Ireland - English - HPRA (Health Products Regulatory Authority)

laneshealth (ireland) limited - choline salicylate; glycerol - ear drops, solution - 20 %w/v +12.6 percent weight/volume - analgesics and anesthetics

Ireland - English - HPRA (Health Products Regulatory Authority)

gr lane health products ltd - glycerol; choline salicylate - ear drops, solution - 20 %w/v +12.6 percent weight/volume - analgesics and anesthetics

Ireland - English - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - choline salicylate; cetalkonium chloride - oromucosal gel - 8.714%w/w +0.010 percent weight/weight - salicylic acid and derivatives; choline salicylate

Ireland - English - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - choline salicylate; cetalkonium chloride - oromucosal gel - 8.714 %w/w+ 0.010 percent weight/weight - salicylic acid and derivatives; choline salicylate

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

reckitt benckiser pty ltd - choline salicylate, quantity: 8.714 % w/w - gel - excipient ingredients: star anise oil; glycerol; purified water; saccharin sodium; hypromellose; cetalkonium chloride; menthol; ethanol - provides fast-acting, soothing relief from the pain and discomfort associated with infant teething disorders, mouth ulcers and sores, and new dentures.

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

noumed pharmaceuticals pty ltd - choline salicylate, quantity: 87 mg/g - gel - excipient ingredients: butylated hydroxyanisole; propylene glycol; glycerol; propyl hydroxybenzoate; ethanol; cetalkonium chloride; purified water; menthol; methyl hydroxybenzoate; methylcellulose; star anise oil - oral pain relief for mouth ulcers and sores. soul pattinson teething gel relieves pain and discomfort associated with mouth ulcers, sores and babies teething ailments. useful in relieving pain and discomfort of new dentures.

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

reckitt benckiser pty ltd - choline salicylate, quantity: 8.714 % w/w - gel - excipient ingredients: ethanol; saccharin sodium; star anise oil; hypromellose; cetalkonium chloride; purified water; menthol; glycerol - provides fast-acting, soothing relief from the pain and discomfort associated with infant teething disorders, mouth ulcers and sores, and new dentures.

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.