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

photocure inc. - hexaminolevulinate hydrochloride (unii: d4f329sl1o) (hexaminolevulinate - unii:g7h20tki67) - hexaminolevulinate hydrochloride 100 mg in 50 ml - cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (cis), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. cysview is used with the karl storz d-light c photodynamic diagnostic (pdd) system to perform blue light cystoscopy (blc ® ) as an adjunct to the white light cystoscopy. cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [ see warnings and precautions (5.2) ]. cysview is contraindicated in patients with: - porphyria, - gross hematuria, - known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. risk summary there are no available data on cysview use in pregnant women to inform a drug associated risk of adverse developmental outcomes. adequate reproductive and developmental toxicity studie

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

photocure inc - hexaminolevulinate hydrochloride (unii: d4f329sl1o) (hexaminolevulinate - unii:g7h20tki67) - hexaminolevulinate hydrochloride 100 mg in 50 ml - cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. cysview is used with the karl storz d-light c photodynamic diagnostic (pdd) system to perform cystoscopy with the blue light setting (mode 2) as an adjunct to the white light setting (mode 1). cysview is not: - a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see warnings and precautions (5.2) ]. - for repetitive use. the potential risks associated with repetitive exposure, including sensitization and adverse effects of blue light have not been evaluated [see warnings and precautions (5.1) ]. cysview is contraindicated in patients with: - porphyria - gross hematuria - bcg immunotherapy or intravesical chemotherapy within the past 90 days - known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid pregnancy

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

medi-physics inc. - iobenguane i-123 (unii: p2th1xyz84) (iobenguane i-123 - unii:p2th1xyz84) - iobenguane i-123 2 mci in 1 ml - adreview is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. adreview is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (h/m) ratio of radioactivity uptake in patients with new york heart association (nyha) class ii or class iii heart failure and left ventricular ejection fraction (lvef) ≤ 35%. among these patients, adreview may be used to help identify patients with lower one and two year mortality risks, as indicated by an h/m ratio ≥ 1.6. limitations of use: in patients with congestive heart failure, adreview utility has not been established for: - selecting a therapeutic intervention or for monitoring the response to therapy; - using the h/m ratio to identify a patient with a high risk for death. adreview is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. risk summary radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. administration of an appropriate thyroid blocking agent is recommended before use of adreview in a pregnant woman to protect the woman and fetus from accumulation of i 123 [see dosage and administration (2.2) ]. there are no available data on adreview use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with iobenguane i 123. all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of adreview. adreview contains 10.3 mg/ml of benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary iodine 123 (i 123), the radionuclide in adreview, is present in human milk. there is no information on the effects on the breastfed infant or on milk production. advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after adreview administration in order to minimize radiation exposure to a breastfed infant. the safety and effectiveness of adreview have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma [see clinical studies (14.1)] . safety and effectiveness in pediatric patients below the age of 1 month or in any pediatric patient with congestive heart failure have not been established. serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. when administering adreview in infants consider the combined daily metabolic load of benzyl alcohol from all sources including adreview (contains 10.3 mg of benzyl alcohol per ml) and other drugs containing benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see warnings and precautions (5.3)] . in clinical studies of adreview in heart disease, 27% of subjects were 65-74 years of age and 17% of subjects were 75 years of age or over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. adreview is excreted by the kidneys, and the risks of adverse reactions, increased radiation dose, and occurrence of falsely negative imaging results, may be greater in patients with severely impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. consider assessment of renal function in elderly patients prior to adreview administration.

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

ge healthcare australia pty ltd - tetrofosmin, quantity: 0.23 mg; stannous chloride dihydrate, quantity: 0.03 mg - injection, solution - excipient ingredients: sodium bicarbonate; sodium gluconate; disodium sulfosalicylate - myoview is indicated as an adjunct in the diagnosis of ischaemic heart disease infarction.

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

luminarie pty ltd - vinorelbine tartrate, quantity: 41.55 mg (equivalent: vinorelbine, qty 30 mg) - capsule, soft - excipient ingredients: gelatin; partially dehydrated liquid sorbitol; polysorbate 80; macrogol 400; titanium dioxide; purified water; iron oxide red - non-small cell lung cancer: velabine is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. ,breast cancer: velabine is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

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

luminarie pty ltd - vinorelbine tartrate, quantity: 27.7 mg (equivalent: vinorelbine, qty 20 mg) - capsule, soft - excipient ingredients: purified water; polysorbate 80; iron oxide yellow; gelatin; titanium dioxide; macrogol 400; partially dehydrated liquid sorbitol - non-small cell lung cancer: velabine is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. ,breast cancer: velabine is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

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

luminarie pty ltd - vinorelbine tartrate, quantity: 110.8 mg (equivalent: vinorelbine, qty 80 mg) - capsule, soft - excipient ingredients: iron oxide yellow; macrogol 400; polysorbate 80; gelatin; purified water; titanium dioxide; partially dehydrated liquid sorbitol - non-small cell lung cancer: velabine is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. ,breast cancer: velabine is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - acalabrutinib - capsules - acalabrutinib 100 mg - mantle cell lymphomacalquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.chronic lymphocytic leukemia or small lymphocytic lymphomacalquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll)or small lymphocytic lymphoma (sll).

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

ge healthcare australia pty ltd - tetrofosmin; stannous chloride dihydrate -

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

medi-physics inc. dba ge healthcare - tetrofosmin (unii: 3j0kpb596q) (tetrofosmin - unii:3j0kpb596q) - tetrofosmin 1.38 mg - myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. myoview is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. none. risk summary there are no data with technetium tc99m tetrafosmin use in pregnant women to inform any drug associated risks. animal reproduction studies with technetium tc99m tetrofosmin have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc99m tetrafosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. risk summary technetium tc99m tetrofosmin is present in human milk in small amounts (<1% of maternal dose). there are no data available regarding the effects of technetium tc99m tetrofosmin on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for myoview and any potential adverse effects on the breastfed child from myoview or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 60 hours (10 half-lives) after technetium tc99m tetrofosmin administration. safety and effectiveness in pediatric patients have not been established. of 2,300 subjects in clinical studies of myoview, 1,053 (46%) were 65 or older and 270 (12%) were 75 or older. no overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.