XOLAIR 150 MG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

OMALIZUMAB

זמין מ:

NOVARTIS ISRAEL LTD

קוד ATC:

R03DX05

טופס פרצבטיות:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

הרכב:

OMALIZUMAB 150 MG/DOSE

מסלול נתינה (של תרופות):

S.C

סוג מרשם:

Required

תוצרת:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

קבוצה תרפויטית:

OMALIZUMAB

איזור תרפויטי:

OMALIZUMAB

סממני תרפויטית:

Allergic asthma Xolair is indicated for patients 6 to 12 years of age with severe persistent asthma and for patients 12 years of age and older with moderate to severe persistent asthma, who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Limitations of use: Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. Xolair is not indicated for the treatment of other allergic conditions.Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control.Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

תאריך אישור:

2015-02-28

עלון מידע

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
XOLAIR
® 150 MG, POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
ACTIVE INGREDIENT:
OMALIZUMAB 150 MG
Inactive
ingredients
and
allergens:
see
section
6
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information about this
medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not
pass it on to others. It may harm them even if it seems to you that
their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
ALLERGIC ASTHMA:
Xolair is indicated for patients 6 to 12 years of age with severe
persistent asthma and for patients 12 years of age and older with
moderate to severe persistent asthma, who have a positive skin
test or in vitro reactivity to a perennial aeroallergen and whose
symptoms are inadequately controlled with inhaled corticosteroids.
Xolair has been shown to decrease the incidence of asthma
exacerbations in these patients.
Limitations of use:
Xolair is not indicated for the relief of acute bronchospasm or
status asthmaticus (asthma attack that lasts longer than 24 hours).
Xolair is not indicated for the treatment of other allergic
conditions.
CHRONIC RHINOSINUSITIS (INFLAMMATION OF THE NOSE AND SINUSES)
WITH NASAL POLYPS:
Xolair is indicated as add-on therapy with intranasal corticosteroids
for the treatment of adults (18 years of age and older) with severe
chronic rhinosinusitis with nasal polyps for whom therapy with
intranasal corticosteroids does not provide adequate disease control.
CHRONIC SPONTANEOUS URTICARIA:
Xolair is indicated as add-on therapy for the treatment of chronic
spontaneous urticaria in adult and adolescent (12 years and above)
patients with inadequate response to H1 antihistamine treatment.
THERAPEUTIC GROUP: obstructive airway disease medicines, other

מאפייני מוצר

XOL_POW_API_30MAR2022 V3
Baesd on
EU SmPC DEC21
1
1.
NAME OF THE MEDICINAL PRODUCT
XOLAIR
® 150MG
OMALIZUMAB
Powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 150 mg of omalizumab*.
After reconstitution one vial contains 125 mg/ml of omalizumab (150 mg
in 1.2 ml).
*Omalizumab is a humanised monoclonal antibody manufactured by
recombinant DNA technology in
a Chinese hamster ovary (CHO) mammalian cell line.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: white to off-white lyophilisate
Solvent: clear and colourless solution
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allergic asthma
Xolair is indicated for patients 6 to 12 years of age with severe
persistent asthma and for patients 12 years
of age and older with moderate to severe persistent asthma, who have a
positive skin test or
_in vitro _
reactivity to a perennial aeroallergen and whose symptoms are
inadequately controlled with inhaled
corticosteroids. Xolair has been shown to decrease the incidence of
asthma exacerbations in these patients.
Limitations of use:
Xolair is not indicated for the relief of acute bronchospasm or status
asthmaticus.
Xolair is not indicated for the treatment of other allergic
conditions.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Xolair is indicated as an add-on therapy with intranasal
corticosteroids (INC) for the treatment of adults
(18 years and above) with severe CRSwNP for whom therapy with INC does
not provide adequate disease
control.
Chronic spontaneous urticaria (CSU)
Xolair is indicated as add-on therapy for the treatment of chronic
spontaneous urticaria in adult and
adolescent (12 years and above) patients with inadequate response to
H1 antihistamine treatment.
XOL_POW_API_30MAR2022 V3
Baesd on
EU SmPC DEC21
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Xolair treatment should be initiated by physicians experienced in the
diagnosis and treatment of moderate
to severe persis