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

virbac ah, inc - milbemycin oxime (unii: 0502pun0gt) (milbemycin oxime - unii:0502pun0gt), lufenuron (unii: 1r754m4918) (lufenuron - unii:1r754m4918) - milbemycin oxime 11.5 mg - sentinel flavor tabs are indicated for use in dogs and puppies, four weeks of age and older, and two pounds body weight or greater. sentinel flavor tabs are also indicated for the prevention of heartworm disease caused by dirofilaria immitis for the prevention and control of flea populations, the control of adult ancylostoma caninum (hookworm), and the removal and control of adult toxocara canis and toxascaris leonina (roundworm) and trichuris vulpis (whipworm) infections. lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. concurrent use of an adulticide product may be necessary for adequate control of adult fleas. without concurrent use of an adulticide, adequate flea control may not be achieved in dogs that have repeated exposure to flea infested animals or environments.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ecolab deutschland gmbh - lactic acid 26,4 mg/g; sodium chloride 6,4 mg/g - concentrate for dip solution - 26,40 mg/ml - 6,40 mg/ml - lactic acid 26.4 mg/ml; sodium chlorite 6.4 mg/ml - disinfectants - cattle

Ireland - English - HPRA (Health Products Regulatory Authority)

virbac s.a. - fipronil; permethrin - spot-on solution - 26.8, 240 mg/pipette - permethrin, combinations - dogs - ectoparasiticide

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

aurobindo pharma limited - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 275 mg - naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout  the management of: - pain - primary dysmenorrhea naproxen sodium tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen 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)] risk summary use of nsaids, including naproxen sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of naproxen sodium use between about 20 and 30 weeks of gestation, and avoid naproxen sodium use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data). premature closure of fetal ductus arteriosus use of nsaids, including naproxen sodium, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0.13, 0.26, and 0.6 times the maximum recommended human daily dose of 1500 mg/day, respectively [see data ]. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre- and post-implantation loss. prostaglandins also have been shown to have an important role in fetal kidney development. in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions premature closure of fetal ductus arteriosus: avoid use of nsaids in women at about 30 weeks gestation and later in pregnancy, because nsaids, including naproxen sodium, can cause premature closure of the fetal ductus arteriosus (see data ). oligohydramnios/neonatal renal impairment: if an nsaid is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. if naproxen sodium treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. if oligohydramnios occurs, discontinue naproxen sodium, and follow up according to clinical practice (see data ). labor or delivery there are no studies on the effects of naproxen sodium during labor or delivery. in animal studies, nsaids, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data there is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin e levels in preterm infants. because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly starting at 30-weeks of gestation, or third trimester) should be avoided. premature closure of fetal ductus arteriosus: published literature reports that the use of nsaids at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment: published studies and postmarketing reports describe maternal nsaid use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. these adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after nsaid initiation. in many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. there have been a limited number of case reports of maternal nsaid use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. these limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal nsaid use. because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to nsaids through maternal use is uncertain. animal data reproduction studies have been performed in rats at 20 mg/kg/day (0.13 times the maximum recommended human daily dose of 1500 mg/day based on body surface area comparison), rabbits at 20 mg/kg/day (0.26 times the maximum recommended human daily dose, based on body surface area comparison), and mice at 170 mg/kg/day (0.6 times the maximum recommended human daily dose based on body surface area comparison) with no evidence of impaired fertility or harm to the fetus due to the drug. risk summary the naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for naproxen sodium and any potential adverse effects on the breastfed infant from the naproxen sodium or from the underlying maternal condition. infertility  females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including naproxen sodium may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including naproxen sodium, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients below the age of 2 years have not been established. pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies [see dosage and administration (2)]. there are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg as naproxen suspension, with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age.  the hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. naproxen was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months. transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions (5.1, 5.2, 5.3, 5.6, 5.14)]. studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. the clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients. caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. as with other drugs used in the elderly, it is prudent to use the lowest effective dose. experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti-inflammatory drugs. elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur. most spontaneous reports of fatal gi events are in the geriatric population [see warnings and precautions (5.2)]. naproxen is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see clinical pharmacology (12.3) ] . geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs [see warnings and precautions (5.6) ].  caution is advised when high doses are required and some adjustment of dosage may be required in these patients. it is prudent to use the lowest effective dose [see clinical pharmacology (12.3)]. naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 ml/min) [see warnings and precautions (5.6), clinical pharmacology (12.3)].

Ireland - English - HPRA (Health Products Regulatory Authority)

alliance pharma (ireland) limited - salicylic acid - cutaneous solution - 26 percent weight/weight - salicylic acid preparations

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

mylan specialty l.p. - pretomanid (unii: 2xoi31yc4n) (pretomanid - unii:2xoi31yc4n) - limited population: pretomanid tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (tb) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug or adults with pulmonary tb resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. approval of this indication is based on limited clinical safety and efficacy data. this drug is indicated for use in a limited and specific population of patients. limitations of use: pretomanid tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. refer to the bedaquiline and linezolid prescribing information. there are no studies or available data on pretomanid use in pregnant women to inform any drug-associated risks. there are risks associated with active tuberculosis during pregnancy (see cl

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

virbac s.a. - permethrin 239,8 mg/0,44 ml; fipronil 26,84 mg/0,4 ml - spot-on solution - 26,8 mg - 240 mg - fipronil 61 mg/ml; permethrin 545 mg/ml - permethrin, combinations - dog

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

northwind pharmaceuticals - losartan potassium (unii: 3st302b24a) (losartan - unii:jms50mpo89) - losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and myocardial infarction. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. losartan potassium tablets may be administered with other antihypertensive agents. losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients [see use in specific populations ( 8.6) and clinical pharmacology ( 12.3)]. losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. in this population, losartan potassium tablets reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see clinical studies ( 14.3)]. losartan potassium tablets are contraindicated: • in patients who are hypersensitive to any component of this product. • for coadministration with aliskiren in patients with diabetes. teratogenic effects pregnancy category d use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. when pregnancy is detected, discontinue losartan as soon as possible. these adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin­-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. perform serial ultrasound examinations to assess the intra-amniotic environment. if oligohydramnios is observed, discontinue losartan potassium, unless it is considered lifesaving for the mother. fetal testing may be appropriate, based on the week of pregnancy. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to losartan potassium for hypotension, oliguria, and hyperkalemia [see use in specific populations ( 8.4)]. losartan potassium has been shown to produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity. with the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated  with  these  effects  exceeded  25 mg/kg/day  (approximately  three  times  the  maximum recommended human dose of 100 mg on a mg/m 2 basis). these findings are attributed to drug exposure in late gestation and during lactation. significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk. it is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. neonates with a history of in utero exposure to losartan potassium: if oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. antihypertensive effects of losartan potassium have been established in hypertensive pediatric patients aged 6 to 16 years. safety and effectiveness have not been established in pediatric patients under the age of 6 or in pediatric patients with glomerular filtration rate <30 ml/min/1.73 m 2 [see dosage and administration ( 2.1), clinical pharmacology ( 12.3), and clinical studies ( 14.1)]. of the total number of patients receiving losartan potassium in controlled clinical studies for hypertension, 391 patients (19%) were 65 years and over, while 37 patients (2%) were 75 years and over. in a controlled clinical study for renal protection in type 2 diabetic patients with proteinuria, 248 patients (33%) were 65 years and over. in a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients (62%) were 65 years and over, while 808 patients (18%) were 75 years and over. no overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in the life study, black patients with hypertension and left ventricular hypertrophy treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with black patients treated with losartan potassium (both cotreated with hydrochlorothiazide in the majority of patients). the primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an intention-to-treat (itt) approach. in the subgroup of black patients  (n=533, 6% of the life  study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 26 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 42 per 1000 patient-years) on losartan potassium. this finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. in addition, blood pressure reductions in both treatment groups were consistent between black and non-black patients. given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. however, the life study provides no evidence that the benefits of losartan potassium on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to black patients [see clinical studies ( 14.2)]. patients with renal insufficiency have elevated plasma concentrations of losartan and its active metabolite compared to subjects with normal renal function. no dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted [see dosage and administration ( 2.3), warnings and precautions ( 5.3) and clinical pharmacology ( 12.3)]. the recommended starting dose of losartan potassium tablets is 25 mg in patients with mild-to-moderate hepatic impairment. following oral administration in patients with mild-to-moderate hepatic impairment, plasma concentrations of losartan and its active metabolite were, respectively, 5 times and 1.7 times those seen in healthy volunteers. losartan potassium has not been studied in patients with severe hepatic impairment [see dosage and administration ( 2.4) and clinical pharmacology ( 12.3)].

Canada - English - Health Canada

pace solutions corp. - sodium dichloroisocyanurate - liquid - 26.5% - sodium dichloroisocyanurate 26.5% - disinfectants (for agents used on object)

Canada - English - Health Canada

squibb diagnostics, division of bristol-myers squibb canada inc. - iopamidol - liquid - 26% - iopamidol 26% - roentgenography