België - Engels - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

life radiopharma berlin gmbh - sodium fluoride (18 f) 100 mbq/ml - 4000 mbq/ml - solution for injection - 0,1-4 gbq/ml - sodium fluoride (f-18) - sodium fluoride (18f)

Ierland - Engels - HPRA (Health Products Regulatory Authority)

carelide - sodium chloride; calcium chloride dihydrate; potassium chloride; sodium lactate solution 60% - solution for infusion - solutions affecting the electrolyte balance; electrolytes

Ierland - Engels - HPRA (Health Products Regulatory Authority)

laboratoire aguettant - sodium chloride; calcium chloride dihydrate; potassium chloride; sodium lactate solution 60% - solution for infusion - solutions affecting the electrolyte balance; electrolytes

Verenigde Staten - Engels - 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.

Malta - Engels - Medicines Authority

fresenius kabi limited cestrian court, eastgate way, manor park, runcorn, cheshire wa7 1nt, united kingdom - chromic chloride, potassium iodide, copper chloride, ferric chloride, zinc chloride, manganese chloride, sodium fluoride, sodium molybdate, sodium selenite - concentrate for solution for infusion - chromic chloride 5.33 µg potassium iodide 16.6 µg copper chloride 340 µg ferric chloride 544 µg zinc chloride 1.36 mg manganese chloride 99 µg sodium fluoride 210 µg sodium molybdate 4.85 µg sodium selenite 10.5 µg - blood substitutes and perfusion solutions

Malta - Engels - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - chromic chloride, copper chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, dihydrate, sodium selenite, zinc chloride - concentrate for solution for infusion - chromic chloride 5.33 µg/ml copper chloride 0.102 mg/ml ferric chloride 0.54 mg/ml manganese chloride 19.8 µg/ml potassium iodide 16.6 µg/ml sodium fluoride 0.21 mg/ml sodium molybdate dihydrate 4.85 µg/ml sodium selenite 17.3 µg/ml zinc chloride 1.05 mg/ml - blood substitutes and perfusion solutions

Australië - Engels - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - nivolumab, quantity: 255.6 mg; relatlimab, quantity: 85.2 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine - opdualag is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - NLM (National Library of Medicine)

houston cyclotron partners lp dba cyclotope - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - 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 fluoride f 18 injection or not to administer sodium fluoride f 18 injection, taking into account the importance of the drug to the mother. the body of scientific inform

Verenigde Staten - Engels - NLM (National Library of Medicine)

ucsf radiopharmaceutical facility - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection 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 fl