Magnevist solution for injection 469.01mg ml 20ml N10
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Active ingredients
Gadopentetic acid
Release form
Solution
Composition
1 ml of solution contains: dimeglumine gadopentetat 469.01 mg (0.5 mmol); osmolality at 37 ° C - 1.96 Osm / kg H2O; viscosity at 20 ° C - 4.9 MPa × s, at 37 ° C - 2.9 MPa × s; density at 20 ° C - 1.21 g / ml, at 37 ° C - 1.195 g / ml; pH 7.0-7.9. Adjuvants: meglumine (corresponds to 196.21 mg of total meglumine) - 0.99 mg, pentetic acid (DTPA) - 0.4 mg, water d / and - 738.5 mg.
Pharmacological effect
Paramagnetic contrast agent for MRI. The contrasting effect is due to the di-N-methylglucamine salt of gadopentetate - a complex of gadolinium with pentetic acid (diethylenetriaminepentaacetic acid - DTPA). When using an appropriate scanning sequence (for example, the T1-weighted spin echo method) to obtain proton magnetic resonance imaging, the gadolinium ion shortens the spin-lattice relaxation time of excited atomic nuclei, which increases the signal intensity and increases the image contrast of certain tissues. Gadopentetic acid dimeglumine salt is practically does not bind to proteins and does not inhibit the activity of enzymes (for example, myocardial Na + -K + -ATP-azu). Magnevist; does not activate the complement system and, therefore, has a very low potential ability to cause anaphylactoid reactions.
Pharmacokinetics
The pharmacokinetics of dimegulmine gadopentetat is similar to the pharmacokinetics of other highly hydrophilic biologically inert compounds (for example, mannitol or inulin). The pharmacokinetics of Magnevist does not depend on the dose. Distribution: After intravenous administration, the compound is rapidly distributed in the extracellular space. In doses of less than 0.25 mmol of dimeglumine gadopentetate / kg body weight (equivalent to 0.5 ml Magnevista / kg) after the rapid distribution phase (lasting several minutes) its concentration in the blood decreases; T1 / 2 90 min. At a dose of 0.1 mmol gadopentetat dimeglumin / kg (equivalent to 0.2 ml Magnevist / kg) after 3 min and 60 min after the introduction of its concentration in the blood plasma is 0.6 mmol and 0.24 mmol, respectively. Magnevist; does not penetrate the intact BBB or the hemato-testicular barrier. A small amount of the drug that penetrates the placental barrier is rapidly excreted from the body of the fetus. Excretion: Gadopentetat dimeglumin is excreted from the body by the kidneys in unchanged form by glomerular filtration.Extrarenal excretion is very insignificant. On average, in 6 hours and 24 hours, the kidneys hatch 83% and 91% of the dose, respectively, with feces less than 1% in 5 days. The renal clearance of dimeglumin gadopentetat in a person with a body surface area of 1.73 m2 is about 120 ml / min. Pharmacokinetics in special clinical situations: In patients with impaired renal function (QC more than 20 ml / min), the active substance is almost completely eliminated by the kidneys; P1 / 2 plasma increases in proportion to the degree of renal impairment; but an increase in extrarenal discharge is not observed. If in patients with severe renal insufficiency (CC less than 20 ml / min) T1 / 2 is up to 30 hours, then gadopentetate dimeglumin can be removed from the body using extracorporeal hemodialysis.
Indications
To enhance the image contrast when performing MRI of the brain and spinal cord (cranial and spinal MRI): - for the detection of tumors, incl. small and poorly visualized, tumor recurrences after surgery or radiotherapy, metastases; - for differential diagnosis for suspected meningiomas, acoustic neuroma of the auditory nerve, tumors with infiltrative growth in nearby tissues (for example, glioma); - for differential diagnosis of some rare tumors ( hemangioblastoma, ependymoma, small pituitary adenomas); - to improve the imaging of intracranial spread of non-cerebral tumors. Additionally, during spinal MRI: - d For the differential diagnosis of intramedullary and extramedullary tumors; - to determine the size of solid tumors in the spinal cord; - to assess the prevalence of intramedullary tumors. To enhance the contrast of the image during a full-body MRI (including studies of the facial skull, neck, chest and abdomen, mammary glands , pelvic organs, musculoskeletal system and imaging of vessels of the whole body): - for detecting a tumor, inflammation, vascular damage; - for determining Ia incidence and tumor boundaries, inflammation, vascular damages; - structure for the differential diagnosis of pathological changes - for assessing the blood supply of normal and abnormal tissue - for differentialdiagnostics of tumors and cicatricial tissue after therapy; - to detect recurrence of intervertebral disk prolapse after surgical intervention; - for simultaneous semi-quantitative evaluation of function and their visualization.
Contraindications
Hypersensitivity to the drug.
Precautionary measures
With caution should use the drug in patients with allergic reactions in history, asthma, with severe circulatory failure, epilepsy, pregnancy. In patients with severely impaired renal function (CC less than 20 ml / min), the expected benefit and potential risk of drug administration should be carefully compared, since removal of a contrast agent in this category of patients may be delayed.
Use during pregnancy and lactation
Safety Magnevist during pregnancy has not been studied. If necessary, use of the drug should be careful. When on / in the introduction of gadopentetic acid in very limited quantities excreted in breast milk (approximately 0.04% of the administered dose). Experience shows that there is no danger to breastfed babies.
Dosage and administration
Magnevist; should be entered only in / in. MRI with contrast should be started immediately after administration. Magnevist; does not apply to the introduction under the brain shells. In the range from 0.14 to 1.5 T, recommendations for the use of Magnevist do not depend on the magnetic field strength. Magnevist; should be collected in the syringe immediately before use. Unused during the examination of the remnants of a contrast agent should be destroyed. For cranial and spinal MRI for adults and children (including newborns and infants) and adolescents, the recommended dose is 0.2 ml / kg body weight. In cases where there is a suspicion of the presence of a pathological focus, it is possible to conduct a repeated contrast study. Repeated administration in a dose of 0.2 ml / kg or 0.4 ml / kg (adults) should be carried out 30 minutes after the first injection with immediate MRI. Administration of an increased dose of Magnevist 0.6 ml / kg to adult patients increases the accuracy of diagnosis for metastatic lesions or recurrences of tumors. A full-body MRI is recommended for adults and children over 2 years of age to administer Magnevist at a dose of 0.2 ml / kg.If the test object is located in an area with poor vascularization and / or with a small extracellular space, it may be necessary to administer the drug at a dose of 0.4 ml / kg to obtain an adequate contrasting effect, especially when using short T1-weighted sequences during scanning. Administration at a dose of 0.6 ml / kg may increase the reliability of diagnosis in a number of pathological lesions or recurrences of tumors. For imaging of vessels, depending on the area of study and the MRI technique used, Adult dose of Magnevist 0.6 ml / kg should be required. The experience of using Magnevist during a full-body MRI in children under 2 years of age is still limited. In such cases, the physician must carefully weigh the ratio of the perceived benefits and potential risks of conducting a study with Magnevist. Patient training For a / in the introduction, it is advisable to use a flexible catheter. The drug is used only in a hospital with the availability of equipment for resuscitation. It is necessary to follow generally accepted precautions when performing MRI (including the absence of cardiac pacemakers, ferromagnetic implants in patients). During intravascular injection of a contrast agent, the patient should be in a horizontal position. After the injection, the patient should be monitored for 30 minutes. In adults and children over 2 years of age, IV should be carried out manually or using an automatic injector. In newborns and in children under 2 years of age, the required dose should be administered manually. For studies using contrast enhancement, T1-weighted sequences are usually used for scanning.
Side effects
The side effects associated with the use of Magnevista are usually mild, moderate and transient. However, the development of severe and life-threatening reactions has been reported. The frequency of side effects: often> (1/100); sometimes (≤1 / 100, but> 1/1000); rarely - (≤1 / 1000). The frequency of adverse reactions according to post-registration clinical studies and according to spontaneous reports. On the part of the body as a whole: sometimes - feeling hot, headache; rarely - back pain, pain in the chest or in the joints, malaise, increased sweating, fainting,increase in body temperature. Local reactions: rarely during extravasation - local pain, sensation of heat or cold, swelling, inflammation, tissue necrosis, phlebitis, thrombophlebitis. Allergic reactions: rarely - angioedema, conjunctivitis, cough, rhinitis, sneezing, bronchospasm, laryngism. , laryngeal / pharyngeal edema, arterial hypotension, shock, skin reactions (urticaria). On the side of the central nervous system and peripheral nervous system: sometimes - dizziness, headaches, paresthesias; seldom - agitation (agitation), confusion, convulsions, tremor, asthenia, coma, drowsiness, speech disorders. For the sense organs: rarely - tearing, eye pain, ear pain, visual impairment, hearing, smell. For heart -vascular system: rarely - reduction of blood pressure, arrhythmia, cardiac arrest, peripheral vasodilation, arterial hypotension, syncope, reflex tachycardia, cyanosis. On the respiratory system: rarely - shortness of breath, respiratory failure, cough, respiratory arrest, pulmonary edema. On the part of the digestive system oh system: sometimes - nausea, vomiting; rarely - abdominal pain, diarrhea, taste perversion, dry mouth, hypersalivation, transient increase in liver enzymes and bilirubin in the blood. From the urinary system: rarely - urinary incontinence, frequent urination; in patients with previous kidney disease, an increase in creatinine level and acute renal failure. Dermatological reactions: rarely - pruritus, redness of the skin (due to vasodilation), rash, edema. Other: rarely - transient increase in serum iron content.
Overdose
Symptoms: possible manifestations of hyperosmoticity of the drug - an increase in pressure in the pulmonary artery, an increase in diuresis, hypervolemia, dehydration. Treatment: it is necessary to monitor renal function (especially in patients with renal insufficiency). Dimeglumine gadopentetat can be removed by hemodialysis.
Interaction with other drugs
In patients taking beta-blockers, hypersensitivity reactions when using contrast agents can be enhanced. Interaction with other drugs is not known.
special instructions
To reduce the risk of aspiration 2 hours before the examination, the patient should refrain from eating. Against the background of Magnevist's application, serious allergic reactions may develop (including anaphylactic shock), most of which occur within 30 minutes after the drug is injected, but in rare cases it may develop delayed reactions (from several hours to several days). Before prescribing the drug, it is necessary to carefully collect the allergic history of patients for the presence of hay fever, urticaria, allergic reactions to seafood and reactions to contrast agents, bronchial asthma. This category of patients is recommended to be sedated (GCS and histamine H1 receptor blockers). Patients with bronchial asthma have an increased risk of developing bronchospasm or hypersensitivity reactions. In case of intracranial tumors or metastases, as well as epilepsy in history, an increase in the incidence of seizures after administration is possible. of contrast agents. When determining the serum iron content by complexometric methods (for example, using bathophenanthroline) during the first 24 hours the qualitative indicator can be reduced, which is explained by the presence of free DTPA in the contrast agent solution. Effect on the ability to drive vehicles and control mechanismsNot the effect of Magnevist was detected; on the ability to drive motor vehicles and other activities that require high concentration of attention and speed of psychomotor reactions.