Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
TALIMOGENE LAHERPAREPVEC
AMGEN EUROPE B.V.
L01XX51
SOLUTION FOR INJECTION
TALIMOGENE LAHERPAREPVEC 10^6 PFU / 1 ML
INTRA-LESIONAL
Required
AMGEN EUROPE B.V., NETHERLANDS
TALIMOGENE LAHERPAREPVEC
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic ( stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
2018-02-12
טסוגוא 9 201 PFU/ML 8 , 10 6 IMLYGIC 10 SOLUTION FOR INJECTION ,ה/דבכנ ת/חקור ,ה/דבכנ ה/אפור לע ךעידוהל תשקבמ ,םושירה תלעב ,יו יב הפוריא ן'גמא ולעב םינוכדע אפורל ן רישכתל קי'גיילמיא 6 10 , 8 10 . .דבלב תורמחהה תונייוצמ וז העדוהב :תורשואמה תויוותהה Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. ןוכדע :אפורל ןולעב 5.2 PHARMACOKINETIC PROPERTIES Biodistribution (within the body) and viral shedding (excretion/secretion) Pharmacokinetic properties updated to include information based on the final results from study 20120324. תופורתה רגאמב םוסרפל חלשנ ןכדועמה אפורל ןולעה ב ולבקל ןתינו ,תואירבה דרשמ רתא םג לע - ץיפמל הינפ ידי ה תרבח ,הפורתה לש ימוקמ ןוסידמ .המראפ :תוחוקל תורש CS@medison.co.il - Medison ןופלט : *5634 רבב הכ , רוד ןב לגיס הנוממ תחקור Belgenin tamamını okuyun
1 _ _ _Revised in December 2020._ 1. NAME OF THE MEDICINAL PRODUCT Imlygic _ _ 10 6 plaque forming units (PFU)/mL solution for injection Imlygic _ _ 10 8 plaque forming units (PFU)/mL solution for injection _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Talimogene laherparepvec is an attenuated herpes simplex virus type-1 (HSV-1) derived by functional deletion of 2 genes ( ICP34.5 and ICP47) and insertion of coding sequence for human granulocyte macrophage colony-stimulating factor (GM-CSF) (see section 5.1). _ _ Talimogene laherparepvec is produced in Vero cells by recombinant DNA _ _ technology. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Imlygic _ _ 10 6 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 10 6 (1 million) plaque forming units (PFU)/mL. Imlygic _ _ 10 8 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 × 10 8 (100 million) plaque forming units (PFU)/mL. Excipient with known effect Each 1 mL vial contains 7.7 mg sodium and 20 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Imlygic _ _ 10 6 plaque forming units (PFU)/mL solution for injection Clear to semi-translucent liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. Imlygic _ _ 10 8 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state. It may contain white, visible, variously shaped, virus-containing particles. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment Belgenin tamamını okuyun