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

sandoz pty ltd - quetiapine fumarate, quantity: 115.13 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; calcium hydrogen phosphate dihydrate; iron oxide yellow; sodium starch glycollate type a; silicon dioxide; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

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

sandoz pty ltd - quetiapine fumarate, quantity: 345.39 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: povidone; calcium hydrogen phosphate dihydrate; silicon dioxide; lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

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

sandoz pty ltd - quetiapine fumarate, quantity: 28.78 mg (equivalent: quetiapine, qty 25 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; silicon dioxide; iron oxide yellow; sodium starch glycollate type a; povidone; magnesium stearate; iron oxide red; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

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

sandoz pty ltd - quetiapine fumarate, quantity: 230.26 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; microcrystalline cellulose; lactose monohydrate; magnesium stearate; silicon dioxide; povidone; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; macrogol 4000 - quetiapine sandoz is indicated for:,bipolar disorder adults ? maintenance treatment of bipolar i disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? treatment of depressive episodes associated with bipolar disorder (see dose and method of administration) ? treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate,children/adolescents aged 10 to 17 years ? monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia (adults and adolescents aged 13 to 17 years) ? treatment of schizophrenia

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

sandoz pty ltd - piperacillin sodium, quantity: 4.253 g; tazobactam sodium, quantity: 0.547 g (equivalent: tazobactam, qty 0.5 g) - injection, powder for - excipient ingredients: - pipertaz sandoz is used to treat serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1) lower respiratory tract infections; 2) urinary tract infections (complicated and uncomplicated); 3) intra-abdominal infections; 4) skin and skin structure infections; 5) bacterial septicaemia; 6) gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, pipertaz sandoz is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in children below the age of 2 years. while pipertaz sandoz (piperacillin/tazobactam) is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibility to pipertaz sandoz (piperacillin/tazobactam). therapy with pipertaz sandoz (piperacillin/tazobactam), however, may be initiated before results of each test are known when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above, however, once these results are available, appropriate therapy should be continued. in serious infections, presumptive therapy with pipertaz sandoz (piperacillin/tazobactam) may be initiated before susceptibility test results are available. combination therapy with pipertaz sandoz (piperacillin/tazobactam) and aminoglycosides may be used int he treatment of serious infections caused by pseudomonas aeruginosa. both drugs shold be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

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

sandoz pty ltd - furosemide, quantity: 40 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; maize starch; lactose monohydrate; magnesium stearate; sodium starch glycollate - oedema: adults. treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. frusemide sandoz is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. hypertension: adults. oral frusemide sandoz may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with frusemide sandoz alone.

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

sandoz pty ltd - codeine phosphate hemihydrate, quantity: 12.8 mg; ibuprofen, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - for the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also contraindications and paediatric use)

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

sandoz pty ltd - docetaxel, quantity: 80 mg - injection, concentrated - excipient ingredients: ethanol; polysorbate 80; citric acid; nitrogen - docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel sandoz in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel sandoz in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. docetaxel sandoz in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel sandoz in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel sandoz in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of =1cm and < 7cm. docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. docetaxel sandoz is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. docetaxel sandoz is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. docetaxel sandoz, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

sandoz pty ltd - docetaxel, quantity: 20 mg - injection, concentrated - excipient ingredients: polysorbate 80; citric acid; ethanol; nitrogen - docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel sandoz in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel sandoz in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. docetaxel sandoz in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel sandoz in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel sandoz in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of =1cm and < 7cm. docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. docetaxel sandoz is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. docetaxel sandoz is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. docetaxel sandoz, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

sandoz pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; sodium chloride - surgical anaesthesia (adults and children over 12 years of age). - epidural block for surgery including caesarean section. - intrathecal anaesthesia. - field block (minor nerve block and infiltration). - major nerve block. analgesia (adults and children over 12 years of age). - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). - continuous peripheral nerve block infusion or intermittent injections for post operative pain management. analgesia (children aged 0 - 12 years). - caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years . - continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years. - peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).