Active substanceGadoteric acidGadoteric acid
Similar drugsTo uncover
  • Dothar
    solution in / in 
    Gerbe     France
  • Dosage form: & nbspsolution for intravenous administration
    Composition:The composition of 1 ml of the solution contains:
    Active substances:
    Gadoteric acid 279.32 mg;
    (corresponds to: DOTA (1,4,7, 10-tetraazocyclododecane-N, N`, N'`, N```-tetraacetic acid) 202.46 mg
    gadolinium oxide 90.62 mg
    Excipients:
    Meglumine 97.6 mg
    water for injection up to 1 ml

    pH: 6.5 to 8.0
    Description:A clear, colorless or pale yellow solution.
    Pharmacotherapeutic group:Contrast agent for MRI
    ATX: & nbsp

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:Dothar has paramagnetic properties that increase the contrast of the image during magnetic resonance diagnostics. The drug is biologically inert, does not have a specific pharmacodynamic effect.
    Pharmacokinetics:
    After intravenous administration Dothar is distributed mainly in the extracellular fluid of the body. The drug does not bind to plasma albumins and does not penetrate the blood-brain barrier.
    In patients with normal renal function, the half-life of plasma is approximately 90 minutes.
    Displayed gadoteric acid in unmodified form by means of glomerular filtration.
    The plasma clearance is lower in patients with renal insufficiency.
    Gadotetric acid is released into breast milk in small amounts and slowly penetrates the placental barrier.
    Indications:
    Increase the contrast of the image when performing magnetic resonance imaging with:
    - diseases of the spinal cord and brain;
    - diseases of the spine;
    - and other conditions, including pathologies requiring angiography.
    Contraindications:
    Hypersensitivity to the active component or any auxiliary substance of the drug. Conditions in which MRI is technically contraindicated (for example, patients with an artificial pacemaker, stenosed vessels).
    The use of the drug is not recommended for angiography in children under 18 years due to insufficient data on efficacy and safety.
    Carefully:The drug should be used with caution when:
    - presence in the anamnesis of allergic reactions (hay fever, hives, bronchial asthma, etc.);
    - severe renal failure;
    - increased convulsive readiness;
    pregnancy.
    Pregnancy and lactation:
    At the present time, there is insufficient data to establish the presence of a teratogenic or fetotoxic effect in gadoteric acid during its introduction during pregnancy. Experimental data show that only a very small amount (<1%) falls into breast milk Dotharem. If it is necessary to administer the drug during lactation, it is recommended to stop breastfeeding and not to resume. least. for 24 hours after the study.
    Clinical data on this issue are not available.
    The use of the drug during pregnancy is only possible if the potential benefit to the mother exceeds the potential risk to the fetus.
    Dosing and Administration:The drug should be administered only intravenously.
    The recommended dose is 0.1 mmol / kg, i.e. 0,2 ml / kg for adults and children.
    When angiography is performed, depending on the results obtained in previous examinations, it may be possible, if necessary, to repeat the introduction of the drug during the examination.
    In some exceptional cases, such as confirming isolated metastases or detecting leptomeningeal tumors, a re-introduction of 0.2 mmol / kg may be prescribed.
    Side effects:
    The classification of adverse reactions is given by the frequency of development (number of reported cases / number of patients):
    Very often (≥1 / 10) headaches and paresthesias.
    Often (≥1 / 100 to <1/1000) cases of anaphylactoid reactions are described. They can be extremely heavy and even lethal, especially in patients with anamnestic indications of allergies.
    These anaphylactoid reactions can occur regardless of the dose administered and are manifested by one or more of the following symptoms: angioedema, anaphylactic shock, collapse and cardiac arrest, lowering of arterial pressure, laryngeal edema, bronchospasm, laryngospasm, pulmonary edema, shortness of breath, stridor, cough, itching, rhinitis, sneezing, conjunctivitis, abdominal pain, chest pain, urticaria and rash. Some of these symptoms may be the first signs of a beginning anaphylactic shock. Perhaps the development of delayed reactions to the introduction of contrast.
    Very rarely (<1/10000):
    Change in general condition: malaise, severe sweating, chilliness, pale skin and fainting.
    Reactions at the injection site: Very rare cases of contrast agent entry into surrounding tissues have been described.
    From the skin and subcutaneous tissue: eczema, rash.
    From the nervous system: generalized convulsions.
    From the musculoskeletal system and connective tissue: muscle cramps, muscle weakness.
    Overdose:
    There have been no cases of overdose to date.
    Overdose is unlikely in patients with normal renal function. There is no specific antidote, the treatment is symptomatic. it is possible to conduct hemodialysis.
    Interaction:Significant interactions of gadoteric acid with other drugs have not been identified.
    Do not mix this drug with others.
    Special instructions:The drug should be administered only intravenously. If the drug gets into the surrounding tissue, local intolerance reactions may develop that require standard local therapy.
    Dothar should not be administered by subarachnoid (or epidural) injection.
    Do not administer by intrathecal route. TO
    As with other contrast agents containing gadolinium, anaphylactoid reactions may develop (see the "Side Effects" section).Most of these reactions develop within half an hour after the administration of the contrast agent. However, as with other contrast agents of this class, the development of delayed reactions within a few days after administration can not be ruled out. In view of this risk, patients should be asked whether they have a history of allergies before the injection of the contrast agent and whether they had previously responded to the introduction of contrast. These patients are at increased risk for developing severe anaphylactoid reactions.
    Anaphylactoid reactions can be intensified in patients taking beta-blockers and in the presence of bronchial asthma. Staling beta-agonists bronchospasm, which arose on the introduction of contrast agent in patients who are on therapy with beta-blockers, is inappropriate.
    During the diagnostic procedure, the patient should be under the supervision of a physician. In the case of an anaphylactoid reaction, the introduction of contrast should be immediately stopped and, if necessary, specific therapy should be maintained for which it is necessary to maintain venous access.To carry out emergency measures in an emergency, there should be appropriate preparations at the ready (for example, epinephrine and antihistamines), an endotracheal tube and a respirator.
    As with the use of other contrast agents containing gadolinium, special care must be taken in patients with increased convulsive readiness. Precautions should be observed, for example, continuous monitoring of the patient's condition. Before the procedure, it is necessary to prepare all the equipment and medicines that may be needed to arrest seizures.
    The decision to use Dothar These patients should be taken only after a thorough assessment of the relationship between risk and benefit.
    Effect on the ability to drive transp. cf. and fur:No data available.
    Form release / dosage:Solution for intravenous administration, 0.5 mmol / ml.
    Packaging:To 5, 10, 15, 20 ml in bottles of glass (type II), sealed with butyl rubber stoppers or 15, 20 ml in glass syringes. One bottle or syringe in a plastic pallet is packed in a cardboard box together with instructions for use.
    Packing for hospitals:
    25 bottles of 10, 15, 20 ml are packed in a cardboard box together with instructions for use.
    Storage conditions:At temperatures not exceeding 30 ° C, out of the reach of children and protected from light.
    Shelf life:3 years. Do not use after the date. indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N010463
    Date of registration:11.09.2012
    The owner of the registration certificate:GerbeGerbe France
    Manufacturer: & nbsp
    GUERBET France
    Information update date: & nbsp08.04.2013
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