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Omalizumab 150mg powder in vial and solvent for solution. Reconstituted xolair contains 125mg/ml of omalizumab (150mg in l .2ml): injection. Omalizumab is a ht1manized monoclonal antibody manufactured from a mammalian cell line.
Ind: Adults & children ( 6 years & above) with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids.
C/I: Hypersensitivity to omalizumab or to any of the excipients.
AIR: Serious/rare adverse reactions include: Angioedema, anaphylactic reactions and other allergic conditions, allergic bronchospasm. Serious additional undesirable effects reported during post marketing observations are: Allergic granulomatous angiitis, idiopatic severe thrombocytopenia. Very common undesirable effect is:
Pyrexia (in children). Most common undesirable effects are: Headache (very common in children), injection site pain, swelling, erythema, pruritus, upper abdominal pain (in children). Uncommon undesirable effects are: Dizziness, ·somnolence, parasthesia, syncope, postural hypotension, flushing, pharyngitis, coughing, nausea, diarrhea, dyspeptic signs and symptoms, urticaria, rash, photosensitivity, weight increase, fatigue, swelling
arms, influenza-like illness. Rare undesirableeffects are : Parasitic infections, laryngoedema. Other additional indesirable effects reported during post marketing observations are: Alopecia, arthralgia, myalgia, joint swelling.
Precautions & warnings: Not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus; no abrupt discontinuation of corticosteroids; caution in use with renal or hepatic impaired patients; patients with autoimmune diseases and immune complexmediated conditions; patients with high risk of
parasitic infections; occurrence of local or systemic allergic reactions, including anaphylaxis; pregnancy; lactation; patients with diabetes mellitus, the glucose-galactose malabsorption syndrome, fructose intolerance or sucrose-isomaltase deficiency should be warned that one l 50mg xolair powder and solvent dose contains 108mg of sucrose. Among the different xolair presentations, only xolair powder vial contains sucrose.
Dosage & admin: One to three injections (i.e 1S0-4S0mg) s.c. every two to four weeks according to body weight and baseline serum total IgE level. Drug inter: None known.
Note: Before prescribing, please read full prescribing information.
150mg vial x 1's pack: 33654.00 MRP
Ind: Adults & children ( 6 years & above) with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids.
C/I: Hypersensitivity to omalizumab or to any of the excipients.
AIR: Serious/rare adverse reactions include: Angioedema, anaphylactic reactions and other allergic conditions, allergic bronchospasm. Serious additional undesirable effects reported during post marketing observations are: Allergic granulomatous angiitis, idiopatic severe thrombocytopenia. Very common undesirable effect is:
Pyrexia (in children). Most common undesirable effects are: Headache (very common in children), injection site pain, swelling, erythema, pruritus, upper abdominal pain (in children). Uncommon undesirable effects are: Dizziness, ·somnolence, parasthesia, syncope, postural hypotension, flushing, pharyngitis, coughing, nausea, diarrhea, dyspeptic signs and symptoms, urticaria, rash, photosensitivity, weight increase, fatigue, swelling
arms, influenza-like illness. Rare undesirableeffects are : Parasitic infections, laryngoedema. Other additional indesirable effects reported during post marketing observations are: Alopecia, arthralgia, myalgia, joint swelling.
Precautions & warnings: Not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus; no abrupt discontinuation of corticosteroids; caution in use with renal or hepatic impaired patients; patients with autoimmune diseases and immune complexmediated conditions; patients with high risk of
parasitic infections; occurrence of local or systemic allergic reactions, including anaphylaxis; pregnancy; lactation; patients with diabetes mellitus, the glucose-galactose malabsorption syndrome, fructose intolerance or sucrose-isomaltase deficiency should be warned that one l 50mg xolair powder and solvent dose contains 108mg of sucrose. Among the different xolair presentations, only xolair powder vial contains sucrose.
Dosage & admin: One to three injections (i.e 1S0-4S0mg) s.c. every two to four weeks according to body weight and baseline serum total IgE level. Drug inter: None known.
Note: Before prescribing, please read full prescribing information.
150mg vial x 1's pack: 33654.00 MRP
