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

global medical solutions australia pty limited - gallium (67ga) citrate, quantity: 74 mbq/ml - injection, solution - excipient ingredients: benzyl alcohol; hydrochloric acid; sodium hydroxide; sodium citrate dihydrate; sodium chloride; water for injections - indications as at 23 december 2003: gallium citrate ga67 injection, u.s.p. may be useful in demonstrating the presence of the following malignancies; hodgkins disease, lymphomas and bronchogenic carcinoma. positive ga67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.

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

uihc – p e t imaging center - edotreotide gallium ga-68 (unii: y68179sy2l) (edotreotide gallium ga-68 - unii:y68179sy2l) - ga 68 dotatoc injection is indicated for use with positron emission tomography (pet) for the localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult and pediatric patients. none risk summary there are no available data on the use of ga 68 dotatoc injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with ga 68 dotatoc. however, all radiopharmaceuticals, including ga 68 dotatoc injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering ga 68 dotatoc injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from ga 68 dotatoc injection and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregn

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

ncs healthcare of ky, inc dba vangard labs - 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 hydrochloride tablets are 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. 1. recurrent ventricular fibrillation. 2. 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 hydrochloride tablets 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 ambul

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

cardinal health - 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 hydrochloride tablets are 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. 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 and electrophysiologic techniques. because of the life-threatening nature of

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

american health packaging - 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 con

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

physicians total care, inc. - 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)

state of florida doh central pharmacy - 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)

rebel distributors corp - 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)

cardinal health - 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. 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 and electrophysiologic techniques. because of the life-threatening nature of the arrhy

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

taro pharmaceuticals u.s.a., inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 100 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 ventric