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 solution contains:
    Active substance:
    Gadodiamide: 287 mg (equivalent to 0.5 mmol)
    Excipients:
    sodium sodiumodium 12.0 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid solution as required to pH 6.0-7.0, water for injection 851.0 mg.
    Description:Transparent colorless or slightly yellowish liquid.
    Pharmacotherapeutic group:Contrast agent for MRI
    ATX: & nbsp

    V.08.C.A   Paramagnetic contrast media

    Pharmacodynamics:
    Paramagnetic properties cause contrast enhancement when performing magnetic resonance imaging (MRI).
    Optimum contrast enhancement is usually observed during the first minutes after administration (depending on the type of pathological process / tissue). Omniscan does not penetrate the intact blood-brain barrier.
    Pharmacokinetics:

    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 min. It is excreted by the kidneys through glomerular filtration. In patients with severe renal dysfunction (glomerular filtration rate <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 4 hours after intravenous injection of gadodiamide, about 85% of the injected drug passes into the urine, after 95% -95% after 24 hours. The renal and total clearance of Omniscan® is almost identical and similar to those of other substances completely released by glomerular filtration. After administration of 0.1 and 0.3 mmol / kg, no dose-dependent changes in the kinetics of the drug were detected.

    Indications:
    Omniscan® is for diagnostic use only.
    Magnetic resonance imaging (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.
    MRI of the heart for the evaluation of coronary heart disease (CHD) by visualization under conditions of myocardial perfusion (under load / at rest and delayed study with contrast enhancement),for the detection and localization of coronary heart disease (CHD) and for distinguishing between ischemia and infarction in patients with known or suspected coronary artery disease.
    Contraindications:

    Hypersensitivity to the active ingredient or any auxiliary substance. Gadodiamide is contraindicated in patients with severe impairment of renal function (creatinine clearance less than 30 ml / min / 1.73 m2), patients who have undergone or are waiting for a liver transplant and newborn children under 4 weeks of age.

    Carefully:
    - ANemia, especially sickle cell and hemolytic
    - hemoglobinopathy
    - liver failure
    Pregnancy and lactation:
    There is no experience with Omniscan® in humans 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. The drug had no effect on fertility or reproduction in rats or in teratological studies in rats and rabbits at doses not toxic to the mother.
    It is not known whether gadodiamide with breast milk in women. Breastfeeding should be discontinued before the introduction of the drug and not resumed at least 24 hours after the test.
    Dosing and Administration:
    The drug is intended for intravenous administration.
    Like all preparations for parenteral administration, Omniscan® should be inspected (visually) before administration for the absence of mechanical inclusions, discoloration, and packaging integrity problems.
    Special patient preparation is not required. Omniskan® is recruited in. syringe immediately before use. Adults and children should be given the required dose in the form of a single intravenous injection.

    In MRI, the heart performs two injections to study perfusion under load and at rest. When performing an intravenous bolus injection for MRI of the heart, it is recommended to use a suitable injector with a contrast medium delivery rate of up to 8 ml / s.

    In order to ensure the introduction of a full dose of contrast medium, the dropper can be washed with 0.9% sodium chloride solution.

    With intravenous jet injection, once with a syringe through the catheter.Omniscan® should be dialed into the syringe immediately before use. 2 hours before the procedure, the patient should stop eating.

    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, because It is during this period that most of the adverse reactions occur. In children under 1 year and patients with moderate-type kidney disease (glomerular filtration rate 30-59 ml / min / 1.73 m2), the use of the drug should be evaluated in terms of risk-benefit and limited to the introduction of a standard dose (0.1 mmol / kg body weight). Repeated administration of the drug should not be performed earlier than 7 days later.

    Contrasting the central nervous system

    For adults and children over 4 weeks.

    The recommended dosage is 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight) with a body weight of up to 100 kg; more than 100 kg - 20 ml is usually enough to provide a diagnostically adequate contrast. The required dose should be administered once intravenously.

    To ensure the completeness of the drug, the intravenous catheter should be washed with a sufficient amount of 0.9% sodium chloride solution.

    For adult patients

    If there is a suspicion of metastases in the brain, a dose of 0.3 mmol / kg bw may be administered to patients weighing up to 100 kg. (equivalent to 0.6 ml / kg of body weight). 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 could be. is administered in the form of a 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 mg / kg body weight).

    Contrasting the whole body

    For adult patients

    For patients weighing up to 100 kg, the recommended dosage is usually 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg body weight) or, in some cases, 0.3 mmol / kg bw. (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).

    For children over 6 months

    The recommended dosage is 0.1 mmol / kg bw. (equivalent to 0.2 ml / kg of body weight)

    As with adults, the necessary dose should be administered once intravenously.

    Magnetic Resonance Study

    MRI in conditions of contrast enhancement should be started soon after the administration of the contrast medium, depending on the pulse mode used and the protocol of the study.The optimum gain is observed a few minutes after the injection (time is determined by the type of lesion / tissue). Usually, the gain is maintained up to 45 minutes after the administration of contrast medium. With contrast enhancement Omniskan®, it is optimal to use T1-weighted pulse sequences. In the studied range of field strengths from 0.15 Tesla to 1.5 Tesla, the relative contrast of the image does not depend on the applied field strength.

    Angiography

    For adult patients

    The recommended dosage is usually 0.1 mmol / kg (0.2 ml / kg).

    In the case of stenosis of the abdominal and iliac arteries, a higher dose of 0.3 mmol / kg (equivalent to 0.6 ml / kg) is used, which allows "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.

    Ischemic heart disease (CHD)

    For adult patients

    The recommended dosage for evaluation of cardiac 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 intervals10 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. The use of the drug according to the indications of CHD in children has not been studied.

    Side effects:
    Classification of undesirable side reactions by frequency of development:
    Very often (≥10%); often (≥1%, <10%); infrequently (≥0.1%, <1%); rarely (≥0.01%, <0.1%); very rarely (<0.01%, including individual messages); frequency is unknown (can not be estimated based on
    available data).

    Immune system disorders:

    Infrequent: allergic reactions of 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
    administration of the drug.
    The frequency is unknown: idiosyncrasy.
    Disorders of the psyche:
    Rarely: anxiety.
    The frequency is unknown: mental disorders.

    Impaired nervous system:
    Often: headache.
    Infrequently: dizziness, paresthesia, short-term perversion of taste sensations.
    Rarely: convulsions (up to the development of epileptic status), tremor, drowsiness, short-term
    a perversion of the sense of smell.
    Frequency is unknown: ataxia, impaired coordination of movements, loss of consciousness (until development
    deep coma), tinnitus.

    Disorders from the side of the organ of vision:

    Rarely: impaired vision.

    Heart Disease:

    The frequency is unknown: tachycardia.

    Vascular disorders:

    Infrequent: redness of the skin

    Disturbances from the respiratory system, chest and mediastinal organs:

    Rarely: dyspnea, cough.
    The frequency is unknown: sneezing, perspiration in the throat, bronchospasm, shortness of breath.

    Disorders from the gastrointestinal tract:

    Often: nausea.
    Infrequent: vomiting, diarrhea.
    The frequency is unknown: decreased appetite, belching, abdominal pain.

    Disturbances from the skin and subcutaneous tissues:

    Infrequently: itching.
    Rarely: urticaria, rash, swelling, including facial edema and angioedema.
    Frequency unknown: nephrogenic systemic fibrosis in patients with severe impairment of function
    kidneys (creatinine clearance less than 30 ml / min / 1.73 m2).

    Disturbances from the musculoskeletal and connective tissue:

    Rarely: arthralgia.
    The 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: in patients with previous severe renal dysfunction, acute renal failure may develop.
    The frequency is unknown: increased serum creatinine.

    General disorders and disorders at the site of administration:

    Often: local soreness or sensation of warmth, coolness or bursting at the injection site.
    Rarely: fever, chills, chest pain.
    The frequency is unknown: increased sweating, sensations of fever, hyperemia of the facial skin. If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:Symptoms: there may be an increase in the manifestations of the described side effects. Treatment is symptomatic. Contrast substance is removed by hemodialysis (in patients with impaired renal function andreceived large doses).
    Interaction:
    Interaction with other drugs is not known.
    The drug should not be mixed in the same syringe with other medicines.
    Special instructions:
    Possible development of adverse reactions, including anaphylactic shock during the administration of the drug, especially in patients with a history of hypersensitivity. In the office it is necessary to create all conditions for immediate, intensive therapy. Before each use of a contrast medium, you should obtain the necessary information about the patient, including important laboratory indicators (for example, serum creatinine concentration blood, an electrocardiogram, an allergy in an anamnesis, the presence of pregnancy). Prior to the study, the patient should eliminate disturbances in the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes. Especially in patients with multiple myeloma, diabetes, polyuria or gout, as well as newborns, infants and young children, elderly patients.
    The absence of contrast enhancement is not an unambiguous testimony to the absence of pathology.Some types of neoplasms or non-contrasting plaques in atherosclerosis are not contrasted. The presence or absence of contrast enhancement can be used for differential diagnosis. Each vial or disposable syringe is intended for use in only one patient.
    Unused remnants of the drug should be destroyed. With the introduction of other drugs, you need to use a separate syringe and needle.
    Patients who are afraid of waiting before the procedure need premedication
    soothing means. Omniscan® can influence results measurements
    concentration of calcium in plasma when used colometric complex techniques often used in hospitals. Therefore, the use of these techniques is not recommended in the first 12-24 hours after Omniscan® administration. If such studies are necessary, other methods are recommended.
    It is necessary to consider the possibility of developing adverse reactions, including serious life-threatening anaphylactoid reactions. Cases of development of NSF in patients with moderate renal failure are unknown.In patients with epilepsy or brain damage, the risk of seizures increases during the study. When conducting studies of such patients (for example, monitoring monitoring) It is necessary to provide for the availability of equipment and medicines to treat possible seizures. In children under 1 year and patients with moderate-grade kidney disease (glomerular filtration rate 30-59 ml / min / 1.73 m), the drug should be evaluated from the point of view of the risk-benefit and is limited to the introduction of a standard dose (0.1 mmol / kg of body weight) and the interval between administration of the drug should be at least 7 days. Caution should also be followed when Omniscan ® is used in patients with hepatorenal syndrome.
    Effect on the ability to drive transp. cf. and fur:It is not known whether Omniskan® influences the ability to drive vehicles and work with machines and mechanisms.
    Form release / dosage:

    The solution for intravenous administration is 0.5 mmol / ml.

    Packaging:

    Primary packaging

    For a drug produced by JI Helskea Ireland, Ireland: on 10,15 and 20 ml of preparation in a colorless glass bottle (Evr.Pharm.type I), sealed with a stopper made of chlorobutyl rubber, crimped with an aluminum cap and covered with a snap-fitting plastic lid on top.

    For a drug produced by JI Helskea AS, Norway: 10 ml, 15 ml and 20 ml of the drug in a syringe made of a transparent polymer.

    Secondary packaging

    For 10 vials, together with the instruction for use, is placed in a cardboard bundle having inside the partition with holes for the vials.

    One syringe, together with the instruction for use, is placed in a cardboard bundle having inside the partition with holes for the syringe.

    Tertiary packaging

    10 packs of syringes are placed in a cardboard box.

    Storage conditions:
    At a temperature of 2 ° C to 30 ° C in a place protected from light and secondary X-ray radiation.
    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:П N015800 / 01
    Date of registration:21.05.2009 / 13.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:JI Halskea LimitedJI Halskea Limited United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
    Information update date: & nbsp07.06.2017
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