Sylvant

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Siltuximab 100mg;  ;  

から入手可能:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN（国際名）:

Siltuximab 100 mg

投薬量:

100 mg

医薬品形態:

Powder for infusion concentrate

構図:

Active: Siltuximab 100mg     Excipient: Histidine Polysorbate 80 Sucrose

処方タイプ:

Prescription

製:

Janssen Sciences Ireland UC

適応症:

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.

製品概要:

Package - Contents - Shelf Life: Vial, glass, Type 1 - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 2 hours reconstituted stored at or below 25°C. prior to dilution 6 hours diluted stored at or below 25°C

承認日:

2014-08-08

情報リーフレット

SYLVANT
®
AUGUST 2022 CMI 3
PIL-SYL-NZ-1210-04
SYLVANT
®
Siltuximab
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
SYLVANT. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING SYLVANT, ASK YOUR DOCTOR
OR PHARMACIST.
Your doctor and pharmacist have more
information.
Keep this information handy. You can
refer to it later if you have any
questions.
Please also refer to Consumer
Medicine Information documents of
other medicines your doctor may
have prescribed for use in
combination with SYLVANT.
WHAT SYLVANT IS USED
FOR
SYLVANT is a prescription medicine
used to treat multicentric Castleman’s
disease (MCD) in patients who do
not have human immunodeficiency
virus (HIV) and human herpesvirus-8
(HHV-8) infection.
Multicentric Castleman’s disease
causes non-cancerous growths
(tumours) to develop in the lymph
nodes in the body. This disease may
also make you feel tired, sweat at
night, have a tingling feeling, and a
loss of appetite.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
HOW IT WORKS
SYLVANT contains the active
ingredient siltuximab. SYLVANT
blocks the action of a specific protein
called “interleukin-6”, which can
cause inflammation. Blocking this
protein helps to reduce the size of the
affected lymph nodes and reduce the
symptoms of the illness such as
feeling tired. This should help you
carry out your normal daily tasks.
BEFORE YOU USE
SYLVANT
WHEN YOU MUST NOT USE IT
DO NOT USE SYLVANT IF YOU KNOW
YOU ARE ALLERGIC TO SILTUXIMAB OR
ANY OF THE OTHER INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction may
include skin rash, itching or hives on
the skin, shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body.
DO NOT USE IT AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
DO NOT USE IT IF THE PACKAGING IS
TORN OR SHOWS

製品の特徴

SYLVANT DATA SHEET – 18Dec2023
SPC-SYL-NZ-1209-05
Page 1 of 15
SYLVANT
®
SILTUXIMAB
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SYLVANT 100 mg powder for infusion concentrate
SYLVANT 400 mg powder for infusion concentrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SYLVANT is a chimeric (human murine) immunoglobulin G1k (IgG1k)
monoclonal antibody
against human Interleukin-6 (IL-6) produced in a Chinese Hamster Ovary
(CHO) cell line.
SYLVANT 100 MG POWDER FOR INFUSION CONCENTRATE
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 INFUSION CONCENTRATE
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.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for infusion 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 DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an
intravenous infusion
administered every 3 weeks until treatment failure.
Intravenous
infusion
(IV)
of
SYLVANT
should
be
administered
by
qualified
healthcare
professionals.
Appropriate
personnel
and
medicinal
product
should
be
available
to
treat
anaphylaxis if it occurs.
TREATMENT CRITERIA
Haematology laboratory tests should be performed prior to each dose of
SYLVANT therapy for
the first 12 months and every 3 dosing cycles thereafter. The
prescriber should consider delaying
SYLVANT DATA SHEET – 18Dec2023
SPC-SYL-NZ-1209-05
Page 2 of 15
treatment if the treatment criteria outlined in Table 1 are not met,
before administering SYLVANT.
Dose reduction is not recommended.
TA