Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg - cipro is indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, proteus vulgaris, providencia stuartii, morganella morganii, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. cipro is indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. cipro is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. cipro is indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli (enterotoxigenic isolates), campylobacter jejuni, shigella boydii † , shigella dysenteri

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - radium ra-223 dichloride (unii: rj00kv3vtg) (radium ra-223 cation - unii:9h414a99md) - radium ra-223 dichloride 30 uci in 1 ml - xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. none. the safety and efficacy of xofigo have not been established in females. based on mechanism of action, xofigo can cause fetal harm when administered to a pregnant female [see clinical pharmacology ( 12.1)] . while there are no human or animal data on the use of xofigo in pregnancy, maternal use of a radioactive therapeutic agent could affect development of a fetus. advise pregnant females and females of reproductive potential of the potential risk to a fetus. risk summary the safety and efficacy of xofigo have not been established in females. there is no data on the presence of radium-223 dichloride in human milk, the effects on the breastfed child, or the effects on milk production. males because of potential effects on spermatogenesis associated with radiation, advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with xofigo [see use in specific populations (8.1)] . males based on mechanism of action, xofigo may impair fertility in males of reproductive potential [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . the safety and efficacy of xofigo in pediatric patients have not been established. in single- and repeat-dose toxicity studies in rats, findings in the bones (depletion of osteocytes, osteoblasts, osteoclasts, fibro-osseous lesions, disruption/disorganization of the physis/growth line) and teeth (missing, irregular growth, fibro-osseous lesions in bone socket) correlated with a reduction of osteogenesis that occurred at clinically relevant doses beginning in the range of 22 – 88 kbq (0.59 - 2.38 microcurie) per kg body weight. of the 600 patients treated with xofigo in the randomized trial, 75% were 65 years of age and over and while 33% were 75 years of age and over. no dosage adjustment is considered necessary in elderly patients. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dedicated hepatic impairment trial for xofigo has been conducted. since radium-223 is neither metabolized by the liver nor eliminated via the bile, hepatic impairment is unlikely to affect the pharmacokinetics of radium-223 dichloride [see clinical pharmacology (12.3)] . based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with mild hepatic impairment. no dose adjustments can be recommended for patients with moderate or severe hepatic impairment due to lack of clinical data. no dedicated renal impairment trial for xofigo has been conducted. based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with existing mild (creatinine clearance [crcl] 60 to 89 ml/min) or moderate (crcl 30 to 59 ml/min) renal impairment. no dose adjustment can be recommended for patients with severe renal impairment (crcl less than 30 ml/min) due to limited data available (n = 2) [see clinical pharmacology (12.3)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - regorafenib (unii: mgn125fs9d) (regorafenib anhydrous - unii:24t2a1doyb) - regorafenib 40 mg - stivarga is indicated for the treatment of patients with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy, and, if ras wild- type, an anti-egfr therapy. stivarga is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (gist) who have been previously treated with imatinib mesylate and sunitinib malate. stivarga is indicated for the treatment of patients with hepatocellular carcinoma (hcc) who have been previously treated with sorafenib. none. risk summary based on animal studies and its mechanism of action, stivarga can cause fetal harm when administered to a pregnant woman. there are no available data on stivarga use in pregnant women. administration of regorafenib was embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations [see data ] . advise pregnant women of the potential hazard to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 in embryo-fetal development studies, a total loss of pregnancy (100% resorption of litter) was observed in rats at doses as low as 1 mg/kg (approximately 6% of the recommended human dose, based on body surface area) and in rabbits at doses as low as 1.6 mg/kg (approximately 25% of the human exposure at the clinically recommended dose measured by auc). in a single dose distribution study in pregnant rats, there was increased penetration of regorafenib across the blood-brain barrier in fetuses compared to dams. daily administration of regorafenib to pregnant rats during organogenesis resulted in fetal findings of delayed ossification at doses > 0.8 mg/kg (approximately 5% of the recommended human dose based on body surface area) and dose-dependent increases in skeletal malformations including cleft palate and enlarged fontanelle at doses ≥ 1 mg/kg (approximately 10% of the clinical exposure based on auc). at doses ≥ 1.6 mg/kg (approximately 11% of the recommended human dose based on body surface area), there were dose-dependent increases in the incidence of cardiovascular malformations, external abnormalities, diaphragmatic hernia, and dilation of the renal pelvis. in pregnant rabbits administered regorafenib daily during organogenesis, there were findings of ventricular septal defects evident at the lowest tested dose of 0.4 mg/kg (approximately 7% of the auc in patients at the recommended dose). at doses of ≥ 0.8 mg/kg (approximately 15% of the human exposure at the recommended human dose based on auc), administration of regorafenib resulted in dose-dependent increases in the incidence of additional cardiovascular malformations and skeletal anomalies, as well as significant adverse effects on the urinary system including missing kidney/ureter; small, deformed and malpositioned kidney; and hydronephrosis. the proportion of viable fetuses that were male decreased with increasing dose in two rabbit embryo-fetal toxicity studies. risk summary there are no data on the presence of regorafenib or its metabolites in human milk, the effects of regorafenib on the breastfed infant, or on milk production. in rats, regorafenib and its metabolites are excreted in milk. because of the potential for serious adverse reactions in breastfed infants from stivarga, do not breastfeed during treatment with stivarga and for 2 weeks after the final dose. contraception females use effective contraception during treatment and for 2 months after completion of therapy. males advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 months following the final dose of stivarga [see nonclinical toxicology (13.1)] . infertility there are no data on the effect of stivarga on human fertility. results from animal studies indicate that regorafenib can impair male and female fertility [see nonclinical toxicology (13.1)]. the safety and efficacy of  stivarga in pediatric patients less than 18 years of age have not been established. animal data in 28-day repeat-dose studies in rats there were dose-dependent findings of dentin alteration and angiectasis. these findings occurred at regorafenib doses as low as 4 mg/kg (approximately 25% of the auc in humans at the recommended dose). in 13-week repeat-dose studies in dogs there were similar findings of dentin alteration at doses as low as 20 mg/kg (approximately 43% of the auc in humans at the recommended dose). administration of regorafenib in these animals also led to persistent growth and thickening of the femoral epiphyseal growth plate. of the 1142 stivarga-treated patients enrolled in randomized, placebo-controlled trials, 40% were 65 years of age and over, while 10% were 75 and over. no overall differences in efficacy were observed between these patients and younger patients. there was an increased incidence of grade 3 hypertension (18% versus 9%) in the placebo-controlled trials among stivarga-treated patients 65 years of age and older as compared to younger patients. in addition, one grade 4 hypertension event has been reported in the 65 years and older age group and none in the younger age group. no dose adjustment is recommended in patients with mild (total bilirubin ≤uln and ast >uln, or total bilirubin >uln to ≤1.5 times uln) or moderate (total bilirubin >1.5 to ≤3 times uln and any ast) hepatic impairment, [see clinical pharmacology (12.3)] . closely monitor patients with hepatic impairment for adverse reactions [see warnings and precautions (5.1)] . stivarga is not recommended for use in patients with severe hepatic impairment (total bilirubin >3x uln) as stivarga has not been studied in this population. no dose adjustment is recommended for patients with renal impairment. the pharmacokinetics of regorafenib have not been studied in patients who are on dialysis and there is no recommended dose for this patient population [see clinical pharmacology (12.3)] . based on pooled data from three placebo-controlled trials (correct, grid and concur), a higher incidence of hfsr and liver function test abnormalities occurred in asian patients treated with stivarga as compared with whites [see warnings and precautions (5.1, 5.5)] . no starting dose adjustment is necessary based on race.

Verenigde Staten - Engels - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]) ,   haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3 )] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies ( 14.4 )]. moxifloxacin hydrochloride is indica

Verenigde Staten - Engels - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin hydrochloride is indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]) ,   haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3 )] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin hydrochloride is indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate 3 mg - natazia® is indicated for use by women to prevent pregnancy. the efficacy of natazia in women with a body mass index (bmi) of > 30 kg/m2 has not been evaluated. natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see clinical studies (14.2)]. natazia is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. the administration of cocs to induce withdrawal bleeding should not be used as a test for pregnancy. cocs should not be used during pregnancy to treat threatened or habitual abortion. wo

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - yasmin® is indicated for use by females of reproductive potential to prevent pregnancy. yasmin is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, yasmin should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. a retrospective database study of women in norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth w

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - drospirenone 3 mg - yaz® is indicated for use by females of reproductive potential to prevent pregnancy.  yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. the effectiveness of yaz for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating and weight gain. in this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of mense

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - darolutamide (unii: x05u0n2rco) (darolutamide - unii:x05u0n2rco) - none. the safety and efficacy of nubeqa have not been established in females. based on its mechanism of action, nubeqa can cause fetal harm and loss of pregnancy [see clinical pharmacology (12.1)]. animal embryo-fetal developmental toxicology studies were not conducted with darolutamide. there are no human data on the use of nubeqa in pregnant females. the safety and efficacy of nubeqa have not been established in females. there are no data on the presence of darolutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production. based on the mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of nubeqa [see use in specific populations (8.1)]. based on animal studies, nubeqa may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of nubeqa in pediatric patients have not been establishe

Verenigde Staten - Engels - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone 3 mg - safyral is indicated for use by females of reproductive potential to prevent pregnancy. safyral is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. safyral is contraindicated in females who are known to have or develop the following conditions: there is no use for contraception in pregnancy; therefore, safyral should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to chcs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, r