Asparaginase 10000 U medac

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

L, ASPARAGINASE

Available from:

medac Gesellschaft Fur klinische Spezialpräparate mbH Theaterstr. 6 22880 Wedel, Germany

ATC code:

L01XX02

INN (International Name):

L-ASPARAGINASE 10000 IU

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

L-ASPARAGINASE 10000 IU

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2005-06-14

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPARAGINASE 10000 U MEDAC POWDER FOR SOLUTION FOR INJECTION
L-Asparaginase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Asparaginase 10000 U medac is and what it is used for
2.
Before you use Asparaginase 10000 U medac
3.
How to use Asparaginase 10000 U medac
4.
Possible side effects
5.
How to store Asparaginase 10000 U medac
6.
Further information
1.
WHAT ASPARAGINASE 10000 U MEDAC IS AND WHAT IT IS USED FOR
Asparaginase 10000 U medac is a medicinal product (cytostatic agent)
which lowers the L-
asparagine level in the tumour cells so that the protein synthesis in
these cells is inhibited.
Asparaginase 10000 U medac is used as part of an antineoplastic
combination therapy of acute
lymphatic leukaemia (ALL) in children and adults as well as in
non-Hodgkin's lymphomas in
children.
2.
BEFORE YOU USE ASPARAGINASE 10000 U MEDAC
DO NOT USE ASPARAGINASE 10000 U MEDAC:
-
if you are hypersensitive (allergic) to L-asparaginase
-
if you have a pancreatitis or a history of pancreatitis at the time of
treatment, as acute
haemorrhagic pancreatitis has been observed following asparaginase
application.
TAKE SPECIAL CARE WITH ASPARAGINASE 10000 U MEDAC:
Patients of reproductive age should use contraception or abstain from
sexual intercourse during
and for up to 3 months after the completion of chemotherapy.
Page 2 of 11
USING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription.
1.
How other drugs may influence the

Summary of Product characteristics

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Asparaginase 5000 U medac
Asparaginase 10000 U medac
Powder for solution for injection
Active substance: L-Asparaginase
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of Asparaginase 5000 (10000) U medac with 21.6 - 24.5 (43.2 –
49.0) mg of powder for
solution for injection contains:
L-Asparaginase (E. C. 3.5.1.1) 83 (167) µkat, corresponding to 5000
(10000) U.
(1 U L-asparaginase releases 1 µmol ammonia from L-asparagine in 1
Minute at 37° C.)
3.
PHARMACEUTICAL FORM
Powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asparaginase
5000
(10000)
U
medac
is
indicated
as
a
component
of
an
anti-neoplastic
combination therapy of acute lymphatic leukaemia (ALL) in children and
adults as well as in
cases of non-Hodgkin’s lymphomas in childhood.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To reduce the risk of a possible IgE-mediated hypersensitivity
reaction, a prick test (place 1
drop of the ready-to-use solution on the volar side of the forearm
using a tube-like instrument
and inject into the epidermis through the drop using a sterile
syringe. Avoid bleeding. Wipe
away the drop of the preparation after 3 minutes. After a further 20
minutes, observe the
reaction: if redness and weals develop, refrain from L-asparaginase
treatment) or an intra-
cutaneous injection (increasing concentrations in an appropriate
dilution) should be carried
out before treatment is started or resumed.
Page 2 of 14
Since not just IgE-mediated allergic reactions that are detectable by
skin testing but also IgG
and IgM-mediated sensitisation has been described in the literature,
the use of an intravenous
test dose before intravenous administration is recommended (1000 U
i.v. as a short infusion 1
hour before the beginning of treatment).
Unless otherwise prescribed, the mean intravenous daily dose in
children and adults in the
monotherapy is 200 U per kg body weight (BW) or 6000 U per m² body
surface area (BSA). It
can be in