Austràlia - anglès - 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections - fluconazole sandoz injection is indicated in adults and children for the following conditions only if fluconazole can not be administered orally. for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral and intravenous therapy has a less favourable ratio of benefits to risks. (see adverse effects.)

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride - fluconazole sandoz injection is indicated in adults and children for the following conditions only if fluconazole can not be administered orally. for treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note. data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. serious and life threatening candida infections in patients who are unable to tolerate amphotericin b. note. it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life threatening candida infections. until such data are available, amphotericin b remains the drug of choice. vaginal candidiasis, when topical therapy has failed. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral and intravenous therapy has a less favourable ratio of benefits to risks. (see adverse effects.)

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - clarithromycin, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; macrogol 4000; hypromellose; titanium dioxide; microcrystalline cellulose; powdered cellulose - clarithromycin sandoz clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin sandoz clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. acute otitis media.note:1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - clarithromycin, quantity: 250 mg - tablet, film coated - excipient ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate - clarithromycin sandoz clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: acute streptococcal pharyngitis; community acquired pneumonia due to chlamydia pneumoniae, mycoplasma pneumoniae, legionella pneumophilia and streptococcus pneumoniae;uncomplicated skin and skin structure infections due to staphylococcus aureus or streptococcus pyogenes;disseminated or localised mycobacterial infections due to mycobacterium avium or mycobacterium intracellulare and skin and skin structure infections due to mycobacterium chelonae. clarithromycin should be used in combination with other anti mycobacterial agents.prevention of disseminated mycobacterium avium complex infection in hiv infected adults with cd4 lymphocyte counts <75 cells/mm 3 (see precautions). disseminated infection due to mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.acute bacterial exacerbation of chronic bronchitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae;combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infection. clarithromycin sandoz clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:acute streptococcal pharyngitis and tonsillitis caused by streptococcus pyogenes; community acquired pneumonia including infections due to chlamydia pneumoniae, mycoplasma pneumoniae and legionella pneumophila; skin and skin structure infections (eg impetigo); disseminated or localised infections due to mycobacterium avium or mycobacterium intracellulare in immunocompromised children, including those with hiv infection or aids. acute otitis media.note:1. penicillins are the drug of first choice in the treatment of acute otitis media. 2. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. there is insufficient evidence of efficacy to support the use of clarithromycin in acute bronchitis in young children. 4. the data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - roxithromycin, quantity: 300 mg - tablet, film coated - excipient ingredients: silicon dioxide; titanium dioxide; hypromellose; lactose monohydrate; croscarmellose sodium; poloxamer; magnesium stearate; microcrystalline cellulose; povidone; macrogol 4000 - roxithromycin sandoz is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms. upper respiratory tract infection: acute pharyngitis, tonsilitis and sinusiti. lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children roxithromycin sandoz 150mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible microorganisms. acute pharyngitis. acute tonsilitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be inititiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; macrogol 4000; magnesium stearate; lactose monohydrate; titanium dioxide; silicon dioxide; poloxamer; hypromellose - adults: roxithromycin sandoz is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms. upper respiratory tract infection: acute pharyngitis, tonsilitis and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin sandoz 150mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible microorganisms. acute pharyngitis. acute tonsilitis. impetigo. appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be inititiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - tamsulosin hydrochloride, quantity: 400 microgram - tablet, modified release - excipient ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica - for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - levetiracetam, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium chloride; water for injections; sodium acetate trihydrate; glacial acetic acid - levetiracetam sandoz concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,levetiracetam sandoz concentrate solution for iv infusion is indicated for: ? use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with jme. ? add on therapy in the treatment of pgtc seizures in adults and children from 4 years of age with ige.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - irbesartan, quantity: 300 mg; hydrochlorothiazide, quantity: 25 mg - tablet, film coated - excipient ingredients: hypromellose; iron oxide black; macrogol 6000; colloidal anhydrous silica; lactose monohydrate; titanium dioxide; croscarmellose sodium; purified talc; microcrystalline cellulose; hyprolose; iron oxide red; magnesium stearate - irbesartan/hct sandoz is indicated for the treatment of hypertension. treatment should not be initiated with this fixed-dose combination.