EVOLTRA 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

CLOFARABINE

Предлага се от:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Международно Name):

CLOFARABINE

Броя в опаковка:

1Units Units

Произведено от:

PHARMACHEMIE B.V.

Данни за продукта

1
EVOLTRA
® 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Concentrate for solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial
contains 20 mg of
clofarabine.
Excipient with known effect:
Each 20 ml vial contains 180 mg of sodium chloride.
For the full list of excipients, see section _List of excipients_.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, practically colourless solution with a pH of 4.5 to 7.5 and an
osmolarity of 270 to 310
mOsm/l.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric
patients (1 to 21 years old) who
have relapsed or are refractory after receiving at least two prior
regimens and where there is no
other treatment option anticipated to result in a durable response.
Safety and efficacy have been
assessed in studies of patients ≤ 21 years old at initial diagnosis
(see section _Pharmacodynamic _
_Properties_).
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy must be initiated and supervised by a physician experienced in
the management of
patients with acute leukaemias.
Posology
_Adults (including the elderly) _
There are currently insufficient data to establish the safety and
efficacy of clofarabine in adult
patients (see section _Pharmacokinetic Properties_).
_Paediatric patients _
_Children and adolescents (≥ 1 year old) _
The recommended dose in monotherapy is 52 mg/m
2
of body surface area administered by
intravenous infusion over 2 hours daily for 5 consecutive days. Body
surface area must be
calculated using the actual height and weight of the patient before
the start of each cycle.
Treatment cycles should be repeated every 2 to 6 weeks (from the
starting day of the previous
cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75
× 10
9
/l) and return to
baseline organ function. A 25% dose reduction may be warranted in
patients experiencing
significant toxicities (see below). There is currently limited
experience of