European Union - English - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. scintimun should not be used for the diagnosis of diabetic foot infection.

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - basiliximab (unii: 9927mt646m) (basiliximab - unii:9927mt646m) - basiliximab 10 mg in 2.5 ml - simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, usp (modified), and corticosteroids. the efficacy of simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated. simulect® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. see composition of simulect under description. simulect® (basiliximab) should be administered under qualified medical supervision. patients should be informed of the potential benefits of therapy and the risks associated with administration of immunosuppressive therapy. while neither the incidence of lymphoproliferative disorders nor opportunistic infections was higher in simulect-treated patients than in placebo-treated patients, patients on immunosuppressive therapy are at increased risk for dev

Australia - English - Department of Health (Therapeutic Goods Administration)

australian nuclear science and technology organisation t/a ansto - sulesomab, quantity: 0.31 mg - injection, powder for - excipient ingredients: glacial acetic acid; stannous chloride dihydrate; sodium acetate trihydrate; sodium chloride; sucrose; potassium sodium tartrate tetrahydrate; hydrochloric acid - use in diagnostic imaging for the investigation of suspected osteomyelitis in long bones and in feet in patients including those with diabetic foot ulcers.

Israel - English - Ministry of Health

novartis israel ltd - basiliximab - powder and solvent for solution for injection/infusion - basiliximab 20 mg/vial - basiliximab - basiliximab - prophylaxis of acute organ rejection in de novo renal transplantation in combination with cyclosporin and corticosteroid based immunosuppression

United States - English - NLM (National Library of Medicine)

mallinckrodt inc. - fanolesomab (unii: 67etm2384n) (fanolesomab - unii:67etm2384n) - kit - 0.25 mg - neutrospectm [technetium (99m tc) fanolesomab] is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. neutrospectm should not be administered to patients who are hypersensitive to any murine proteins or other component of the product. the user should wear waterproof gloves during the entire procedure and while withdrawing the patient dose from the neutrospectm vial. transfer sodium pertechnetate tc 99m injection, usp with an adequately shielded, sterile syringe. adequate shielding should be maintained at all times until the preparation is administered to the patient, disposed of in an approved manner, or allowed to decay to background levels. a shielded, sterile syringe should be used to withdraw and inject the labeled preparation. before reconstituting a vial, it should be inspected for cracks and any indication that the integrity of the vacuum seal has been lost. the material should not be used if integrity of the vacuum

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - basiliximab, quantity: 20 mg - injection, powder for - excipient ingredients: sucrose; mannitol; glycine; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate - simulect is indicated for the prophylaxis of acute organ rejection in renal transplantation.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - basiliximab -

European Union - English - EMA (European Medicines Agency)

immunomedics gmbh - sulesomab - osteomyelitis; radionuclide imaging - diagnostic agents - this medicinal product is for diagnostic use only.leukoscan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.leukoscan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - basiliximab - graft rejection; kidney transplantation - immunosuppressants - simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years).it is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - basiliximab 10mg (murine/human; formulated with a 7.5% total overage);   - powder for injection - 10 mg - active: basiliximab 10mg (murine/human; formulated with a 7.5% total overage)   excipient: dibasic sodium phosphate glycine mannitol monobasic potassium phosphate sodium chloride sucrose water for injection - simulect is indicated for the prophylaxis of acute organ rejection in de novo renal transplantation in adult and paediatric patients. it is to be used concomitantly with cyclosporin for microemulsion- and corticosteroid-based immunosuppression or in a triple maintenance immunosuppressive regimen containing cyclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.