Zessly
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-11-2023
Karatteristiċi tal-prodott
(SPC)
28-11-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
10-02-2020
Ingredjent attiv:
infliximab
Disponibbli minn:
Sandoz GmbH
Kodiċi ATC:
L04AB02
INN (Isem Internazzjonali):
infliximab
Grupp terapewtiku:
Immunosuppressants
Żona terapewtika:
Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Indikazzjonijiet terapewtiċi:
Treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Sommarju tal-prodott:
Revision: 12
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-05-18
Fuljett ta 'informazzjoni
50
B. PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZESSLY 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
infliximab
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 reminder card, which contains
important safety
information you need to be aware of before and during your treatment
with Zessly.
•
If you have any further questions, ask your doctor.
•
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. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zessly is and what it is used for
2.
What you need to know before you use Zessly
3.
How Zessly will be given
4.
Possible side effects
5.
How to store Zessly
6.
Contents of the pack and other information
1.
WHAT ZESSLY IS AND WHAT IT IS USED FOR
Zessly contains the active substance infliximab. Infliximab is a
monoclonal antibody - a type of
protein that attaches to a specific target in the body called TNF
(tumour necrosis factor) alpha.
Zessly belongs to a group of medicines called ‘TNF blockers’. It
is used in adults for the following
inflammatory diseases:
•
Rheumatoid arthritis
•
Psoriatic arthritis
•
Ankylosing spondylitis (Bechterew’s disease)
•
Psoriasis.
Zessly is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Zessly works by selectively attaching to TNF alpha and blocking its
action. TNF alpha is involved
in inflammatory processes of the body so blocking it can reduce the
inflammation in your body.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints. If you
have active rheumatoid arthritis
you will first be given other medicines. If these medicines
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zessly 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of infliximab. Infliximab is a chimeric
human-murine IgG1 monoclonal
antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant
DNA technology. After
reconstitution each ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate)
The powder is a freeze-dried white pellet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS
Zessly, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as
well as the improvement in physical function in:
•
adult patients with active disease when the response to
disease-modifying antirheumatic
drugs (DMARDs), including methotrexate, has been inadequate.
•
adult patients with severe, active and progressive disease not
previously treated with
methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured
by X-ray, has been demonstrated (see section 5.1).
ADULT CROHN’S DISEASE
Zessly is indicated for:
•
treatment of moderately to severely active Crohn’s disease, in adult
patients who have not
responded despite a full and adequate course of therapy with a
corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such
therapies.
•
treatment of fistulising, active Crohn’s disease, in adult patients
who have not responded
despite a full and adequate course of therapy with conventional
treatment (including
antibiotics, drainage and immunosuppressive therapy).
PAEDIATRIC CROHN’S DISEASE
Zessly is indicated for treatment of severe, active Crohn’s disease,
in children and adolescents aged
6 to 17 years, who have not responded to conventional therapy
including a corticost
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