metalyse - PIO Nas

PT. Boehringer lngelheim Indonesia
1.
Medical and Regulatory Affairs
PRODUCT INFORMATION
No. 0245-06
December 09, 2013
METALYSE®
Powder and solvent for solution for injection
Composition
METALYSE" 8,000units:
1vial contains 8,000units (4 0mg) tenecteplase
1pre-filled syringe contains 8ml water for injections
METALYSE" 10,000units:
1vial contains 10,000units (50mg) tenecteplase
1pre-filled syringe contains 10ml water for injections
Excipients:••
trace residue:
L-arginine, phosphoric acid, polysorbate 20
gentamicin from manufacturing process
The reconstituted solution contains 1,000units (5mg) tenecteplase per ml.
Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for
tenecteplase and is not comparable with units used for other thrombolytic agents.
Indications
METALYSE" is indicated for the thrombolytic treatment of acute myocardial infarction (AMI). Treatment
should be initiated as soon as possible after symptom onset
Dosage and administration
METALYSE" should be administered on the basis of body weight ,with a maximum dose of 10,000 units (50
mg tenecteplase). The volume required to administer the correct dose can be calculated from the following
scheme:
Patients' body weight category
(kg)
<60
�60to<70
�70to<80
�80to<90
�90
Tenecteplase
(U)
6,000
7,000
8,000
9,000
10,000
Tenecteplase Corresponding volume of re-constituted
solution (ml)
(mg)
6
30
7
35
8
40
9
45
10
50
The required dose should be administered as a single intravenous bolus over 5to 10seconds.
Remarks: Black (Current CCDS 0245-02); Blue (Proses at BPOM CCDS 0245-03to 05) Red (Proposed as
update CCDS 0245-06)