İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - acetylsalicylic acid - gastro-resistant tablet - 75 milligram(s) - platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azithromycin dihydrate, quantity: 524.1 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; maize starch; sodium lauryl sulfate; sodium starch glycollate type a; colloidal anhydrous silica; lactose monohydrate; hypromellose; titanium dioxide; macrogol 4000 - azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity: 1. lower respiratory tract infections: acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenzae or moraxella catarrhalis.community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment. community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae. 2. upper respiratory tract infections: acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae. acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. uncomplicated skin and skin structure infections: uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage. 4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis. . note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other medicines for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma. azithromycin is also indicated for the prevention of infection due to mycobacterium avium-intracellular complex (mac) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with hiv infection and cd4 cell count less than or equal to 75 cells/microliter (see precautions). disseminated infection due to mycobacterium avium-intracellular complex should be excluded by a negative blood culture prior to commencement of therapy.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - azithromycin dihydrate, quantity: 524 mg - tablet, film coated - excipient ingredients: lactose monohydrate; hypromellose; triacetin; calcium hydrogen phosphate; titanium dioxide; pregelatinised maize starch; crospovidone; sodium lauryl sulfate; magnesium stearate - azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. lower respiratory tract infections:,acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenza or moraxella catarrhalis.,community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment.,community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae.,2. upper respiratory tract infections:,acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae.,acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. uncomplicated skin and skin structure infections:,uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage.,4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis.,note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required.,azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma.,azithromycin is also indicated for the prevention of infection due to mycobacterium avium-intracellulare complex (mac) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with hiv infection and cd4 cell count less than or equal to 75 cells/?l (see precautions). disseminated infection due to mycobacterium avium-intracellulare complex should be excluded by a negative blood culture prior to commencement of therapy.,azithromycin is indicated for use in children for the treatment of the following infections:,1. acute streptococcal pharyngitis/tonsillitis:,note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. the 20 mg/kg azithromycin dose appears to be as effective as penicillin in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,2. chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.

Ermenistan - İngilizce - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

berlin-chemie a.g. - pancreatin (lipase, amylase, protease) - tablets gastro-resistant - not less than 10000u+ not less than 7500u+ not less than-375u

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; purified talc; ascorbic acid; hypromellose; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; iron oxide red; magnesium stearate - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; iron oxide yellow; titanium dioxide; citric acid monohydrate; purified talc; ascorbic acid; lactose monohydrate; hypromellose; microcrystalline cellulose; pregelatinised maize starch; iron oxide red; butylated hydroxyanisole - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: citric acid monohydrate; lactose monohydrate; titanium dioxide; ascorbic acid; hypromellose; purified talc; microcrystalline cellulose; iron oxide yellow; pregelatinised maize starch; iron oxide red; magnesium stearate; butylated hydroxyanisole - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 5 mg - tablet, film coated - excipient ingredients: magnesium stearate; ascorbic acid; lactose monohydrate; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; purified talc; butylated hydroxyanisole; citric acid monohydrate; hypromellose; iron oxide yellow - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - simvastatin, quantity: 80 mg - tablet, film coated - excipient ingredients: citric acid monohydrate; butylated hydroxyanisole; lactose monohydrate; hypromellose; titanium dioxide; indigo carmine aluminium lake; purified talc; ascorbic acid; microcrystalline cellulose; magnesium stearate; quinoline yellow aluminium lake; pregelatinised maize starch - adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,simvastatin sandoz is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.,simvastatin sandoz is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh). prior to initiating therapy with simvastatin sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - simvastatin, quantity: 40 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; citric acid monohydrate; lactose monohydrate; purified talc; ascorbic acid; hypromellose; pregelatinised maize starch; butylated hydroxyanisole; titanium dioxide; iron oxide red; magnesium stearate - adjunct to diet for treatment of hypercholesterolaemia.prior to initiating therapy with noumed simvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. noumed simvastatin is indicated in patients at high risk of coronary heart disease (chd) (with or without hypercholesterolaemia) including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris.these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.