Nucala

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Mepolizumab 144mg ((100 mg/mL after reconstitution with 1.2 mL of WFI, delivers 1 mL))

थमां उपलब्ध:

GlaxoSmithKline NZ Limited

INN (इंटरनेशनल नाम):

Mepolizumab 144 mg ((100 mg/mL after reconstitution with 1.2 mL of WFI, delivers 1 mL))

डोज़:

100 mg/mL

फार्मास्यूटिकल फॉर्म:

Powder for injection

रचना:

Active: Mepolizumab 144mg ((100 mg/mL after reconstitution with 1.2 mL of WFI, delivers 1 mL)) Excipient: Dibasic sodium phosphate heptahydrate Hydrochloric acid Polysorbate 80 Sucrose

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

GlaxoSmithKline LLC

चिकित्सीय संकेत:

Nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I, clear, 10 mL, with bromobutyl rubber (non-latex) stopper, alu overseal & plastic flip-cap - 1 dose units - 48 months from date of manufacture stored at or below 25°C protect from light. Do not freeze 6 hours reconstituted stored at or below 30°C. Do not freeze.

प्राधिकरण की तारीख:

2016-05-02

सूचना पत्रक

NUCALA
1
NUCALA
_mepolizumab 100 mg powder for injection _
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 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 (12 years of
age and over) 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 medicines to control asthma
symptoms and flare ups.
NUCALA does not treat acute
asthma symptoms, such as a sudden
a

उत्पाद विशेषताएं

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