Xeljanz
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
07-12-2023
Valmisteyhteenveto
(SPC)
07-12-2023
Julkisesta arviointikertomuksesta
(PAR)
12-06-2023
Aktiivinen ainesosa:
Tofacitinib
Saatavilla:
Pfizer Europe MA EEIG
ATC-koodi:
L04AA29
INN (Kansainvälinen yleisnimi):
tofacitinib
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Rheumatoid
Käyttöaiheet:
Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1).Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
Tuoteyhteenveto:
Revision: 28
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-03-22
Pakkausseloste
142
B. PACKAGE LEAFLET
143
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XELJANZ 5 MG FILM-COATED TABLETS
XELJANZ 10 MG FILM-COATED TABLETS
tofacitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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.
In addition to this leaflet, 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 XELJANZ and during
treatment with XELJANZ. Keep this Patient Alert Card with you.
WHAT IS IN THIS LEAFLET
1.
What XELJANZ is and what it is used for
2.
What you need to know before you take XELJANZ
3.
How to take XELJANZ
4.
Possible side effects
5.
How to store XELJANZ
6.
Contents of the pack and other information
1.
WHAT XELJANZ IS AND WHAT IT IS USED FOR
XELJANZ is a medicine that contains the active substance tofacitinib.
XELJANZ is used for the treatment of the following inflammatory
diseases:
rheumatoid arthritis
psoriatic arthritis
ulcerative colitis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis and juvenile psoriatic
arthritis
RHEUMATOID ARTHRITIS
XELJANZ is used to treat adult patients with moderate to severe active
rheumatoid arthritis, a
long-term disease that mainly causes pain and swelling of your joints.
XELJANZ is used together with methotrexate when previous rheumatoid
arthritis treatment was not
sufficient or was not well tolerated. XELJANZ can also be taken on its
own in those cases where
methotrexate treatment is not tolerated or treatment with methotrexate
is not advised.
XELJANZ has been shown to re
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
XELJANZ 5 mg film-coated tablets
XELJANZ 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XELJANZ 5 mg film-coated tablets
Each film-coated tablet contains tofacitinib citrate, equivalent to 5
mg tofacitinib.
_Excipient with known effect_
Each film-coated tablet contains 59.44 mg of lactose.
XELJANZ 10 mg film-coated tablets
Each film-coated tablet contains tofacitinib citrate, equivalent to 10
mg tofacitinib.
_Excipient with known effect_
Each film-coated tablet contains 118.88 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
XELJANZ 5 mg film-coated tablets
White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one
side and “JKI 5” on the other.
XELJANZ 10 mg film-coated tablets
Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one
side and “JKI 10” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Rheumatoid arthritis
Tofacitinib in combination with methotrexate (MTX) is indicated for
the treatment of moderate to
severe active rheumatoid arthritis (RA) in adult patients who have
responded inadequately to, or who
are intolerant to one or more disease-modifying antirheumatic drugs
(DMARDs) (see section 5.1).
Tofacitinib can be given as monotherapy in case of intolerance to MTX
or when treatment with MTX
is inappropriate (see sections 4.4 and 4.5).
Psoriatic arthritis
Tofacitinib in combination with MTX is indicated for the treatment of
active psoriatic arthritis (PsA)
in adult patients who have had an inadequate response or who have been
intolerant to a prior
disease-modifying antirheumatic drug (DMARD) therapy (see section
5.1).
3
Ankylosing spondylitis
Tofacitinib is indicated for the treatment of adult patients with
active ankylosing spondylitis (AS) who
have responded inadequately to conventional therapy.
Ulcerative colitis
Tofacitinib is indicated for the treatment of adult patients with
moderate
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