Kevzara
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
07-07-2023
Karatteristiċi tal-prodott
(SPC)
07-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
29-06-2017
Ingredjent attiv:
sarilumab
Disponibbli minn:
Sanofi Winthrop Industrie
Kodiċi ATC:
L04AC14
INN (Isem Internazzjonali):
sarilumab
Grupp terapewtiku:
Immunosuppressants
Żona terapewtika:
Arthritis, Rheumatoid
Indikazzjonijiet terapewtiċi:
Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2017-06-23
Fuljett ta 'informazzjoni
56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KEVZARA 150 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
KEVZARA 200 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
sarilumab
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.
In addition to this leaflet, you will be given a patient alert card,
which contains important safety
information that you need before and during treatment with Kevzara.
WHAT IS IN THIS LEAFLET
1.
What Kevzara is and what it is used for
2.
What you need to know before you use Kevzara
3.
How to use Kevzara
4.
Possible side effects
5.
How to store Kevzara
6.
Contents of the pack and other information
1.
WHAT KEVZARA IS AND WHAT IT IS USED FOR
WHAT KEVZARA IS
Kevzara contains the active substance sarilumab. It is a type of
protein called a monoclonal antibody.
WHAT KEVZARA IS USED FOR
Kevzara is used to treat adults with moderately to severely active
rheumatoid arthritis if previous
therapy did not work well enough or was not tolerated. Kevzara can be
used alone or together with a
medicine called methotrexate.
It may help you by:
•
slowing down damage to joints
•
improving your ability to perform daily activities.
HOW KEVZARA WORKS
•
Kevzara attaches to another protein called interleukin-6 (IL-6)
receptor and blocks its action.
•
IL-6 plays a major role in the symptoms of rheumatoid arthritis such
as pain, swollen joints,
morning stiffness, and fatigue.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KEVZARA
_ _
DO NOT USE KEVZARA:
•
if you are allergic to sarilu
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kevzara 150 mg solution for injection in pre-filled syringe
Kevzara 150 mg solution for injection in pre-filled pen
Kevzara 200 mg solution for injection in pre-filled syringe
Kevzara 200 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kevzara 150 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution
(131.6 mg/ml).
Kevzara 150 mg solution for injection in pre-filled pen
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution
(131.6 mg/ml).
Kevzara 200 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution
(175 mg/ml).
Kevzara 200 mg solution for injection in pre-filled pen
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175
mg/ml).
Sarilumab is a human monoclonal antibody produced in Chinese Hamster
Ovary cells by recombinant
DNA technology.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless to pale yellow sterile solution of approximately pH
6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kevzara in combination with methotrexate (MTX) is indicated for the
treatment of moderately to
severely active rheumatoid arthritis (RA) in adult patients who have
responded inadequately to, or who
are intolerant to one or more disease modifying anti rheumatic drugs
(DMARDs). Kevzara can be
given as monotherapy in case of intolerance to MTX or when treatment
with MTX is inappropriate
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by healthcare
professionals experienced in the diagnosis
and treatment of rheumatoid arthritis. Patients should be given the
patient alert card.
3
Posology
The recommended dose of sarilumab is 200 mg once every 2 weeks
administered as a subcutaneous
injection.
Reduction of dose from 200 mg on
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