Canada - English - Health Canada

therapeutic foods co. - choline bitartrate; ammonium chloride; calcium chloride; glutamic acid hydrochloride; magnesium glycerophosphate; betaine hydrochloride; calcium glycerophosphate; potassium bicarbonate - capsule - 9mg; 7mg; 7mg; 7mg; 4mg; 21mg; 161mg; 14mg - choline bitartrate 9mg; ammonium chloride 7mg; calcium chloride 7mg; glutamic acid hydrochloride 7mg; magnesium glycerophosphate 4mg; betaine hydrochloride 21mg; calcium glycerophosphate 161mg; potassium bicarbonate 14mg - minerals

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

global isotopes, llc d/b/a zevacor molecular - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 4 mci in 1 ml - choline c11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of use : 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. there are no adequate and well controlled studies with choline c11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown. it is not known whether choline c11 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capa

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

washington university school of medicine - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se: 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause f

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

mayo clinic - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se:   11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. animal reproduction studies have not been conducted with 11 c-choline. all radiopharmaceuticals, including choline c 11 injection, have a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. assess pregnancy status before administering choline c 11 injection to a female of child bearing potential. choline c 11 injection should be given to a pregnant woman only if clearly needed. choline c 11 injection is not indicated for use in women. it is not known whether choline c 11 injection is excreted in human milk.  because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from choline c 11 injection, nursing mothers should use alternative infant nutrition sources (e.g., stored breast milk or infant formula) and pump and discard breast milk for 8 hours (>10 half lives of radioactive decay for 11 c isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of choline c 11 injection have not been established in pediatric patients.

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

ucsf radiopharmaceutical facility - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml - choline c 11 injection is indicated for positron emission tomography (pet) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (ct) or magnetic resonance imaging (mri). in these patients, 11 c-choline pet imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. suspected prostate recurrence is based upon elevated blood prostate specific antigen (psa) levels following initial therapy. in clinical studies, images were produced with pet/ct coregistration. limitation of u se: 11 c-choline pet imaging is not a replacement for histologic verification of recurrent prostate cancer. none. pregnancy category c. there are no adequate and well controlled studies with choline c 11 injection in pregnant women and the fetal radiation dose from a 11 c-choline pet imaging study is unknown.  it is not known whether choline c 11 injection can cause fetal harm when administered to a pregnant w

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

hospira, inc. - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml - magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 meq/l) and the serum calcium level is normal (4.3 to 5.3 meq/l) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

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

hospira, inc. - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml - magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium (mg++ ) level is usually below the lower limit of normal (1.5 to 2.5 meq/liter) and the serum calcium (ca++ ) level is normal (4.3 to 5.3 meq/liter) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection, usp is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively. parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

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

physicians total care, inc. - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml - magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium (mg++ ) level is usually below the lower limit of normal (1.5 to 2.5 meq/liter) and the serum calcium (ca++ ) level is normal (4.3 to 5.3 meq/liter) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection, usp is also indicated as a parenteral anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. however, other effective drugs are available for this purpose. parenteral administration of the drug is contraindi

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

exela pharma sciences, llc - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml - magnesium sulfate injection, usp is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. in such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 meq/l) and the serum calcium level is normal (4.3 to 5.3 meq/l) or elevated. in total parenteral nutrition (tpn), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

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

methapharm inc. - methacholine chloride (unii: 0w5etf9m2k) (methacholine - unii:03v657zd3v) - methacholine 100 mg in 100 mg - provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. provocholine is contraindicated in the following: - hypersensitivity to methacholine or other parasympathomimetic agents. reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. - baseline fev1 < 60% predicted (adults or pediatric patients) or <1.5 l (adults) risk summary the available data from published literature on provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant wo