Imatinib

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Aktív összetevők:

Imatinib mesilate 119.5mg equivalent to imatinib 100 mg

Beszerezhető a:

REX Medical Ltd

Adagolás:

100 mg

Gyógyszerészeti forma:

Capsule

Összetétel:

Active: Imatinib mesilate 119.5mg equivalent to imatinib 100 mg Excipient: Colloidal silicon dioxide Crospovidone Gelatin Iron oxide red Iron oxide yellow Lactose Magnesium stearate Purified water Titanium dioxide  

Recept típusa:

Prescription

Terápiás javallatok:

- Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+CML). - Treatment of adult and paediatic patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. - Treatment of adult patients with new 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. - Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). - Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Termék összefoglaló:

Package - Contents - Shelf Life: Blister pack, Al-PVC/PE/PVDC - 60 capsules - 24 months from date of manufacture stored at or below 30°C protect from moisture

Engedély dátuma:

2017-10-04

Betegtájékoztató

1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
IMATINIB
100 mg (60 capsules) and 400 mg (30 capsules)
WHAT IS IN THIS LEAFLET
The information enclosed answers several general questions about
Imatinib.
This leaflet does not include all the accessible information on
Imatinib.
All medication has benefits and risks. Your doctor will have
considered the risks of
you using Imatinib against the benefits expected.
Discuss with your doctor any concerns you may have.
This leaflet was last updated on the date at the end of the leaflet.
Check with your doctor or pharmacist to make sure you have the most up
to date
information on Imatinib as there may be new information available.
The most recent leaflet available for Imatinib can be found at
www.medsafe.govt.nz
KEEP THIS INFORMATION WITH YOUR MEDICINE AND REFER TO THIS LEAFLET IF
YOU HAVE
ANY QUERIES.
WHAT IMATINIB IS USED FOR
Imatinib is used for the treatment of chronic myeloid leukaemia (CML)
in adults and
children and acute lymphoblastic leukaemia with Philadelphia
chromosome positive
(Ph-positive ALL) in adults.
In these categories of leukaemia (CML and ALL), white blood cells grow
uncontrolled
due to an enzyme that is produced by an abnormal chromosome.
Imatinib works by destroying the abnormal cells while not affecting
the normal cells.
Imatinib works by reducing the growth of the abnormal cells.
Other treatments that Imatinib is used for in adults are:
•
_HYPEREOSINOPHILIC _
_SYNDROME _
_(HES) _
_AND/OR _
_CHRONIC _
_EOSINOPHILIC _
_LEUKAEMIA (CEL). _
2
Blood diseases where “eosinophils” (a type of blood cell) start to
grow
uncontrolled.
•
_SYSTEMIC MASTOCYTOSIS (SM). _
A cancer where particlar blood cells, named “mast” cells, grow
uncontrollably.
•
_GASTRO-INTESTINAL STROMAL TUMOURS (GIST). _
A cancer of the stomach and bowels that affects the tissue surrounding
the
stomach and bowels and the cells grow uncontrollably.
•
_DERMATOFIBROSARCOMA PROTUBERANS (DFSP). _
A tissue cancer where certain
cells underneath the skin starts
to
grow
uncontrolled.
•
_M

Termékjellemzők

Page
1
of
24
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Imatinib 100mg capsule
Imatinib 400mg capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib 100 mg and 400 mg as Imatinib mesilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Imatinib Capsules 100 mg consist of light-yellow granules in a size 3
hard gelatin capsule
with a brown cap and white body.
Imatinib Capsules 400 mg consist of light-yellow granules filled in a
size 00EL hard gelatin
capsule with a brown cap and brown body.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Imatinib is indicated for the
•
Treatment
of
adult
and
paediatric
patients
with
newly
diagnosed
Philadelphia
chromosome positive chronic myeloid leukaemia (Ph+CML) (Please refer
to section 4.2
Dose and Method of Administration for paediatric use).
•
Treatment of adult and paediatric patients with Ph+CML in blast
crisis, accelerated
phase, or in chronic phase after failure of interferon-alpha therapy
(Please refer to
section 4.2 Dose and Method of Administration for paediatric use).
•
Treatment of adult 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.
•
Treatment of adult patients with systemic mastocytosis (SM) without
the D816V c-KIT
mutation or with c-Kit mutational status unknown.
•
Treatment of adult patients with hypereosinophilic syndrome (HES)
and/or chronic
eosinophilic leukaemia (CEL).
•
treatment of adult patients with KIT+ (CD117) unresectable and/or
metastatic malignant
gastrointestinal stromal tumours (GIST).
•
Adjuvant treatment of adult patients following resection of KIT+GIST.
•
Treatment
of
adult
patients
with
unresectable,
recurrent
and/or
metastatic
dermatofibrosarcoma protuberans