· sergant sparciai besivystancia sunkia pasikartojanciai recidyvuojancia isstine skleroze.

· the disease is severe and progressing rapidly.

· Pacientai, kuriems itin sparciai vystosi sunkios formos pasikartojanciai recidyvuojanti isstin

· Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or

(zr.5. 1);arba· Sparciai besivystancia sunkia pasikartojanciai recidyvuojancia isstine skleroze sergantiems

or· Patients with rapidly evolving severe relapsing remitting multiple sclerosis (see 5.1) .

Ligos eig modifikuojanti TYSABRI monoterapija skirta itin aktyvios formos pasikartojanciai recidyvuojancios isstins sklerozs gydymui sioms pacient grupms:

TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:

Esant labai sunkiai, gyvybei pavojingai ar pasikartojanciai infekcinei ligai, doz gali bti padidinta iki 400 mg tris kartus per par.

In case of very serious, life-threatening or recurrent infections the dosage can be increased to 400 mg three times daily.

Vaistas vartojamas pasikartojanciai recidyvuojanciai IS (kai pacientams pasireiskia pasikartojantys priepuoliai, po kuri seka besimptomiai periodai ­ remisijos) gydyti:

It is used in the type of MS known as relapsing-remitting (when the patient has attacks -relapses, followed by periods with no symptoms -remissions) , when:

Ligos eig modifikuojanti TYSABRI monoterapija skirta pasikartojanciai recidyvuojancios isstins sklerozs gydymui, siekiant mazinti pamjim dazn ir stabdyti negalumo vystymsi.

TYSABRI is indicated as a single disease modifying therapy in relapsing remitting multiple sclerosis to prevent relapses and delay progression of disability.

Nuo sparciai besivystancios pasikartojanciai recidyvuojancios IS gydyt pacient pogrupyje (pacientai, patyr 2 ir daugiau pamjim ir turintys 1 ar daugiau Gd+ lezij) metinis pamjim

In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion) , the annualised relapse rate was 0.282 in the Tysabri treated group (n = 148) and 1.455 in the placebo group (n = 61) (p 0.001) .Hazard ratio

Vaisto monoterapijos veiksmingumas buvo tiriamas dvej met trukms atsitiktini imci, dvigubai koduotuose, placebo kontroliuojamuose klinikiniuose tyrimuose (AFFIRM studija) , kuriuose dalyvavo pasikartojanciai recidyvuojancia IS sergantys pacientai, pries traukim tyrimus patyr bent 1 klinikin pamjim per metus ir kuri rodiklis pagal Kurtzke isplstin negalumo bsenos skal (EDSS) buvo nuo 0 iki 5.

Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.