STREPTASE 1,500,000I International Unit Pdr for Soln for Injection
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
16-05-2024
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Δραστική ουσία:
STREPTOKINASE
Διαθέσιμο από:
Hoechst Marion Roussel Irl Ltd
INN (Διεθνής Όνομα):
STREPTOKINASE
Δοσολογία:
1,500,000I International Unit
Φαρμακοτεχνική μορφή:
Pdr for Soln for Injection
Καθεστώς αδειοδότησης:
Withdrawn
Ημερομηνία της άδειας:
2007-03-01
Αρχείο Π.Χ.Π.
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Streptase Injection, 1,500,000 IU
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Streptokinase 1,500,000 International Units.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for sterile concentrate
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Streptase is a fibrinolytic agent which may be used for:
The treatment of acute myocardial infarction within 24 hours of the onset of symptoms.
Intravascular dissolution of thrombi and emboli in extensive deep vein thrombosis; pulmonary embolism; acute or sub-
acute occlusion of peripheral arteries; central retinal venous or arterial thrombosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Acute myocardial infarction
Streptase should be given by intravenous infusion in 50 - 200ml 0.9% physiological saline, 5% glucose, 5% fructose,
Ringer-lactate solution or Haemaccel as soon as possible after the onset of symptoms.
_Systemic administration: _A single dose of 1.5 million IU streptokinase should be infused over one hour. No laboratory
controls are necessary.
_Local application (intra-arterial catheter lysis): _Patients with acute myocardial infarction should be given a bolus dose
of 20,000 IU streptokinase by intracoronary infusion, followed by a maintenance dose of 2,000-4,000 IU/min for a
period of 30-90 minutes.
As usual when performing angiography heparin should be administered, if necessary beforehand, as a safeguard against
catheter-induced thrombosis. The success of treatment can be confirmed by angiography. If adequate blood flow
continues for more than 15 minutes, the result can be counted as successful and treatment can be terminated.
_Adjuvant treatment: _Treatment with aspirin (150 mg daily) for at least 4 weeks is recommended after strepto
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