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

pfizer australia pty ltd - methotrexate, quantity: 1000 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

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

pfizer australia pty ltd - methotrexate, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - antineoplastic chemotherapy - treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic and meningeal leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemia. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methotrexate is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. high dose therapy - the use of very high doses is made possible by vials for injection containing 500 mg and 1000 mg (see precautions). diseases treated with these doses administered in the form of single-drug or combination therapy, include osteogenic sarcoma, acute leukaemia, bronchogenic carcinoma and epidermoid carcinoma of the head and n

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

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium metabisulfite; phenol; water for injections; sulfuric acid; disodium edetate - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. if the organisms are resistant, other appropriate therapy should be instituted. in patients in whom gram-negative septicaemia, neonatal sepsis or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cefalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. the decision to continue tobramycin therapy should be based upon the results of susceptibility studies, the severity of infection and the important additional concepts discussed in the product information leaflet.

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

pfizer australia pty ltd - tobramycin, quantity: 80 mg - injection, solution - excipient ingredients: water for injections; disodium edetate; sodium hydroxide; sulfuric acid - for the treatment of serious infections of the following type where they are caused by susceptible organisms: skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. if susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should

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

pfizer australia pty ltd - lidocaine, quantity: 20 mg/g - gel - excipient ingredients: glacial acetic acid; propylene glycol; sodium hydroxide; hyetellose; acetic acid; water for injections - for local anaesthesia and lubrication of the urethra prior to catheterisation, exploration by sound and other endourethral operations and examinations, cystoscopy and symptomatic treatment of painful cystitis and urethritis.

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

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 52.7 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - bupivacaine injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: surgical anaesthesia - epidural block for surgery - field block (minor and major nerve blocks and infiltration). analgesia - continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - field block (minor nerve block amd infiltration). the choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.

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

pfizer australia pty ltd - lidocaine, quantity: 20 mg/ml; chlorhexidine gluconate, quantity: 0.5 mg/ml - gel - excipient ingredients: glacial acetic acid; water for injections; sodium hydroxide; propylene glycol; hyetellose; acetic acid - for local anaesthesia and lubrication of the urethra prior to catheterization. cystoscopy and symptomatic treatment of painful cystisis and urethritis.

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

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 52.8 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - bupivacaine injection is indicated for the production of local or regional anaesthesia and analgesia in individuals as follows: surgical anaesthesia - epidural block for surgery - field block (minor and major nerve blocks and infiltration). analgesia - continuous epidural infusion or intermittent bolus epidural administration for analgesia in post operative pain or labour pain. - field block (minor nerve block amd infiltration). the choice of 2 strengths, 0.25% and 0.5%, makes it possible to vary the degree of motor blockade.

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

pfizer australia pty ltd - midazolam, quantity: 1 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium chloride; water for injections - intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. intermittent intravenous administration or continuous infusion for: sedation in intensive care units. intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

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

pfizer australia pty ltd - midazolam, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - intravenously as an agent for: conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy,coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid. induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be obtained with a narrower dose range and in a shorter period of time. intermittent intravenous administration or continuous infusion for: sedation in intensive care units. intramuscularly for: preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.