Australia - English - 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.

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

sandoz pty ltd - cyproterone acetate, quantity: 50 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate - women: moderately severe to severe signs of androgenisation. moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. cyproterone sandoz 50mg inhibits the influence of male sex hormones which are also produced by the female. it is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. if cyproterone sandoz 50mg is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. this also promotes regular menstruation. men: reduction to drive in sexual deviations. cyproterone sandoz 50mg reduces the force of the sexual urge in men with sexual deviations. whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. a prerequisite for therapy is the desire by the patient for treatment. cyproterone sandoz 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. inoperable prostatic carcinoma. to suppress flare with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

Australia - English - 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.)

Australia - English - 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.)

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

sandoz pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium acetate; water for injections - tramadol sandoz injections are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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

sandoz pty ltd - atenolol, quantity: 50 mg - tablet, film coated - excipient ingredients: maize starch; magnesium carbonate hydrate; magnesium stearate; gelatin; sodium lauryl sulfate; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - atenolol sandoz is indicated in the management of:,- all grades of hypertension, including hypertension of renal origin,- frequent disabling angina without evidence of cardiac failure,- cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias, including those associated with acute myocardial infarction),- myocardial infarction: late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.