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

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

bayer australia ltd - choline bitartrate, quantity: 267.41 mg (equivalent: choline, qty 110 mg); docosahexaenoic acid (dha)-rich oil derived from microalgae schizochytrium sp., quantity: 469.725 mg (equivalent: docosahexaenoic acid, qty 200 mg) - capsule, soft - excipient ingredients: lecithin; yellow beeswax; silicon dioxide; iron oxide red; gelatin; purified water; glycerol; ethylcellulose; sunflower oil; ascorbyl palmitate; mixed (low-alpha type) tocopherols concentrate; rosmarinus officinalis - helps maintains/support healthy foetal cns/brain development ; enhance/promote healthy foetal development ; maintains/support healthy foetal development ; maintain/support healthy pregnancy ; helps enhance/promote maternal health ; maintain/support maternal health ; helps enhance/promote preconception health ; maintain/support preconception health ; maintain/support placenta health/growth

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

australian by nature pty ltd - ascorbic acid,astragalus membranaceus,betacarotene,biotin,bupleurum falcatum,calcium hydrogen phosphate dihydrate,calcium pantothenate,choline bitartrate,chromic chloride hexahydrate,colecalciferol,copper gluconate,cyanocobalamin,citrus bioflavonoids extract,d-alpha-tocopheryl acid succinate,ferrous fumarate,folic acid,fucus vesiculosus,heavy magnesium oxide,inositol,lysine hydrochloride,manganese sulfate monohydrate,nicotinamide,nicotinic acid,potassium sulfate,pyridoxine hydrochloride,retinol -

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

bausch & lomb australia pty ltd - acetylcholine chloride, quantity: 10 mg/ml - diluent, not applicable - excipient ingredients: sodium acetate; magnesium chloride hexahydrate; potassium chloride; calcium chloride dihydrate; water for injections - miochol-e is used to obtain complete miosis of the iris in seconds after placement of the intraocular lens (iol) in cataract surgery; and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.

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

lannett company, inc. - choline magnesium trisalicylate (unii: djj95fjp1h) (salicylic acid - unii:o414pz4lpz) - salicylic acid 500 mg in 5 ml - osteoarthritis, rheumatoid arthritis and acute painful shoulder : salicylates are considered the base therapy of choice in the arthritides; and choline magnesium trisalicylate preparation is indicated for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and other arthritides. choline magnesium trisalicylate liquid is indicated in the long-term management of these diseases and especially in the acute flare of rheumatoid arthritis. choline magnesium trisalicylate liquid is also indicated for the treatment of acute painful shoulder. choline magnesium trisalicylate liquid is effective and generally well tolerated, and is logical choice whenever salicylate treatment is indicated. it is particularly suitable when a once-a-day or b.i.d. dosage regimen is important to patient compliance; when gastrointestinal intolerance to aspirin is encountered; when gastrointestinal microbleeding or hematologic effects of aspirin are considered a patient hazard; and when interference (or the risk of int

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

merck sharp & dohme (australia) pty ltd - vorinostat, quantity: 100 mg - capsule - excipient ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; sorbitan monolaurate; potable water; gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - zolinza is indicated for the treatment of cutaneous manifestations in patients with cutaneous t-cell lymphoma (ctcl) who have progressive, persistent or recurrent disease subsequent to prior systemic therapies.

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

the university of texas md anderson cancer center - choline c-11 (unii: m4as4xgd4q) (choline c-11 - unii:m4as4xgd4q) - choline c-11 33.1 mci in 1 ml