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liebel-flarsheim company llc - diatrizoate meglumine (unii: 3x9mr4n98u) (diatrizoic acid - unii:5uvc90j1lk) - diatrizoate meglumine 660 mg in 1 ml

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

liebel-flarsheim company llc - iothalamate meglumine (unii: xuw72gop7w) (iothalamic acid - unii:16chd79mix) - iothalamate meglumine 430 mg in 1 ml - conray 43 is indicated for use in lower extremity venography, intravenous infusion urography, contrast enhancement of computed tomographic brain images and arterial digital subtraction angiography. conray 43 may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic ct scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with ct alone and in supplying additional features of the lesions. in other cases, the contrast agent may allow visualization of lesions not seen with ct alone, or may help to define suspicious lesions seen with unenhanced ct (see clinical pharmacology). su

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liebel-flarsheim company llc - iothalamate meglumine (unii: xuw72gop7w) (iothalamic acid - unii:16chd79mix) - iothalamate meglumine 172 mg in 1 ml - cysto-conray ii is indicated for use in retrograde cystography and cystourethrography. see warnings concerning inadvertant intrathecal administration.

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

merck sharp & dohme corp. - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin 50 mg in 1 ml - indications: banamine transdermal pour-on is indicated for the control of pyrexia associated with bovine respiratory disease and acute bovine mastitis, and the control of pain associated with foot rot in beef cattle 2 months of age and older and dairy cattle. not for use in beef and dairy bulls intended for breeding over 1 year of age, replacement dairy heifers over 20 months of age, dry dairy cows, dairy calves, or veal calves. contraindications: nsaids inhibit production of prostaglandins which are important in signaling the initiation of parturition. the use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. do not use banamine transdermal pour-on within 48 hours of expected parturition. do not use in animals showing hypersensitivity to flunixin meglumine.

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

e-z-em canada inc - diatrizoate meglumine (unii: 3x9mr4n98u) (diatrizoic acid - unii:5uvc90j1lk) - diatrizoate meglumine 660 mg in 1 ml

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

bayer healthcare pharmaceuticals inc. - gadopentetate dimeglumine (unii: rh248g8v27) (gadopentetate - unii:v7ok6j19hq) - magnevist injection is indicated for use with magnetic resonance imaging (mri) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. magnevist injection is indicated for use with mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. magnevist injection is indicated for use in mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body. magnevist is contraindicated in patients with: gbcas cross the placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data). in animal

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pfizer laboratories div pfizer inc - tafamidis meglumine (unii: zu7cf08a1a) (tafamidis - unii:8fg9h9d31j) - vyndaqel and vyndamax are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (attr-cm) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. none. risk summary based on findings from animal studies, vyndaqel and vyndamax may cause fetal harm when administered to a pregnant woman. however, limited available human data with vyndaqel use in pregnant women (at a dose of 20 mg per day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproductive studies, oral administration of tafamidis meglumine to pregnant rabbits during organogenesis resulted in adverse effects on development (embryofetal mortality, fetal body weight reduction and fetal malformation) at a dosage providing approximately 9 times the human exposure (auc) at the maximum recommended human dose (mrhd) of vyndaqel (80 mg), and increased incidence of fetal skeletal variation at a dosage providing equivalent human exposure (auc) at the mrhd. postnatal mortality, growth retardation, and impaired learning and memory were observed in offspring of pregnant rats administered tafamidis meglumine during gestation and lactation at a dosage approximately 2 times the mrhd based on body surface area (mg/m2 ) (see data) . advise pregnant women of the potential risk to a fetus. report pregnancies to the pfizer reporting line at 1-800-438-1985. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, 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. data animal data in pregnant rats, oral administration of tafamidis meglumine (0, 15, 30, and 45 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights at ≥30 mg/kg/day (approximately 10 times the human exposure at the mrhd based on auc). the no-observed-adverse-effect-level (noael) for embryofetal development in rats was 15 mg/kg/day (approximately 7 times the human exposure at the mrhd based on auc). in pregnant rabbits, oral administration of tafamidis meglumine (0, 0.5, 2, and 8 mg/kg/day) throughout organogenesis resulted in increased embryofetal mortality, reduced fetal body weights, and an increased incidence of fetal malformations at 8 mg/kg/day (approximately 9 times the human exposure at the mrhd based on auc), which was also maternally toxic. increased incidences of fetal skeletal variations were observed at doses ≥0.5 mg/kg/day (approximately equivalent to the human exposure at the mrhd based on auc). in the pre- and postnatal study, pregnant rats received oral administration of tafamidis meglumine at doses of 0, 5, 15, or 30 mg/kg/day throughout pregnancy and lactation (gestation day 7 to lactation day 20). decreased survival and body weights, delayed male sexual maturation and neurobehavioral effects (learning and memory impairment) were observed in the offspring of dams treated at 15 mg/kg/day (approximately 2 times the mrhd on a mg/m2 basis). the noael for pre- and postnatal development in rats was 5 mg/kg/day (approximately equivalent to the mrhd on a mg/m2 basis). risk summary there are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. tafamidis is present in rat milk (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. based on findings from animal studies which suggest the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with vyndaqel or vyndamax. data pregnant and lactating female rats were administered repeated daily oral doses of tafamidis meglumine (15 mg/kg/day) followed by a single oral gavage dose of 14 c-tafamidis meglumine on lactation day 4 or 12. radioactivity was observed in milk by 1 hour post-dose and increased thereafter. the ratio of the highest radioactivity associated with 14 c tafamidis meglumine in milk (8 hours post-dose) vs. plasma (1 hour post-dose) was approximately 1.6 on day 12, indicating tafamidis meglumine is transferred to milk after oral administration. contraception females based on findings from animal studies, vyndaqel and vyndamax may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . consider pregnancy planning and prevention for females of reproductive potential. the safety and effectiveness of vyndaqel and vyndamax have not been established in pediatric patients. no dosage adjustment is required for elderly patients (≥65 years) [see clinical pharmacology (12.3)] . of the total number of patients in the clinical study (n=441), 90.5% were 65 and over, with a median age of 75 years.

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aspen veterinary resources, ltd - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400), phenol (unii: 339ncg44tv) (phenol - unii:339ncg44tv) - indications    horse : vetameg® (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. it is also recommended for the alleviation of visceral pain associated with colic in the horse.    cattle : vetameg® is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. vetameg® is also indicated for the control of inflammation in endotoxemia. contraindications    horse : there are no known contraindications to this drug when used as directed. intra-arterial injection should be avoided. horses inadvertently injected intra-arterially can show adverse reactions. signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness. signs are transient and disappear without antidotal medication within a few minutes. do not use in horses showing hypersensitivity to flunixin meglumine.    cattle : nsaids inhibit production of prostaglandins which

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

aspen veterinary resources - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - indications horse: vetameg (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. it is also recommended for the alleviation of visceral pain associated with colic in the horse. cattle: vetameg (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. vetameg is also indicated for the control of inflammation in endotoxemia. contraindications horse: there are no known contraindications to this drug when used as directed. intra-arterial injection should be avoided. horses inadvertently injected intra-arterially can show adverse reactions. signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness. signs are transient and disappear without antidotal medication within a few minutes. do not use in horses showing hypersensitivity to flunixin meglumine. cattle: nsaids inhibit production of prostaglandins which are important in signaling the initiation of parturition. the use of flunixin can delay parturition and prolong labor which may increase the risk of still birth. do not use vetameg (flunixin meglumine injection)within 48 hours of expected parturition. do not use in animals showing hypersensitivity to flunixin meglumine. use judiciously when renal impairment or gastric ulceration are suspected. safety horse: a 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was safe. no changes were observed in hematology, serum chemistry, or urinalysis values. intravenous dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days produced no changes in blood or urine parameters. no injection site irritation was observed following intramuscular injection of the 0.5 mg/lb recommended dose. some irritation was observed following a 3-fold dose administered intramuscularly. cattle: no flunixin-related changes (adverse reactions) were noted in cattle administered a 1x (2.2 mg/kg; 1.0 mg/lb) dose for 9 days three times the maximum clinical duration. minimal toxicity manifested itself at moderately elevated doses (3x and 5x) when flunixin was administered daily for 9 days, with occasional findings of blood in the feces and/or urine. discontinue use if hematuria or fecal blood are observed.

Canada - English - Health Canada

avir pharma inc. - gadopentetate dimeglumine - solution - 469mg - gadopentetate dimeglumine 469mg - miscellaneous therapeutic agents