Active substanceGadodiamideGadodiamide
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  • Gadodiamide
    solution in / in 
    JODAS EKSPOIM, LLC     Russia
  • Hadodiamide-TL
    solution in / in 
  • Omniscan®
    solution in / in 
    JI Halskea Limited     United Kingdom
  • Dosage form: & nbspsolution for intravenous administration
    Composition:
    1 ml of the preparation contains:
    Active substance: gadodiamide monohydrate 287.0 mg in terms of gadodiamide (0.5 mmol)
    Auxiliary substances: tosodium aldiamide 12.0 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid solution to pH 5.5 to 7.0, water for injection to 1 ml.
    Description:Transparent, colorless or slightly yellowish solution.
    Pharmacotherapeutic group:Contrast agent for magnetic resonance imaging (MRI)
    ATX: & nbsp

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:Gadodiamide is a neutral paramagnetic contrast medium for MRI. Strengthens contrast, facilitates visualization of abnormal structures and formations of the central nervous system (CNS), because free electrons of gadolinium atoms, having paramagnetic properties, generate a local magnetic field that accelerates the reorientation of extracellular fluid protons induced by the magnetic field of the apparatus; causes a signal amplification in the areas of the blood-brain barrier (BBB).Optimal contrast enhancement occurs in the first minutes after the injection (depending on the type of pathological process and the tissue being examined) and lasts 45 minutes.
    Pharmacokinetics:
    Gadodiamide does not penetrate intact GEB. The drug is quickly distributed in the extracellular fluid. Volume of distribution (200 ± 61 ml / kg) corresponds to the volume of extracellular fluid. Gadodiamide is not metabolized, does not bind to blood plasma proteins.
    The half-distribution period is approximately 4 minutes, and the half-life (T1/2) - about 70 min. Gadodiamide is excreted mainly by the kidneys. The kidney and overall clearance of the gadodiamide are almost identical (1.7 and 1.8 ml / min / kg, respectively) and correspond to the clearance of drugs that are excreted mainly by glomerular filtration.
    In patients with impaired renal function (glomerular filtration rate (GFR) <30 mL / min / 1.73 m2) T1/2 extends proportionally to the degree of decrease in the rate of filtration. In patients with normal renal function, about 85% of the drug passes into the urine in 4 hours after intravenous injection of the gadodiamide, and after 95 hours at 95-98%.
    Indications:
    MRI of the brain and spinal cord in adults and children older than 4 weeks. Contrasting the whole body in adults and children older than 6 months. MRI angiography in adults.Cardiac MRI in adults to assess coronary heart disease (CHD) by means of imaging in a myocardial perfusion (at a load / alone and delayed investigation with contrast enhancement) for the detection and localization of CHD, detection of ischemia portions and infarction in patients with known or suspected IHD.
    Contraindications:Hypersensitivity to the active component or any auxiliary substance of the drug, severe renal dysfunction (GFR <30 mL / min / 1.73 m2), postoperative liver transplant, pregnancy and the period of breastfeeding, newborn babies up to 4 weeks.
    Carefully:Anemia (sickle cell and hemolytic), hemoglobinopathies, liver failure, hepatorenal syndrome patients, allergies, asthma, epilepsy or brain disease, a history of adverse reactions to administration of a radiopaque substance (except allergic reactions).
    Pregnancy and lactation:
    There is no experience of using gadodiamide in people during pregnancy. Do not use the drug to examine pregnant women,when MRI with contrast enhancement seems to be extremely necessary and the intended benefit to the mother from its use exceeds the potential risk to the fetus.
    Until now, the possibility of getting gadodiamide in the milk of a nursing woman has not been studied. After the introduction of the drug mother breastfeeding should be discontinued and its resumption is possible not earlier than 24 hours after the introduction.
    Dosing and Administration:
    Intravenously sprayed, once through the catheter with a syringe. With a patient's body weight of up to 100 kg, 0.1 mmol / kg (0.2 ml / kg); with a body weight of more than 100 kg - 10 mmol (20 ml). The drug is injected into the syringe immediately before use; To ensure complete administration of the dose, the cannula is washed with 5 ml of a 0.9% solution of sodium chloride. The beginning of the study - a few minutes after the introduction, the end - for 1 hour (no more).
    With MRI, the heart performs two injections to study myocardial perfusion under load and at rest. 2 hours before the procedure, the patient should not eat. When performing an intravenous bolus injection for MRI of the heart, it is recommended to use a suitable injector at a rate of infusion of up to 8 ml / s. When the drug is administered, the patient should be in a horizontal position.Within 30 minutes after the end of the procedure, medical supervision of the patient is carried out. It is during this period that most of the adverse reactions occur.
    Contrasting the central nervous system (CNS)
    The recommended dose for adults and children is 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight) per body weight up to 100 kg; with a body weight of more than 100 kg is usually sufficient to provide a diagnostic adequate contrast of 20 ml.
    If there is a suspicion of brain metastases, a dose of 0.3 mmol / kg body weight (equivalent to 0.6 ml / kg body weight) may be administered to adults with a body weight of up to 100 kg.
    With a body weight of more than 100 kg, a dose of 60 ml is usually sufficient. A dose of 0.3 mmol / kg body weight can be administered in the form of a single bolus injection. In the case of indistinct images after injection, a second bolus injection at a dose of 0.1 mmol / kg of body weight is administered after 20 minutes at a dose of 0.2 mmol / kg body weight (equivalent to 0.4 ml / kg body weight).
    Contrasting the whole body
    For adults and children older than 6 months, the recommended dose is 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight) with a body weight of up to 100 kg or, in some cases, 0.3 mmol / kg body weight ( is equivalent to 0, 6 ml / kg of body weight).If the patient has a body weight of more than 100 kg, 20 ml, or 60 ml, is usually sufficient for diagnostic contrasting (for some cases). The required dose should be administered once intravenously.
    MRI in contrast enhancement should be started immediately after the administration of contrast medium, depending on the pulse mode used and the protocol of the study. The optimum gain is noted a few minutes after the injection (time is determined by the type of tissue damage). Usually, the gain is maintained up to 45 minutes after the administration of contrast medium. With contrast enhancement by the gadodiomide, it is optimal to use T1-weighted pulse sequences.
    Angiography
    For adult patients, the recommended dose is usually 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight). In the case of stenosis of abdominal and iliac arteries, a higher dose up to 0.3 mmol / kg of body weight (equivalent to 0.6 ml / kg) is used, which allows obtaining additional diagnostic information. For optimal contrast, visualization should be performed on the first pass of the contrast medium, during and immediately after injection, depending on the equipment used.
    CHD
    For adult patients, the recommended dose for assessing myocardial perfusion is usually 0.15 mmol / kg body weight (equivalent to 0.3 ml / kg body weight), which is divided into 2 separate doses of 0.075 mmol / kg body weight (equivalent to 0.15 ml / kg body weight) and administered at an interval 10 minutes. The first injection is administered under conditions of pharmacological stress, the second - at rest. The drug that causes pharmacological stress should be injected through a separate catheter. In the case of evaluation of late gain, a total dose of 0.15 mmol / kg body weight is recommended. In patients 65 years of age and older, dose adjustment is not required.
    Side effects:
    The frequency of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rarely (1/10 000), the frequency is unknown (can not be estimated from the available data).
    Immune system disorders: infrequently - allergic reactions of the skin and mucous membranes, hypersensitivity; frequency unknown - anaphylactoid reactions, incl. anaphylactic shock.
    Disorders of the psyche: rarely - anxiety.
    From the nervous system: often headache; infrequently - dizziness, paresthesia, transient dysgeusia; rarely - cramps, tremors, drowsiness, transient dysosmia.
    Disorders from the side of the organ of vision: rarely - visual impairment.
    Heart Disease: frequency is unknown - tachycardia.
    Vascular disorders: infrequently - "hot flashes".
    Disturbances from the respiratory system, chest and mediastinal organs: rarely shortness of breath, cough; frequency unknown - sneezing, sore throat, bronchospasm, severe respiratory failure.
    Disorders from the gastrointestinal tract: often - nausea, infrequently - vomiting, diarrhea.
    Disturbances from the skin and subcutaneous tissues: infrequently - itching of the skin; rarely - swine, hives; Edema, including edema of the face and edema Quincke.
    Disturbances from the musculoskeletal and connective tissue: rarely - arthralgia, myalgia.
    Disorders from the kidneys and urinary tract: rarely acute renal failure; frequency unknown - development of nephrogenic systemic fibrosis (NFR) in patients with severe renal impairment (GFR <30 mL / min / 1.73 m2).
    Other: fever, chills, hyperemia of the facial skin, asymptomatic change in serum iron content (8 to 48 hours after administration).
    Local reactions: pain in the injection site.
    Overdose:
    Overdose is unlikely in patients with normal renal function. In the case of applying large doses of the drug in patients with renal insufficiency gadodiamide can be removed from the body by hemodialysis. There is no specific antidote.
    Treatment: symptomatic.
    Interaction:Pharmaceutically incompatible with other medicines.
    Special instructions:
    MRI is technically contraindicated in patients with an artificial pacemaker, stented vessels. The absence of contrast enhancement during MRI is not an unambiguous testimony to the absence of pathological processes. Some types of disseminated malignant lesions or inactive plaques with multiple sclerosis do not enhance the signal.
    The presence or absence of contrast enhancement can be used to conduct a differential diagnosis of various types of pathological processes.In connection with the possibility of developing an anaphylactic shock during the introduction of the drug, it is necessary to create all conditions for immediate intensive therapy.
    When using the drug, you should be especially careful if you have a history of allergies; bronchial asthma, t. they may be at a higher risk of developing bronchospasm; as well as when examining patients who have previously had an anamnesis development of adverse reactions to the introduction of radiopaque substance (with the exception of allergic reactions); patients with epilepsy or diseases of the brain; can be at risk of increased seizure. It should be borne in mind that most allergic reactions develop within half an hour after the administration of the drug.
    Gadodiamide affects the results of measuring the concentration of calcium, serum iron in the blood using some colorimetric methods (it is not recommended to use these methods within 12-24 hours after the introduction of the gadodiamide). The drug contains sodium in the composition, which must be taken into account for patients who follow a diet with a low sodium content.
    Before the study, it is necessary to investigate the function of the kidneys. there is a risk of developing NSF in patients with moderate renal insufficiency (GFR 30-59 ml / min / 1.73 m2).
    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with gadodiamide can be atypical and mistaken for vagal reactions.
    In children under 1 year of age and patients with moderate-grade kidney disease (GFR 30-59 ml / min / 1.73 m2) application of the drug is possible only after a careful assessment of the potential benefit and possible risk from the study, and is limited to the introduction of a standard dose (0.1 mmol / kg body weight) and the interval between administration of the drug should be at least 7 days.
    Caution should be observed when using gadodiamide in patients with hepatorenal syndrome.
    One vial of the drug is used for only one patient, unused residues are discarded. When changing the color of the solution or the presence of large particles, it can not be used.
    Effect on the ability to drive transp. cf. and fur:Special studies on the impact on the ability to drive vehicles or work with machinery were not conducted.However, given the side effects profile, when using the drug in outpatients, they should avoid driving or potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:The solution for intravenous administration is 0.5 mmol / ml.
    Packaging:
    For 10, 15, 20 ml of the preparation in a colorless glass bottle (USP, type I), hermetically sealed with a rubber stopper and covered with an aluminum cap.
    For 10, 15, 20 ml of the drug in a syringe of transparent polypropylene.
    For 1 or 10 vials with instructions for use in a cardboard box.
    For 1 or 10 syringes together with instructions for use in a cardboard pack.
    Storage conditions:In a place protected from light and secondary X-rays at a temperature of 2 to 30 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002763
    Date of registration:15.12.2014
    Expiration Date:15.12.2019
    The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.03.2017
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