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Medizinisch geprüft von Kovalenko Svetlana Olegovna, Apotheke Zuletzt aktualisiert am 01.04.2022
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Intra-arteriell *
Йодиксанол Injection (270 mg I / ml) ist für die intraarterielle digitale Subtraktionsangiographie angezeigt.
Йодиксанол Injection (320 mg I / ml) ist für die Angiocardiographie (linke Ventrikulographie und selektive Koronararteriographie), periphere Arteriographie, viszerale Arteriographie und zerebrale Arteriographie indiziert.
Intravenös *
Die Йодиксанол-Injektion (270 mg I / ml) ist für die CECT-Bildgebung von Kopf und Körper, die ausgeschiedene Urographie und die periphere Venographie angezeigt.
Die Йодиксанол-Injektion (320 mg I / ml) ist für die CECT-Bildgebung von Kopf und Körper sowie für die ausgeschiedene Urographie angezeigt.
* Informationen zu den Konzentrationen und Dosen für die pädiatrische Bevölkerung finden Sie unter VORSICHTSMASSNAHMEN - Pädiatrische Anwendung, KLINISCHE PHARMAKOLOGIE- Spezielle Populationen, und DOSIERUNG UND VERWALTUNG Abschnitte.
Zur pädiatrischen Dosierung siehe das Ende davon Sektion.
Allgemeines
Die Kombination aus Volumen und Konzentration der zu verwendenden Йодиксанол-Injektion sollte individualisiert werden, wobei Faktoren wie Alter, Körpergewicht, Größe des Gefäßes und Blutflussrate innerhalb des Gefäßes zu berücksichtigen sind. Spezifische Dosisanpassungsstudien zu Alter, Geschlecht, Gewicht und Nierenfunktion wurden mit Йодиксанол nicht durchgeführt. Wie bei anderen jodierten Kontrastmitteln können niedrigere Dosen ein geringeres Risiko aufweisen. Die Wirksamkeit der Йодиксанол-Injektion unter den empfohlenen Dosen wurde nicht nachgewiesen. Andere Faktoren wie die erwartete Pathologie, der Grad und das Ausmaß der erforderlichen Trübung, die zu untersuchende Struktur (en) oder der zu untersuchende Bereich, die vom Patienten betroffenen Krankheitsprozesse sowie die anzuwendende Ausrüstung und Technik sollten berücksichtigt werden.
Die empfohlene Höchstdosis Jod beträgt 80 Gramm.
Wenn während der Injektion eine Nebenwirkung auftritt, sollten Sie die Injektion sofort abbrechen, wenn dies aufgrund der Art und Schwere des Ereignisses gerechtfertigt ist.
Die Patienten sollten vor und nach der intravaskulären Verabreichung von jodierten Kontrastmitteln ausreichend hydratisiert sein (siehe WARNHINWEISE) und VORSICHTSMASSNAHMEN).
Intra-Arterielle Verabreichung
Йодиксанол 320 mgI / ml wird für die intraarterielle Injektion bei der radiologischen Kontrastbewertung von arteriellen Läsionen des Gehirns, der Koronarararterien und des linken Ventrikels sowie für die intraarterielle Injektion bei der radiologischen Kontrastbewertung peripherer Arterien empfohlen. Йодиксанол wird auch für die intraarterielle digitale Subtraktionsangiographie empfohlen, wie in der nachstehenden Dosierungskarte angegeben.
Die Injektionsraten sollten ungefähr der Durchflussrate in dem injizierten Gefäß entsprechen. Das erforderliche Volumen hängt von der Größe, der Durchflussrate und dem Krankheitszustand des injizierten Gefäßes, von der Größe und dem Zustand des Patienten sowie von der verwendeten Bildgebungstechnik ab. Die üblichen Einzelinjektionsvolumina oder die Gesamtdosis pro Patient (ml / kg) für Erwachsene und Jugendliche über 12 Jahre sind in den folgenden Tabellen aufgeführt.
ERWACHSENE und ERWÄLTE ÜBER 12 JAHRE MITTELGEBRAUCHS EINZELN FÜR DIE INJEKTION IN AUSGEWÄHLTE ARTERIEN
Intraarterielle Injektionsstellen | ARTERIOGRAPHIE | IA-DSA * | Maximale Gesamtdosis | |
320 mgI / ml | 270 mgI / ml | 320 mgI / ml | ||
Karotisarterien | 10 - 14 ml | 5 - 8 ml | ||
Wirbelarterien | 10 - 12 ml | 5 - 8 ml | Normalerweise 175 ml nicht überschreiten | |
Rechte Koronararterie | 3 - 8 ml | Normalerweise 200 ml nicht überschreiten | ||
Linke Koronararterie | 3 - 10 ml | |||
Linker Ventrikel | 20 - 45 ml | |||
Nierenarterien | 8 - 18 ml | 10 - 25 ml | - | Normalerweise 250 ml nicht überschreiten |
Aortographie | 30 - 70 ml | 20 - 50 ml | 10 - 50 ml | |
Hauptzweige von Aorta | 10 - 70 ml | 5 - 30 ml | 2 - 10 ml | |
Aortofemoral Runoffs | 20 - 90 ml | - | 6 - 15 ml | |
Periphere Arterien | 15 - 30 ml | - | 3 - 15 ml | |
* IA-DSA = Intra-Arterielle digitale Subtraktionsangiographie |
Intravenöse Verabreichung
Kontrastverstärkte Computertomographie (CECT)
Die intravenöse Verabreichung von Йодиксанол Injection (270 mg I / ml und 320 mg I / ml) wird zur Kontrastverbesserung bei der Bewertung neoplastischer und nichtneoplastischer Läsionen von Kopf und Körper (intrathorakale, intraabdominale und retroperitoneale Regionen), Bewertungen der Nierenfunktion, empfohlen und Bewertungen des peripheren Venensystems. Ausgewählte Dosierungen für verschiedene Indikationen bei Erwachsenen und pädiatrischen Patienten sind in den folgenden Tabellen aufgeführt.
ERWACHSENE und ERWÄLTE ÜBER 12 JAHRE ALTER GEBRAUCHSÜNDIGKEIT Йодиксанол DOSIERUNG FÜR INTRAVENOUS CONTRAST ADMINISTRATION
Studientyp | Kommentar | 270 mgI / ml | 320 mgI / ml | Maximales Gesamtvolumen |
CECT des Kopfes oder Körpers | Bolus-Infusion | 75 - 150 ml 100 - 150 ml | 75 - 150 ml 100 - 150 ml | 150 ml |
Ausscheidungsumschlag | Normale Nierenfunktion | 1 ml / kg | 1 ml / kg | 100 ml |
Venographie | Pro unterer Extremität | 50 - 150 ml | 250 ml |
Pädiatrische Dosierung
Die empfohlene Dosis bei Kindern über 1 Jahr zur Bewertung von:
Intraarterielle Verabreichung für Zerebral-, Herzkammern und verwandte Hauptarterien sowie Viszeral Studies:
Йодиксанол 320 mgI / ml als 1 bis 2 ml / kg. Die empfohlene Gesamtdosis von Йодиксанол sollte 4 ml / kg nicht überschreiten.
Intravenöse Verabreichung für kontrastverbesserte computergestützte Tomographie oder expretorive Urographie:
Йодиксанол 270 mgI / ml als 1 bis 2 ml / kg. Die empfohlene Gesamtdosis von Йодиксанол sollte 2 ml / kg nicht überschreiten.
Die Sicherheits- und Wirksamkeitsbeziehungen anderer Dosen, Konzentrationen oder Verfahren wurden nicht festgelegt. (Sehen KLINISCHE PHARMAKOLOGIE - Spezielle Populationen, und VORSICHTSMASSNAHMEN - Pädiatrische Anwendung Abschnitte.)
Die maximale Gesamtdosis von Jod in der pädiatrischen Bevölkerung wurde nicht festgelegt.
Drogenhandel
Wie bei allen Kontrastmitteln sollte Йодиксанол Injection aufgrund des Potenzials für chemische Inkompatibilität nicht mit intravenösen Verabreichungslinien gemischt oder injiziert werden, die andere Arzneimittel, Lösungen oder vollständige Nährstoffeinreichungen enthalten.
Die sterile Technik muss bei allen Verfahren angewendet werden, bei denen Kontrastmittel mit Gefäßinjektionen injiziert werden. Йодиксанол Die Injektion kann sowohl bei Körpertemperatur als auch bei Raumtemperatur verabreicht werden. Wenn nicht wegwerfbare Geräte verwendet werden, sollte sorgfältig darauf geachtet werden, eine Restkontamination mit Spuren von Reinigungsmitteln zu verhindern.
Das Entnehmen von Kontrastmitteln aus ihren Behältern sollte unter strengen aseptischen Bedingungen nur mit sterilen Spritzen und Transfervorrichtungen erfolgen. Kontrastmittel, die in andere Liefersysteme übertragen wurden, sollten sofort verwendet werden.
Parenterale Produkte sollten vor der Verabreichung visuell auf Partikel und Verfärbungen untersucht und nicht angewendet werden, wenn Partikel beobachtet werden oder eine deutliche Verfärbung aufgetreten ist.
Йодиксанол Injection ist für die intrathekale Anwendung nicht angezeigt.
In der pädiatrischen Bevölkerung sind längeres Fasten und die Verabreichung eines Abführmittels vor der Injektion von Йодиксанол kontraindiziert.
WARNINGS
Serious Adverse Events-Inadvertent Intrathecal Administration
Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.
Nonionic, iodinated contrast media inhibit blood coagulation in vitro less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiocardiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications, may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended, including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions, and minimizing the length of the procedure. Serious or rare fatal reactions have been associated with the administration of iodine-containing radiopaque media. It is of utmost importance to be completely prepared to treat any reaction associated with the use of any contrast agent.
Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. (See PRECAUTIONS.) Intravascularly administered iodine-containing radiopaque media are potentially hazardous in patients with multiple myeloma or other paraproteinaceous diseases, who are prone to disease induced renal insufficiency and/or renal failure. Although neither the contrast agent nor dehydration has been proven to be the cause of renal insufficiency (or worsening renal insufficiency) in myelomatous patients, it has been speculated that the combination of both may be causative. Special precautions, including maintenance of normal hydration and close monitoring, are required. Partial dehydration in the preparation of these patients is not recommended since it may predispose the patient to precipitation of the myeloma protein. Reports of thyroid storm following the intravascular use of iodinated radiopaque contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of any contrast agent. Administration of radiopaque materials to patients known to have, or suspected of having, pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure, and measures for the treatment of hypertensive crisis should be readily available. These patients should be monitored very closely during contrast-enhanced procedures.
Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when the agents are administered intravascularly.
PRECAUTIONS
General
CONTRAST AGENTS ARE ASSOCIATED WITH RISK AND INCREASED RADIATION EXPOSURE, AND THE DECISION TO USE ENHANCEMENT SHOULD BE BASED UPON A CAREFUL EVALUATION OF CLINICAL, OTHER RADIOLOGIC DATA, AND THE RESULTS OF UNENHANCED CT FINDINGS.
Patients receiving contrast agents, and especially those who are medically unstable, must be closely supervised. Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all types should always be available.
Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes.
Pediatrics
Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL.
Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to prolonged elimination of iodinated contrast agents.
The injection rates in small vascular beds, and the relationship of the administered volume or concentration of iodinated contrast agents in small neonates, infants and small pediatric patients, have not been established. Caution should be exercised in selecting the volume.
Dehydration, Renal Insufficiency, Congestive Heart Failure
Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, congestive heart disease, diabetic patients, and other patients such as those on medications which alter renal function and the elderly with age-related renal impairment. Patients should be adequately hydrated prior to and following intravascular administration of iodinated contrast agent. Dose adjustments in renal impairment have not been studied.
Iodinated contrast agents may cross the blood-brain barrier. In patients where the blood-brain barrier is known or suspected to be disrupted, or in patients with normal blood-brain barrier and associated renal impairment, CAUTION MUST BE EXERCISED IN THE USE OF AN IODINATED CONTRAST AGENT. (See Pharmacodynamics.)
Patients with congestive heart failure receiving concurrent diuretic therapy may have relative intravascular volume depletion, which may affect the renal response to the contrast agent osmotic load. These patients should be observed following the procedure to detect delayed hemodynamic renal function disturbances.
Immunologic Reactions
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Increased risk is associated with a history of a previous reaction to contrast agent, a known sensitivity to iodine and known allergies (i.e., bronchial asthma, drug, or food allergies), other hypersensitivities, and underlying immune disorders, autoimmunity or immunodeficiencies that predispose to specific or nonspecific mediator release. If during administration there is evidence of an allergy-like reaction, the injection should be discontinued and appropriate treatment initiated.
Skin testing cannot be relied upon to predict severe reactions and may itself be hazardous to the patient. A thorough medical history with emphasis on allergy and hypersensitivity, immune, autoimmune and immunodeficiency disorders, and prior receipt of and response to the injection of any contrast agent may be more accurate than pretesting in predicting potential adverse reactions.
Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. Extreme caution should be exercised in considering the use of iodinated contrast agents in patients with these histories or disorders.
Patients with a history of allergy or drug reaction should be observed for several hours after drug administration.
Anesthesia
General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions have been reported in these patients. It is not clear if this is due to the inability of the patient to identify untoward symptoms or to the hypotensive effect of anesthesia, which can prolong the circulation time and increase the duration of exposure to a contrast agent.
Angiocardiography
In angiographic procedures, the possibility of dislodging plaques, or damaging or perforating the vessel wall with resultant pseudoaneurysms, hemorrhage at puncture site, dissection of coronary artery, etc., should be considered during catheter  anipulations and contrast agent injection. Angiography may be associated with local and distal organ damage, ischemia, thrombosis and organ failure (e.g., brachial plexus palsy, chest pain, myocardial infarction, sinus arrest, hepatorenal function abnormalities, etc.). Test injections to ensure proper catheter placement are suggested. During these procedures, increased thrombosis and activation of the complement system has also occurred. (See WARNINGS.)
Angiocardiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism. (See Pharmacodynamics.) In an uncontrolled study of 204 patients who received Йодиксанол Injection and who had cardiovascular disease associated with either Class II-IV congestive failure, angina, recent myocardial infarction, left ventricular ejection fraction of < 35% or valvular disease, the patients were evaluated for the types of interventions needed for treatment of adverse events. The reported type and frequency of adverse events were comparable to those in all clinical intraarteriographic studies. Of 204 patients, 63 (31%) of patients had 99 adverse events. Of the 99 events, 68 (68%) required medical intervention of some type. Patients with 17 (17%) of these adverse events required treatment with cardioversion, multiple medications, prolonged hospitalization or intensive care. These interventions were not compared to a control group of similar patients who did not have coronary arteriography.
Selective coronary arteriography should be performed only in patients for whom the expected benefits outweigh the procedural risk. Also, the inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure.
Venography
In addition to the general precautions previously described, special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection, venous thrombosis or a totally obstructed venous system. Extreme caution during injection of a contrast agent is necessary to avoid extravasation. This is especially important in patients with severe arterial or venous disease.
General Adverse Reactions With Contrast Agents
The following adverse reactions are possible with any parenterally administered iodinated contrast agent. Severe life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Most deaths occur during injection or five to ten minutes later, the main feature being cardiac arrest, with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. Based upon clinical literature reported deaths from the administration of other iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%).
The reported incidence of adverse reactions to contrast agents in patients with a history of allergy is twice that of the general population. Patients with a history of a previous reaction to a contrast agent are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.
Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.
Adverse reactions to injectable contrast agents fall into two categories: chemotoxic reactions and idiosyncratic reactions. Chemotoxic reactions result from the physicochemical properties of the contrast agent, the dose and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast agent are included in this category.
Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening, and treatment is urgent and mandatory.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term animal studies have not been performed with iodixanol to evaluate carcinogenic potential. Iodixanol was not genotoxic in a series of studies including the Ames test, the CHO/HGPRT assay, a chromosome aberration assay in CHO cells, and a mouse micronucleus assay. Iodixanol did not impair the fertility of male or female rats when administered at doses up to 2.0 gI/kg (1.3 times the maximum recommended dose for a 50 kg human, or approximately 0.2 times the maximum recommended dose for a 50 kg human following normalization of the data to body surface area estimates).
Pregnancy
Teratogenic Effects - Pregnancy Category B
Reproduction studies performed in rats and rabbits at doses up to 2.0 gI/kg [1.3 times the maximum recommended dose for a 50 kg human, or approximately 0.2 (rat) and 0.4 (rabbit) times the maximum recommended dose for a 50 kg human following normalization of the data to body surface estimates] have not revealed evidence of impaired fertility or harm to the fetus due to iodixanol. Adequate and well-controlled studies in pregnant women have not been conducted. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether Йодиксанол Injection is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast agents are administered to nursing women because of the potential for adverse reactions, and consideration should be given to temporarily discontinue nursing.
Pediatric Use
The safety and efficacy of Йодиксанол has been established in the pediatric population over 1 year of age for arterial studies and for intravenous procedures. Use of Йодиксанол in these age groups is supported by evidence from adequate and well controlled studies of Йодиксанол in adults and additional safety data obtained in pediatric studies. Although Йодиксанол has been administered to pediatric patients less than 1 year of age, the relative safety of the volumes injected, the optimal concentrations, and the potential need for dose adjustment because of prolonged elimination half-lives have not been systematically studied. (See CLINICAL PHARMACOLOGY – Special Populations section).
Йодиксанол (iodixanol) Injection was administered to 459 pediatric patients. There were 26 patients administered Йодиксанол Injection in the birth to < 29 day age range, 148 from 29 days to 2 years, 263 from 2 to < 12 years, and 22 from 12 to 18 years. The mean age was 4.4 years (range < 1 day to 17.4 years). Of the 459 patients, 252 (55%) were male and 207 (45%) were female. The racial distribution was: Caucasian-81%, Black-14%, Oriental-2%, and other or unknown-4%. The demographic information for the pool of patients who received a comparison contrast agent was similar.
In pediatric patients who received intravenous injection for computerized tomography or excretory urography, a concentration of 270 mgI/mL was used in 144 patients, and a concentration of 320 mgI/mL in 154 patients. All patients received one intravenous injection of 1-2 mL/kg.
In pediatric patients who received intra-arterial and intracardiac studies, a concentration of 320 mgI/mL was used in 161 patients. Of the 161 patients in the intra-arterial studies, the mean age was 2.6 years. Twenty-two patients were < 29 days of age; 78 were 29 days to 2 years of age; and 61 were over 2 years. Most of these pediatric patients received initial volumes of 1-2 mL/kg and most patients had a maximum of 3 injections.
Optimal volumes, concentrations or injection rates of Йодиксанол have not been established because different injection volumes, concentrations, and injection rates were not studied. The relationship of the volume of injection with respect to the size of the target vascular bed has not been established. The potential need for dose adjustment to maximize efficacy of computerized tomography, or to minimize the toxicity to other immature body tissues, has not been studied in neonates or infants with immature renal function.
In the above patients, adverse events were associated with decreasing age and intra-arterial procedures. In general the type of adverse events reported are similar to those of adults. Although the frequency of events appears to be comparable, the percentages cannot be confirmed because of the different ability of pediatric and adult patients to report adverse events.
ADVERSE EVENTS REPORTED IN PEDIATRIC PATIENTS WHO RECEIVED Йодиксанол (BY AGE, ROUTE OF ADMINISTRATION, AND CONCENTRATION OF IODINE)
Age Range | Number of Patients with Adverse Events | |
< 29 days | 8/24 (33%) | P < 0.05 between the < 29 day and 1-2 year patient groups. |
> 29 days - 6 months | 9/43 (20%) | |
> 6 months - 12 months | 26/91 (28%) | |
1 year - 2 year | 8/49 (17%) | |
> 2 years | 40/263 (15%) | |
Intra-arterial injections | 42/161 (26%) | P < 0.05 |
Intravenous injections | 32/298 (10%) | |
270 mgI/mL | 11/144 (8%) | P < 0.05 |
320 mgI/mL | 53/315 (17%) |
(For additional information see the CLINICAL PHARMACOLOGY – Special Populations, and DOSAGE AND ADMINISTRATION sections.)
Geriatric Use
Of the total number of patients in clinical studies of Йодиксанол in the U.S., 254/757 (34%) were 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse Events
Йодиксанол (iodixanol) Injection was administered to 1244 patients. The comparators administered to 861 patients included low osmolar nonionic, and high and low osmolar ionic contrast media. For complete demographics, see Clinical Trials section. Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including Йодиксанол Injection. In clinical trials, 3/1244 patients given Йодиксанол Injection and 1/861 patients given a comparator died within 5 days or later after drug administration. Also, 7/1244 patients given Йодиксанол Injection and 8/861 given a comparator had serious adverse events.
Rare reports of anaphylaxis have been documented during postmarket surveillance. As with other contrast agents, Йодиксанол is often associated with sensations of discomfort, warmth or pain. In a subgroup of 1259 patients, for whom data are available; similar percentages of patients (30%) who received Йодиксанол or a comparator had application site discomfort, pain, warmth or cold. Йодиксанол had a trend toward fewer patient reports of moderate or severe pain or warmth; however, whether or not this related to the dose, rate of administration, site of injection or concentration has not been determined.
The following table of incidence of events is based upon blinded, controlled clinical trials with Йодиксанол Injection in controlled clinical studies in which Йодиксанол (1244 patients) was compared with low osmolar nonionic (iohexol, iopromide), a low osmolar ionic (ioxaglate), and a high osmolar ionic (diatrizoate) contrast agents. This listing includes all reported adverse events regardless of attribution. Adverse events (AEs) are listed by body system and in decreasing order of occurrence greater than 0.5% in the Йодиксанол group.
As the table shows, one or more adverse events were recorded in 248 of 1244 (20%) patients during the clinical trials, with the administration of Йодиксанол Injection or within the defined duration of the study follow-up period (24 to 72 hours). In intravenous and intra-arterial procedures, the incidence and type adverse reaction was similar to those of the studied nonionic comparators (iohexol). In a 757 patient subgroup for which data are available, women reported more adverse events 83/299 (27.8%) than men 77/458 (16.2%). Women reported more chest pain (9/299 or 3%) than men (4/458 or 0.8%).
EACH ADVERSE EVENT REPORTED IN CONTROLLED CLINICAL TRIALS IN GREATER THAN 0.5% OF THE ADULT Йодиксанол INJECTION PATIENTS
NUMBER OF PATIENTS EXPOSED | Йодиксанол N=1244 | Pooled Comparators N=861 | |
Number of Patients With Any Adverse Event | 248 (19.9%) | 194 (22.5%) | |
Body As a Whole | Patients With Any Event | 41 (3.3%) | 22 (2.6%) |
Edema (any location) | 7 (0.6%) | 0 (0%) | |
Cardiovascular | Patients With Any Event | 37 (3.0%) | 39 (4.5%) |
Angina Pectoris/Chest Pain | 28 (2.2%) | 22 (2.6%) | |
Gastrointestinal | Patients With Any Event | 51 (4.1%) | 46 (5.3%) |
Diarrhea | 7 (0.6%) | 6 (0.7%) | |
Nausea | 35 (2.8%) | 32 (3.7%) | |
Vomiting | 10 (0.8%) | 11 (1.3%) | |
Nervous System | Patients With Any Event | 101 (8.1%) | 60 (7.0%) |
Agitation, Anxiety, Insomnia, Nervousness | 10 (0.8%) | 0 (0%) | |
Dizziness | 8 (0.7%) | 8 (0.9%) | |
Headache/Migraine | 31 (2.5%) | 15 (1.7%) | |
Paresthesia | 12 (1.0%) | 1 (0.1%) | |
Sensory Disturbance | 10 (0.8%) | 9 (1.0%) | |
Syncope | 8 (0.6%) | 1 (0.1%) | |
Vertigo | 30 (2.4%) | 20 (2.3%) | |
Skin | Patients With Any Eventa | 42 (4.6%) | 18 (2.1%) |
Nonurticarial Rash or Erythema | 26 (2.1%) | 4 (0.5%) | |
Pruritus | 20 (1.6%) | 3 (0.3%) | |
Urticaria | 6 (0.5%) | 10 (1.2%) | |
Special Senses | Patients With Any Event | 57 (4.6%) | 38 (4.4%) |
Parosmia | 6 (0.5%) | 4 (0.5%) | |
Taste Perversion | 43 (3.5%) | 32 (3.7%) | |
Scotoma | 14 (1.1%) | 2 (0.2%) | |
a Does not include application site. |
The following selected adverse events were reported in ≤ 0.5% of the 1244 patients in controlled clinical trials who received Йодиксанол Injection.
Body as a Whole—General Disorders: back pain, fatigue, malaise.
Cardiovascular Disorders: arrhythmias, cardiac failure, conduction abnormalities, hypotension, myocardial infarction.
Nervous System: cerebral vascular disorder, convulsions, hypoesthesia, stupor, confusion.
Gastrointestinal System Disorders: dyspepsia.
Hypersensitivity Disorders: pharyngeal edema.
Respiratory System Disorders: asthma, bronchitis, dyspnea, pulmonary edema, rhinitis.
Renal System Disorders: abnormal renal function, acute renal failure, hematuria.
Peripheral Vascular Disorders: flushing, peripheral ischemia.
Skin and Appendage Disorders: hematoma, increased sweating.
Special Senses, Other Disorders: tinnitus.
Vision Disorders: abnormal vision.
Additional adverse events reported in other clinical studies and in foreign postmarketing surveillance and foreign clinical trials with the use of Йодиксанол Injection are: anaphylactic reactions, anaphylactoid reactions, hypoglycemia, amnesia, cardiac arrest, hypertension, dyskinesia, hemorrhage not otherwise specified, polymyalgia rheumatica, pulmonary embolism, respiratory depression, and cortical blindness.
Pediatrics
For demographics, see Pediatric Use section.
The overall character, quality, and severity of adverse reactions in pediatric patients is similar to that reported in adult populations from domestic and foreign postmarketing surveillance and other information. Selected commonly reported adverse events in pediatrics include: vomiting, nausea, fever, rash, and pruritus. Less frequently reported events are apnea, disseminated intravascular coagulation, atrioventricular block and bundle branch block, arrhythmia, cardiac failure, renal failure and taste perversion.
Die nachteiligen Auswirkungen einer Überdosierung eines Kontrastmittels können lebensbedrohlich sein und hauptsächlich das Lungen- und Herz-Kreislauf-System betreffen. Die Behandlung einer Überdosierung zielt auf die Unterstützung aller lebenswichtigen Funktionen und die sofortige Einleitung einer symptomatischen Therapie ab. Йодиксанол Injection bindet nicht an Plasma oder Serumprotein und kann dialysiert werden.
Verteilung
In einem in vitro Humanplasmastudie, Iodixanol, band nicht an Protein. Das Verteilungsvolumen betrug 0,26 l / kg Körpergewicht, was mit der Verteilung auf den extrazellulären Raum übereinstimmt.
Stoffwechsel
Iodixanol-Metaboliten wurden nicht nachgewiesen.
Ausscheidung
Plasma- und Urinspiegel legen nahe, dass die Körperclearance von Iodixanol hauptsächlich auf die renale Clearance zurückzuführen ist. Bei Erwachsenen werden ungefähr 97% der injizierten Dosis von Iodixanol innerhalb von 24 Stunden unverändert im Urin ausgeschieden, wobei weniger als 2% innerhalb von fünf Tagen nach der Injektion in den Kot ausgeschieden werden. Bei 40 gesunden jungen männlichen Freiwilligen, die eine einmalige intravenöse Verabreichung von Йодиксанол Injection in Dosen von 0,3 bis 1,2 gI / k Körpergewicht erhielten, betrug die Eliminationshalbwertszeit 2,1 h (± 0,1); und die renale Clearance betrug 110 ml / min (± 14), entsprechend der glomerulären Filtration l (10). Diese Werte waren unabhängig von der verabreichten Dosis.