Nucala

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Mepolizumab 100 mg/mL

から入手可能:

GlaxoSmithKline NZ Limited

投薬量:

100 mg/mL

医薬品形態:

Solution for injection

構図:

Active: Mepolizumab 100 mg/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate heptahydrate Disodium edetate Polysorbate 80 Sucrose Water for injection

処方タイプ:

Prescription

適応症:

Nucala is indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over.

製品概要:

Package - Contents - Shelf Life: Syringe, glass, in safety device - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 7 days not refrigerated stored at or below 30°C protect from light. in unopened carton, no return to refrigeration 8 hours opened stored at or below 30°C

承認日:

2020-05-01

情報リーフレット

NUCALA
1
NUCALA
_mepolizumab 100 mg in 1 mL pre-filled pen (auto-injector);
mepolizumab 100 mg in 1 mL pre-filled _
_syringe (safety syringe) _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using NUCALA.
This leaflet answers some common
questions about NUCALA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using NUCALA
against the benefits he or she expects
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NUCALA IS USED
FOR
NUCALA is a medicine which
contains the active substance
mepolizumab, a monoclonal
antibody. This antibody blocks a
specific protein called interleukin-5.
By blocking the action of interleukin-
5, NUCALA limits the production of
more eosinophils (a type of white
blood cell) from the bone marrow
and lowers the number of eosinophils
in the bloodstream and the lungs.
NUCALA is used to treat severe
eosinophilic asthma, chronic
rhinosinusitis with nasal polyps,
eosinophilic granulomatosis with
polyangiitis (EGPA), or
Hypereosinophilic Syndrome (HES).
_SEVERE EOSINOPHILIC ASTHMA _
Some people with severe asthma
have too many eosinophils (a type of
white blood cell) in the blood, lungs
and tissues. Having too many
eosinophils in your blood can
damage the airways and can cause
your asthma to get worse or can
increase the number of your asthma
flare ups.
NUCALA is used to treat asthma by
reducing the frequency of asthma
flare ups in adolescents (over 12
years of age) and adults who are
already receiving asthma medicines,
but whose asthma flare ups are not
well controlled by medicines such as
high-dose corticosteroid inhalers or
beta-agonist inhalers.
NUCALA can also be used to help
reduce the daily dose of oral
corticosteroids in patients taking
these medi

製品の特徴

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
NUCALA (mepolizumab) powder for injection and solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepolizumab is a humanised monoclonal antibody (IgG1, kappa) directed
against human
interleukin-5 (IL-5). Mepolizumab is expressed as a soluble
glycoprotein secreted from a
recombinant Chinese hamster (rch) ovary cell line.
Powder for injection
Each vial delivers mepolizumab 100 mg (100 mg/mL after
reconstitution).
Solution for injection in pre-filled pen (auto-injector) or pre-filled
syringe (safety syringe)
Each pre-filled pen (auto-injector) or pre-filled syringe
(safety-syringe) delivers 100 mg
mepolizumab in 1 mL (100 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection
Sterile lyophilised white powder in a single-use vial. It contains no
preservative.
Solution for injection in pre-filled pen (auto-injector) or pre-filled
syringe (safety syringe)
Clear to opalescent, colourless to pale yellow to pale brown solution
in a single-use, pre-
filled pen or syringe. It contains no preservative.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SEVERE EOSINOPHILIC ASTHMA
NUCALA is indicated as an add-on treatment for severe eosinophilic
asthma in patients
aged 12 years and over (see Section 5.1 Pharmacodynamic properties).
CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRSWNP)
NUCALA is indicated as an add-on treatment in adult patients (18 years
and above) with
severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an
inadequate response to
intranasal corticosteroids (see Section 5.1 PHARMACODYNAMIC
PROPERTIES, Clinical
efficacy and safety).
RELAPSED OR REFRACTORY EGPA
NUCALA is indicated as an add-on treatment for relapsing or refractory
Eosinophilic
2
Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18
years and over (see
section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical Efficacy and
Safety).
HYPEREOSINOPHILIC SYNDROME (HES)
NUCALA is indicated as an add-on treatment for adult