Bélgica - inglês - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pharmanovia a.s. - mepivacaine hydrochloride 5 mg; nicotinamide 40 mg; polyestradiol phosphate 80 mg - powder and solvent for solution for injection - 80 mg - 5 mg - 40 mg - mepivacaine hydrochloride 5 mg; nicotinamide 40 mg; polyestradiol phosphate 80 mg - polyestradiol phosphate

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - hydrocortisone sodium succinate, quantity: 133.7 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, [invented name] 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 ? congenital adrenal hyperplasia ? nonsuppurative thyroiditis ? hypercalcaemia associated with cancer. 2. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ? post-traumatic osteoarthritis ? synovitis of osteoarthritis ? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) ? acute and subacute bursitis ? epicondylitis ? acute nonspecific tenosynovitis ? acute gouty arthritis ? psoriatic arthritis ? ankylosing spondylitis. 3. collagen diseases during an exacerbation or as maintenance therapy in selected cases of: ? systemic lupus erythematosus ? systemic dermatomyositis (polymyositis) ? acute rheumatic carditis. 4. dermatological diseases ? pemphigus ? severe erythema multiforme (stevens-johnson syndrome) ? exfoliative dermatitis ? bullous dermatitis herpetiformis ? severe seborrhoeic dermatitis ? severe psoriasis ? mycosis fungoides. 5. 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). 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye, such as: ? herpes zoster ophthalmicus ? iritis, iridocyclitis ? chorioretinitis ? diffuse posterior uveitis and choroiditis ? optic neuritis ? sympathetic ophthalmia ? anterior segment inflammation ? allergic conjunctivitis ? allergic corneal marginal ulcers ? keratitis. 7. gastrointestinal diseases to tide the patient over a critical period of the disease in: ? ulcerative colitis (systemic therapy) ? regional enteritis (systemic therapy). 8. respiratory diseases ? symptomatic sarcoidosis ? loeffler?s syndrome not manageable by other means ? berylliosis ? fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy ? aspiration pneumonitis. 9. haematological disorders ? acquired (autoimmune) haemolytic anaemia ? erythroblastopenia (rbc anaemia) ? idiopathic thrombocytopenic purpura in adults (iv only; im administration is contraindicated) ? secondary thrombocytopenia in adults ? congenital (erythroid) hypoplastic anaemia. 10. neoplastic diseases for palliative management of: ? leukaemias and lymphomas in adults ? acute leukaemia in childhood. 11. 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. 12. miscellaneous ? tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurological or myocardial involvement.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - hydrocortisone hydrogen succinate, quantity: 127.6 mg (equivalent: hydrocortisone, qty 100 mg) - injection, powder for - excipient ingredients: sodium hydroxide; monobasic sodium phosphate monohydrate; 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, hydrocortisone 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,? congenital adrenal hyperplasia,? nonsuppurative thyroiditis,? hypercalcaemia associated with cancer.,2. rheumatic disorders,as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:,? post-traumatic osteoarthritis,? synovitis of osteoarthritis,? rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may ,require low dose maintenance therapy),? acute and subacute bursitis,? epicondylitis,? acute nonspecific tenosynovitis,? acute gouty arthritis,? psoriatic arthritis,? ankylosing spondylitis.,3. collagen diseases,during an exacerbation or as maintenance therapy in selected cases of:,? systemic lupus erythematosus,? systemic dermatomyositis (polymyositis),? acute rheumatic carditis.,4. dermatological diseases,? pemphigus,? severe erythema multiforme (stevens-johnson syndrome),? exfoliative dermatitis,? bullous dermatitis herpetiformis,? severe seborrhoeic dermatitis,? severe psoriasis,? mycosis fungoides.,5. 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).,6. ophthalmic diseases,severe acute and chronic allergic and inflammatory processes involving the eye, such as:,? herpes zoster ophthalmicus,? iritis, iridocyclitis,? chorioretinitis,? diffuse posterior uveitis and choroiditis,? optic neuritis,? sympathetic ophthalmia,? anterior segment inflammation,? allergic conjunctivitis,? allergic corneal marginal ulcers,? keratitis.,7. gastrointestinal diseases,to tide the patient over a critical period of the disease in:,? ulcerative colitis (systemic therapy),? regional enteritis (systemic therapy).,8. respiratory diseases,? symptomatic sarcoidosis,? loeffler?s syndrome not manageable by other means,? berylliosis,? fulminating or disseminated pulmonary tuberculosis when used concurrently with ,appropriate antituberculous chemotherapy,? aspiration pneumonitis.,9. haematological disorders,? acquired (autoimmune) haemolytic anaemia,? erythroblastopenia (rbc anaemia),? idiopathic thrombocytopenic purpura in adults (iv only; im administration is ,contraindicated),? secondary thrombocytopenia in adults,? congenital (erythroid) hypoplastic anaemia.,10. neoplastic diseases,for palliative management of:,? leukaemias and lymphomas in adults,? acute leukaemia in childhood.,11. 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.,12. miscellaneous,? tuberculous meningitis with subarachnoid block or impending block when used ,concurrently with appropriate antituberculous chemotherapy,? trichinosis with neurological or myocardial involvement.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - follitropin alfa, quantity: 150 iu; lutropin alfa, quantity: 75 iu - injection, powder for - excipient ingredients: sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; methionine; polysorbate 20; phosphoric acid; sodium hydroxide - pergoveris is indicated for the stimulation of follicular development in women with severe lh and fsh deficiency.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: nitrogen; water for injections; sulfobutyl betadex sodium - voriconazole ? aft is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Estados Unidos - inglês - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.1 mg in 1 d - estradiol transdermal system is indicated for:   limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.   limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. estradiol transdermal system is contraindicated in women with any of the following conditions: - undiagnosed abnormal genital bleeding - known, suspected or history of breast cancer - known or suspected estrogen-dependent neoplasia - active dvt, pe, or a history of these conditions - active arterial thromboembolic disease (for example, stroke and mi), or a history of these conditions - known anaphylactic reaction or angioedema or hypersensitivity with estradiol transdermal system - known liver impairment or disease - known protein c, protein s, or antithrombin de

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriconazole wockhardt is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriwok is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ampicillin, quantity: 1 g - injection, powder for - excipient ingredients: - treatment of infections due to susceptible strains of gram-positive and gram-negative organisms. bacteriological studies to determine the organism and its sensitivity should be undertaken.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - ampicillin, quantity: 1 g - injection, powder for - excipient ingredients: - treatment of infections due to susceptible strains of gram-positive and gram-negative organisms (see microbiology). bacteriological studies to determine the causative organisms and their sensitivity to ampicillin sodium should be preformed.