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

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

Canada - English - Health Canada

bioenergy inc. - choline (choline bitartrate) - tablet (extended-release) - 400mg - choline (choline bitartrate) 400mg - lipotropic agents

Canada - English - Health Canada

twin laboratories inc. - choline (choline bitartrate) - capsule - 350mg - choline (choline bitartrate) 350mg - other nutritional agents

Canada - English - Health Canada

international nutrition ltd. - choline (choline bitartrate) - tablet - 100mg - choline (choline bitartrate) 100mg - other nutritional agents

Ireland - English - HPRA (Health Products Regulatory Authority)

acic europe limited - methacholine chloride - powder for nebuliser solution - 100 milligram(s) - other diagnostic agents; methacholine

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

physician therapeutics llc - theophylline anhydrous (unii: 0i55128jyk) (theophylline anhydrous - unii:0i55128jyk) - theophylline anhydrous 100 mg - indications and usage theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. contraindications theophylline extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product. pediatric use theophylline is safe and effective for the approved indications in pediatric patients. the maintenance dose of theophylline must be selected with caution in pediatric patients since the rate of theophylline clearance is highly variable across the age range of neonates to adolescents (see clinical pharmacology, table i, warnings, and dosage and administration, table v). geriatric use elderly patients are at significantly greater risk of experiencing serious toxicity from theophylline than younger patients due to pharmacokinetic and pharmacodynamic changes associated