Australia - English - 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: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type a; magnesium stearate; maize starch; sodium lauryl sulfate; 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.

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

pfizer australia pty ltd - azithromycin dihydrate, quantity: 628.93 mg (equivalent: azithromycin, qty 600 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; calcium phosphate; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; lactose monohydrate; hypromellose; triacetin - 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 haemphilus 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 conjunctivits 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/microliter (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 20mg/kg azithromycin dose appears to be almost 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.

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

pfizer australia pty ltd - azithromycin dihydrate, quantity: 524.1 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; calcium hydrogen phosphate; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; lactose monohydrate; hypromellose; triacetin - 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 haemphilus 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 conjunctivits 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/microliter (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 20mg/kg azithromycin dose appears to be almost 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

roche products (ireland) ltd - valganciclovir - film-coated tablet - 450 milligram(s) - nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Ireland - English - HPRA (Health Products Regulatory Authority)

cheplapharm arzneimittel gmbh - valganciclovir - film-coated tablet - nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Ireland - English - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - chlorambucil - film-coated tablet - 2 milligram(s) - nitrogen mustard analogues; chlorambucil

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - cyclophosphamide monohydrate - coated tablet - 50 milligram(s) - nitrogen mustard analogues; cyclophosphamide

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - cyclophosphamide - coated tablet - cyclophosphamide 50 mg - antineoplastic agents

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

bayer australia ltd - levonorgestrel, quantity: 125 microgram; ethinylestradiol, quantity: 50 microgram - tablet, sugar coated - excipient ingredients: calcium carbonate; magnesium stearate; purified talc; glycol montanate; lactose monohydrate; maize starch; macrogol 6000; sucrose; povidone - oral contraception

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

bayer east africa limited, kenya - levonorgestrel , ethinylestradiol - film coated tablet - levonorgestrel 150, ethinylestradiol 30