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

biomedical research foundation of northwest louisiana - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 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 risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation d

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

sofie co. - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f18 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. risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data ). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation

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

petnet solutions, inc. - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection 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 has a 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. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection 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 fl

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

sandoz pty ltd - levodopa, quantity: 75 mg; carbidopa, quantity: 18.75 mg (equivalent: carbidopa monohydrate, qty 20.25 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; magnesium stearate; maize starch; mannitol; povidone; glycerol; hypromellose; polysorbate 80; iron oxide red; sucrose; titanium dioxide - stalevo is indicated for the management of patients with parkinson's disease who are experiencing motor fluctuations.

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

glaxosmithkline australia pty ltd - hpv type 16 l1 protein, quantity: 20 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: monobasic sodium phosphate; aluminium hydroxide hydrate; water for injections; 3-o-desacyl-4'-monophosphoryl lipid a; sodium chloride - cervarix is indicated in females from 10 to 45 years of age for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by human papillomavirus types 16 and 18. lmmunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations (see precautions and clinical trials).

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 20 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 40 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride - gardasil is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.

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

medis pharma pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: sodium sulfate; hyprolose; carmellose sodium; microcrystalline cellulose; magnesium stearate; trehalose dihydrate; powdered cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin - levodopa/carbidopa/entacapone is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

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

stada pharmaceuticals australia pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: trehalose dihydrate; microcrystalline cellulose; carmellose sodium; hyprolose; sodium sulfate; magnesium stearate; powdered cellulose; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin - levodopa/carbidopa/entacapone is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

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

accord-uk ltd - carbidopa; levodopa; entacapone - oral tablet - 18.75mg ; 75mg ; 200mg

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - aldesleukin 18 miu (interleukin-2 (recombinant human));   - powder for injection - 18 miu - active: aldesleukin 18 miu (interleukin-2 (recombinant human))   excipient: dibasic sodium phosphate dihydrate mannitol monobasic sodium phosphate dihydrate sodium laurilsulfate - proleukin is indicated for the treatment of metastatic renal cell carcinoma (mrcc).