Tanzania - English - Tanzania Medicinces & Medical Devices Authority

knight escrow company limited, tanzania - mayo table -

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

mayo clinic - ammonia n-13 (unii: 9oqo0e343z) (ammonia n-13 - unii:9oqo0e343z) - ammonia n-13 37.5 mci in 1 ml - ammonia n 13 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. none pregnancy category c animal reproduction studies have not been conducted with ammonia n 13 injection usp. it is also not known whether ammonia n 13 injection usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ammonia n 13 injection usp should be given to a pregnant woman only if clearly needed. it is not known whether this drug 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 ammonia n 13 injection usp, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for n 13 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 ammonia n 13 injection usp has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults [see dosage and administration (2.4) ].

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.

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)

mayo clinic - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 240 mci in 1 ml - fludeoxyglucose f 18 injection usp is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none pregnancy category c animal reproduction studies have not been conducted with fludeoxyglucose f 18 injection usp. it is also not known whether fludeoxyglucose f 18 injection usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. consider alternative diagnostic tests in a pregnant woman; administer fludeoxyglucose f 18 injection usp only if clearly needed. it is not known whether fludeoxyglucose f 18 injection usp is excreted in human milk. consider alternative diagnostic tests in women who are breast-feeding. use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if fludeoxyglucose f 18 injection usp is administered to a woman who is breast-feeding. the safety and effectiveness of fludeoxyglucose f 18 injection usp in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. in pediatric patients with epilepsy, the recommended dose is 2.6 mci. the optimal dose adjustment on the basis of body size or weight has not been determined. in the oncology or cardiology settings, the safety and effectiveness of fludeoxyglucose f 18 injection usp have not been established in pediatric patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratoires mayoly spindler - alverine citrate - capsule, hard - 60 milligram(s) - other drugs for functional gastrointestinal disorders; alverine

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

adcock -

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

zhejiang cuifu cosmetics co., ltd - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - a hand sanitizer to help reduce bacteria that potentially can cause disease. recommended for repeated use. for use when soap and water are not available.

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

mayoly uk ltd - urea [13-c] - oral tablet - 50mg

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

janssen-cilag pty ltd - infliximab, quantity: 100 mg - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; monobasic sodium phosphate monohydrate; polysorbate 80; sucrose - rheumatoid arthritis in adults: remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: patients with active disease despite treatment with methotrexate; patients with active disease who have not previously received methotrexate. remicade should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate. ankylosing spondylitis: remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. psoriatic arthritis: remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remicade may be administered in combination with methotrexate. psoriasis: remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established. crohn's disease in adults and in children and adolescents (6-17 years): remicade is indicated for the treatment of moderate to severe crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. refractory fistulising crohn's disease: remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. ulcerative colitis in adults and in children and adolescents (6 to 17 years); remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.