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

pfizer australia pty ltd - bupivacaine hydrochloride monohydrate, quantity: 5.27 mg/ml (equivalent: bupivacaine hydrochloride, qty 5 mg/ml); adrenaline (epinephrine) acid tartrate, quantity: 9.1 microgram/ml (equivalent: adrenaline (epinephrine), qty 5 microgram/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium metabisulfite; citric acid; sodium citrate - pfizer bupivacaine with adrenaline 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 postoperative pain or labour pain,- field block (minor nerve block and 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 - bupivacaine hydrochloride monohydrate, quantity: 2.64 mg/ml (equivalent: bupivacaine hydrochloride, qty 2.5 mg/ml); adrenaline (epinephrine) acid tartrate, quantity: 4.5 microgram/ml (equivalent: adrenaline (epinephrine), qty 2.5 microgram/ml) - injection, solution - excipient ingredients: sodium citrate; citric acid; sodium metabisulfite; water for injections; sodium chloride - pfizer bupivacaine with adrenaline 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 postoperative pain or labour pain,- field block (minor nerve block and infiltration),the choice of 2 strengths, 0.25%, and 0.5% makes it possible to vary the degree of motor blockade.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

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

pfizer australia pty ltd - daptomycin, quantity: 350 mg - inhalation, powder for - excipient ingredients: sodium hydroxide; citric acid - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

pfizer australia pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: citric acid; sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age):,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.,paediatric patients (1 to 17 years of age):,daptomycin is not indicated for treatment of patients less than 1 year of age.,daptomycin has not been studied in treatment of infective endocarditis in children.,complicated skin and skin structure infections,pfizer daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),pfizer daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

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

pfizer australia pty ltd - methotrexate, quantity: 500 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - 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 - paracetamol, quantity: 1 g - injection, solution - excipient ingredients: glucose monohydrate; sodium citrate dihydrate; water for injections; glacial acetic acid; hydrochloric acid; sodium acetate trihydrate; sodium hydroxide - for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

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

pfizer australia pty ltd - paracetamol, quantity: 500 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium citrate dihydrate; sodium acetate trihydrate; glucose monohydrate; sodium hydroxide; glacial acetic acid; water for injections - for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

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

pfizer australia pty ltd - latanoprost -

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

pfizer australia pty ltd - daunorubicin, quantity: 20 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - indications as at 22 november 2004 : daunorubicin injection is indicated for the treatment of the following: acute lymphocytic (lymphoblastic) leukaemia: daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. however, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease. acute myeloblastic leukaemia: daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g. cytarabine). disseminated solid tumours: daunorubicin has been investigated for use in these tumours and found to be effective in some cases of disseminated neuroblastoma and rhabdomyosarcoma.