SYLVANT 100 MG

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

SILTUXIMAB

Dostupné z:

MEDISON PHARMA LTD

ATC kód:

L04AC11

Forma lieku:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Zloženie:

SILTUXIMAB 100 MG

Spôsob podávania:

I.V

Typ predpisu:

Required

Výrobca:

CILAG AG, SWITZERLAND

Terapeutické oblasti:

SILTUXIMAB

Terapeutické indikácie:

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.

Dátum Autorizácia:

2020-03-31

Príbalový leták

J-C Health Care Ltd.
Kibbutz Shefayim 6099000, ISRAEL
tel [phone]
fax [phone]
Kibbutz Shefayim, 6099000
ISRAEL
Phone: [phone] Fax: [phone]
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,

Súhrn charakteristických

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