NUCALA POWDER FOR SOLUTION FOR INJECTION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MEPOLIZUMAB

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

L04AC06

الشكل الصيدلاني:

POWDER FOR SOLUTION FOR INJECTION

تركيب:

MEPOLIZUMAB 100 MG

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO SMITH KLINE MANUFACTURING S.P.A., ITALY

المجال العلاجي:

MEPOLIZUMAB

الخصائص العلاجية:

Severe eosinophilic asthmaNucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientsChronic 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 corticosteroids and surgery in the last 10 years do not provide adequate disease control.Eosinophilic Granulomatosis with Polyangiitis (EGPA)Nucala is indicated for the treatment of adult patients with 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.

تاريخ الترخيص:

2021-11-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACIST’S REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a physician’s prescription only
Nucala Powder for Solution for Injection
Powder for solution for injection
Each vial contains 100 mg mepolizumab (100 mg/ml after
reconstitution).
For a list of the inactive and allergenic ingredients in the
preparation – see
section 2 “Important information about some of the ingredients of
the medicine”
and section 6 “Further information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is used for treatment of:

Adult patients with severe eosinophilic asthma, which is not
responding to
other treatments, in combination with other medicines.

Adult
patients
with
severe
chronic
rhinosinusitis
with
nasal
polyps
(CRSwNP), for whom corticosteroid treatment and surgery in the past
ten
years did not achieve adequate control of the disease. The medicine is
given
in combination with intranasal corticosteroids.

Adult patients with eosinophilic granulomatosis with polyangiitis
(EGPA) -
Churg-Strauss Disease.

Adult patients with hypereosinophilic syndrome (HES) that is not
adequately
controlled, with no non-hematological secondary cause. The medicine is
given in combination with other medicines.
Therapeutic group
Monoclonal antibody, medicines for obstructive airway diseases.
Nucala
Powder
for
Solution
for
Injection
contains
the
active
ingredient
mepolizumab,
a monoclonal antibody
, a type of protein designed to recognize
a specific target substance in the body.
Mepolizumab, the active substance in Nucala Powder for Solution for
Injection,
blocks a protein called
interleukin-5
.
By blocki

خصائص المنتج

NUCALA POWDER FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Nucala powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg mepolizumab. After reconstitution, each ml
of solution contains 100 mg
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
Powder for solution for injection.
Lyophilised white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe eosinophilic asthma
Nucala is indicated as an add-on treatment for severe refractory
eosinophilic asthma in adult patients (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 corticosteroids and surgery
in the last 10 years do not provide
adequate disease control.
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Nucala is indicated for the treatment of adult patients with
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nucala should be prescribed by physicians experienced in the diagnosis
and treatment of severe refractory
eosinophilic asthma, CRSwNP, EGPA or HES.
Posology
_ _
_Severe eosinophilic asthma_
_ _
_Adults _
_ _
The recommended dose of mepolizumab is 100 mg administered
subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. The need for continued
therapy should be considered at least on
an annual basis as determined by physician assessment of the
patient’s disease severity and level of control
of exacerbations
.
_CRSwNP _
_ _
_Adults _
_ _
The recommended dose of mepolizumab is 100 mg adm