Oncaspar 750 Uml powder for solution for injectioninfusion

Country: Malaysia

Language: English

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

Active ingredient:

Pegaspargase

Available from:

SERVIER MALAYSIA SDN BHD

INN (International Name):

Pegaspargase

Units in package:

1 Vials

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Summary of Product characteristics

1
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Oncaspar 750 U/ml powder for solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3,750 Units (U)** of pegaspargase*.
After reconstitution, 1 ml of solution contains 750 U pegaspargase
(750 U/ml).
* The active substance is a covalent conjugate of
_Escherichia coli_
-derived L-asparaginase with
monomethoxypolyethylene glycol
**One unit is defined as the quantity of enzyme required to liberate 1
µmol ammonia per minute at
pH 7.3 and 37°C
The potency of this medicinal product should not be compared to the
one of another pegylated or
non-pegylated protein of the same therapeutic class. For more
information, see section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oncaspar is indicated as a component of antineoplastic combination
therapy in acute lymphoblastic
leukaemia (ALL) in paediatric patients from birth to 18 years, and
adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oncaspar should be prescribed and administered by physicians and/or
health care personnel
experienced in the use of antineoplastic products. It should only be
given in a hospital setting where
appropriate resuscitation equipment is available. Patients should be
closely monitored and carefully
observed for any adverse reactions throughout the administration
period (see section 4.4).
Posology
Oncaspar is usually administered as part of combination chemotherapy
protocols with other
antineoplastic agents (see also section 4.5).
_Paediatric patients and adults ≤21 years _
The recommended dose in patients with a body surface area (BSA) ≥0.6
m
2
and who are ≤