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.

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 - 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

United States - English - NLM (National Library of Medicine)

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj), famtozinameran (unii: jsv288q5cv) (famtozinameran - unii:jsv288q5cv) - pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for use under an emergency use authorization (eua) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 5 years of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5), hereafter referred to as pfizer-biontech covid-19 vaccine, bivalent, supplied in a multiple dose vial with an orange cap and a label with an orange border, which is authorized for use in individuals 5 through 11 years of age. the vial labels state: age 5y to <12y. the carton labels state: for age 5 years to <12 years. do not administer pfizer-biontech covid-19 vaccine, bivalent to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine or the pfizer-biontech covid-19 vaccine, bivalent [

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