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bluepoint laboratories - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is indicated for the treatment of patients with: 1.1adenocarcinoma of the colon and rectum 1.2adenocarcinoma of the breast 1.3gastric adenocarcinoma 1.4pancreatic adenocarcinoma  none. pregnancy category d risk summary  there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)]. 

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

avpak - miconazole nitrate (unii: vw4h1cyw1k) (miconazole - unii:7nno0d7s5m) - topical antifungal cures most athlete’s foot (tinea pedis) and ring worm (tinea corporis). under professional supervision, miconazole nitrate 2% solution can be used for the treatment of superficial skin infections caused by yeast (candida albicans).

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

guardian drug company - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. potassium chloride is contraindicated in patients on potassium sparing diuretics. there are no human data related to use of potassium chloride during pregnancy, and animal studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background 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 2-4% and 15-20%, respectively.  risk summary the normal potassium ion content of human milk is about 13 meq per liter. since potassium from oral supplements such

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

northwind pharmaceuticals, llc - sulfamethoxazole (unii: je42381tnv) (sulfamethoxazole - unii:je42381tnv), trimethoprim (unii: an164j8y0x) (trimethoprim - unii:an164j8y0x) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. urinary tract infections for the treatment of urinary tract infections due to susceptible strains of the following organisms: escherichia coli , klebsiella species, enterobacter species, morganella morganii , proteus mirabilis and proteus vulgaris . it is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

northwind pharmaceuticals, llc - nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin macrocrystals capsules is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli, enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader t

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

aurobindo pharma limited - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summary based on animal reproduction studies and its mechanism of action, sunitinib malate can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity (embryolethality, craniofacial and skeletal malformations) at 5.5 and 0.3 times the combined auc (the combined systemic exposure of sunitinib plus its active metabolite) in patients administered the recommended daily doses (rdd) of 50 mg, respectively (see data). advise females of reproductive potential of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in a female fertility and early embryonic development study, female rats were administered oral sunitinib (0.5, 1.5, 5 mg/kg/day) for 21 days prior to mating and for 7 days after mating. embryolethality was observed at 5 mg/kg/day (approximately 5 times the combined auc in patients administered the rdd of 50 mg). in embryo-fetal developmental toxicity studies, oral sunitinib was administered to pregnant rats (0.3, 1.5, 3, 5 mg/kg/day) and rabbits (0.5, 1, 5, 20 mg/kg/day) during the period of organogenesis. in rats, embryolethality and skeletal malformations of the ribs and vertebrae were observed at the dose of 5 mg/kg/day (approximately 5.5 times the combined auc in patients administered the rdd of 50 mg). no adverse fetal effects were observed in rats at doses ≤3 mg/kg/day (approximately 2 times the combined auc in patients administered the rdd of 50 mg). in rabbits, embryolethality was observed at 5 mg/kg/day (approximately 3 times the combined auc in patients administered the rdd of 50 mg), and craniofacial malformations (cleft lip and cleft palate) were observed at ≥1 mg/kg/day (approximately 0.3 times the combined auc in patients administered the rdd of 50 mg). sunitinib (0.3, 1, 3 mg/kg/day) was evaluated in a pre- and postnatal development study in pregnant rats. maternal body weight gains were reduced during gestation and lactation at doses ≥1 mg/kg/day (approximately 0.5 times the combined auc in patients administered the rdd of 50 mg). at 3 mg/kg/day (approximately 2 times the combined auc in patients administered the rdd of 50 mg), reduced neonate body weights were observed at birth and persisted in the offspring of both sexes during the preweaning period and in males during postweaning period. no adverse developmental effects were observed at doses ≤1 mg/kg/day. there is no information regarding the presence of sunitinib and its metabolites in human milk. sunitinib and its metabolites were excreted in rat milk at concentrations up to 12-fold higher than in plasma (see data) . because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with sunitinib malate and for at least 4 weeks after the last dose. data animal data in lactating female rats administered 15 mg/kg, sunitinib and its metabolites were excreted in milk at concentrations up to 12-fold higher than in plasma. sunitinib malate can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating treatment with sunitinib malate. contraception females advise females of reproductive potential to use effective contraception during treatment with sunitinib malate and for at least 4 weeks after the last dose. males based on findings in animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception during treatment with sunitinib malate and for 7 weeks after the last dose. infertility based on findings in animals, sunitinib malate may impair male and female fertility [see nonclinical toxicology (13.1)] . the safety and effectiveness of sunitinib malate in pediatric patients have not been established. safety and pharmacokinetics of sunitinib were assessed in an open-label study (nct00387920) in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. in addition, efficacy, safety and pharmacokinetics of sunitinib was assessed in another open-label study (nct01462695) in pediatric patients 2 years to <17 years of age (n=27) with high-grade glioma or ependymoma. the maximum tolerated dose (mtd) normalized for body surface area (bsa) was lower in pediatric patients compared to adults. sunitinib was poorly tolerated in pediatric patients. the occurrence of dose-limiting cardiotoxicity prompted an amendment of the nct00387920 study to exclude patients with previous exposure to anthracyclines or cardiac radiation. no responses were reported in patients in either of the trials. apparent clearance and volume of distribution normalized for bsa for sunitinib and its active major metabolite were lower in pediatrics as compared to adults. the effect on open tibial growth plates in pediatric patients who received sunitinib malate has not been adequately studied. see juvenile animal toxicity data below. juvenile animal toxicity data physeal dysplasia was present in cynomolgus monkeys with open growth plates treated with sunitinib for ≥3 months (3 month dosing 2, 6, 12 mg/kg/day; 8 cycles of dosing 0.3, 1.5, 6 mg/kg/day) at doses that were >0.4 times the combined auc (the combined systemic exposure of sunitinib plus its active metabolite) in patients administered the rdd of 50 mg. the no-effect level (noel) was 1.5 mg/kg/day in monkeys treated intermittently for 8 cycles, but was not identified in monkeys treated continuously for 3 months. in developing rats treated continuously for 3 months (1.5, 5, and 15 mg/kg) or 5 cycles (0.3, 1.5, and 6 mg/kg/day), bone abnormalities consisted of thickening of the epiphyseal cartilage of the femur and an increase of fracture of the tibia at doses ≥5 mg/kg (approximately 10 times the combined auc in patients administered the rdd of 50 mg). additionally, tooth caries were present in rats at >5 mg/kg. the incidence and severity of physeal dysplasia were dose related and reversible upon cessation of treatment; however, findings in the teeth were not. in rats, the noel in bones was ≤2 mg/kg/day. of the 7527 patients with gist, rcc (advanced and adjuvant), or pnet who received sunitinib malate, 32% were 65 years and older, and 7% were 75 years and older. patients aged 65 years of age and older had a higher incidence of grade 3 or 4 adverse reactions (67%) than younger patients (60%). 　 in the gist study, 73 (30%) of the patients who received sunitinib malate were 65 years and older. in the mrcc study, 152 (41%) of patients who received sunitinib malate were 65 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. 　 in the pnet study, 22 (27%) of the patients who received sunitinib malate were 65 years and older. clinical studies of sunitinib malate did not include sufficient numbers of patients with pnet to determine if patients 65 years of age and older respond differently than younger patients. no dose adjustment is required in patients with mild or moderate (child-pugh class a or b) hepatic impairment [see clinical pharmacology (12.3)] . sunitinib malate was not studied in patients with severe (child-pugh class c) hepatic impairment. no dose adjustment is recommended in patients with mild (clcr 50 to 80 ml/min), moderate (clcr 30 to <50 ml/min), or severe (clcr <30 ml/min) renal impairment who are not on dialysis [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with end-stage renal disease (esrd) on hemodialysis [see clinical pharmacology (12.3)] .

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - afatinib dimaleate 29.56mg equivalent to afatinib 20 mg - film coated tablet - 20 mg - active: afatinib dimaleate 29.56mg equivalent to afatinib 20 mg excipient: colloidal silicon dioxide crospovidone hypromellose lactose monohydrate macrogol 400 magnesium stearate microcrystalline cellulose polysorbate 80 purified talc titanium dioxide - giotrif is indicated as monotherapy for the treatment of patients with: locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. tumours must have epidermal growth factor receptor (egfr) mutations. locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

vi-jon, llc - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - alcohol 578 mg in 1 ml - antiseptic - to decrease bacteria on the skin that could cause disease - recommended for repeated use - skin irritation develop - condition persists for more than 72 hours

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

northwind pharmaceuticals - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, usp and other antibacterial drugs, levofloxacin tablets, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. levofloxacin tablets, usp are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levo

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

iroko pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 40 mg - tivorbex is indicated for treatment of mild to moderate acute pain in adults. tivorbex is contraindicated in the following patients:  - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7 , 5.9 ) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7 ,   5.8 ) ]  - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1 ) ] pregnancy category c in the first and second trimesters of pregnancy; category d in the third trimester. risk summary use of nsaids, including tivorbex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including tivorbex, in pregnant women starting at 30 weeks of ge