देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Omalizumab
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Omalizumab
1 Pre-Filled Syringes
Vetter Pharma-Fertigung GmbH & Co. KG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ XOLAIR ® _ _ Omalizumab (75mg/0.5ml and 150mg/ml) solution for injection in pre-filled syringe 1 WHAT IS IN THIS LEAFLET 1. WHAT XOLAIR IS USED FOR 2. HOW XOLAIR WORKS 3. BEFORE YOU USE XOLAIR 4. HOW TO USE XOLAIR 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF XOLAIR 8. PRODUCT DESCRIPTION 9. MANUFACTURER 10. PRODUCT REGISTRATION HOLDER 11. DATE OF REVISION 12. SERIAL NUMBER 13. INSTRUCTION FOR USE WHAT XOLAIR IS USED FOR _ALLERGIC ASTHMA (ADULTS AND ADOLESCENTS _ _– 12 YEARS OF AGE AND ABOVE) _ Xolair (omalizumab) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). _ALLERGIC ASTHMA (CHILDREN – 6 TO < 12 _ _YEARS OF AGE) _ Xolair is indicated as add-on therapy to improve asthma control with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions. _CHRONIC RHINOSINUSITIS WITH NASAL POLYPS _ _(CRSWNP) _ Xolair is used to treat CRSwNP in adults (18 years of age and older) whose disease is not well controlled with their current CRSwNP medicines. Xolair helps reduce the size of the polyps and improves symptoms caused by CRSwNP including nasal congestion, loss of sense of smell, post-nasal drip and runny nose. _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. HOW IT WORKS _ALLERGIC AS पूरा दस्तावेज़ पढ़ें
Novartis Page 2 Malaysia Package Leaflet 11 Dec 2019 Xolair XOLAIR Systemic drug for obstructive airway diseases. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Powder: white to off-white lyophilizate in a glass vial. Solvent: clear and colorless solution in a glass ampoule One vial of Xolair ® 75 mg powder and solvent for solution for injection delivers 75 mg of omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (75 mg in 0.6 mL). One vial of Xolair ® 150 mg powder and solvent for solution for injection delivers 150 mg of omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (150 mg in 1.2 mL). SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Clear to slightly opalescent, colorless to pale brownish-yellow solution in a 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. ACTIVE SUBSTANCE Omalizumab is a humanized monoclonal antibody manufactured from a mammalian cell line. Certain dosage strengths and dosage forms may not be available in all countries. EXCIPIENTS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Powder: Sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20 Solvent: Water for injection SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, polysorbate 20, water for injection. Pharmaceutical formulations may vary between countries. INDICATIONS ALLERGIC ASTHMA ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND ABOVE) Xolair (omalizumab) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). Novartis Page 3 Malaysia Package Leaflet 11 Dec 2019 Xolair CHILDREN (6 TO < 12 YEARS OF AGE) Xolair is indicated as add-on therapy to improve asthma control with severe persistent allergic asthma who have a positive skin test or in vit पूरा दस्तावेज़ पढ़ें