LEUNASE FOR INJECTION 10000 iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

L-ASPARAGINASE

Available from:

KYOWA KIRIN ASIA PACIFIC PTE. LTD.

ATC code:

L01XX02

Dosage:

10000 iu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

L-ASPARAGINASE 10000 iu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

NIPRO PHARMA CORPORATION (ODATE PLANT)

Authorization status:

ACTIVE

Authorization date:

1988-06-23

Patient Information leaflet

Antineoplastic enzyme preparation 
LEUNASE INJ. 
L-asparaginase for injection 

. 
[DESCRIPTION] 
(1) 
[COMPOSITION] 
Each vial of LEUNASE Inj contains 5,000
KU or 10,000 KU of lyophilized L-
asparaginase. It is

A WHITE POWDER TO BE RECONSTITUTED INTO  an injectable
solution 
before use. 
(One KU of L-asparaginase
is equivalent to the amount of L-Asparaginase that 
decomposes L-asparagine and produces 1
µmole of ammonia per minute at 37°C.) 
(2) 
PRODUCT DESCRIPTION 
Unit 
5,000 KU 
10,000 KU 
Color 
White 
White 
pH range 
6.5 – 7.5 
6.5 – 7.5 
Stability : Comparatively stable to heat, pH and light in the
crystal state. 
Stability pH range in aqueous solution is 6.0 to 8.5. 
[INDICATIONS] 
Acute leukemia (including blastic crisis in
chronic leukemia), malignant lymphoma. 
[DOSAGE AND ADMINISTRATION] 
The usual dose is 50 to 200 KU/kg to be administered
by intravenous drip infusion every 
day or every other day. 
The dosage may be adjusted depending on the age and condition
of patient 
Prescription-only drug 
Storage 
Store in a cool place (below 15
°C 
(59
°F) 
Expiration date 
2 years (do not use after the 
expiration date indicated on the 
package) 
Contraindications  
(LEUNASE  Inj. is contraindicated in the following patients.) 
Patients with a
history of serious hypersensitivity to any of the
components of the product. 
Page 1 of 9 
(PREPARATION) 
See 7. Precautions Concerning Use 
[PRECAUTIONS] 
1.
CAREFUL ADMINISTRATION (LEUNASE SHOULD BE ADMINISTERED WITH
CARE IN THE
FOLLOWING PATIENTS.) 
1) Patients with
pancreatitis or a history of pancreatitis [Exacerbation or recurrence
of pancreatitis may occur.]
2) Patients with hepatic dysfunction [Hyperammonemia is liable
to occur.]
3) Patients with renal dysfunction [
azotemia
 may occur.]
4) Patients with
marrow suppression [Administration of LEU

Summary of Product characteristics

CONTRAINDICATIONS
(LEUNASE INJ. IS CONTRAINDICATED IN THE FOLLOWING PATIENTS.)
Patients with a history of serious hypersensitivity to any of the
components of
the product.
[DESCRIPTION]
1.
COMPOSITION
Each vial of LEUNASE Inj. contains 5,000 KU or 10,000 KU of
lyophilized L-asparaginase. It
is
A WHITE POWDER TO BE RECONSTITUTED INTO
an injectable solution before use.
(One KU of L-asparaginase is equivalent to the amount of
L-asparaginase that decomposes
/DVSDUDJLQHDQGSURGXFHVѥPROHRIDPPRQLDSHUPLQXWHDW
°
C.)
2.
PRODUCT DESCRIPTION
Unit
5,000 KU
10,000 KU
Color
White
White
pH range


Stability : Comparatively stable to heat, pH and light in the crystal
state.
Stability pH range in aqueous solution is 6.0 to 8.5.
[INDICATIONS]
Acute leukemia (including blastic crisis in chronic leukemia),
malignant lymphoma.
[DOSAGE AND ADMINISTRATION]
The usual dose is 50 to 200 KU/kg to be administered by intravenous
drip infusion every day or
every other day. The dosage may be adjusted depending on the age and
condition of the patient.
(PREPARATION)
6HH3UHFDXWLRQV&RQFHUQLQJ8VH
[PRECAUTIONS]
1. CAREFUL ADMINISTRATION (LEUNASE SHOULD BE ADMINISTERED WITH CARE IN
THE FOLLOWING
PATIENTS.)
1)
Patients with pancreatitis or a history of pancreatitis [Exacerbation
or recurrence of pancre-
atitis may occur.]
2)
Patients with hepatic dysfunction [Hyperammonemia is liable to occur.]


3DWLHQWVZLWKUHQDOG\VIXQFWLRQ>$]RWHPLDPD\RFFXU@
4)
Patients with marrow suppression [Administration of LEUNASE may
exacerbate marrow
suppression.]
5)
Patients complicated with infection [Administration of LEUNASE may
aggravate infection due
to marrow suppression.]
6)
Patients with varicella [Fatal systemic disorders may occur.]
2. IMPORTANT PRECAUTIONS
1)
Since
SERIOUS COAGULOPATHY SUCH AS CEREBRAL HEMORRHAGE, CEREBRAL AND
PULMONARY
HEMORRHAGE
may occur, patients should be monitored with frequent testing for
fibrinogen,
plasminogen, AT-III, protein C, etc. during treatment, and, if any
abnormality is noted, ap