XELJANZ 5 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

TOFACITINIB

Dostopno od:

PFIZER PHARMACEUTICALS ISRAEL LTD

Koda artikla:

L04AA29

Farmacevtska oblika:

TABLETS

Sestava:

TOFACITINIB 5 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Terapevtsko območje:

TOFACITINIB

Terapevtske indikacije:

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). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. 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. Ulcerative colitis Tofacitinib 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 Ankylosing spondylitis Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapyJuvenile idiopathic arthritis (JIA) 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.

Datum dovoljenje:

2019-06-30

Lastnosti izdelka

Xeljanz 5 10 XR11 LPD CC 160124
008
-
2023
5052, 2022-0076602, 2022-0080121, 2023-0086394
1.
NAME OF THE MEDICINAL PRODUCT
XELJANZ 5 mg
XELJANZ 10 mg
XELJANZ XR 11 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XELJANZ 5 mg tablets
Each tablet contains tofacitinib citrate, equivalent to 5 mg
tofacitinib.
_Excipient with known effect _
Each tablet contains 59.44 mg of lactose.
XELJANZ 10 mg tablets
Each tablet contains tofacitinib citrate, equivalent to 10 mg
tofacitinib.
_Excipient with known effect _
Each tablet contains 118.88 mg of lactose.
Xeljanz XR 11 mg extended-release tablets
Each extended-release tablet contains tofacitinib citrate, equivalent
to 11 mg tofacitinib.
_Excipient with known effect_
Each extended-release tablet contains 152.23 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
XELJANZ 5 mg tablets
White, round film coated tablet with
“Pfizer” on one side and “JKI
5” on the other.
XELJANZ 10 mg tablets
Blue, round film coated tablet with
“Pfizer” on one side and “JKI
10” on the other.
Xeljanz XR 11 mg extended-release tablets
Pink oval tablet with a drilled hole at one end of the tablet band and
"JKI 11" printed on one side of the
tablet.
PATIENT SAFETY INFORMATION CARD
The marketing of Xeljanz is subject to a risk management plan (RMP)
including a 'Patient
safety information card'. The 'Patient safety information card',
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain to
the patient the need to review the card before starting treatment.
PRESCRIBER GUIDE
This Product is marketed with prescriber guide providing important
safety information. Please
ensure you are familiar with this material as it contains important
safety information.
Xeljanz 5 10 XR11 LPD CC 160124
008
-
2023
5052, 2022-0076602, 2022-0080121, 2023-0086394
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR
ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS
PATIENTS TREATED WITH XELJAN