4.1 Therapeutic indications
1) Allergy and anaphylaxis: Drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, bronchial asthma and occupational asthma.
2) Arteritis/collagenosis: Giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis.
3) Blood disorders: Haemolytic anaemia (autoimmune), leukaemia (acute and chronic lymphatic), malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
4) Cardiovascular disorders: Post myocardial infarction syndrome, rheumatic fever with severe carditis.
5) Endocrine disorders: Primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
6) Gastrointestinal disorders: Crohn's disease, ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), autoimmune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis.
7) Hypercalcaemia: Sarcoidosis, vitamin D excess.
8) Infections (with appropriate chemotherapy): Helminthic infestations, Herxheimer reaction, infectious mononucleosis, biliary tuberculosis, mumps orchitis (adults), tuberculous meningitis, rickettsial disease.
9) Muscular disorders: Polymyositis, dermatomyositis.
10) Neurological disorders: Infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy.
11) Ocular disease: Scleritis, posterior uveitis, retinal vasculitis, pseudo tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease.
12) Renal disorders: Lupus nephritis, acute interstitial nephritis, minimal change nephrotic syndrome.
13) 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.
14) Rheumatic disorders: Rheumatoid arthritis, polymyalgic rheumatica, juvenile chronic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease.
15) Skin disorders: Pemphigus vulgaris, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum.
16) Miscellaneous: Sarcoidosis, hyperpyrexia, Behcets syndrome, immuno-suppression 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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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).