Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
OMALIZUMAB
NOVARTIS ISRAEL LTD
R03DX05
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
OMALIZUMAB 150 MG/DOSE
S.C
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
OMALIZUMAB
OMALIZUMAB
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.
2015-02-28
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 Lestu allt skjalið
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 Lestu allt skjalið