Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3271
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Magnevist (Injection)
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| dailymed-instance:dosage |
The recommended dosage of MAGNEVIST Injection is 0.2 mL/kg (0.1 mmol/ kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.<br/>Drug Handling:: 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 injection of MAGNEVIST Injection. As with other gadolinium contrast agents, MAGNEVIST Injection has not been established for use in magnetic resonance angiography. Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.
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| dailymed-instance:descripti... |
MAGNEVIST ' (brand of gadopentetate dimeglumine) Injection is the N- methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). MAGNEVIST Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection. MAGNEVIST Injection is a 0.5-mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato-(5-)-]gadolinate(2-)(2:1) with a molecular weight of 938, an empirical formula of CHGdNO, and has the following structural formula: Each mL of MAGNEVIST Injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. MAGNEVIST Injection contains no antimicrobial preservative. MAGNEVIST Injection has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below: PARAMETER Osmolality (mOsmol/ kg water) at 37��C 1,960 Viscosity (CP) at 20��C 4.9 at 37��C 2.9 Density (g/mL) at 25��C 1.195 Specific gravity at 25��C 1.208 Octanol: HO at 25��C and pH7 log P= -5.4 MAGNEVIST Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/ kg water. MAGNEVIST Injection is hypertonic under conditions of use.
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Pharmacokinetics: The pharmacokinetics of intravenously administered gadopentetate dimeglumine in normal subjects conforms to a two compartment open-model with mean distribution and elimination half-lives (reported as mean��SD) of about 0.2��0.13 hours and 1.6��0.13 hours, respectively. Upon injection, the meglumine salt is completely dissociated from the gadopentetate dimeglumine complex. Gadopentetate is exclusively eliminated in the urine with 83��14% (mean��SD) of the dose excreted within 6 hours and 91��13% (mean��SD) by 24 hours, post-injection. There was no detectable biotransformation or decomposition of gadopentetate dimeglumine. The renal and plasma clearance rates (1.76��0.39 mL/min/kg and 1.94��0.28 mL/min/kg, respectively) of gadopentetate 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 (266��43 mL/kg) is equal to that of extracellular water and clearance is similar to that of substances which are subject to glomerular filtration. In vitro laboratory results indicate that gadopentetate does not bind to human plasma protein. In vivo protein binding studies have not been done.<br/>Pharmacodynamics: Gadopentetate dimeglumine is a paramagnetic agent and, as such, it 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 pathological brain tissue depends in part on variations in the radiofrequency signal intensity that occur with 1) changes in proton density; 2) alteration of the spin-lattice or longitudinal relaxation time (T1); and 3) variation of the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadopentetate dimeglumine decreases the T1 and T2 relaxation time in tissues where it accumulates. At usual dosesthe effect is primarily on the T1 relaxation time. Gadopentetate dimeglumine does not cross the intact blood-brain barrier and, therefore, does not accumulate in normal brain or in lesions that do not have an abnormal blood-brain barrier, e. g., cysts, mature post-operative scars, etc. However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of gadopentetate dimeglumine in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of MAGNEVIST in various lesions are not known.
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None.
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| dailymed-instance:supply |
MAGNEVIST Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/ mL of gadopentetate dimeglumine. MAGNEVIST Injection is supplied in the following sizes: 5 mL single-dose vials, rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-05 5 mL single-dose vials (RFID), rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-40 10 mL single-dose vials, rubber stoppered, in individual cartonsBoxes of 20 NDC 50419-188-01 10 mL single-dose vials (RFID), rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-42 10 mL pre-filled disposable syringe,Boxes of 5NDC 50419-188-36 10 mL pre-filled disposable syringe (RFID),Boxes of 5NDC 50419-188-43 15 mL single-dose vials, rubber stoppered, in individual cartons,Boxes of 20NDC 50419-188-15 15 mL single-dose vials (RFID), rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-44 15 mL pre-filled disposable syringe,Boxes of 5 NDC 50419-188-37 15 mL pre-filled disposable syringe (RFID),Boxes of 5NDC 50419-188-45 20 mL single-dose vials, rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-02 20 mL single-dose vials (RFID), rubber stoppered, in individual cartons,Boxes of 20 NDC 50419-188-46 20 mL pre-filled disposable syringe,Boxes of 5NDC 50419-188-38 20 mL pre-filled disposable syringe (RFID),Boxes of 5 NDC 50419-188-47
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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 readminstration .
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| dailymed-instance:overdosag... |
Systemic consequences associated with overdosage of MAGNEVIST Injection have not been reported.
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| dailymed-instance:genericMe... |
Gadopentetate dimeglumine
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| dailymed-instance:fullName |
Magnevist (Injection)
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| dailymed-instance:adverseRe... |
The mean age of the 1272 patients who received MAGNEVIST Injection in clinical trials was 46.4 years (range 2 to 93 years). Of these patients, 55% (700) were male and 45% (572) were female. Of the 1271 patients who received MAGNEVIST Injection and for whom race was reported, 82.1% (1043) were Caucasian, 9.7% (123) were Black, 5.3% (67) were Hispanic, 2.1% (27) were Oriental/ Asian, and 0.9% (11) were other. The most common noted adverse event is headache with an incidence of 4.8%. The majority of headaches are transient and of mild to moderate severity. Nausea is the second most common adverse experience at 2.7%. Injection site coldness/localized coldness is the third most common adverse experience at 2.3%. Dizziness occurred in 1% of the patients. The following additional adverse events occurred in fewer than 1% of the patients: Body as a Whole: Injection site symptoms, namely, pain, localized warmth, and burning sensation; substernal chest pain, back pain, fever, weakness, generalized coldness, generalized warmth, localized edema, tiredness, chest tightness, trembling, shivering, tension in extremities, regional lymphangitis, pelvic pain, and anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms) rarely resulting in death. Cardiovascular: Hypotension, hypertension, arrhythmia, tachycardia, migraine, syncope, vasodilation, pallor, non-specific ECG changes, angina pectoris, death related to myocardial infarction or other undetermined causes, phlebitis, thrombophlebitis, deep vein thrombophlebitis, compartment syndrome requiring surgical intervention. Digestive: Gastrointestinal distress, stomach pain, teeth pain, increased salivation, abdominal pain, vomiting, constipation, diarrhea. Nervous System: Agitation, anxiety, thirst, anorexia, nystagmus, drowsiness, diplopia, stupor, convulsions (including grand mal), paresthesia. Respiratory System: Throat irritation, rhinorrhea, sneezing, dyspnea, wheezing, laryngismus, cough, respiratory complaints. Skin: Rash, sweating, pruritus, urticaria (hives), facial edema, erythema multiforme, epidermal necrolysis, pustules. Special Senses: Tinnitus, conjunctivitis, visual field defect, taste abnormality, dry mouth, lacrimation disorder (tearing), eye irritation, eye pain, ear pain.<br/>OVERDOSAGE: Systemic consequences associated with overdosage of MAGNEVIST Injection have not been reported.
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| dailymed-instance:indicatio... |
Central Nervous System: MAGNEVIST Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. MAGNEVIST Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.<br/>Extracranial/Extraspinal Tissues: MAGNEVIST is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.<br/>Body: MAGNEVIST Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).
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Magnevist
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