Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
SILTUXIMAB
MEDISON PHARMA LTD
L04AC11
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
SILTUXIMAB 100 MG
I.V
Required
CILAG AG, SWITZERLAND
SILTUXIMAB
Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
2020-03-31
J-C Health Care Ltd. Kibbutz Shefayim 6099000, ISRAEL tel +972-9-959-1111 fax +972-9-958-3636 Kibbutz Shefayim, 6099000 ISRAEL Phone: 09-9591111 Fax: 09-9583636 םירישכתה לש אפורל ןולעב ןוכדע :ןודנה Sylvant 100mg, Sylvant 400mg ,םידבכנ ת/חקור ,ה/אפור תא םכתעידיל איבהל וננוצרב םירישכתה לש אפורל ןולעה ןוכדע Sylvant 100mg, Sylvant 400mg . :תרשואמה היוותהה SYLVANT is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. :אפורל ןולעב ושענש םייתוהמה םייונישה ןלהל שגדומ קוחמה טסקטה וליאו ןולעל ףסוה לוחכב שגדומה טסקטה רשאכ ףרוצמה ןולעב םינמוסמ םייונישה .הרמחה ןמסמ בוהצ ןומיס םע לוחכב שגדומה טסקטה ,ףסונב .הצוח וק םע םודאב 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hepatic impairment There is not conclusive data about the possible association between SYLVANT Following treatment and incidencewith SYLVANT in clinical trials, transient or intermittent mild-to- moderate elevation of adverse events (AEs) and serious adverse events (SAEs). However it cannot be excluded that patients with hepatic transaminase levels or other liver impairment may experience higher-grade AEs and SAEs compared with the overall population.function tests such as bilirubin have been reported. SYLVANT--treated patients with known liverhepatic impairment as well as patients with elevated transaminase or elevated bilirubin levels should be monitored. Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded 4.8 UNDESIRABLE EFFECTS Summary of the safety profile Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, সম্পূর্ণ নথি পড়ুন
SYLV-SPC-0221-V1 SPC/SYL/IL/1200/01 1 1. NAME OF THE MEDICINAL PRODUCT SYLVANT 100 mg powder for concentrate for solution for infusion SYLVANT 400 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SYLVANT 100 mg powder for concentrate for solution for infusion Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. SYLVANT 400 mg powder for concentrate for solution for infusion Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion. After reconstitution the solution contains 20 mg siltuximab per mL. Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). The product is a freeze-dried white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SYLVANT is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision. Posology The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure. _Treatment criteria_ Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter. Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met. Dose reduction is not recommended. SYLV-SPC-0221-V1 SPC/SYL/IL/1200/01 2 TABLE 1: TREATMENT CRI সম্পূর্ণ নথি পড়ুন