IMATINIB-CPL Imatinib (as mesilate) 50 mg capsule blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

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

Beszerezhető a:

Cipla Australia Pty Ltd

Gyógyszerészeti forma:

Capsule

Összetétel:

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

Az alkalmazás módja:

Oral

db csomag:

30's

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

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)

Termék összefoglaló:

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: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2018-12-10

Betegtájékoztató

Imatinib-CPL
1
IMATINIB-CPL
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-CPL?
Imatinib-CPL contains the active ingredient imatinib mesilate.
Imatinib-CPL 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).
Imatinib-CPL 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 Imatinib-CPL? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMATINIB-CPL?
Do not use if you have ever had an allergic reaction to Imatinib-CPL
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-CPL? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Imatinib-CPL 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-CPL?
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
Imatinib-CPL? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMATINIB-