New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - conjugated estrogens 0.625mg (15mg as a dessication with lactose. includes 3% overage.);  ; medroxyprogesterone acetate 5mg (includes 4% overage); conjugated estrogens 0.625mg (15mg as a dessication with lactose. includes 3% overage.); medroxyprogesterone acetate 5mg (includes 4% overage) - tablet - active: conjugated estrogens 0.625mg (15mg as a dessication with lactose. includes 3% overage.)   medroxyprogesterone acetate 5mg (includes 4% overage) excipient: calcium sulfate carnauba wax glyceryl mono-oleate iron oxide red lactose monohydrate macrogols magnesium stearate methylcellulose microcrystalline cellulose   opacode black s-8-27741 povidone shellac stearic acid sucrose     titanium dioxide   active: conjugated estrogens 0.625mg (15mg as a dessication with lactose. includes 3% overage.) medroxyprogesterone acetate 5mg (includes 4% overage) excipient: calcium sulfate carnauba wax glyceryl mono-oleate indigo carmine lactose monohydrate macrogols magnesium stearate methylcellulose microcrystalline cellulose opacode black s-8-27741 povidone shellac stearic acid sucrose titanium dioxide  

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

pfizer australia pty ltd - gentamicin, quantity: 80 mg - injection, solution - excipient ingredients: sulfuric acid; water for injections; sodium hydroxide; disodium edetate - indications as at november 2000; for the treatment of infections due to one or more susceptible strains of bacteria, including pseudomonas aeruginosa, proteus species (indole positive and indole negative), escherichia coli, klebsiella, enterobacter and serratia species and staphylococcus (including strains resistant to other antibiotics). gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. in suspected or documented gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. therapy may be instituted before obtaining results of susceptibi

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine 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 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 pfizer-biontech covid-19 vaccine

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine and pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) are 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 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine and 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 multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age. do not administer pfizer-biontech covid-19 vaccine or 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 [see description (13)] .       p

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine 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 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine supplied in a multiple dose vial with a gray cap and label with a gray border, which is authorized for use in individuals 12 years of age and older. do not administer pfizer-biontech covid-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 pfizer

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

pfizer manufacturing belgium nv - tozinameran (unii: 5085zfp6sj) (tozinameran - unii:5085zfp6sj) - pfizer-biontech covid-19 vaccine 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 6 months of age and older. this eua prescribing information pertains only to pfizer-biontech covid-19 vaccine 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 to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the pfizer-biontech covid-19 vaccine [see description (13)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage i

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 12 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. 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 [see description (13)] . risk summary no data are available regarding the use of pfizer-biontech covid-19 vaccine, bivalent during pregnancy. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, t

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - exemestane 25mg - coated tablet - 25 mg - active: exemestane 25mg excipient: crospovidone hydrated silica hypromellose   macrogol 6000 magnesium carbonate magnesium stearate mannitol methyl hydroxybenzoate polysorbate 80 polyvinyl alcohol powdered cellulose simeticone sodium starch glycolate sucrose   titanium dioxide - · the adjuvant treatment of postmenopausal women with oestrogen receptor positive or receptor unknown early breast cancer after initial adjuvant tamoxifen to reduce the risk of recurrence (distant and loco-regional) and contralateral breast cancer · the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy · the third-line hormonal treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease progressed following treatment with anti-oestrogens and either non-steroidal aromatase inhibitors or progestins.

Philippines - English - FDA (Food And Drug Administration)

pfizer, inc.; distributor: pfizer, inc. - bupivacaine hydrochloride - solution for injection - 5mg / ml

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

pfizer laboratories div pfizer inc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxorubicin hydrochloride injection/for injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. doxorubicin hydrochloride injection/for injection is indicated for the treatment of doxorubicin hydrochloride injection/for injection are contraindicated in patients with: risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride injection/for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride injection/for injection during the 1st trimester. available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 (see data) . advise pregnant women of the potential risk to a fetus. 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. data animal data doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. teratogenicity and embryotoxicity were also seen using discrete periods of treatment. the most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies. doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis. risk summary doxorubicin was measured in the milk of one lactating patient after therapy with 70 mg/m2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. the peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. doxorubicin was detectable in the milk up to 72 hours. there are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with doxorubicin hydrochloride injection/for injection and for 10 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride injection/for injection. contraception females doxorubicin hydrochloride injection/for injection can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin hydrochloride injection/for injection and for 6 months after treatment. [see use in specific populations (8.1)] . males doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride injection/for injection and for 3 months after treatment [see nonclinical toxicology (13.1)] . males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see nonclinical toxicology (13.1), use in specific populations (8.1)] . infertility females in females of reproductive potential, doxorubicin hydrochloride may cause infertility and result in amenorrhea. premature menopause can occur. recovery of menses and ovulation is related to age at treatment [see nonclinical toxicology (13.1)] . males doxorubicin hydrochloride may result in oligospermia, azoospermia, and permanent loss of fertility. sperm counts have been reported to return to normal levels in some men. this may occur several years after the end of therapy [see nonclinical toxicology (13.1)] . based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction. risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride. doxorubicin hydrochloride, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. there are no recommended dose adjustments based on age. doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in infants less than 2 years as compared to adults [see clinical pharmacology (12.3)] . clinical experience in patients who were 65 years of age and older who received doxorubicin hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients. the clearance of doxorubicin was reduced in patients with elevated serum total bilirubin levels. doxorubicin hydrochloride injection/for injection is contraindicated in patients with severe hepatic impairment (defined as child pugh class c or serum bilirubin levels greater than 5 mg/dl) [see contraindications (4)] . reduce the dose of doxorubicin hydrochloride injection/for injection in patients with serum total bilirubin levels greater than 1.2 mg/dl [see dosage and administration (2.4), warnings and precautions (5.5)] .