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

hameln pharma ltd - calcium gluconate - solution for injection - 100mg/1ml

Malta - English - Medicines Authority

iason gmbh feldkirchner str. 4, a-8054 graz, austria - fluorocholine - solution for injection - fluorocholine (18-f) 100 mbq/ml - diagnostic radiopharmaceuticals

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

mayo clinic - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 91.5 mci in 1 ml - sodium fluoride f 18 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 usp has the 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 usp. prior to the administration of sodium fluoride f 18 injection usp to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection usp should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection usp 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 usp or not to administer sodium fluoride f 18 injection usp, taking into account the importance of the drug to the mother. the body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). to minimize the risks to a nursing infant, interrupt nursing for at least 24 hours. in reported clinical experience in approximately 100 children, weight-based doses (2.1 mbq/kg) ranging from 19 mbq-148 mbq (0.5-4 mci) were used. sodium fluoride f 18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. children are more sensitive to radiation and may be at higher risk of cancer from sodium fluoride f 18 injection usp.

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

fresenius kabi australia pty ltd - chromic chloride hexahydrate, quantity: 5.33 microgram/ml; ferric chloride hexahydrate, quantity: 540 microgram/ml; sodium selenite, quantity: 17.29 microgram/ml; sodium fluoride, quantity: 210 microgram/ml; cupric chloride dihydrate, quantity: 102.3 microgram/ml; potassium iodide, quantity: 16.6 microgram/ml; sodium molybdate dihydrate, quantity: 4.85 microgram/ml; manganese chloride tetrahydrate, quantity: 19.79 microgram/ml; zinc chloride, quantity: 1.05 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; xylitol - to meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate

Singapore - English - HSA (Health Sciences Authority)

dch auriga singapore - sulfur hexafluoride - injection, powder, for solution - 8 microlitres/ml - sulfur hexafluoride 8 microlitres/ml

Belgium - English - 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)

Ireland - English - 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

Ireland - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun medical limited - sodium chloride potassium chloride sodium lactate solution calcium chloride dihydrate - solution for infusion - 500ml,1000 %v/v

Malta - English - 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