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ACTILYSE, pulbere liofilizata Forma de prezentare: Flacon cu substanta liofilizata a 20 mg alteplase. Flacon substanta liofilizata a 50 mg alteplase.

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Flacoane solvent a 20, respectiv 50 ml apa distilata.Actiune terapeutica: Tratamentul fibrinolitic al infarctului de miocard, la pacientii la care tratamentul poate fi inceput in termen de 6-12 ore de la manifestarea primelor simptome. Tratamentul trombolitic in embolia pulmonara masiva acuta, cu instabilitate hemodinamica. Se recomanda ca diagnosticul sa fie confirmat, atunci cand este posibil, prin intermediul unor teste obiective ca, de exemplu angiografia pulmonara sau proceduri neinvazive, de exemplu explorarea ecografica pulmonara. Nu exista date referitoare la efectele pozitive asupra mortalitatii si a prognosticului pe termen mai lung, in ceea ce priveste embolismul la pacientii cu o hemodinamica instabila.Dozare, mod de administrare: Se recomanda ca Actilyse sa fie administrat cat mai curand posibil dupa manifestarea primelor simptome.

In conditii aseptice, continutul flaconului de Actilyse (20 sau 50 mg substanta activa) se dizolva cu apa distilata (20 sau 50 ml, in functie de cantitatea de substanta activa continuta), pentru a obtine concentratia necesara de Actilyse 1 mg/1 ml care se administreaza intravenos. Solutia reconstituita poate fi in continuare diluata cu ser fiziologic (0,9%) pana la obtinerea unei concentratii de minimum 0,2 mg/ml.

Infarctul de miocard: In primele 6 ore, la pacientii peste 65 kg: 15 mg in injectie intravenoasa in bolus, apoi 50 mg in perfuzie, in cursul primelor 30 de minute, urmata de 35 mg in perfuzie timp de 60 de minute, pana la atingerea dozei maxime de mg. La pacientii sub 65 kg: 15 mg prin injectare intravenoasa in bolus, apoi 0,75 mg/kg corp, timp de 30 min (maximum 50 mg), urmata de 0,5 mg/kg corp, timp de 60 minute, pana la atingerea dozei maxime de 35 mg. Peste 6 ore, dar pana la 12 ore: 10 mg prin injectie intravenoasa in bolus, 50 mg perfuzie in cursul primei ore, perfuzia a 10 mg, in 30 de minute, pana la atingerea dozei maxime de 100 mg, in cursul urmatoarelor 3 ore. La pacientii sub 65 kg doza totala nu va depasi 1,5 mg/kg corp.

Tratament adjuvant: Heparina, timp de cel putin 24 de ore. Se recomanda sa se inceapa tratamentul prin injectarea in bolus a 5 000 unitati de heparina si sa se continue cu perfuzarea a 1 000 unitati pe ora.

Perfuzia se va adapta in functie de valorile timpului de protrombina, care trebuie sa scada de 1,5 pana la de 2,5 ori din valoarea initiala. Acid acetilsalicilic administrat imediat ce acest lucru este posibil dupa inceperea trombozei si se va continua in primele luni dupa producerea infarctului de miocard. Embolie pulmonara: 10 mg, prin injectare intravenoasa in bolus, timp de 1-2 min, 90 mg prin perfuzare intravenoasa, timp de 2 ore. Doza totala de 100 mg Actilyse in cursul a doua ore. La pacientii sub 65 kg doza totala nu va depasi 1,5 mg/kg corp. Tratament adjuvant: Dupa tratamentul cu Actilyse, se va incepe (sau relua) administrarea heparinei, atunci cand valorile timpului de protrombina se situeaza sub nivelul unei valori care reprezinta de doua ori limita normala.

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