Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - doxycycline hyclate, quantity: 115.4 mg (equivalent: doxycycline, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; macrogol 4000 - infections caused by the following organisms; mycoplasma pneumoniae (primary atypical pneumonia); rickettsiae (queensland tick typhus, epidemic typhus fever, q fever, murine endemic typhus fever, australo-pacific endemic scrub typhus); chlamydia psittaci (psittacosis); chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline alone, or in combination with topical agents). borreliae (relapsing fever). calymmatobacterium (donovania) granulomatis (granuloma inguinale). infection caused by the following gram-negative microorganisms: vibrio species (chlorea), brucella sp. (brucellosis; in conjunction with streptomycin), haemophilus ducreyi (chancroid), yersinia pestis (plague), francisella turarenis (tularaemia), bartonella bacilliformis (bartonellosis), bacteroides sp. when penicillin is contraindicated, doxy-100 is an alternative drug in the treatment of infections due to : treponema pallidum (syphilis); treponema pertenue (yaws); neisseria gonorrhoea (see dosage and administration). doxy-100 is not the drug of choice in the treatment of any type of staphylococcal infection or infections due to streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxy-100 should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice. in acute intestinal amoebiasis, doxycycline may be a useful adjunct to amoebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example, chloroquine.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - doxycycline hyclate, quantity: 57.7 mg (equivalent: doxycycline, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; macrogol 4000 - infections caused by the following microorganisms: mycoplasma pneumoniae (primary atypical pneumonia); rickettsiae (queensland tick typhus, epidemic typhus fever, q fever, murine endemic typhus fever, australo-pacific endemic scrub typhus): chlamydia psittaci (psittacosis); chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline alone or in combination with topical agents). borreliae (relapsing fever); calymmatobacterium (donovania) granulomatis (granuloma inguinale). infections caused by the following gram-negative microorganisms: vibrio sp. (cholera); brucella sp. (brucellosis, in conjunction with streptomycin); haemophilus ducreyi (chancroid); yersinia pestis (plague); francisella tularensis (tularaemia); bartonella bacilliformis (bartonellosis); bacteroides sp. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum (syphilis); treponema perenue (yaws); neisseria gonorrhoea (see dosage and administration). doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection of infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, enterococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory infections due to group a b-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice. in acute intestinal amoebiasis doxycycline may be a useful adjunct to amoebicides. in severe acne, doxycycline may be a useful adjunctive therapy. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. note: the 50mg tablet is not a paediatric formulation.

Европейски съюз - английски - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil krka prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil.no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Европейски съюз - английски - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil mylan prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - minocycline hydrochloride dihydrate, quantity: 54 mg (equivalent: minocycline, qty 50 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; povidone; microcrystalline cellulose; sodium starch glycollate; sodium lauryl sulfate; titanium dioxide; hypromellose; indigo carmine; sunset yellow fcf; quinoline yellow; macrogol 400 - infections due to the following organisms, provided that they have been shown by bacteriological testing to be susceptible to minocycline: escherichia coli; enterobacter aerogenes; haemophilus influenzae; klebsiella and proteus. in addition, infections due to streptococcus pyogenes (group a beta-haemolytic) and streptococcus faecalis, however, because a large proportion of these organisms are resistant to tetracyclines, minocycline should be used only if the organisms have definitely been shown to be sensitive. tetracyclines, including minocycline, are not the drugs of choice in the treatment of staphylococcal infections. minocycline may be considered for the treatment of such infections only if other suitable agents are not available and the organism has been shown to be sensitive to minocycline. minocycline may be used in the treatment of tetracycline resistant acne.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 2.6525 g (equivalent: methylprednisolone, qty 2 g) - injection, powder for - excipient ingredients: dibasic sodium phosphate; sodium hydroxide; 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.,? c

Австралия - английски - 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: monobasic sodium phosphate monohydrate; dibasic sodium phosphate; sodium hydroxide - 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.,? c

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 1.326 g (equivalent: methylprednisolone, qty 1 g) - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate; sodium hydroxide - 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.,? c

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 165.78 mg (equivalent: methylprednisolone, qty 125 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; sodium hydroxide; dibasic sodium phosphate - 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - methylprednisolone sodium succinate, quantity: 53.05 mg (equivalent: methylprednisolone, qty 40 mg) - injection, powder for - excipient ingredients: monobasic sodium phosphate; dibasic sodium phosphate; lactose monohydrate; sodium hydroxide - 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.