Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Omalizumab, Quantity: 75 mg
Novartis Pharmaceuticals Australia Pty Ltd
Omalizumab
Injection, solution
Excipient Ingredients: water for injections
Subcutaneous
1 active vial & 1 diluent ampoule
(S4) Prescription Only Medicine
Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic rhinosinusitis with nasal polyps (CRSwNP),Xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2006-01-10
1 AUSTRALIAN PRODUCT INFORMATION – XOLAIR ® (OMALIZUMAB) SOLUTION FOR INJECTION AND POWDER FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Omalizumab (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Omalizumab is a recombinant DNA-derived humanised monoclonal antibody produced in Chinese hamster ovary cells that selectively binds to human immunoglobulin E (IgE). Solution for injection in pre-filled syringe Each pre-filled syringe of 0.5 mL contains 75 mg of omalizumab. Each pre-filled syringe of 1 mL contains 150 mg of omalizumab. Powder for injection vial with diluent for solution for injection One vial of Xolair® 75 mg powder for injection contains 75mg of omalizumab. A reconstituted single use vial delivers 75 mg omalizumab per 0.6 mL (125 mg/mL). One vial of Xolair® 150 mg powder for injection contains 150 mg of omalizumab. A reconstituted single use vial delivers 150mg omalizumab per 1.2 mL (125 mg/mL). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Clear to slightly opalescent, colourless to pale brownish-yellow preservative free solution in a pre- filled syringe. Powder for injection vial with diluent Xolair is a sterile, white, preservative free lyophilised powder that is reconstituted with water for injections and administered as a subcutaneous (SC) injection. Powder: white to off-white lyophilizate in a glass vial. Diluent: clear and colourless solution in a glass ampoule. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ALLERGIC ASTHMA _Children 6 to < 12 years of age _ 2 In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION). _Adults and adolescents ≥ 12 years of age _ Xolair is indicated for the ma Прочетете целия документ