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

vifor (international) inc. - difelikefalin acetate (unii: 0p70ar5byb) (difelikefalin - unii:na1u919mro) - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (ckd-ap) in adults undergoing hemodialysis (hd). limitations of use korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. none risk summary the limited human data on use of korsuva in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. in animal reproduction studies, intravenous injection of difelikefalin to pregnant rats and rabbits during the period of organogenesis at doses 711 and 10 times the maximum recommended human dose (mrhd), respectively, resulted in no adverse effects in either rats or rabbits (see data) . 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 2-4% and 15-20%, respectively. data animal data in an embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.25, 2.5, and 25 mg/kg/day during the period of organogenesis. difelikefalin was not associated with embryofetal lethality or fetal malformations. difelikefalin increased the incidences of skeletal variations (wavy ribs and incompletely ossified ribs) at the dose of 25 mg/kg/day (711 times the mrhd based on auc comparison). in an embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rabbits at doses of 0.025, 0.05, and 0.1 mg/kg/day during the period of organogenesis. maternal toxicity evidenced by decreased maternal body weight gain was noted in all dose groups. difelikefalin was not associated with embryofetal lethality or fetal malformations at doses up to 0.1 mg/kg/day (10 times the mrhd based on auc comparison). in a prenatal and postnatal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.6, 2.5, and 10 mg/kg/day beginning on gestation day 7 and continuing through lactation day 20. persisting effects on decreased maternal body weight and/or maternal body weight gain as well as food consumption were noted at doses greater than or equal to 2.5 mg/kg/day (68 times the mrhd based on auc comparison). no maternal effects were observed at 0.6 mg/kg/day (14 times the mrhd based on auc comparison). no difelikefalin-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at doses up to 10 mg/kg/day (282 times the mrhd based on auc comparison). risk summary there are no data regarding the presence of korsuva in human milk or effects on the breastfed infant or on milk production. studies in rats showed difelikefalin was transferred into the milk in lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for korsuva and any potential adverse effects on the breastfed child from korsuva or from the underlying maternal condition. data animal data difelikefalin was administered to lactating rats by intravenous injection at doses of 0.6, 2.5, or 10 mg/kg/day from gestation day 7 through lactation day 14. difelikefalin was detected in the milk of the lactating rats with the concentration ratio for milk:plasma of 0.04 to 0.05 across the doses. there was no measurable difelikefalin in the plasma of nursing pups. the safety and effectiveness of korsuva in pediatric patients have not been established. of the 848 subjects in the placebo-controlled studies who received korsuva, 278 subjects (32.8%) were 65 years of age and older and 98 subjects (11.6%) were 75 years of age and older. no overall differences in safety or effectiveness of korsuva have been observed between patients 65 years of age and older and younger adult subjects, with the exception of the incidence of somnolence which was higher in korsuva-treated subjects 65 years of age and older (7.0%) than in korsuva-treated subjects less than 65 years of age (2.8%), and was comparable in both placebo age groups (3.0% and 2.1%, respectively). no differences in plasma concentrations of korsuva were observed between subjects 65 years of age and older and younger adult subjects [see clinical pharmacology ( 12.3)] . the influence of mild-to-moderate hepatic impairment on the pharmacokinetics of korsuva was evaluated in a population pharmacokinetic analysis which concluded that no korsuva dosage adjustments are needed in these populations [see clinical pharmacology ( 12.3)] . the influence of severe hepatic impairment on the pharmacokinetics of korsuva in subjects undergoing hd has not been evaluated; therefore, use of korsuva in this population is not recommended.

Israel - English - Ministry of Health

cts ltd - difelikefalin as acetate - solution for injection - difelikefalin as acetate 50 mcg / 1 ml - difelikefalin - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - bacillus anthracis (sterne 34f2 strain) - parenteral liquid/solution/suspension - bacillus anthracis (sterne 34f2 strain) vaccine-microbial active 0.0 ml - immunotherapy - cattle | pigs | sheep | beef | boar | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ew - bacillus anthracis | anthrax

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproperties pty. ltd. - herpes virus of turkeys (hvt) strain fc 126 - misc. vaccines or anti sera - herpes virus of turkeys (hvt) strain fc 126 vaccine-viral active 4000.0 pfu/dose - immunotherapy - embryonated chicken egg | poultry chicks | chickens | day old chicks | hatchlings - marek's disease | herpes virus of turkeys (hvt)

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - infectious bursal disease virus (ibd) strain v877 - misc. vaccines or anti sera - infectious bursal disease virus (ibd) strain v877 vaccine-viral active 0.0 p - immunotherapy - fowl - infectious bursal disease | vaccine | bursal disease | equine rotavirus

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

meda pharmaceuticals inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see clinical studies (14)] . the clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. edluar is contraindicated in patients: neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation (see clinical considerations and data) . published data on the use of zolpidem during pregnancy have not identified a drug-associated risk of and major birth defects (see data). oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are un

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

mylan pharmaceuticals inc. - prasugrel hydrochloride (unii: g89jq59i13) (prasugrel - unii:34k66tbt99) - prasugrel 5 mg - prasugrel tablets are indicated to reduce the rate of thrombotic cv events (including stent thrombosis) in patients with acute coronary syndrome (acs) who are to be managed with percutaneous coronary intervention (pci) as follows: prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (mi), or nonfatal stroke compared to clopidogrel. the difference between treatments was driven predominantly by mi, with no difference on strokes and little difference on cv death [see clinical studies (14)] . prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ich) [see warnings and precautions (5.1) and adverse reactions (6.1)] . prasugrel tablets are contraindicated in patients with a history of prior transient ischemic attack (tia) or stroke. in triton-timi 38 (tr ial to assess i mprovement in t herapeutic outcomes by o ptimizing platelet inhibition with prasugrel), patients with a history of tia or ischemic stroke (> 3 months prior to enrollment) had a higher rate of stroke on prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ich]) than on clopidogrel (1.2%; all thrombotic). in patients without such a history, the incidence of stroke was 0.9% (0.2% ich) and 1.0% (0.3% ich) with prasugrel tablets and clopidogrel, respectively. patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from triton-timi 38. patients who experience a stroke or tia while on prasugrel tablets generally should have therapy discontinued [see adverse reactions (6.1) and clinical studies (14)] . prasugrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see adverse reactions (6.2)] . there are no data with prasugrel tablets use in pregnant women to inform a drug-associated risk. no structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see data] . due to the mechanism of action of prasugrel tablets, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel tablets and possible risks to the fetus when prescribing prasugrel tablets to a pregnant woman [see boxed warning and warnings and precautions (5.1, 5.3)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. in embryo-fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. a slight decrease in fetal body weight was observed, but there were no structural malformations in either species. in prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure. there is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. metabolites of prasugrel were found in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prasugrel tablets and any potential adverse effects on the breastfed child from prasugrel tablets or from the underlying maternal condition. following a 5 mg/kg oral dose of [14 c]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood. safety and effectiveness in pediatric patients have not been established. in a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met. in triton-timi 38, 38.5% of patients were ≥ 65 years of age and 13.2% were ≥ 75 years of age. the risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (prasugrel tablets compared with clopidogrel) was similar across age groups. patients ≥ 75 years of age who received prasugrel tablets 10 mg had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). in patients ≥ 75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received prasugrel tablets and in 3 patients (0.3%) who received clopidogrel. because of the risk of bleeding, and because effectiveness is uncertain in patients ≥ 75 years of age [see clinical studies (14)] , use of prasugrel tablets is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where their effect appears to be greater and their use may be considered [see warnings and precautions (5.1), clinical pharmacology (12.3), and clinical studies (14)] . in triton-timi 38, 4.6% of patients treated with prasugrel tablets had body weight < 60 kg. individuals with body weight < 60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see dosage and administration (2), warnings and precautions (5.1), and clinical pharmacology (12.3)] . consider lowering the maintenance dose to 5 mg in patients < 60 kg. the effectiveness and safety of the 5 mg dose have not been prospectively studied [see dosage and administration (2) and clinical pharmacology (12.3)] . no dosage adjustment is necessary for patients with renal impairment. there is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding [see warnings and precautions (5.1) and clinical pharmacology (12.3)] . no dosage adjustment is necessary in patients with mild to moderate hepatic impairment (child-pugh class a and b). the pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see warnings and precautions (5.1) and clinical pharmacology (12.3)] . in healthy subjects, patients with stable atherosclerosis, and patients with acs receiving prasugrel, there was no relevant effect of genetic variation in cyp2b6, cyp2c9, cyp2c19, or cyp3a5 on the pharmacokinetics of prasugrel’s active metabolite or its inhibition of platelet aggregation.

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

mylan pharmaceuticals inc. - acitretin (unii: lch760e9t7) (acitretin - unii:lch760e9t7) - acitretin 10 mg - pregnancy: acitretin capsules must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. acitretin capsules also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. acitretin is a metabolite of etretinate (tegison), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. potentially, any fetus exposed can be affected. clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin capsules or for 2 months after cessation of therapy. this allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. the mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. it is not known whether substances other than ethanol are associated with transesterification. acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. these doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m2 comparison. major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. acitretin capsules should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity. because of the teratogenicity of acitretin, a program called the mymac program, my m ylan a citretin c ommitment, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. the mymac program requirements are described below and program materials are available at www.acitretincommitment.com or may be requested by calling 1-877-446-3679 (1-877-4-info-rx) (see also precautions section). important information for women of childbearing potential: acitretin capsules should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. females of reproductive potential must not be given a prescription for acitretin capsules until pregnancy is excluded. acitretin capsules are contraindicated in females of reproductive potential unless the patient meets all of the following conditions: there have been 25 cases of reported conception when the male partner was taking acitretin. the pregnancy outcome is known in 13 of these 25 cases. of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).3 timing of paternal acitretin treatment relative to conception delivery of healthy neonate spontaneous abortion induced abortion total at time of conception 5a 5 1 11 discontinued ~ 4 weeks prior 1b 1 discontinued ~ 6 to 8 months prior 1 1 a four of 5 cases were prospective. b with malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck,    hypoplasia of lungs bilateral, pulmonary atresia, vsd with overriding truncus arteriosus). for all patients: an acitretin capsules medication guide must be given to the patient each time acitretin capsules are dispensed, as required by law. acitretin capsules are indicated for the treatment of severe psoriasis in adults. because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. in females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed contraindications and warnings - acitretin capsules can cause severe birth defects). most patients experience relapse of psoriasis after discontinuing therapy. subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. see boxed contraindications and warnings. acitretin capsules are contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed warnings: hepatotoxicity , warnings: lipids and possible cardiovascular effects, and precautions). an increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. consequently, the combination of methotrexate with acitretin capsules is also contraindicated (see precautions: drug interactions). since both acitretin capsules and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see warnings: pseudotumor cerebri). acitretin capsules are contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .

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

pfizer laboratories div pfizer inc - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 25 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain effectiveness of vibramycin and other antibacterial drugs, vibramycin 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. doxycycline is indicated for the treatment of the following infections: doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administration section and information for patients subsection of the precautions section.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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

apotheca inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets usp are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14) ] . none. pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may