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

global isotopes, llc d/b/a zevacor molecular - fluoride ion f-18 (unii: 4m4we5n2ge) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 10 mci in 1 ml - sodium fluoride f18 injection, usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk.  because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

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

fresenius kabi australia pty ltd - alanine, quantity: 14 g/l; arginine, quantity: 12 g/l; glycine, quantity: 11 g/l; histidine, quantity: 3 g/l; isoleucine, quantity: 5 g/l; leucine, quantity: 7.4 g/l; lysine acetate, quantity: 9.31 g/l (equivalent: lysine, qty 6.6 g/l); methionine, quantity: 4.3 g/l; phenylalanine, quantity: 5.1 g/l; proline, quantity: 11.2 g/l; serine, quantity: 6.5 g/l; taurine, quantity: 1 g/l; threonine, quantity: 4.4 g/l; tryptophan, quantity: 2 g/l; tyrosine, quantity: 400 mg/l; valine, quantity: 6.2 g/l - injection, solution - excipient ingredients: glacial acetic acid; water for injections - to supply amino acids as part of a composite admixture of total parenteral nutrition.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - chromic chloride hexahydrate; copper chloride dihydrate; ferric chloride hexahydrate; manganese chloride tetrahydrate; potassium iodide; sodium fluoride; sodium molybdate dihydrate; sodium selenite anhydrous; zinc chloride - concentrate for solution for infusion - electrolyte solutions; electrolytes in combination with other drugs

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - zinc chloride; copper chloride 2h2o; manganese chloride 4h2o; sodium selenite anhydrous; sodium fluoride; potassium iodide - concentrate for solution for infusion - . percent volume/volume - electrolyte solutions; electrolytes in combination with other drugs

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

puretek corporation - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - fluoride ion 1 mg - for once daily self-applied systemic use as a dental caries preventive in pediatric patients. it has been established that ingestion of fluoridated drinking water (1 ppm f*) during the period of tooth development results in a significant decrease in the incidence of dental caries. fluoride chewable tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm f*. fluoride chewable tablets 1.0 mg are contraindicated when the fluoride content of drinking water is 0.3 ppm f* or more and should not be administered to pediatric patients under the age of 6 years. do not administer fluoride chewable tablets (any strength) to pediatric patients under age 6 months.

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun medical limited - sodium chloride; potassium chloride; sodium lactate solution; calcium chloride dihydrate - solution for infusion - 6/6.24/0.40/0.27 %v/v - solutions affecting the electrolyte balance; electrolytes

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

dent-mat holdings, llc. - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o), potassium nitrate (unii: ru45x2jn0z) (nitrate ion - unii:t93e9y2844) - fluoride ion 5 mg in 1 g - fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. do not use in children under 12 years of age unless recommended by a dentist or physician. 8.1 pregnancy pregnancy category b it has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. there are no adequate or well controlled clinical studies in pregnant women. however, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in chi

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bracco uk ltd - sulfur hexafluoride - powder and solvent for dispersion for injection - 8microlitre/1ml

Israel - English - Ministry of Health

dexcel ltd, israel - sulphur hexafluoride - powder and solvent for dispersion for injection - sulphur hexafluoride 8 mcl/ml - sulfur hexafluoride - this medicinal product is for diagnostic use only. sonovue is for use with ultrasound imaging to enhance the echogenicity of the blood, which results in an improved signal to noise ratio. sonovue should only be used in patients where study without contrast enhancement is inconclusive.echocardiography: sonovue is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.doppler of macrovasculature: sonovue increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extracranial carotid or peripheral arteries by improving the doppler signal to noise ratio. sonovue increases the quality of the doppler flow image and the duration of clinically useful signal enhancement in portal vein assessment.doppler of microvasculature: sonovue improves display of the vascularity of liver and breast lesions during doppler sonography, leading to more specific lesion characterisation.