UROKINASE-GREEN CROSS INJ. 60000 iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

UROKINASE

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

B01AD04

Dosage:

60000 iu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

UROKINASE 60000 iu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CHINA CHEMICAL & PHARMACEUTICAL CO., LTD.

Authorization status:

ACTIVE

Authorization date:

1999-10-05

Summary of Product characteristics

Fibrinolytic Enzyme Preparation
UROKINASE- GREEN CROSS INJ.
60,000 IU
Urokinase is a plasminogen activator present in traces within human
urine.
UROKINASE-GREEN CROSS INJ. 60,000 IU, prepared by isolation and
purification
from
human
urine
while
still
intact,
has
a
minor
antigenicity and toxicity and has been broadly used as a remedy for
various types of thrombosis and embolism. Thus, its usefulness has
been confirmed.
COMPOSITION
UROKINASE-GREEN CROSS INJ. 60,000 IU is a sterile lyophilized
preparation of urokinase isolated and purified from fresh human
urine. Each vial contains 60,000 IU of urokinase and also contains
40mg of human serum albumin as inactive ingredient.
INDICATIONS
Treatment of the following thrombotic-occlusive diseases:
Š
Cerebral thrombosis (within 5 days after the onset of symptoms,
and without hemorrhage detectable by computed tomography)
Š
Peripheral arterial-venous occlusion (within 10 days after the
onset of symptoms)
DOSAGE AND ADMINISTRATION
Reconstitute the contents of one vial with 10 mL of physiological
saline and inject intravenously. Preferably instill as an admixture
with
physiological saline or glucose injection.
[Thrombotic-occulsive diseases]
Š
Cerebral thrombosis: Administer 60,000 IU once a day for about 7
days.
Š
Peripheral arterial-venous occlusion: Administer 60,000 to
240,000 IU on first day of treatment followed by tapered doses for
about 7 days.
WARNINGS
Serious hemorrhagic cerebral infarction in patients receiving
the
drug
has
been
reported.
The
diagnosis
of
cerebral
thrombosis should be fully confirmed in the patient to be
treated in order to avoid use of the drug in patients with
cerebral embolisms who are apt to develop hemorrhagic
cerebral infarction on thrombolytic therapy
PRECAUTIONS FOR USE
(1) GENERAL PRECAUTIONS
1)
Hemorrhagic cerebral infarction may occur in patients receiving
this
product.
Therefore,
the
patient
should
be
thoroughly
examined
by
means
of
computed
tomography
and
clinical
assessments be made with regard to the status of onset of the
sym