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

curium us llc - gallium chloride ga-67 (unii: a04b19o2b0) (gallium cation ga-67 - unii:99t03j52w0) - gallium cation ga-67 2 mci in 1 ml - gallium citrate ga 67 injection may be useful to demonstrate the presence and extent of hodgkin's disease, lymphoma, and bronchogenic carcinoma. positive gallium ga-67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. gallium citrate ga 67 injection may be useful as an aid in detecting some acute inflammatory lesions. none.

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

lantheus medical imaging, inc. - gallium citrate ga-67 (unii: 4ljk511z86) (gallium cation ga-67 - unii:99t03j52w0) - gallium cation ga-67 2.0 mci in 1 ml - gallium citrate ga 67 injection may be useful in demonstrating the presence of the following malignancies: hodgkins disease, lymphomas and bronchogenic carcinoma. positive ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. gallium citrate ga 67 injection may be useful as an aid in detecting some acute inflammatory lesions. none known.

Israel - English - Ministry of Health

isorad ltd, israel - gallium (67ga) citrate; sodium citrate - solution for injection - gallium (67ga) citrate 1.5 - 2 mci; sodium citrate 1.5 - 2 mg - gallium (67ga) citrate - gallium (67ga) citrate - inflammatory lesions and abscesses. primary and metastatic tumors hodgkin's disease. lymphomas and brochogenic carcinoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

curium netherlands b.v. - gallium (67 ga) citrate - solution for injection - 37 megabecquerel(s)/millilitre - other diagnostic radiopharmaceuticals for inflammation and infection detection; gallium (67ga) citrate

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

a-s medication solutions - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see warnings below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. - recurrent ventricular fibrillation. - recurrent hemodynamically unstable ventricular tachycardia. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring

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

ucsf radiopharmaceutical facility - gallium ga-68 gozetotide (unii: zj0ekr6m10) (gallium ga-68 gozetotide - unii:zj0ekr6m10) - gallium ga 68 gozeotide injection is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer: - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. none risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there are no available data with gallium ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. all radiopharmaceuticals, including gallium ga 68 gozetotide injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide injection. risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there ar

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

a-s medication solutions - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations) . in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo- fetal toxicity at doses less than the maximum recommended human maintenance dose (see data) . advise pregnant women of the potential risk to a 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. clinical considerations disease-associated maternal and or embryo/fetal risk the incidence of ventricular tachycardia is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may therefore, increase during pregnancy due to the increased propensity to ectopic activity. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions amiodarone and its metabolite have been shown to cross the placenta. adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, qt prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal  growth restriction, and premature birth. monitor the newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias. labor and delivery risk of arrhythmias may increase during labor and delivery. patients treated with amiodarone hydrochloride should be monitored continuously during labor and delivery [see warnings and precautions (5.4)] . data animal data in pregnant rats and rabbits during the period of organogenesis, amiodarone hydrochloride in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose*) had no adverse effects on the fetus. in the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose*) caused abortions in greater than 90% of the animals. in the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption. (these doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recommended human maintenance dose*) adverse effects on fetal growth and survival also were noted in one of two strains of mice at a dose of 5 mg/kg/day (approximately 0.04 times the maximum recommended human maintenance dose*). *600 mg in a 60 kg patient (doses compared on a body surface area basis) risk summary amiodarone and one of its major metabolites, dea, are present in breastmilk at between 3.5% and 45% of the maternal weight- adjusted dosage of amiodarone. there are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk. breastfeeding is not recommended during treatment with amiodarone hydrochloride [see warnings and precautions (5.6, 5.7)]. infertility based on animal fertility studies, amiodarone hydrochloride may reduce female and male fertility. it is not known if this effect is reversible. [see nonclinical toxicology (13.1)]. the safety and effectiveness of amiodarone hydrochloride in pediatric patients have not been established. normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see clinical pharmacology (12.3)] . in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

australian nuclear science and technology organisation t/a ansto - gallium (67ga) citrate, quantity: 100 mbq/ml - injection, solution - excipient ingredients: benzyl alcohol; sodium hydroxide; sodium citrate dihydrate; water for injections - (as per r46108) gallium (67ga) citrate injection bp may be useful in demonstrating the presence and extent of hodgkin's disease, lymphomas and bronchogenic carcinoma. positive intake in the absence of prior symptoms may indicate a potential disease state. new indications as specified in the letter of 18 october 1993 from dr alex proudfoot: gallium (67ga) citrate injection bp may be useful in demonstrating the presence and extent of hodgkin's disease, lymphomas and bronchogenic carcinoma. positive uptake in the absence of prior symptoms may indicate a potential disease state. gallium (67ga) may also be useful as an aid in detecting some acute inflammatory lesions. gallium (67ga) citrate injection bp may also be useful as an aid in detecting some acute inflammatory lesions. (as per r46110) gallium (67ga) citrate injection bp may be useful in demonstrating the presence and extent of hodgkin's disease, lymphomas and bronchogenic carcinoma. positive uptake in the absence of prior symptoms may indicate a potent

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

ucla biomedical cyclotron - gallium ga-68 gozetotide (unii: zj0ekr6m10) (gallium ga-68 gozetotide - unii:zj0ekr6m10) - gallium ga 68 gozetotide injection is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer: - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. none risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there are no available data with gallium ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. all radiopharmaceuticals, including gallium ga 68 gozetotide injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide. risk summary gallium ga 68 gozetotide injection is not indicated for use in females. there are no data

Canada - English - Health Canada

curium canada inc - gallium citrate ga 67 - solution - 74mbq - gallium citrate ga 67 74mbq - roentgenography