עלון מידע

61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLYMBIC 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SOLYMBIC 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 SOLYMBIC
and during
treatment with SOLYMBIC. 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 SOLYMBIC is and what it is used for
2.
What you need to know before you use SOLYMBIC
3.
How to use SOLYMBIC
4.
Possible side effects
5.
How to store SOLYMBIC
6.
Contents of the pack and other information
1.
WHAT SOLYMBIC IS AND WHAT IT IS USED FOR
SOLYMBIC contains the active substance adalimumab, a selective immuno
suppressive agent.
SOLYMBIC is intended for treatment of rheumatoid arthritis,
enthesitis-related arthritis in children 6
to 17 years, ankylosing spondylitis, axial spondyloarthritis without
radiographic evidence of
ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis
suppurativa, paediatric psoriasis
(patients weighing either 23 to 28 kg or 47 kg and greater), Crohn’s
disease in adults and children,
ulcerative colitis and non-infectious uveitis affecting the back of
the e

מאפייני מוצר

1
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
SOLYMBIC 20 mg solution for injection in pre-filled syringe.
SOLYMBIC 40 mg solution for injection in pre-filled syringe.
SOLYMBIC 40 mg solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLYMBIC 20 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 20 mg of adalimumab in
0.4 mL (50 mg/mL) solution.
SOLYMBIC 40 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 40 mg of adalimumab in
0.8 mL (50 mg/mL) solution.
SOLYMBIC 40 mg solution for injection in pre-filled pen
Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL
(50 mg/mL) solution.
Adalimumab is a recombinant human monoclonal antibody expressed in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
SOLYMBIC 20 mg solution for injection in pre-filled syringe
SOLYMBIC 40 mg solution for injection in pre-filled syringe
Solution for injection.
SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick)
Solution for injection.
Clear and colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
SOLYMBIC 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.
SOLYMBIC can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate