CIPLA IMATINIB Imatinib (as mesilate) 50 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

imatinib mesilate, Quantity: 59.75 mg (Equivalent: imatinib, Qty 50 mg)

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: lactose; crospovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified water; Gelatin

Administration route:

Oral

Units in package:

30's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Imatinib capsules indicated for: - 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/myeloproflierative 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) - adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

Product summary:

Visual Identification: Light yellow granules filled in size 4 hard gelatin capsule with opaque white body and opaque white cap. The cap is imprinted with Cipla 50 with black ink.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 12 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-12-10

Patient Information leaflet

Cipla Imatinib
1
CIPLA IMATINIB
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 CIPLA IMATINIB?
Cipla Imatinib contains the active ingredient imatinib mesilate. Cipla
Imatinib 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).
Cipla Imatinib is also used to treat adults for
myelodysplastic/myeloproliferative diseases (MDS/MPD), aggressive
systemic
mastocytosis (ASM), hypereosinophilic syndrome (HES) and or chronic
eosinophilic leukaemia (CEL) and for
dermatofibrosarcoma protuberans (DFSP). For more information, see
Section 1. Why am I using Cipla Imatinib? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA IMATINIB?
Do not use if you have ever had an allergic reaction to Cipla Imatinib
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 Cipla Imatinib? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Imatinib 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 CIPLA IMATINIB?
For CML, the usual dose for an adult is 400 to 600 mg each day. For
Ph-positive ALL the usual dose is 600 mg each day. For
children treated with CML and Ph-positive ALL, the dose depends on the
size of the child. For MDS/MPD, the starting dose is
400 mg. For ASM and HES/CEL, the usual starting dose is 400 mg. For
some patients the starting dose may be 100 mg. For
DFSP, the starting dose is 800 mg per day.
More instructions can be found in Section 4. How do I use Cipla
Imatinib? in the full CMI.
5.
WHAT SHOULD I