4.1 Therapeutic indications
Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies unresponsive to conventional treatment.
Arteritis/collagenosis: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis.
Blood disorders: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
Cardiovascular disorders: post-myocardial infarction syndrome, rheumatic fever with severe carditis.
Endocrine disorders: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
Gastro-intestinal disorders: regional ileitis (Crohn's disease), ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis.
Hypercalcaemia: sarcoidosis, vitamin D excess.
Infections (with appropriate chemotherapy): helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
Muscular disorders: polymyositis, dermatomyositis.
Neurological disorders: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy.
Ocular disease: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease.
Renal disorders: lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis, nephrotic syndrome.
Respiratory disease: allergic pneumonitis, asthma, occupational asthma, pulmonary aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body, aspiration of stomach contents, pulmonary sarcoid, drug induced lung disease, adult respiratory distress syndrome, spasmodic croup, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy.
Rheumatic disorders: rheumatoid arthritis, polymyalgia rheumatica, juvenile chronic arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease.
Skin disorders: pemphigus vulgaris, exfoliative dermatitis, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum.
Miscellaneous: sarcoidosis, hyperpyrexia, Behçets disease, immunosuppression in organ transplantation.
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This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease.
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Long-term testosterone replacement therapy is mainly monitored by trough levels of serum testosterone (S-T), while urinary testosterone (U-T) is used by forensic toxicology to evaluate testosterone doping.
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