XELJANZ 10 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

TOFACITINIB

제공처:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC 코드:

L04AA29

약제 형태:

TABLETS

구성:

TOFACITINIB 10 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

치료 영역:

TOFACITINIB

치료 징후:

XELJANZ 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..

승인 날짜:

2022-07-18

제품 특성 요약

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