XELJANZ tofacitiinib (as citrate) 1mg/mL oral solution bottle

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

tofacitinib citrate, Quantity: 1.62 mg/mL (Equivalent: tofacitinib, Qty 1 mg/mL)

Sẵn có từ:

Pfizer Australia Pty Ltd

Dạng dược phẩm:

Solution

Thành phần:

Excipient Ingredients: xylitol; lactic acid; sucralose; sodium benzoate; hydrochloric acid; purified water; Flavour

Tuyến hành chính:

Oral

Các đơn vị trong gói:

240 ml

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Rheumatoid Arthritis (RA),XELJANZ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. XELJANZ can be used alone or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs), including methotrexate.,Psoriatic Arthritis (PsA),XELJANZ in combination with conventional synthetic DMARDs is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior DMARD therapy.,Ulcerative Colitis (UC),XELJANZ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.,Ankylosing Spondylitis (AS),XELJANZ is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.,Juvenile Idiopathic Arthritis (JIA),XELJANZ is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.

Tóm tắt sản phẩm:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2023-01-25

Tờ rơi thông tin

XELJANZ
®
X
E
L
J
A
N
Z
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I TAKING XELJANZ?
XELJANZ contains the active ingredient tofacitinib. XELJANZ is used to
treat rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, and ulcerative colitis in adults, and polyarticular
course juvenile idiopathic arthritis and juvenile psoriatic arthritis
in
children 2 years of age and older. For more information, see Section
1. Why am I taking XELJANZ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE XELJANZ?
Do not take XELJANZ if you have ever had an allergic reaction to
tofacitinib or any of the ingredients listed at the end of the CMI. Do
not take XELJANZ if you are already using a biological medicine or a
medicine that strongly suppresses the immune system, or if
you have severe liver problems. Talk to your doctor if you have any
other medical conditions, take any other medicines, plan to have
surgery, are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know
before I take XELJANZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XELJANZ and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I TAKE XELJANZ?
The usual adult dose for RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS and
ANKYLOSING SPONDYLITIS is one 5 mg tablet taken twice a
day. The usual adult dose for ULCERATIVE COLITIS is one 10 mg tablet
taken twice a day for 8 weeks (induction), followed by one 5 mg
tablet taken twice a day (maintenance). In children, the dose for
POLYARTICULAR COURSE JUVENILE IDI

Đặc tính sản phẩm

Version: pfpxelja10423
Supersedes: pfpxelja20123
Page 1 of 80
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
WARNINGS
XELJANZ AND XELJANZ XR SHOULD ONLY BE USED IF NO SUITABLE TREATMENT
ALTERNATIVES ARE AVAILABLE IN PATIENTS:
•
WITH HISTORY OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE OR OTHER
CARDIOVASCULAR RISK
FACTORS (SUCH AS CURRENT OR PAST, LONG-TIME SMOKERS)
•
WITH MALIGNANCY RISK FACTORS (E.G. CURRENT MALIGNANCY OR HISTORY OF
MALIGNANCY)
•
WHO ARE 65 YEARS OF AGE AND OLDER.
SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE: MORTALITY;
MAJOR ADVERSE
CARDIOVASCULAR EVENTS (INCLUDING MYOCARDIAL INFARCTION); THROMBOSIS;
MALIGNANCY
AND LYMPHOPROLIFERATIVE DISORDER (EXCLUDING NONMELANOMA SKIN CANCER
[NMSC]);
SKIN CANCER AND USE IN THE ELDERLY.
AUSTRALIAN PRODUCT INFORMATION
XELJANZ

, XELJANZ XR TOFACITINIB (AS CITRATE)
1
NAME OF THE MEDICINE
tofacitinib (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XELJANZ 5 mg film-coated tablet
Each 5 mg tablet contains 8.078 mg of tofacitinib citrate equivalent
to 5 mg of tofacitinib free
base active pharmaceutical ingredient.
_Excipients with known effect _
Contains sugars (lactose monohydrate).
XELJANZ 10 mg film-coated tablet
Each 10 mg tablet contains 16.155 mg of tofacitinib citrate equivalent
to 10 mg of tofacitinib
free base active pharmaceutical ingredient.
_Excipients with known effect _
Contains sugars (lactose monohydrate).
▼

Version: pfpxelja10423
Supersedes: pfpxelja20123
Page 2 of 80
XELJANZ XR 11 mg extended release film-coated tablet
Each 11 mg tablet contains 17.771 mg of tofacitinib citrate equivalent
to 11 mg of tofacitinib
free base active pharmaceutical ingredient.
XELJANZ 1 mg/mL oral solution
Each 1 mL of oral solution contains 1.62 mg of tofacitinib citrate
equivalent to 1 mg of
tofacitinib free base active pharmaceutical i