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

petnet solutions, inc. - 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

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)

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

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

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

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

nukemed, inc. dba spectronrx - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - 1 indications and usage sodium fluoride f 18 injection is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. 4 contraindications none. 8 use in specific populations 8.1 pregnancy pregnancy category c any radiopharmaceutical including sodium fluoride f18 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 reproduction 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. 8.3 nursing mothers 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 reac

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

the university of utah dba cyclotron radiochemistry lab huntsman cancer institute - 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, 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 sodi

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

jubilant drax image radiopharmacies, inc. dba jubilant radiopharma - 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 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 sodiu

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

the feinstein institutes for medical research - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 600 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 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, 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 af

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

ncm usa bronx llc - 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, 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 f18 injection, usp has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproduction 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 sodiu

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.