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

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 663.13 mg (equivalent: methylprednisolone, qty 500 mg) - injection, powder for - excipient ingredients: sodium hydroxide; dibasic sodium phosphate; monobasic sodium phosphate monohydrate - when oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-medrol powder for injection is indicated only for intravenous or intramuscular use in the following conditions:,endocrine disorders,? primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).,? acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogues are used).,? preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.,? shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.,? congenital adrenal hyperplasia,? nonsuppurative thyroiditis,? hypercalcaemia associated with cancer.,rheumatic disorders,as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:,? ankylosing spondylitis,? psoriatic arthritis,? acute and subacute bursitis,? epicondylitis,? synovitis of osteoarthritis,? acute gouty arthritis,? acute nonspecific tenosynovitis,? post-traumatic osteoarthritis,? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy).,collagen disease,during an exacerbation or as maintenance therapy in selected cases of:,? systemic lupus erythematosus,? systemic dermatomyositis (polymyositis),? acute rheumatic carditis.,dermatological diseases,? bullous dermatitis herpetiformis,? pemphigus,? severe psoriasis,? severe seborrhoeic dermatitis,? exfoliative dermatitis,? mycosis fungoides,? severe erythema multiforme (stevens-johnson syndrome).,allergic states,control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:,? bronchial asthma,? drug hypersensitivity reactions,? contact dermatitis,? urticarial transfusion reactions,? atopic dermatitis,? serum sickness,? acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).,ophthalmic diseases,severe acute and chronic allergic and inflammatory processes involving the eye, such as:,? allergic corneal marginal ulcers,? allergic conjunctivitis,? chorioretinitis,? anterior segment inflammation,? herpes zoster ophthalmicus,? iritis, iridocyclitis,? diffuse posterior uveitis and choroiditis,? keratitis,? optic neuritis,? sympathetic ophthalmia.,gastrointestinal diseases,to tide the patient over a critical period of the disease in:,? ulcerative colitis (systemic therapy),? regional enteritis (systemic therapy).,respiratory diseases,? symptomatic sarcoidosis,? berylliosis,? aspiration pneumonitis,? loeffler?s syndrome not manageable by other means,? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.,haematologic disorders,? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated),? secondary thrombocytopenia in adults,? acquired (autoimmune) haemolytic anaemia,? erythroblastopenia (rbc anaemia),? congenital (erythroid) hypoplastic anaemia.,neoplastic diseases,for palliative management of:,? leukaemias and lymphomas in adults,? acute leukaemia of childhood.,oedematous states,? to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.,nervous system,? acute exacerbations of multiple sclerosis.,miscellaneous,? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.,? trichinosis with neurologic or myocardial involvement.,? solu-medrol is beneficial as adjunctive therapy in the treatment of acquired immunodeficiency syndrome (aids) patients with moderate to severe pneumocystis jiroveci pneumonia (pcp) when given within the first 72 hours of initial anti-pneumocystis treatment.

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

boehringer ingelheim pty ltd - alteplase, quantity: 20 mg - injection, powder for - excipient ingredients: phosphoric acid; arginine; polysorbate 80; nitrogen - myocardial infarction: actilyse is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. treatment should be initiated as soon as possible after the onset of symptoms. the treatment can be initiated within 12 hours of symptom onset.,pulmonary embolism:actilyse is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate.,acute ischaemic stroke:actilyse is indicated for thrombolytic treatment of acute ischaemic stroke. treatment must be started as early as possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). the treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.

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

servier laboratories (aust) pty ltd - pegaspargase, quantity: 750 u/ml - solution, powder for - excipient ingredients: sucrose; dibasic sodium phosphate; monobasic sodium phosphate; sodium chloride; sodium hydroxide; hydrochloric acid - oncaspar is indicated as a component of antineoplastic combination therapy in patients with acute lymphoblastic leukaemia (all).

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

pfizer australia pty ltd - pentamidine isetionate, quantity: 300 mg - injection, powder for - excipient ingredients: - pentamidine isethionate is indicated for intravenous administration in the treatment of the following conditions: . as an alternative first line treatment for pneumocystis carinii infection in aids patients; . as second line treatment for pneumocystis carinii infection in non-aids patients; . as second line treatment of leishmaniasis (visceral and cutaneous), except leishmania aethiopica where it may be used as first line treatment; . as second line treatment for trypanosomiasis (except for the trypanosomiasis rhodesiense strain due to lack of efficacy).

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

pfizer australia pty ltd - hydrocortisone sodium succinate, quantity: 132.85 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate - when oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, solu-cortef powder for injection is indicated for intravenous or intramuscular use in the following conditions: 1. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used). preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Malta - English - Medicines Authority

vocate pharmaceuticals s.a 150, gounari str, 166 74 glyfada, athens, greece - voriconazole - powder for solution for infusion - voriconazole 200 mg - antimycotics for systemic use

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - tigecycline - powder for solution for infusion - tigecycline 10 mg/ml - antibacterials for systemic use

Malta - English - Medicines Authority

pharmsol europe limited the victoria centre unit 2, lower ground floor, valletta road, mosta mst 9012 , malta - ceftriaxone - powder for solution for injection/infusion - ceftriaxone 1000 mg - antibacterials for systemic use

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

accord healthcare pty ltd - mycophenolate mofetil, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; citric acid; polysorbate 80 - tradename] is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.,[tradename] is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.