Nucala
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
13-10-2022
Valmisteyhteenveto
(SPC)
13-10-2022
Julkisesta arviointikertomuksesta
(PAR)
13-12-2021
Aktiivinen ainesosa:
Mepolizumab
Saatavilla:
GlaxoSmithKline Trading Services
ATC-koodi:
R03DX09
INN (Kansainvälinen yleisnimi):
mepolizumab
Terapeuttinen ryhmä:
Drugs for obstructive airway diseases,
Terapeuttinen alue:
Asthma
Käyttöaiheet:
Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older .Chronic rhinosinusitis with nasal polyps (CRSwNP)Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control.Eosinophilic granulomatosis with polyangiitis (EGPA)Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA).Hypereosinophilic syndrome (HES)Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.
Tuoteyhteenveto:
Revision: 18
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-12-01
Pakkausseloste
94
B. PACKAGE LEAFLET
95
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUCALA 100 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
mepolizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nucala is and what it is used for
2.
What you need to know before you use Nucala
3.
How to use Nucala
4.
Possible side effects
5.
How to store Nucala
6.
Contents of the pack and other information
7.
Step-by-step instructions for use
1.
WHAT NUCALA IS AND WHAT IT IS USED FOR
Nucala contains the active substance MEPOLIZUMAB,
a
_monoclonal antibody_
, a type of protein
designed to recognise a specific target substance in the body. It is
used to treat
SEVERE ASTHMA
and
EGPA
(Eosinophilic Granulomatosis with Polyangiitis) in adults, adolescents
and children aged 6
years and older. It is also used to treat
CRSWNP
(Chronic Rhinosinusitis with Nasal Polyps) and
HES
(Hypereosinophilic syndrome) in adults.
Mepolizumab, the active substance in Nucala, blocks a protein called
_interleukin-5_
. By blocking the
action of this protein
_, _
it limits the production of eosinophils from the bone marrow and
lowers the
number of eosinophils in the bloodstream and the lungs.
SEVERE EOSINOPHILIC ASTHMA
Some people with severe asthma have too many
_eosinophils_
(a type of white blood cell) in the blood
and lungs. This condition is called
_eosinophilic asthma – _
the type of asthma Nucala can treat.
Nucala can reduce your number of asthma attacks, if you or your child
are already using medicines
such as high dose inhalers, but your asthma is not well controlled by
these medicines.
If you are taking medicines called
_oral corticosteroids,_
Nucala can also help reduce the dai
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nucala 100 mg solution for injection in pre-filled pen
Nucala 100 mg solution for injection in pre-filled syringe
Nucala 40 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nucala 100 mg solution for injection in pre-filled pen
Each 1 ml pre-filled pen contains 100 mg of mepolizumab.
Nucala 100 mg solution for injection in pre-filled syringe
Each 1 ml pre-filled syringe contains 100 mg of mepolizumab.
Nucala 40 mg solution for injection in pre-filled syringe
Each 0.4 mL pre-filled syringe contains 40 mg of mepolizumab.
Mepolizumab is a humanised monoclonal antibody produced in Chinese
hamster ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
A clear to opalescent, colourless to pale yellow to pale brown
solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory
eosinophilic asthma in adults,
adolescents and children aged 6 years and older (see section 5.1).
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Nucala is indicated as an add-on therapy with intranasal
corticosteroids for the treatment of adult
patients with severe CRSwNP for whom therapy with systemic
corticosteroids and/or surgery do not
provide adequate disease control.
Eosinophilic granulomatosis with polyangiitis (EGPA)
Nucala is indicated as an add-on treatment for patients aged 6 years
and older with relapsing-remitting
or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
3
Hypereosinophilic syndrome (HES)
Nucala is indicated as an add-on treatment for adult patients with
inadequately controlled
hypereosinophilic syndrome without an identifiable non-haematologic
secondary cause (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nucala should be prescribed by physicians experienced in the diagnosis
and treatmen
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