NUCALA mepolizumab 100 mg solution for injection in pre-filled pen

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Mepolizumab, Quantity: 100 mg

Διαθέσιμο από:

GlaxoSmithKline Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, solution

Σύνθεση:

Excipient Ingredients: sucrose; dibasic sodium phosphate heptahydrate; citric acid monohydrate; polysorbate 80; disodium edetate; water for injections

Οδός χορήγησης:

Subcutaneous

Μονάδες σε πακέτο:

1 mL, 1 mL (starter pack)

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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, Clinical Trials).,Chronic Rhinosinusitis with Nasal Polyps (CRSwNP),NUCALA is indicated as 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 2 Trials).,Relapsed or refractory EGPA,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 (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).

Περίληψη προϊόντος:

Visual Identification: Clear to opalescent, colourless to pale yellow to pale brown solution in a pre-filled pen.; Container Type: Cartridge; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2019-12-02

Φύλλο οδηγιών χρήσης

NUCALA
_mepolizumab 100 mg in 1 mL pre-filled pen (auto-injector)_
AUSTRALIAN 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 or
eosinophilic granulomatosis with
polyangiitis (EGPA).
_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 medicines to control asthma
symptoms and flare ups.
NUCALA DOES NOT TREAT ACUTE
ASTHMA SYMPTOMS, SUCH AS A
SUDDEN ASTHM

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
NUCALA (MEPOLIZUMAB) POWDER FOR INJECTION AND SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Mepolizumab
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 ovary cell line.
Powder for injection
Each vial contains 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
NUCALA is a sterile lyophilised white powder for injection in a
single-use vial. It contains no
preservative.
Solution for injection in pre-filled pen (auto-injector) or pre-filled
syringe (safety syringe)
NUCALA is a 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,
Clinical
Trials).
CHRONIC RHINOSINUSITIS WITH NASAL POLYPS (CRSWNP)
NUCALA is indicated as 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
2
Trials).
RELAPSED OR REFRACTORY EGPA
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 (see
section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
NUCALA