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

pfizer australia pty ltd - zinc chloride, quantity: 5.3 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - zinc chloride injection is intended for use as an additive to compatible intravenous fluids or total parenteral nutrition solutions. it is indicated for the prevention and treatment of zinc deficiency, which may be characterised by growth deterioration, skin lesions, alopecia, impaired reproductive development and function, and delayed or inhibited wound healing.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - zinc chloride 5.3 mg/ml equivalent to 5.1 mg zn/2ml - solution for injection - 10.6 mg/2ml - active: zinc chloride 5.3 mg/ml equivalent to 5.1 mg zn/2ml excipient: water for injection

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.

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

pfizer manufacturing belgium nv - raxtozinameran (unii: n36vhk46pr) (raxtozinameran - unii:n36vhk46pr) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of pfizer-biontech covid-19 vaccine (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months through 11 years of age. pfizer-biontech covid-19 vaccine (2023-2024 formula), which is supplied in multiple dose vials with yellow caps and labels with yellow borders, and in single dose vials with blue caps and labels with blue borders, is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the united states under certain circumstances including, but not limited to, when the secretary of hhs declares that use of eua authority is justified, based on a determination that there is a public-health emergency, or a significant potential for a public-health emergency, that affects, or has a significant potential to affect, national security or the health and security of united states citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). criteria for issuing an eua include: information regarding available alternative vaccines for the prevention of covid-19 in individuals 6 months through 11 years of age there may be clinical trials or availability under eua of other covid-19 vaccines, including vaccines that contain or encode the spike protein of the sars-cov-2 omicron variant lineage xbb.1.5 (omicron xbb.1.5). do not administer pfizer-biontech covid-19 vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a pfizer-biontech covid-19 vaccine.       risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data on comirnaty, pfizer-biontech covid-19 vaccine, bivalent or pfizer-biontech covid-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of pfizer-biontech covid-19 vaccine (original monovalent) on 4 occasions, twice prior to mating and twice during gestation. these studies revealed no evidence of harm to the fetus due to the vaccine (see animal data ). clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant individuals infected with sars-cov-2 are at increased risk of severe covid-19 compared with non-pregnant individuals. data animal data in a developmental toxicity study, 0.06 ml of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modrna) (30 mcg) and other ingredients included in a single human dose of pfizer-biontech covid-19 vaccine (original monovalent) was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. no vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. risk summary it is not known whether pfizer-biontech covid-19 vaccine is excreted in human milk. data are not available to assess the effects of pfizer-biontech covid-19 vaccine on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pfizer-biontech covid-19 vaccine and any potential adverse effects on the breastfed child from pfizer-biontech covid-19 vaccine or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. pfizer-biontech covid-19 vaccine is authorized for use in individuals 6 months through 11 years of age. pfizer-biontech covid-19 vaccine is not authorized for use in individuals younger than 6 months of age or individuals 12 years of age and older. as reported in an independent publication (kamar n, abravanel f, marion o, et al. three doses of an mrna covid-19 vaccine in solid-organ transplant recipients. n engl j med ), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously. a third dose of the original monovalent pfizer-biontech covid-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. following the third dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post dose 3. among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. all 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. the prevalence of anti-sars-cov-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose. patients should still be counseled to maintain physical precautions to help prevent covid-19. in addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. your child is being offered the pfizer-biontech covid-19 vaccine (2023-2024 formula) to prevent coronavirus disease 2019 (covid-19), which is caused by the virus sars-cov-2. this fact sheet contains information to help you understand the risks and benefits of the pfizer-biontech covid-19 vaccine (2023-2024 formula), hereafter referred to as pfizer-biontech covid-19 vaccine, which your child may receive because there is currently a pandemic of covid-19. talk to your child’s vaccination provider if you have questions. this fact sheet may have been updated. for the most recent fact sheet, please see https://www.covidvaxoption.com the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) to make the pfizer-biontech covid-19 vaccine available during the covid-19 pandemic (for more details about an eua please see “what is an emergency use authorization? ” at the end of this document). the pfizer-biontech covid-19 vaccine is not an fda-approved vaccine in the united states. read this fact sheet for information about the pfizer-biontech covid-19 vaccine. what is covid-19? covid-19 is caused by a coronavirus called sars-cov-2. you can get covid-19 through close contact with another person who has the virus. it is predominantly a respiratory illness that can affect other organs. people with covid-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. symptoms may appear 2 to 14 days after exposure to the virus. symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. what is the pfizer-biontech covid-19 vaccine? the pfizer-biontech covid-19 vaccine is a vaccine for use in individuals 6 months through 11 years of age to prevent covid-1910. the fda has authorized the emergency use of the pfizer-biontech covid-19 vaccine under an eua. the pfizer-biontech covid-19 vaccine may not protect everyone. what should you mention to the vaccination provider before your child gets the pfizer-biontech covid-19 vaccine? tell the vaccination provider about all of your child’s medical conditions, including if your child: how is the vaccine given? the pfizer-biontech covid-19 vaccine is given as an injection into the muscle. individuals 6 months through 4 years of age individuals 5 through 11 years of age immunocompromised individuals 6 months through 11 years of age additional doses of pfizer-biontech covid-19 vaccine may be administered. for more information, talk to your child’s healthcare provider. who should not get pfizer-biontech covid-19 vaccine? a person should not get pfizer-biontech covid-19 vaccine if they had: what are the ingredients in this vaccine? pfizer-biontech covid-19 vaccine contains the following ingredients: messenger ribonucleic acid (mrna), lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-n,n-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, and sucrose. pfizer-biontech covid-19 may also contain sodium chloride. has this vaccine been used before? millions of individuals 6 months of age and older have received a pfizer-biontech covid-19 vaccine under eua. in a clinical trial, approximately 1,200 individuals 6 months through 23 months of age, approximately 1,800 individuals 2 through 4 years of age, and approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of the pfizer-biontech covid-19 vaccine (original monovalent). in another clinical trial, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the pfizer-biontech covid-19 vaccine (original monovalent). in clinical trials, 60 individuals 6 months through 4 years of age, 113 individuals 5 through 11 years of age, 107 individuals 12 through 17 years of age, 103 individuals 18 through 55 years of age, and 106 individuals greater than 55 years of age received a dose of pfizer-biontech covid-19 vaccine, bivalent. the pfizer-biontech covid-19 vaccine is made in the same way as the pfizer-biontech covid-19 vaccine (original monovalent) and pfizer-biontech covid-19 vaccine, bivalent, but it encodes the spike protein of sars-cov-2 omicron variant lineage xbb.1.5 (omicron xbb.1.5). what are the benefits of pfizer-biontech covid-19 vaccine? fda has authorized the pfizer-biontech covid-19 vaccine to provide protection against covid-19. the duration of protection against covid-19 is currently unknown. what are the risks of pfizer-biontech covid-19 vaccine? there is a remote chance that the vaccine could cause a severe allergic reaction. a severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. for this reason, the vaccination provider may ask your child to stay at the place where your child received the vaccine for monitoring after vaccination. signs of a severe allergic reaction can include: myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mrna covid-19 vaccines. myocarditis and pericarditis following pfizer-biontech covid-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. in most of these individuals, symptoms began within a few days following vaccination. the chance of having this occur is very low. you should seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after your child receives a dose of the vaccine: additional symptoms, particularly in children, may include: side effects that have been reported with pfizer-biontech covid-19 vaccines include: these may not be all the possible side effects. serious and unexpected side effects may occur. the possible side effects are still being studied. what should i do about side effects? if your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. call the vaccination provider or your child’s healthcare provider if your child has any side effects that bother your child or do not go away. report vaccine side effects to fda/cdc vaccine adverse event reporting system (vaers). the vaers toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. please include “pfizer-biontech covid-19 vaccine (2023-2024 formula) eua” in the first line of box #18 of the report form. in addition, you can report side effects to pfizer inc. at the contact information provided below. www.pfizersafetyreporting.com 1-866-635-8337 1-800-438-1985 what if i decide not to have my child get the pfizer-biontech covid-19 vaccine? under the eua, there is an option to accept or refuse receiving this vaccine. should you decide for your child not to receive this vaccine, it will not change the standard medical care. are there other vaccines for preventing covid-19 besides the pfizer-biontech covid-19 vaccine? other vaccines to prevent covid-19 may be available under eua, including vaccines that encode the spike protein of the sars-cov-2 omicron variant lineage xbb.1.5 (omicron xbb.1.5). can my child receive pfizer-biontech covid-19 vaccine at the same time as other vaccines? data have not been submitted to fda on administration of pfizer-biontech covid-19 vaccine at the same time as other vaccines. if you are considering having your child receive pfizer-biontech covid-19 vaccine with other vaccines, discuss the options with your child’s healthcare provider. what if my child is immunocompromised? immunocompromised individuals 6 months through 11 years of age may receive additional doses of pfizer-biontech covid-19 vaccine (see how is the vaccine given? above). vaccinations may not provide full immunity to covid-19 in people who are immunocompromised; therefore, your child should continue to maintain physical precautions to help prevent covid-19. your child’s close contacts should be vaccinated as appropriate. what about pregnancy or breastfeeding? if your child is pregnant or breastfeeding, discuss the options with your child’s healthcare provider. will this vaccine give my child covid-19? no. this vaccine does not contain sars-cov-2 and cannot give your child covid-19. additional information if you have questions, visit the website or call the telephone number provided below. to access the most recent fact sheets, please scan the qr code provided below. www.cvdvaccine.com 1-877-829-2619 (1-877-vax-co19) how can i learn more? where will vaccination information be recorded? the vaccination provider may include your child’s vaccination information in your state/local jurisdiction’s immunization information system (iis) or other designated system. for more information about iiss, visit: https://www.cdc.gov/vaccines/programs/iis/about.html what is the countermeasures injury compensation program? the countermeasures injury compensation program (cicp) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. generally, a claim must be submitted to the cicp within one (1) year from the date of receiving the vaccine. to learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427. what is an emergency use authorization (eua)? the fda has made pfizer-biontech covid-19 vaccine available under an emergency access mechanism called an eua. an eua is supported by a secretary of health and human services (hhs) declaration that circumstances exist to justify the emergency use of drugs and biological products during the covid-19 pandemic. a product authorized for emergency use has not undergone the same type of review by fda as an fda-approved product. fda may issue an eua when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. in addition, the fda decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent covid-19 during the covid-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. all of these criteria must be met to allow for the product to be used under eua during the covid-19 pandemic. the eua is in effect for the duration of the covid-19 eua declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). manufactured for biontech manufacturing gmbh an der goldgrube 12 55131 mainz, germany manufactured by pfizer inc., new york, ny 10001 lab-1572-3.0 revised: 11 september 2023 scan to capture that this fact sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. gdti: 0886983000585

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

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.