METALYSE

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

TENECTEPLASE

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

TENECTEPLASE

Dosis:

10.000 U

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 10000 UNIT+1 PFS PELARUT @ 10 ML

Diproduksi oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG - Federal Republic of Germany

Tanggal Otorisasi:

2019-07-29

Karakteristik produk

PT. BOEHRINGER LNGELHEIM INDONESIA
Medical and Regulatory Affairs
PRODUCT INFORMATION
No. 0245-06
METALYSE
®
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION
METALYSE" 8,000 units:
1
vial contains 8,000 units (4 0 mg) tenecteplase
1
pre-filled syringe contains 8
ml water for injections
METALYSE" 10,000 units:
1 vial contains 10,000 units (50 mg) tenecteplase
1 pre-filled syringe contains 10
ml water for injections
Excipients:••
L-arginine, phosphoric acid, polysorbate 20
trace residue:
gentamicin from manufacturing process
The reconstituted solution contains 1,000 units (5
mg) tenecteplase per ml.
1.
December 09, 2013
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
Tenecteplase
Tenecteplase
Corresponding volume of
re-constituted
(kg)
(U)
(mg)
solution (ml)
<60
6,000
3 0
6
�60to<70
7,000
35
7
�70to<80
8,000
4 0
8
� 80to
< 90
9,000
45
9
�90
10,000
50
10
The required dose should be administered as a single intravenous bolus
over 5 to 10 seconds.
Remarks:
BLACK
(Current CCDS 0245-02);
BLUE
(Proses at BPOM CCDS 0245-03to 05)
RED
(Proposed as
update CCDS 0245-06)