Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3950
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ProHance (Injection, Solution)
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Central Nervous System: ADULTS: The recommended dose of ProHance (Gadoteridol) Injection is 0.1 mmol/kg
(0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (>60 mL/min). In patients suspected of having poorly enhancing lesions, in the presence of negative or equivocal scans, a second dose of 0.2 mmol/kg (0.4 mL/kg) may be given up to 30 minutes after the first dose. CHILDREN (2-18 years): The recommended dose of ProHance is 0.1 mmol/kg
(0.2 mL/kg) administered as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (>60 mL/min). The safety and efficacy of doses>0.1 mmol/kg, and sequential and/or repeat procedures has not been studied.<br/>Extracranial/Extraspinal Tissues: ADULTS: The recommended dose of ProHance is 0.1 mmol/kg (0.2 mL/kg) administered
as a rapid intravenous infusion (10 mL/min-60 mL/min) or bolus (>60 mL/min). CHILDREN: Safety and efficacy for extracranial/extra-spinal tissues has not been
established.Dose adjustments in renal and liver impairment have not been studied. To ensure complete injection of the contrast medium, the injection should be followed by a 5 mL normal saline flush. The imaging procedure should be completed within 1 hour of the first injection of ProHance (Gadoteridol) Injection.
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ProHance (Gadoteridol) Injection is a nonionic contrast medium for magnetic
resonance imaging (MRI), available as a 0.5M sterile clear colorless to slightly yellow
aqueous solution for intravenous injection. Each vial is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device. Gadoteridol is the gadolinium complex of 10-(2-hydroxy-propyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid with a molecular weight of 558.7, an empirical formula of CHNOGd and has the following structural formula: Each mL of ProHance contains 279.3 mg gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection. ProHance contains no antimicrobial preservative.ProHance has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below: ProHance has an osmolality 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.
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Pharmacokinetics: The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two-compartment open model with mean distribution and elimination half-lives (reported as mean��SD) of about 0.20��0.04 hours and 1.57��0.08 hours, respectively. Gadoteridol is eliminated in the urine with 94.4��4.8% (mean��SD) of the dose excreted within 24 hours post-injection. It is unknown if biotransformation or decomposition of gadoteridol occur in vivo. The renal and plasma clearance rates (1.41��0.33 mL/ min/kg and 1.50��0.35 mL/ min/kg, respectively) of gadoteridol are essentially identical, indicating no alteration in elimination kinetics on passage through the kidneys and that the drug is essentially cleared through the kidney. The volume of distribution (204��58 mL/kg) is equal to that of extracellular water, and clearance is similar to that of substances which are subject to glomerular filtration. It is unknown if protein binding of ProHance occurs in vivo.<br/>Pharmacodynamics: Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent. In magnetic resonance imaging (MRI), visualization of normal and pathologic brain tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) differences in proton density; 2) differences of the spin-lattice or longitudinal relaxation times (T1); and 3) differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadoteridol decreases T1 relaxation times in the target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences. Gadoteridol does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that have a normal blood-brain barrier, e.g., cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of gadoteridol in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetics of ProHance in various lesions is not known.
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None known.
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ProHance (Gadoteridol) Injection is a clear, colorless to slightly yellow solution
containing 279.3 mg/mL of gadoteridol in rubber stoppered vials. ProHance is available in boxes of five 50mL Pharmacy Bulk Packages (NDC 0270-1111-70).
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WARNING: NEPHROGENIC SYSTEMIC FIBROSIS: Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with: In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration .
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General: Gadoteridol is cleared from the body by glomerular filtration. The hepato-biliary enteric pathway of excretion has not been demonstrated with ProHance. Dose adjustments in renal or hepatic impairment have not been studied. Therefore, caution should be exercised in patients with either renal or hepatic impairment. In a patient with a history of grand mal seizure, the possibility to induce such a seizure by ProHance is unknown. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic
or cardiovascular reactions, or other idiosyncratic reactions (see ADVERSE
REACTIONS), should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders. Diagnostic procedures that involve the use of contrast agents should be carried out under direction of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. When ProHance (Gadoteridol) Injection is to be injected using nondisposable equipment, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. After ProHance is drawn into a syringe, the solution should be used immediately. Repeat Procedures: Repeated procedures have not been studied. Sequential use during the same diagnostic session has only been studied in central nervous system use. (See Pharmacokinetics under CLINICAL PHARMACOLOGY and Central
Nervous System under DOSAGE AND ADMINISTRATION).<br/>Information for patients:: Patients scheduled to receive ProHance should be instructed to inform their physician
if the patient;
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Clinical consequences of overdose with ProHance have not been reported.
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gadoteridol
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ProHance (Injection, Solution)
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The adverse events described in this section were observed in clinical trials involving 1251 patients (670 males and 581 females). Adult patients ranged in age from 18-91 yrs. Pediatric patients ranged from 2-17 years. The racial breakdown was 83% Caucasian, 8% Black, 3% Hispanic, 2% Asian, and 1% other. In 2% of the patients, race was not reported. The most commonly noted adverse experiences were nausea and taste perversion with an incidence of 1.4%. These events were mild to moderate in severity. The following additional adverse events occurred in fewer than 1% of the patients: The following adverse drug reactions have also been reported:
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Nephrogenic Systemic Fibrosis (NSF): Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate<30 mL/min/1.73m) and in patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced MRI. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium-based contrast agent in order to enhance the contrast agent's elimination. The usefulness of hemodialysis in the prevention of NSF is unknown. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and the degree of renal function impairment at the time of exposure. Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents. These reports have not always identified a specific agent. Where a specific agent was identified, the most commonly reported agent was gadodiamide (Omniscan), followed by gadopentetate dimeglumine (Magnevist) and gadoversetamide (OptiMARK). NSF has also developed following sequential administrations of gadodiamide with gadobenate dimeglumine (MultiHance) or gadoteridol (ProHance). The number of post-marketing reports is subject to change over time and may not reflect the true proportion of cases associated with any specific gadolinium-based contrast agent. The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents. Published reports are limited and predominantly estimate NSF risks with gadodiamide. In one retrospective study of 370 patients with severe renal insufficiency who received gadodiamide, the estimated risk for development of NSF was 4% (J Am Soc Nephrol 2006;17:2359). The risk, if any, for the development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent prior to any readministration. . Deoxygenated sickle erythrocytes have been shown in in vitro studies to align perpendicular to a magnetic field which may result in vaso-occlusive complications in vivo. The enhancement of magnetic moment by ProHance may possibly potentiate sickle erythrocyte alignment. ProHance in patients with sickle cell anemia and other hemoglobinopathies has not been studied. Patients with other hemolytic anemias have not been adequately evaluated following administration of ProHance to exclude the possibility of increased hemolysis. Patients with a history of allergy, drug reactions or other hypersensitivity-like disorders should be closely observed during the procedure and for several hours after drug administration. .
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Central Nervous System: ProHance (Gadoteridol) Injection is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.<br/>Extracranial/Extraspinal Tissues: ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.
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ProHance
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