IMATINIB RBX imatinib (as mesilate) 100 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

imatinib mesilate, Quantity: 119.5 mg

可用日期:

Sun Pharma ANZ Pty Ltd

INN（国际名称）:

imatinib mesilate

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red

给药途径:

Oral

每包单位数:

60, 180

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

IMATINIB RBX is indicated for the: ? treatment of patients with chronic myeloid leukaemia (CML) ? treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) ? treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST (see Dosage and Administration and Clinical Trials) ? treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

產品總結:

Visual Identification: Dark yellow to brownish-orange, film-coated, round tablets, debossed with 'I' and '1' on either side of break line on one side and plain on the other.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2015-11-26

资料单张

IMATINIB RBX
1
IMATINIB RBX
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.
1.
WHY AM I USING IMATINIB RBX?
IMATINIB RBX is used to treat adults and children/adolescents who have
chronic myeloid leukaemia (CML) and acute
lymphoblastic leukaemia with Philadelphia chromosome positive
(Ph-positive ALL). It is also used to treat myelodysplastic
/myeloproliferative diseases (MDS/MPD), aggressive systemic
mastocytosis (ASM), hypereosinophilic syndrome (HES) and or
chronic eosinophilic leukaemia (CEL), dermatofibrosarcoma protuberans
(DFSP).
For more information, see Section 1. Why am I using IMATINIB RBX? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMATINIB RBX?
Do not use if you have ever had an allergic reaction to IMATINIB RBX
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
IMATINIB RBX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other medicines,
vitamins or supplements. Some medicines may interfere
with IMATINIB RBX 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 USE IMATINIB RBX?
For CML, the usual dose for an adult is 400 to 600 mg each day and the
maximum dose is 800 mg each day. For Ph-positive ALL
the usual dose is 600 mg each day. For MDS/MPD, the starting dose is
400 mg. For ASM and HES/CEL, the usual starting dose is
400 mg.
More instructions can be found in Section 4. How do I use IMATINIB
RBX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMATINIB RBX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
IMATINIB RBX.
•
You may need regular blood tes

产品特点

Imatinib RBX PI v6
Page 1 of 55
AUSTRALIAN PRODUCT INFORMATION
IMATINIB RBX
IMATINIB (AS MESILATE)
1. NAME OF THE MEDICINE
Imatinib (as mesilate)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg or 400 mg of imatinib
(equivalent to 119.5 mg or 478
mg imatinib mesilate, respectively).
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
IMATINIB RBX 100 mg film-coated tablet: dark yellow to brownish
orange, film-coated,
round tablet debossed with ‘I’ and ‘1’ on either side of break
line on one side and plain on other
side of the tablet.
IMATINIB RBX 400 mg film-coated tablet: dark yellow to brownish
orange, film-coated oval
tablet debossed with ‘I’ and ‘2’ on either side of break line
on one side and plain on other side
of the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IMATINIB RBX is indicated for the:
•
treatment of patients with chronic myeloid leukaemia (CML)
•
treatment
of
adult
and
paediatric
patients
with
newly
diagnosed
Philadelphia
chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated
with
chemotherapy
•
treatment of adult patients with relapsed or refractory Ph+ ALL as
monotherapy
•
treatment
of
adult
patients
with
myelodysplastic/myeloproliferative
diseases
(MDS/MPD) associated with platelet-derived growth factor receptor
(PDGFR) gene
re-arrangements, where conventional therapies have failed
•
treatment of adult patients with aggressive systemic mastocytosis
(ASM), where
conventional therapies have failed
•
treatment of adult patients with hypereosinophilic syndrome (HES)
and/or chronic
eosinophilic leukaemia (CEL)
•
treatment of patients with KIT (CD117) positive unresectable and/or
metastatic
malignant gastrointestinal stromal tumours (GIST)
•
adjuvant treatment of adult patients at high risk of recurrence
following complete gross
resection of KIT (CD117)-positive primary GIST (see Dosage and
Administration and
Attachment 1
Imatinib RBX PI v6
Page 2 of 55
Clinical