IMATIQUAL imatinib 100 mg film-coated tablets blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

imatinib mesilate, Quantity: 119.469 mg (Equivalent: imatinib, Qty 100 mg)

Pieejams no:

Teva Pharma Australia Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

imatinib mesilate

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol

Ievadīšanas:

Oral

Vienības iepakojumā:

180 film-coated tablets, 60 film-coated tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

1) IMATIQUAL (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (CML). 2) IMATIQUAL (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. 3) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy. 4) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements, where conventional therapies have failed. 5) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. 6) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). 7) IMATIQUAL (imatinib) is indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST) 8) IMATIQUAL (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. 9) IMATIQUAL (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Produktu pārskats:

Visual Identification: Imatinib tablets 100 mg are dark yellow to brownish orange round film coated tablets debossed with IT and 1 divided by score line on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2016-06-10