Alexan solution for injection/infusion

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

cytarabine

Предлага се от:

EBEWE Pharma Ges. m.b.H. Nfg. KG

АТС код:

L01BC01

INN (Международно Name):

cytarabine

дозиране:

50mg/ml

Лекарствена форма:

solution for injection/infusion

Броя в опаковка:

(1) glass vial 10ml

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2018-10-27

Данни за продукта

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1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Alexan
®
Solution for injection and infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alexan
®
100 mg: One vial with 5 ml solution contains 100 mg cytarabine (20
mg/ml).
Alexan
®
500 mg: One vial with 10 ml solution contains 500 mg cytarabine (50
mg/ml).
Alexan
®
1000 mg: One vial with 20 ml solution contains 1000 mg cytarabine (50
mg/ml).
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection and infusion
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alexan is used in adults.
1. Standard treatment:
Cytarabine is a cytostatic drug for the induction therapy of a
clinical remission and/or
maintenance therapy in patients with:

acute non-lymphoblast leukaemia,

acute lymphoblast leukaemia,

acute myeloid leukaemia,

diffuse hystiocytic lymphoma (non-Hodgkin’s lymphoma with high level
of
malignancy).
2. High dose cytarabine therapy is indicated in patients with:

refractory acute non-lymphoblast leukaemia,

refractory acute lymphoblast leukaemia,

blast crisis in chronic myeloid leukaemia,

leukaemias with particular risk, e.g. acute leukaemias with secondary
carcinoma
after previous chemotherapy and/or irradiation,

refractory non-Hodgkin’s lymphomas.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The treatment with Alexan should be initiated under the monitoring or
consultation of a
physician with experience in treatment with cytostatics.
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2
It must be assumed that effective cytarabine plasma levels are between
0.01 and
0.15

g/ml. The dose must be determined exactly and individually, preferably
according to
body surface area (BSA).
Cytarabine is used in combination with other cytostatic substances
within complex therapy
protocols.
Only general dosing recommendations can be given. For exact dosing,
see treatment
protocols in the specialised literature.
Patients with hepatic or renal impairment
In pat