Active substanceSodium amidotrisoateSodium amidotrisoate
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  • Dosage form: & nbspinjection
    Composition:

    Trazograph® 60%

    1 ml of the solution contains:

    Active substances:

    Meglumine amidotrisoate 600 mg

    (iodine content 282 mg)

    Excipients: sodium dihydrophosphate (dihydrate), sodium calcium edetate, water for injection

    Trazograph® 76%

    1 ml of the solution contains:

    Active substances:

    Meglumine amidotrisoate 660 mg

    Sodium amidotrisoate 100 mg

    (iodine content 370 mg)
    Excipients: sodium calcium edetate, water for injection.

    Description:

    Trazograph® 60% is a clear, slightly viscous liquid from colorless to light yellow

    Trazograph® 76% is a clear, slightly viscous liquid from colorless to light yellow in color. Can crystallize at room temperature or below room temperature.

    Pharmacotherapeutic group:X-ray contrast medium.
    ATX: & nbsp

    V.08   Contrast substances

    Pharmacodynamics:

    Trazograph® is an ionic triiodinated radiocontrast agent. Increases the contrast of the image due to absorption of X-rays in the composition of the drug stably connected with iodine.

    Pharmacokinetics:

    Trazograf® is not metabolized, not accumulates in the liver and eliminates in a chemically unchanged form by glomerular filtration.

    With intravascular administration, Trazograf® is rapidly distributed in the intercellular space; with plasma proteins bind not more than 10% of the drug. The drug does not penetrate the intact blood-brain barrier.

    Intravenous jet administration of Trazograph ® in a dose of 1 ml / kg of body weight allows already in 5 minutes to reach high concentrations of the drug in blood plasma, corresponding to 2-3 g of iodine per liter. Half-life is 1-2 hours.

    Indications:

    Trazograph® 76%

    Excretory urography

    - Infusion urography Coronary angiography

    - Aortography

    - Angiocardiography

    - Selective angiography

    - Splenoportography

    - Children - for excretory urography

    Trazograph® 60%

    Excretory urography

    - Infusion urography

    - Retrograde pyelography Cystography

    - Angiocardiography Peripheral arteriography Selective angiography Phlebography

    Contraindications:

    hypersensitivity to iodine-containing drugs severe forms of hyperthyroidism

    Circulatory insufficiency with decompensation phenomena

    marked renal and hepatic impairment

    active pulmonary tuberculosis and emphysema

    myocardial damage

    severe arterial hypertension

    pregnancy

    state of shock and collapse

    epilepsy

    Trazograf® should not be used for myelography, ventriculography and cisternography in connection with possible neurotoxic reactions.

    Carefully:

    Carefully should apply the drug in violation of kidney function, liver, cardiovascular insufficiency, severe cerebral arteriosclerosis, decompensated diabetes mellitus, hyperthyroidism, nodular goiter, plasmacytoma, pregnancy.

    Pregnancy and lactation:

    At pregnancy a preparation appoint or nominate only in cases if the attending physician considers it absolutely necessary in view of possible risk for a fetus. During pregnancy, hysterosalpingography is prohibited.

    Excretion of the drug with breast milk is insignificant and, according to the available experience, the likelihood of harm to the child is small, however, before prescribing the drug during lactation, it is necessary to take into account the possible danger to the child.

    Dosing and Administration:

    Preparation of the patient for the procedure.

    The introduction of contrast media is carried out on an empty stomach, however, the intake of water is not limited. Preliminary violations of water electrolyte exchange should be eliminated, if any. This is especially important for patients with uncompensated diabetes mellitus, polyuria, oliguria or gout, generalized myeloma, as well as in young children and elderly patients, who can not limit fluid intake before applying hypertonic radiopaque means.

    When angiography of the vessels of the abdominal cavity and urography for better diagnosis it is recommended to thoroughly clean the intestines of the patient. Therefore, two days before the examination, patients should avoid eating foods that cause flatulence (especially legumes, salads, fruits, black and fresh bread, as well as any vegetables in their raw form). The last meal should be no later than 18 hours before the start of the examination. In addition, it is advisable to take an overnight laxative. Thoracic and small children large intervals in the intake of food, as well as the appointment of laxatives are contraindicated.

    Patients who are afraid of the procedure, it is necessary to appoint sedatives.

    For patients with pheochromocytoma, preliminary preparation with alpha-adrenergic receptor blockers is recommended in order to avoid the risk of developing a hypertensive crisis.

    General rules of the procedure

    To dial into the syringe, the contrast agent should be immediately before the start of the study.

    The remnants of contrast medium not used in the study are no longer used. Angiography requires frequent rinsing of used catheters with saline solution to minimize the possible risk of thromboembolism. It should be borne in mind that the contrast agent is better tolerated and injected easier if it is heated to body temperature immediately before use. When using a thermostat, only the amount of ampoules of contrast medium that is to be used should be heated to 37 ° C.

    It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, in view of the risk of developing severe hypersensitivity reactions.

    Intravascular injection of radiopaque means, if possible, is best done when the patient is lying down.After the injection, careful monitoring of the patient for at least 30 minutes is necessary, since most complications occur precisely in the first half hour after the administration of the drug.

    If several high single doses are required to clarify the diagnosis, the interval between injections should be 10-15 minutes (to compensate for increased serum osmolarity due to the inflow of interstitial fluid). If once more than 300 ml of contrast medium is administered, intravenous infusion of solutions of electrolytes is prescribed.

    I. Study of the kidneys and urinary tract.

    Trazograf solution is used for excretory urography, retrograde pyelography and cystography by intravenous or intracavitary (in the bladder, renal pelvis) administration.

    1.1. Excretory urography

    Adults inject intravenously with 20-50 ml of 60% solution or 20 ml of 76% Traizograf solution at a rate of 0.3 ml / s. In patients with increased body weight, 76% Traizograf solution is more appropriate.

    Children due to the physiologically reduced concentration ability of an immature kidney nephron require relatively high doses of Trazograf® 76%:

    - up to 1 year: 6 ml

    - from 1 year to 2 years: 8 ml

    - from 2 to 6 years: 10 ml

    - from 6 to 12 years: 12-14 ml

    - from 12 to 15 years: 16 ml

    1.1. Infusion urography

    A mixture of 80 ml of 60% or 76% Trazograf® solution and 80 ml of a 5% dextrose solution at a rate of 20-30 drops per minute is injected intravenously into adults.

    1.2. Retrograde pyelography

    For intracavitary administration, Trazograf® should be diluted with an isotonic sodium chloride solution or 5% dextrose solution until a 30% solution is obtained. A 30% solution of Trazograf® is introduced retrograde through a catheter into the urinary tract at low pressure under visual radiographic control (not allowing pain in the lumbar region), usually at a dose of 3-8 ml; in the case of ectasia of the cavities of the system - up to 20 ml and more, depending on the degree of expansion of the cavities of the kidneys.

    1.3. Cystography

    A 30% solution of Trazograf® is injected into the bladder retrograde or through epicystostom under visual radiology in a volume slightly smaller than the capacity of the bladder (100-200 ml).

    2. Angiografiya.

    Trazograf® is used for angiocardiography, aortography, arteriography, selective angiography, phlebography by intravascular injection, and also with splenoportography.

    2.1. With aortography in the aorta, 30-60 ml of 76% solution of the drug is administered at a rate of 25-35 ml / sec .;

    2.2. With angiocardiography, apply up to 60 ml of 76% Traizograf solution at a rate of 10-30 ml / sec .;

    2.3. With peripheral arteriography - 20-40 ml is administered intraarterially on the lower extremity, 10-20 ml of 60% Trazograf solution at the rate of 8-12 ml / sec on the upper limb;

    2.4. In selective angiography, a 60% and 76% Traizograf solution is used in an amount corresponding to the volume of the bed of the test vessel at a rate of 3-12 ml / sec .;

    2.5. With phlebography, 20-40 ml is injected intravenously on the lower extremity, 10-20 ml of 60% solution of the drug on the upper limb at a rate of 3-5 ml / sec .;

    2.6. With splenoportografii injected into the spleen 30-50 ml of 76% Traizograf solution at a rate of 8 ml / sec.

    Side effects:

    Adverse events associated with intravascular application of iodine-containing contrast agents are usually transient and are classified as light or moderate, although severe, life-threatening reactions have also been observed, including those that have been lethal.


    With intravascular injection of the contrast agent, the most frequently observed: nausea, vomiting, redness of the skin, a feeling of heat.Reducing the feeling of heat and nausea can be achieved if the contrast medium is injected slowly or take short breaks (every 3-5 minutes) during the administration of the drug.

    It is also possible to develop the following symptoms: chills, fever, sweating, headache, dizziness, pallor of the skin, weakness, urge for vomiting and a feeling of suffocation, shortness of breath, sneezing, lacrimation, rising or lowering of blood pressure, itching, urticaria, swelling, cramps, muscle tremor. It is possible that the occurrence of such adverse reactions may be a harbinger of a beginning anaphylactic shock. In case of shock, the administration of contrast medium should be stopped immediately and, if necessary, appropriate intravenous therapy should be prescribed. Allergic and anaphylactoid reactions can occur regardless of the amount and method of administration of the contrast agent. Hyperergic reactions occur more often in patients predisposed to allergies.

    Severe adverse reactions that require emergency care can manifest as circulatory disorders,which are expressed in the expansion of peripheral vessels and subsequent lowering of arterial pressure, reflex tachycardia, dyspnea, cyanosis, agitated state, confusion, until loss of consciousness. In this regard, when conducting a study to provide emergency care, appropriate medication, an endotracheal tube and an artificial respiration device should be available.

    In single cases, mainly in patients suffering from epilepsy or brain diseases, neurological complications such as coma, disorientation, drowsiness, temporary paresis, visual impairment, and epileptic seizures may develop.

    In some cases, the use of the drug may develop phlebitis, thrombosis. In rare cases, reversible renal failure may occur.

    Overdose:

    In case of accidental overdose or significantly reduced renal function, the drug can be withdrawn from the body by extracorporeal dialysis.

    Interaction:

    It should be borne in mind that iodine-containing radiopaque agents reduce the ability of thyroid tissue to accumulate radioisotope drugs in diagnostic studies for a period of more than two weeks.

    In patients suffering from diabetic nephropathy and taking biguanides, the administration of a contrast agent may result in the development of lactic acidosis. To prevent this complication, you should stop taking biguanides 48 hours before the procedure. To resume the administration of biguanides, you should ensure that there is no impairment of kidney function.

    Hypersensitivity reactions may be more pronounced in patients taking beta-blockers.

    Patients taking interleukin are more likely to experience delayed reactions (eg, fever, rash, itching, joint pain) and flu-like symptoms. special instructions

    When storing the drug, crystals may fall out. In such cases, the ampoule should be heated in a water bath (with a temperature of about 60 ° C), periodically shaking. If the crystals disappear, and upon cooling to 33-37 ° C they will not fall out again, the solution is usable.

    Special instructions:not described
    Effect on the ability to drive transp. cf. and fur:

    In rare cases, there is the possibility of slowing down the reaction, which can disrupt the ability to drive vehicles and work with other mechanisms.

    Form release / dosage:

    Solution for injection 60%, 76%

    To 20 ml in an ampoule of orange glass (type 1) with a notch.

    - 5 ampoules in a non-cellular cardboard package, complete with ampoule knife and instructions for use are placed in a cardboard box.

    - 5 ampoules complete with an ampoule knife and instructions for use in a thermo container (thermocock). 1 the thermowell is placed in a cardboard box.

    Packaging:ampoules of dark glass (5) / complete with a knife ampoule / -termocontainers
    ampoules of dark glass (5) / complete with a knife of ampoule / -packing without cell contour
    Storage conditions:

    Store at a temperature not exceeding 30 ° C. Do not freeze! Protect from light and secondary X-rays.

    Keep out of the reach of children.

    Shelf life:

    5 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013931 / 02
    Date of registration:17.06.2008
    The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India
    Manufacturer: & nbsp
    Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India
    Information update date: & nbsp03.12.2009
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