ATRIANCE 5 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

NELARABINE

Tilgængelig fra:

NOVARTIS ISRAEL LTD

ATC-kode:

L01BB

Lægemiddelform:

SOLUTION FOR INFUSION

Sammensætning:

NELARABINE 5 MG/ML

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

FAREVA UNTERACH GMBH, AUSTRIA

Terapeutisk gruppe:

PURINE ANALOGUES

Terapeutiske indikationer:

Atriance 5 mg/ml is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

Autorisation dato:

2022-12-31

Indlægsseddel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
:
30.05.2013
םש
רישכת
תילגנאב
רפסמו
םושירה
:
ATRIANCE 5MG/ML (137-71-31525)
םש
לעב
םושירה
GLAXOSMITHKLINE (ISRAEL) LTD :
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
אפורל ןולעב
אפורל ןולעב
תורמחהה
תושקובמה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
ADVERSE EVENTS
------
Post – Marketing Data
_…_
_Rare_: Rhabdomyolysis, blood creatine
phosphokinase increased
ב"צמ
ובש ,ןולעה
נמוסמ
תו
תורמחהה
שקובמה
תו
םודאב
.
םייוניש
םניאש
רדגב
תורמחה
ונמוס
)ןולעב(
עבצב
.קורי
רבעוה
ראודב
ינורטקלא
ךיראתב
30.05.2013

Produktets egenskaber

ATR API AUG21 V1
EU SmPC 11.20
ATRIANCE
® 5 MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
ATRIANCE
® 5 MG/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 5 mg of nelarabine.
Each vial contains 250 mg of nelarabine.
Excipient with known effect
Each ml of solution contains 1.770 mg (77 micromols) of sodium.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atriance is indicated for the treatment of patients with T-cell acute
lymphoblastic leukaemia
(T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has
not responded to or
has relapsed following treatment with at least two chemotherapy
regimens.
Due to the small patient populations in these disease settings, the
information to support these
indications is based on limited data.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nelarabine must only be administered under the supervision of a
physician experienced in the
use of cytotoxic agents.
Posology
Complete blood counts including platelets must be monitored regularly
(see sections 4.4
and 4.8).
_Adults and adolescents (aged 16 years and older) _
The recommended dose of nelarabine for adults and adolescents aged 16
years and older is
1,500 mg/m
2
administered intravenously over two hours on days 1, 3 and 5 and
repeated
every 21 days.
_ _
ATR API AUG21 V1
EU SmPC 11.20
_Children and adolescents (aged 21 years and younger) _
_ _
The recommended dose of nelarabine for children and adolescents (aged
21 years and
younger) is 650 mg/m
2
administered intravenously over one hour daily for 5 consecutive
days, repeated every 21 days.
In clinical studies, the 650 mg/m
2
and 1,500 mg/m
2
dose have both been used in patients in
the age range 16 to 21 years. Efficacy and safety were similar for
both regimens. The
prescribing physician should consider which regimen is appropriate
when treating patients in
this age range.
Limited clinical pharmacology data are available