Nucala 100mg Powder for Solution for Injection

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

MEPOLIZUMAB

Saatavilla:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Kansainvälinen yleisnimi):

MEPOLIZUMAB

Kpl paketissa:

1 Vials

Valmistaja:

GlaxoSmithKline Manufacturing S.p.A

Valmisteyhteenveto

CONFIDENTIAL
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[GSK logo]
NUCALA
MEPOLIZUMAB
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepolizumab is a humanised monoclonal antibody (IgG1, kappa), directed
against human
interleukin-5 (IL-5) produced in Chinese hamster ovary cells by
recombinant DNA technology.
_NUCALA _
is
supplied
as
a
sterile
lyophilised
powder
for
subcutaneous
injection
after
reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for
Injection, the resulting
concentration is 100 mg/mL and delivers 1 mL, with a pH of 7.0.
PHARMACEUTICAL FORM
Powder for solution for injection.
Lyophilised white powder.
CLINICAL PARTICULARS
INDICATIONS
SEVERE EOSINOPHILIC ASTHMA
_NUCALA_
is indicated as an add-on maintenance treatment for patients aged 12
years old and
older with severe eosinophilic asthma who:
•
have at least two exacerbations in the preceding 12 months on current
standard of care
(high doses of inhaled corticosteroids plus additional maintenance
treatment) and/or
requirement for treatment with systemic corticosteroids, and
•
have a blood eosinophil count of ≥ 150 cells/µL (0.15 GI/L) at
initiation of treatment
with
_NUCALA _
OR ≥ 300 cells/µL (0.3 GI/L) in the past 12 months.
_NUCALA_
is not indicated for other eosinophilic conditions or for relief of
acute bronchospasm
or status asthmaticus (
_see Warnings and Precautions)_
.
DOSAGE AND ADMINISTRATION
_NUCALA _
should be prescribed by a specialist experienced in the diagnosis and
treatment of
severe eosinophilic asthma.
_NUCALA _
should be reconstituted and administered by a health care
professional.
CONFIDENTIAL
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Following reconstitution,
_NUCALA _
should only be administered as a subcutaneous injection
(e.g. upper arm, thigh, or abdomen) (see
_Use and Handling_
).
POSOLOGY
:
SEVERE EOSINOPHILIC ASTHMA
ADULTS AND ADOLESCENTS (12 YEARS AND OLDER)
The recommended dose is 100 mg of
_NUCALA _
administered by subcutaneous (SC) injection
once every 4 weeks.
The safety and efficacy of NUCALA have not been established in
adolescents weighing less
than 45kg