Hadodiamide-TL (Gadodiamide-TL)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceGadodiamideGadodiamide
Similar drugsTo uncover
  • Gadodiamide
    solution in / in 
    JODAS EKSPOIM, LLC     Russia
  • Hadodiamide-TL
    solution in / in 
    TECHNOLOGY OF DRUGS, LTD.     Russia
  • 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 hydrate in terms of gadodiamide - 287.0 mg (0.5 mmol);

    Excipients: sodium chloride, hydrochloric acid *, sodium hydroxide *, water for injection.

    * Use as a 1 M solution of hydrochloric acid or 1 M sodium hydroxide solution to provide a pH value of the solution in the range of 6.0 to 6.5.

    Description:

    Transparent colorless or yellowish solution.

    Pharmacotherapeutic group:Contrast agent for magnetic resonance imaging
    ATX: & nbsp

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:Physicochemical properties of the drug Gadodiamide-TL are given in the table below.

    Osmolality (mOsm / kg H2O) at a temperature of 37 ° C

    780

    Viscosity (mPa*from)

    - at a temperature of 20 ° C

    2,2

    - at a temperature of 37 ° C

    1,4

    Density (g / cm2)3)

    1,15

    pH

    5,5-7,0

    Pharmacodynamics

    Gadodiamide is a neutral paramagnetic contrast medium for magnetic resonance imaging (MRI). Strengthens the contrast, facilitates the visualization of abnormal structures and formations of the central nervous system (CNS), since free electrons of gadolinium atoms,possessing paramagnetic properties, generate a local magnetic field that accelerates the reorientation of extracellular fluid protons induced by the magnetic field of the apparatus; causes signal amplification in the areas of impaired blood-brain barrier functions. Optimal contrast enhancement occurs in the first minutes after the injection (depending on the type of pathological process and the tissue being examined) and stored for 45 minutes.

    Pharmacokinetics:

    Gadodiamide does not penetrate the intact blood-brain barrier. The drug is quickly distributed in the extracellular fluid. The volume of distribution is equivalent to the volume of extracellular fluid. The drug is not metabolized, does not bind to blood plasma proteins.

    The half-distribution time is approximately 4 minutes, and the half-life (T1 / 2) - about 70 minutes. It is excreted by the kidneys through glomerular filtration. In patients with severe renal dysfunction (glomerular filtration rate (GFR) <30 mL / min / 1.73 m2) T1 / 2 is extended proportionally to the degree of decrease in the filtration rate. In patients with normal renal function 4 hours after intravenous injection of gadodiamide, about 85% of the injected drug passes into the urine, after 95% -95% after 24 hours.The kidney and overall clearance of the gadodiamide are almost identical and similar to those of other substances completely released by glomerular filtration. After administration of the drug at doses of 0.1 and 0.3 mmol / kg, dose-dependent changes in the kinetics of the drug were not detected.

    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.

    - Magnetic resonance angiography in adults.

    - MRI of the heart for the evaluation of coronary heart disease (CHD) by visualization in the conditions of myocardial perfusion (at load / at rest and delayed study with contrast enhancement), for the detection and localization of IHD and the differentiation of ischemia and infarction in patients with known or suspected CHD.

    Contraindications:

    - Hypersensitivity to the gadodiamide or any auxiliary substance included in the preparation.

    - Severe renal impairment (GFR <30 mL / min / 1.73 m2).

    - Patients who have been or are waiting for a liver transplant.

    - Newborns under 4 weeks of age.

    Carefully:

    Anemia (sickle cell, hemolytic), hemoglobinopathy, liver failure, patients with impaired renal function (GFR 30-59 ml / min / 1.73 m2), patients with hepatorenal syndrome, allergies, bronchial asthma, epilepsy, brain diseases, the presence in the anamnesis of undesirable reactions to the introduction of radiopaque substance (with the exception of allergic reactions).

    Pregnancy and lactation:

    Pregnancy

    There is no experience of using gadodiamide in people during pregnancy. Do not use the drug for examination of pregnant women, except when the MRI with contrast enhancement is very necessary and the intended benefit to the mother from its use exceeds the potential risk to the fetus.

    Breastfeeding period

    Until now, it is not known whether gadodiamide penetrate into breast milk. Breastfeeding should be discontinued before the introduction of the drug and do not resume at least 24 hours after the test.

    Fertility

    In experimental preclinical studies it was shown that gadodiamide does not affect fertility and does not have a teratogenic effect.

    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 0.9% sodium chloride solution. The beginning of the study - a few minutes after the introduction, the end - for 1 hour (no more).

    With MRI of the heart, 2 injections are performed 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 that a suitable injector be used 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, the patient is monitored physically, since most adverse reactions occur during this period.

    Contrasting the central nervous system

    The recommended dose for adults and children is 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight) with a body weight of up to 100 kg. With a body weight of more than 100kg To ensure a diagnostically adequate contrast, 20 ml of solution is usually sufficient.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. At a body weight of more than 100 kg, a dose of 60 ml of solution 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 at a dose of 0.1 mmol / kg body weight, a second bolus injection at a dose of 0.2 mmol / kg body weight (equivalent to 0.4 ml / kg body weight) is administered after 20 minutes.

    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 (equivalent to 0.6 ml / kg body weight). With a patient body weight of more than 100 kg, 20 ml or 60 ml of solution is usually sufficient for diagnostic contrast, respectively (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 the abdominal and iliac arteries, a higher dose is applied - up to 0.3 mmol / kg of body weight (equivalent to 0.6 ml / kg), which allows obtaining additional diagnostic information. For optimal contrast, visualization should be performed at the first passage of contrast medium, during and immediately after injection (depending on the equipment used).

    CHD

    In adult patients, the recommended dose for evaluating myocardial perfusion is 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 of more than 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. To estimate 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:

    Undesirable reactions are systematized relative to each of the organ systems using the following frequency classification: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100 ), rarely (from ≥1 / 10,000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (can not be estimated from available data).

    Immune system disorders: infrequently - allergic reactions from the skin and mucous membranes, hypersensitivity; rarely anaphylactic shock / anaphylactoid reactions, which may be the first signs of a beginning shock. Late adverse reactions may occur between several hours to several days after drug administration: the frequency is unknown - idiosyncrasy.

    Disorders of the psyche: rarely - anxiety; frequency unknown - mental disorders.

    From the nervous system: often - headache; infrequently - dizziness, paresthesia, short-term perversion of taste sensations; rarely - convulsions (up to the development of epileptic status), tremors, drowsiness, short-term perversion of smell; frequency is unknown - ataxia, impaired coordination of movements, loss of consciousness (right up to the development of deep coma), tinnitus.

    Disorders from the side of the organ of vision: rarely - visual impairment.

    Heart Disease: frequency is unknown - tachycardia.

    Vascular disorders: infrequent - redness of the skin ("hot flashes").

    Disturbances from the respiratory system, organs of the thorax and mediastinum: rarely - dyspnea, cough; frequency unknown - sneezing, sore throat, bronchospasm, severe respiratory failure.

    Disorders from the gastrointestinal tract: often - nausea; infrequently - vomiting, diarrhea; frequency unknown - decreased appetite, belching, abdominal pain.

    Disorders from the rut and subcutaneous tissues: infrequently - itching of the skin; rarely - rashes, hives, swelling, including swelling of the face and swelling of Quincke; frequency unknown - nephrogenic systemic fibrosis in patients with severe impaired renal function (creatinine clearance <30 mL / min / 1.73 m2).

    Disturbances from the musculoskeletal and connective tissue: rarely - arthralgia; frequency is unknown - myalgia.

    Violations from the blood and lymphatic system: the frequency is unknown - an asymptomatic decrease in serum iron content (within 8 to 48 hours after drug administration).

    Disorders from the kidneys and urinary tract: rarely acute renal failure; frequency unknown - development of nephrogenic systemic fibrosis in patients with severe renal impairment (GFR <30 mL / min / 1.73 m2).

    General disorders and disorders at the site of administration: often - local soreness or sensation of heat, coolness or bursting at the injection site; rarely - fever, chills, chest pain; the frequency is unknown - increased sweating, a feeling of heat, hyperemia of the facial skin.

    If any of the side effects listed in the manual are aggravated or you notice any other side effects, not specified in the instructions, inform the doctor about it.

    Overdose:

    Overdose is unlikely in patients with normal renal function. When overdose in patients with renal insufficiency gadodiamide can be removed from the body by hemodialysis. There is no specific antidote.Treatment is symptomatic.

    Interaction:

    Data on the interaction of the drug Gadodiamid-TL with other drugs are not available.

    The drug should not be mixed in the same syringe with other medicines.
    Special instructions:

    Conducting MRI is contraindicated in patients with an artificial pacemaker, stented vessels.

    The absence of contrast enhancement during MRI is not an unambiguous evidence of the absence of pathological processes, since some types of disseminated malignant neoplasms or inactive plaques in multiple sclerosis do not enhance the signal. The presence or absence of contrast enhancement can be used to conduct differential diagnosis of various types of pathological processes.

    In connection with the possibility of developing adverse reactions (including anaphylactic shock) during the administration of the drug, especially in patients with a history of hypersensitivity, it is necessary to create all conditions for immediate intensive therapy during the administration of the drug.

    Before the study, violations of the water-electrolyte balance should be eliminated and sufficient supply should be ensuredfluid and electrolytes, especially in patients with multiple myeloma, diabetes mellitus, polyuria or gout, as well as newborns, infants and young children, elderly patients. Special care should be taken in patients with a history of allergy, bronchial asthma, as they may be at a higher risk of developing bronchospasm, as well as in patients who have a history of unwanted reactions to the introduction of radiopaque substances (with the exception of allergic reactions). It should be borne in mind that most allergic reactions develop within half an hour after the administration of the drug.

    In patients with epilepsy or brain damage, the risk of seizures increases during the study. When conducting studies in such patients, it is necessary to provide for the availability of equipment and medicines to treat possible seizures.

    Gadodiamide affects the results of measuring the concentration of calcium and serum iron in the blood plasma using some colorimetric methods. Therefore, the use of these techniques is not recommended in the first 12-24 hours after the administration of the gadodiamide.If such studies are necessary, other methods are recommended.

    The drug contains sodium in the composition, which must be taken into account in patients who observe a diet with a low content of sodium chloride.

    Before the study, it is necessary to investigate the function of the kidneys, since in patients with moderate renal insufficiency (GFR 30-59 ml / min / 1.73 m2) there is a risk of developing nephrogenic systemic fibrosis.

    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) the use of the drug should be evaluated from the point of view of the benefit-risk relationship from the study and is limited to the introduction of a standard dose (0.1 mmol / kg body weight), so the interval between injections should be at least 7 days.

    Care should also be taken when using gadodiamide in patients with hepatorenal syndrome.

    One vial of the drug is used for only one patient, unused residues are discarded.When the color of the solution is changed or large particles are present, the solution of the gadodiamide can not be used.

    Effect on the ability to drive transp. cf. and fur:

    Studies on the impact on the ability to drive vehicles or work with machinery were not conducted. It is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions within 24 hours after the study.

    Form release / dosage:

    The solution for intravenous administration is 0.5 mmol / ml.

    Packaging:

    For 10 ml, 15 ml or 20 ml in bottles of colorless glass, corked bromobutyl, crimped caps aluminum or combined of aluminum and plastic.

    For 1 or 10 vials, together with instructions for medical use, are placed in a pack of corrugated cardboard or corrugated cardboard.

    Storage conditions:

    In a place protected from light and secondary X-ray radiation, at a temperature not exceeding 25 ° С.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004291
    Date of registration:15.05.2017
    Expiration Date:15.05.2022
    The owner of the registration certificate:TECHNOLOGY OF DRUGS, LTD. TECHNOLOGY OF DRUGS, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.06.2017
    Illustrated instructions
      Instructions
      Up