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

aspen veterinary resources - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin meglumine 50 mg in 1 ml - horse: vetameg® 50 mg/ml 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® 50 mg/ml is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. vetameg® 50 mg/ml is also indicated for the control of inflammation in endotoxemia. horse: there are no known contra-indications 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 partu

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

mwi veterinary supply co - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin meglumine 50 mg in 1 ml - horse: prevail® 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: prevail® is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. prevail® is also indicated for the control of inflammation in endotoxemia. 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 flu

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

vettek - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin meglumine 50 mg in 1 ml - indications horse: flunixin injection (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: flunixin injection (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. flunixin injection 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 flunixin injection (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.

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

bimeda, inc. - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin meglumine 50 mg in 100 ml - indication flunazine-s (flunixin meglumine injection) is indicated for the control of pyrexia associated with swine respiratory disease. contraindications there are no known contraindications to this drug in swine when used as directed. do not use in animals showing hypersensitivity to flunixin meglumine. use judiciously when renal impairment or gastric ulceration is suspected.

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

mwi veternary supply, inc. - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400), phenol (unii: 339ncg44tv) (phenol - unii:339ncg44tv) - flunixin meglumine 50 mg in 1 ml - indications    horse : prevail™ (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 : prevail™ (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. prevail™ 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 pr

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

vetone/mwi - flunixin meglumine (unii: 8y3jk0jw3u) (flunixin - unii:356ib1o400) - flunixin meglumine 50 mg in 1 ml - indications horse: prevail™ (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: prevail™ (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. prevail™ 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 inhibition of parturition. the use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. do not use prevail™ (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.

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

bracco diagnostics inc - gadobenate dimeglumine (unii: 3q6ppc19po) (gadolinium cation (3+) - unii:azv954tz9n) - gadobenate dimeglumine 529 mg in 1 ml - multihance is indicated for intravenous use in magnetic resonance imaging (mri) of the central nervous system (cns) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. multihance is indicated for use in magnetic resonance angiography (mra) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. multihance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents [see warnings and precautions (5.3)] . risk summary 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 reproduction studies, gadobenate dimeglumine has been shown to be teratogenic in rabbits following repeated intravenous administration during organogenesis at doses up to 6 times the recommended human dose. there were no adverse developmental effects observed in rats with intravenous administration of gadobenate dimeglumine during organogenesis at doses up to three times the recommended human dose (see data) . because of the potential risks of gadolinium to the fetus, use multihance only if imaging is essential and cannot be delayed. the estimated background risk of major birth defects and miscarriage for 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 to 4% and is 15 to 20%, respectively. data human data contrast enhancement is visualized in the placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the maternal indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. reproductive toxicology gadobenate dimeglumine has been shown to be teratogenic in rabbits when administered intravenously at 2 mmol/kg/day (6 times the recommended human dose based on body surface area) during organogenesis (day 6 to 18) inducing microphthalmia/small eye and/or focal retinal fold in 3 fetuses from 3 separate litters. in addition, multihance administered intravenously at 3 mmol/kg/day (10 times the recommended human dose based on body surface area) has been shown to increase intrauterine deaths in rabbits. there was no evidence that multihance induced teratogenic effects in rats at doses up to 2 mmol/kg/day (3 times the recommended human dose based on body surface area), however, rat dams exhibited no systemic toxicity at this dose. there were no adverse effects on the birth, survival, growth, development and fertility of the f1 generation at doses up to 2 mmol/kg in a rat peri- and post-natal (segment iii) study. risk summary limited literature reports that breastfeeding after gadobenate dimeglumine administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose. there is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. additionally, there is limited gbca gastrointestinal absorption. the developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for multihance and any potential adverse effects on the breastfed infant from multihance or from the underlying maternal condition. multihance is approved for intravenous use for mri of the cns to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to less than 17 years of age. pediatric use is based on evidence of effectiveness in adults and in 202 pediatric patients 2 years of age and older, in addition to experience in 105 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dose adjustment according to age is necessary in pediatric patients two years of age and older. for pediatric patients, less than 2 years of age, the recommended dosage range is 0.1 to 0.2 ml/kg [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of multihance has not been established in preterm neonates. of the total number of 4967 adult subjects in clinical studies of multihance, 33% were 65 or older. no overall differences in safety or effectiveness were observed between these elderly subjects and the younger subjects. the drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to multihance may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function it may be useful to monitor renal function.

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

bracco diagnostics inc - diatrizoate meglumine (unii: 3x9mr4n98u) (diatrizoic acid - unii:5uvc90j1lk), diatrizoate sodium (unii: v5403h8vg7) (diatrizoic acid - unii:5uvc90j1lk) - diatrizoate meglumine 660 mg in 1 ml - gastrografin (diatrizoate meglumine and diatrizoate sodium solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). the preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. gastrografin may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. do not administer to patients with a known hypersensitivity to gastrografin or any of its components.

Australia - English - Department of Health (Therapeutic Goods Administration)

bracco pty ltd - gadobenate dimeglumine, quantity: 529 mg/ml - injection, solution - excipient ingredients: water for injections - multihance is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (mri) indicated for: for use in adults for the enhancement of magnetic resonance imaging (mri) of the liver and central nervous system (cns) for diagnostic use only. for use in adult patients with suspected or known vascular disease for contrast-enhanced magnetic resonance angiography of the abdominal or peripheral arteries where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

bracco pty ltd - gadobenate dimeglumine -