Magnevist® (Magnevist®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceGadopentetic acidGadopentetic acid
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  • Gadopentetova acid-TL
    solution in / in 
    TECHNOLOGY OF DRUGS, LTD.     Russia
  • Magnevist®
    solution in / in 
    Bayer AG     Germany
    • Dosage form: & nbspSolution for intravenous administration, 0.5 mmol / ml
    Composition:An aqueous solution containing 1 ml:
    Active substances: 469.01 mg dimeglumine salt of gadopentetic acid (equivalent to 0.5 mmol dimeglumen gadopentetate).
    Excipients: meglumine, diethylenetriaminepentaacetic acid, water for injection.
    Description:Transparent, colorless or almost colorless liquid, free from foreign particles.
    Pharmacotherapeutic group:Contrast agent for magnetic resonance imaging (MRI).
    ATX: & nbsp

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:
    Magnevist® is a paramagnetic contrast medium for MRI. The contrasting effect is due to the di-N-methylglucamine salt of the gadopentetate-gadolinium complex with pentetic acid (diethylenetriaminepentaacetic acid). Using the 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 the excited atomic nuclei,which increases the intensity of the signal and increases the contrast of the image of certain tissues.
    Dimeglumina gadopentate practically does not bind to proteins and does not inhibit enzyme activity (eg, myocardial Na, K-ATPase). Magnevist® does not activate the complement system and therefore has a very low potential to cause anaphylactoid reactions.
    Pharmacokinetics:
    Characteristic

    Magnevist® (0.5 mmol / ml)

    Concentration of contrast agent (mg / ml)

    469

    Osmolality (Osm / kg H2ABOUT) at 37 ° C

    1,96

    Viscosity (mPascal-sec)

    At 20 ° C

    At 37 ° C


    4,9

    2,9

    Density (g / ml)

    At 20 ° C

    At 37 ° C


    1,210

    1,195

    The pH value

    7,0-7,9


    Dimeglumine gadopentetova acid is a compound with pronounced paramagnetic properties, greatly shortening the relaxation time, even at low concentrations. The paramagnetic efficiency or relaxation ability, determined from the effect on the spin-lattice relaxation time of plasma protons, is about 4.95 l / mmol-sec (it depends weakly on the magnetic field strength). Diethylenetriaminepentaacetic acid forms a strong complex with a paramagnetic gadolinium ion with extremely high stability (logK = 22-2S).The dimeglumic salt of the gadopentetate is characterized by high hydrophilicity (the distribution coefficient of n-butanol / buffer at pH 7.6 is about 0.0001).

    In its pharmacokinetics, dimegluminum hapopentate resembles other high-hydrophilic biologically inert compounds (eg, mannitol or inulin). Pharmacokinetics Magnevist® does not depend on the dose.
    Distribution
    After intravenous administration, the compound is rapidly distributed into the extracellular space. In doses less than 0.25 mmol dimeglumen gadopentetate / kg body weight (equivalent to 0.5 ml Magnevist®/ kg body weight) after a rapid distribution phase lasting several minutes, its concentration in the blood decreases; elimination half-life is 90 minutes. At a dose of 0.1 mmol dimeglumin gadopentetate / kg (equivalent to 0.2 ml Magnevist®/ kg of body weight) at 3 and 60 minutes after administration, its concentration in the blood plasma is 0.6 and 0.24 mmol / l, respectively.
    Does not penetrate through intact BBB and the hematotestick barrier. A small amount that penetrates the placental barrier is quickly removed from the fetus.
    Excretion
    Hypopen-tate of dimeglumine is mainly excreted from the body by the kidneys in an unchanged form with the help of glomerular filtration. On average, at 6 and 24 hours 83% and 91% of the administered dose are allocated by the kidneys, respectively. After injection for 5 days with feces less than 1% of the administered dose was withdrawn. The renal clearance of dimegluminum gadopentetate at a body surface of 1.73 m2 is about 120 ml / min.
    Indices in patients with renal insufficiency
    Almost completely elimination of dimegluminum gadopentetate occurs in kidneys even in patients with impaired renal function (creatinine clearance> 20 ml / min); the half-life from plasma increases in proportion to the degree of impaired renal function, but no increase in extrarenal excretion is observed. With the elongation of the half-life of serum up to 30 hours in patients with severe renal failure (creatinine clearance less than 20 ml / min), dimegluminum hapopentate can be removed from the body by means of extracorporeal hemodiapisis.
    Indications:MRI of the brain and spinal cord (cranial and spinal MRI) (to enhance the contrast of the image)
    - for detection of tumors, including small and poorly visualized, tumor recurrences after surgical or radiation treatment, metastasis;
    - for the differential diagnosis in suspected meningioma, acoustic neuroma, tumor infiltrative germinating into surrounding tissues (e.g., glioma);
    - for the differential diagnosis of certain rare tumors such as hemangioblastoma, epindioma, pituitary adenoma small size, and to improve visualization of intracranial tumor dissemination process;
    additionally with spinal MRI:
    - for differential diagnosis of intra- and extra-medullary-located tumors;
    - to determine the size of solid tumors of the spinal cord; for the detection of intramedullary prevalence of tumors.
    Contrast enhancement during MRI of the whole body, namely the study of the facial skull, the neck, the chest and abdominal cavity, mammary glands in women, pelvic organs, musculoskeletal system and receiving vessels whole body image:
    - for detection of a tumor, inflammatory process, damage to blood vessels;
    - to determine the prevalence and boundaries of the tumor, inflammatory focus, vascular damage;
    - for differential diagnosis of the structure of pathological formations;
    - for evaluation of blood supply in normal and pathologically altered tissues;
    - for differential diagnosis of tumors and scar tissue after therapy;
    - to detect recurrence of intervertebral disk prolapse after surgery;
    - for simultaneous semiquantitative evaluation of kidney function and their visualization.
    Contraindications:Hypersensitivity to the components of the drug.
    Carefully:Allergic reactions in the anamnesis, bronchial asthma, severe circulatory failure, epilepsy, pregnancy. The benefit should be carefully compared with the risk in patients with severe impairment of kidney function (creatinine clearance less than 20 ml / min), t. the allocation of a contrast agent in such patients may be delayed.
    Pregnancy and lactation:Pregnancy
    Security Magnevist® in pregnant women has not been studied. Therefore, in these cases, the drug should be used with caution.
    Lactation
    Magnevist® penetrates into breast milk in women in very limited quantities. Approximately 0.04% of the administered dose penetrates into breast milk. The experience shows that there is no danger for infants who are breastfed.
    Dosing and Administration:Magnevist® should be administered only intravenously. MRI with contrast can be started immediately after administration. Magnevist® Do not use to inject under the membranes of the brain.
    In the range of 0.14 to 1.5 T recommendations for use Magnevist® do not depend on the strength of the magnetic field.
    Magnevist® should be typed into the syringe just before the injection. The solution of contrast medium unused during the study should be destroyed.
    Preparation of the patient
    For intravenous administration of a contrast agent, it is advisable to use a flexible catheter.
    Apply only in a hospital with the availability of equipment for resuscitation.
    During MRI, it is necessary to follow the usual safety measures for this method (for example, patients should not have pacemakers, and vascular clips of ferromagnetic materials).
    Intravenous administration of a contrast agent, if possible, is best done when the patient is lying down. After the introduction, the patient should be monitored for 30 minutes. In adults and children older than 2 years, intravenous administration Magnevist® can be carried out in a "manual" way or with an automatic injector.
    In newborns (up to a month) and children under the age of 2 years, the required dose should be administered "manually".
    For studies using contrasting, T1-weighted sequences are commonly used for scanning.
    Doses
    Cranial and spinal MRI.
    Adults, adolescents and children (including newborns and infants) The recommended dose is 0.2 ml / kg body weight. In the case when there is a suspicion of the presence of a pathological focus, a re-contrast study is possible. Repeated dosing of 0.2 ml / kg or a dose of 0.4 ml / kg is performed 30 minutes after the first administration with immediate MRI.
    Introduction to Adult Patients 0.6 ml Magnevist® per 1 kg of body weight often increases the reliability of diagnosis in metastatic lesions or relapses of tumors.MRI of the whole body
    Adults and children over 2 years old
    Recommended introduction Magnevist® in a dose of 0.2 ml / kg of body weight.
    When the location of the object of investigation in a region with poor vascularization and / or a small extracellular space, adequate to produce a contrast effect may be necessary to introduce a drug at a dose of 0.4 ml / kg body weight, especially when using relatively short T1-weighted sequences during scanning.
    Administering a dose of 0.6 ml / kg body weight can increase diagnostic accuracy in a number of pathological lesions or relapses of tumors.
    For vascular imaging, depending on the area of ​​study and the MRI technique used, an adult dose Magnevist® 0.6 ml / kg body weight.
    Experience of application Magnevist® in children under 2 years of age, according to "MRI of the whole body" is limited. In such cases, the physician should carefully weigh the benefit / risk ratio before conducting the study with Magnevist®.
    Side effects:Side effects associated with use Magnevist®, usually expressed weakly or in an average degree and inherently transitory.However, the development of severe and life-threatening reactions has been reported. To express the approximate frequency of side effects in the text, their definitions are used: "frequent", "infrequent", "rare".

    Frequent

    Frequency > 1:100

    Not frequent

    Frequency ≤ 1: 100, but > 1:100

    Rare

    Frequency ≤ 1: 1000

    * Frequency of adverse reactions according to post-registration clinical studies and according to spontaneous reports.

    General reactions and reactions at the site of administration.
    Not frequent: a feeling of heat, a headache.
    Rare: back pain, joint pain, chest pain, malaise, increased sweating, fainting, fever, perivascular administration of contrast agent causes the appearance of local pain and can lead to inflammation and necrosis of the tissue, a feeling of cold, a feeling of warmth and swelling, phlebitis and thrombophlebitis.
    Anaphylactoid reactions / hypersensitivity.
    Rare: vascular edema, conjunctivitis, cough, rhinitis, sneezing, bronchospasm, laryngeal spasm, larynx / pharyngeal edema, arterial hypotension, shock, skin reactions: see skin and subcutaneous tissue.
    Nervous system.
    Not frequent: dizziness, headache, paresthesia.
    Rare: agitation, confusion, impaired vision, smell, hearing or speech, convulsions, tremor, pain in the ears, asthenia, coma, drowsiness.
    Organs of vision.
    Rare: lacrimation, pain in the eyes.
    The cardiovascular system.
    Rare: lowering blood pressure, arrhythmia and cardiac arrest. Vascular reactions accompanied by peripheral vasodilation, subsequent arterial hypotension and syncope, reflex tachycardia, dyspnea, cyanosis, pulmonary edema.
    Respiratory system.
    Rare: shortness of breath, respiratory failure, cough, stopping breathing.
    Gastrointestinal tract.
    Not frequent: nausea, vomiting.
    Rare: abdominal pain, diarrhea, taste perversion, dry mouth, hypersalivation.
    Hepatobiliary system.
    Rare: a transient increase in the level of hepatic enzymes.
    Skin and subcutaneous tissue.
    Rare: redness of the skin (vasodilation), swelling, hives, itching, rash.
    Kidney and urinary system.
    Rare: urinary incontinence, frequent urge to urinate, in patients with a previous kidney pathology increased serum creatinine and acute renal failure.
    Blood.
    Rare: transient increase in the level of iron and bilirubin in the serum.
    Overdose:(with the administration of more than 0.3 mmol / kg body weight)
    In case of an overdose Magnevist® the effects caused by its hyperosmosis can increase: an increase in pressure in the pulmonary artery, an increase in diuresis, hypervolemia, dehydration.
    Patients with renal pathology need to monitor kidney function. In case of an overdose or with severe renal failure Magnevist® can be removed from the body by hemodialysis.
    Interaction:In patients taking beta-blockers, hypersensitivity reactions when using contrast agents can be strengthened.
    Interactions with other drugs are not known.
    Special instructions:Children under the age of 2 years do not have experience with Magnevist® by the indication "whole-body MRI".
    To reduce the risk of aspiration 2 hours before the test, the patient should refrain from eating.
    Sometimes after application Magnevist® due to hypersensitivity, allergic reactions are observed. There is the possibility of developing serious reactions, including allergic shock. Most of these reactions occur within half an hour after the administration of the contrast agent. However, in rare cases, deferred reactions may develop.
    Before the introduction of a contrast agent, patients should be informed about the presence of an allergic anamnesis (for example, allergies to sea food, hay fever, urticaria), sensitivity to contrast agents and the presence of bronchial asthma. In such patients, the incidence of adverse reactions to contrast agents is higher and for them, prescription of antihistamines and / or glucocorticoids is indicated for premedication.
    Patients with bronchial asthma have an increased risk of developing bronchospasm or hypersensitivity reactions.
    In MRI, the presence of intracranial tumors or metastases, as well as epilepsy, can increase the incidence of seizures for the administration of contrast media.
    Effect on diagnostic tests
    Since the solution Magnevist® contains a small amount of free diethylenetriaminepentaacetic acid, during 24 hours after the administration of the drug, the results of complexometric tests of quantitative determination of iron in serum may be underestimated.
    Effect on the ability to drive transp. cf. and fur:No effects were found.
    Form release / dosage:
    The solution for intravenous administration is 0.5 mmol / ml.
    Packaging:

    To 5 (10, 15, 20, 30) ml in bottles of glass of hydrolytic class 1, sealed with a rubber stopper and rolled with an aluminum cap with a plastic polyurethane lid. For 10 (15, 20) ml in syringes of hydrolytic class 1 glass or plastic syringes from a colorless cycloolefin polymer. Each syringe is placed in a special sealed container of PVC.

    For 1 (5, 10) vials or containers, along with the instructions for use are placed in a cardboard box.

    Storage conditions:In the dark place.
    In a place inaccessible to children.
    Shelf life:Shelf life 5 years.
    Do not use after the expiry date printed on the package.
    After removing the cap from the protective cap of the vial or preparing the syringe for injection Magnevist® should be introduced on the same day to avoid microbial contamination.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015832 / 01
    Date of registration:30.06.2009 / 02.11.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Bayer AGBayer AG Germany
    Manufacturer: & nbsp
    BAYER, AG Germany
    Information update date: & nbsp18.09.2014
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