Trazograph^® (Solution) Instructions for Use

Marketing Authorization Holder

Unique Pharmaceutical Laboratories (India)

ATC Code

V08AA01 (Amidotrizoic acid)

Active Substance

Sodium amidotrizoate (Rec.INN registered by WHO)

Dosage Forms

	Trazograph®	Injection 60%: amp. 20 ml 5 pcs.
		Injection 76%: amp. 20 ml 5 pcs.

Dosage Form, Packaging, and Composition

Injection 60% clear, slightly viscous, from colorless to light yellow.

Excipients : sodium dihydrogen phosphate dihydrate, disodium edetate calcium, water for injection.

20 ml – dark glass ampoules (5) – thermal containers (1) – cardboard packs.
20 ml – dark glass ampoules (5) – non-cell contour packages (1) – cardboard packs.

Injection 76% clear, slightly viscous, from colorless to light yellow; crystallization may occur at room temperature or below room temperature.

Excipients : sodium hydroxide, calcium disodium edetate, water for injection.

Excipients : disodium edetate calcium, water for injection.

20 ml – dark glass ampoules (5) – thermal containers (1) – cardboard packs.
20 ml – dark glass ampoules (5) – non-cell contour packages (1) – cardboard packs.

Clinical-Pharmacological Group

Radiocontrast ionic diagnostic agent for intravascular and intracavitary administration

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Trazograph^® is an ionic triiodinated radiocontrast agent. It enhances image contrast by absorbing X-rays with the stably bound iodine contained in the preparation.

Pharmacokinetics

It is not metabolized, does not accumulate in the liver, and is eliminated in chemically unchanged form by glomerular filtration.

When administered intravascularly, Trazograph^® is rapidly distributed in the interstitial space; no more than 10% of the drug binds to plasma proteins. The drug does not penetrate the intact blood-brain barrier.

Intravenous bolus injection of Trazograph^® at a dose of 1 ml/kg body weight allows reaching high plasma concentrations of the drug, corresponding to 2-3 g of iodine/l, within 5 minutes. T_1/2 is 1-2 hours.

Indications

Trazograph^® 76%

• Excretory urography;
• Infusion urography;
• Coronary angiography;
• Aortography;
• Angiocardiography;
• Selective angiography;
• Splenoportography;
• Children – for performing excretory urography.

Trazograph^® 60%

• Excretory urography;
• Infusion urography;
• Retrograde pyelography;
• Cystography;
• Angiocardiography;
• Peripheral arteriography;
• Selective angiography;
• Phlebography.

ICD codes

Dosage Regimen

Patient preparation for the procedure

Contrast media administration is performed on an empty stomach, but water intake is not restricted. Any existing water-electrolyte imbalances must be corrected beforehand. This is especially important for patients with decompensated diabetes mellitus, polyuria, oliguria, or gout, generalized myeloma, as well as for young children and elderly patients, for whom fluid intake should not be restricted before using hypertonic radiocontrast agents.

For abdominal angiography and urography, thorough bowel cleansing of the patient is recommended to improve diagnosis. Therefore, for 2 days before the examination, patients should avoid foods that cause flatulence (primarily legumes, salads, fruits, black and fresh bread, as well as any raw vegetables). The last meal should be no later than 18 hours before the start of the examination. Furthermore, it is advisable to take a laxative the evening before. Infants and young children are contraindicated for long intervals between meals and the prescription of laxative medications.

Patients experiencing fear of the procedure should be prescribed sedatives.

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

General procedure rules

The contrast medium should be drawn into the syringe immediately before the start of the examination.

Unused remnants of the contrast medium from the examination are not to be used again. When performing angiography, frequent flushing of the used catheters with saline is required to minimize the possible risk of thromboembolism. It should be considered that the contrast medium is better tolerated and easier to inject if it is warmed to body temperature immediately before use. When using a thermostat, only the number of ampoules of contrast medium intended for use should be warmed to 37°C (98.6°F).

Pre-testing of individual sensitivity using small doses of the drug is not recommended due to the risk of severe hypersensitivity reactions.

Intravascular administration of the radiocontrast medium, if possible, is best performed with the patient in a lying position. After injection, careful observation of the patient for at least 30 minutes is necessary, as most complications occur within the first half hour after drug administration. If several high single doses are required for diagnostic clarification, the interval between injections should be 10-15 minutes (to compensate for increased serum osmolarity due to the influx of interstitial fluid). If more than 300 ml of contrast medium is administered at one time, intravenous infusion of electrolyte solutions is prescribed.

Examination of kidneys and urinary tract

Trazograph^® solution is used for excretory urography, retrograde pyelography, and cystography by intravenous or intracavitary (into the bladder, renal pelvises) administration.

Excretory urography

Adults are administered intravenously as a bolus 20-50 ml of 60% solution or 20 ml of 76% Trazograph^® solution at a rate of 0.3 ml/sec. For patients with increased body weight, it is more appropriate to use the 76% Trazograph^® solution.

In children, due to the physiologically reduced concentrating capacity of the still immature kidney nephron, relatively high doses of Trazograph^® 76% are required: up to 1 year – 6 ml, from 1 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.

Infusion urography

Intravenously by drip, adults are administered a mixture of 80 ml of 60% or 76% Trazograph^® solution and 80 ml of 5% dextrose solution at a rate of 20-30 drops/min.

Retrograde pyelography

For intracavitary administration, it is advisable to dilute Trazograph^® with isotonic sodium chloride solution or 5% dextrose solution to obtain a 30% solution. The 30% Trazograph^® solution is administered retrogradely through a catheter into the urinary tract under slight pressure under visual X-ray control (avoiding pain in the lumbar region), usually in a dose of 3-8 ml; in case of ectasia of the cavity system – up to 20 ml or more depending on the degree of kidney cavity dilation.

Cystography

A 30% Trazograph^® solution is introduced into the bladder retrogradely or through an epicystostomy under visual X-ray control in a volume slightly less than the bladder capacity (100-200 ml).

Angiography

Trazograph^® is used for angiocardiography, aortography, arteriography, selective angiography, phlebography by intravascular administration, as well as for splenoportography.

• For aortography, 30-60 ml of 76% drug solution is injected into the aorta at a rate of 25-35 ml/sec;
• For angiocardiography, up to 60 ml of 76% Trazograph^® solution is used at a rate of 10-30 ml/sec;
• For peripheral arteriography – intra-arterially in the lower limb, 20-40 ml is administered, in the upper limb – 10-20 ml of 60% Trazograph^® solution at a rate of 8-12 ml/sec;
• For selective angiography, 60% and 76% Trazograph^® solution is used in an amount corresponding to the volume of the studied vessel bed at a rate of 3-12 ml/sec;
• For phlebography – intravenously in the lower limb, 20-40 ml is administered, in the upper limb – 10-20 ml of 60% drug solution at a rate of 3-5 ml/sec;

For splenoportography, 30-50 ml of 76% Trazograph^® solution is injected into the spleen at a rate of 8 ml/sec.

Adverse Reactions

Side effects associated with the intravascular use of iodine-containing contrast media are usually transient and are mild or moderate in severity, although severe, life-threatening reactions, including fatal ones, have been observed.

With intravascular administration of the contrast medium, the most frequent observations were: nausea, vomiting, skin redness, sensation of heat. Reduction of the feeling of heat and nausea can be achieved if the contrast medium is administered slowly or short breaks (every 3-5 minutes) are made during the drug administration.

It is also possible to develop the following symptoms: chills, fever, sweating, headache, dizziness, pale skin, weakness, retching and feeling of suffocation, difficulty breathing, sneezing, lacrimation, increase or decrease in blood pressure, itching, urticaria, edema, convulsions, muscle tremor. It is possible that the occurrence of such side reactions may be a precursor to the onset of anaphylactic shock. In case of shock, the administration of the contrast medium must 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 medium. Hyperergic reactions occur more often in patients predisposed to allergies.

Severe adverse reactions requiring emergency care can manifest as circulatory disorders, which are expressed in dilation of peripheral vessels and subsequent decrease in blood pressure, reflex tachycardia, shortness of breath, cyanosis, agitation, confusion, up to loss of consciousness. In this regard, when conducting the examination, appropriate medications, an endotracheal tube, and a ventilator should be ready for emergency care. In isolated cases, mainly in patients suffering from epilepsy or brain diseases, the development of neurological complications is possible, such as: coma, disorientation, drowsiness, temporary paresis, visual impairment, as well as epileptic seizures.

In some cases, with the use of the drug, the development of phlebitis and thrombosis is possible.

In rare cases, reversible renal failure may occur.

Contraindications

• Severe forms of hyperthyroidism;
• Circulatory failure with signs of decompensation;
• Severe renal and hepatic insufficiency;
• Active pulmonary tuberculosis and pulmonary emphysema;
• Myocardial lesions;
• Severe arterial hypertension;
• State of shock and collapse;
• Epilepsy;
• Pregnancy;
• Hypersensitivity to iodine-containing drugs.

Trazograph^® should not be used for myelography, ventriculography, and cisternography due to possible neurotoxic reactions.

With caution, the drug should be used in cases of impaired renal function, hepatic function, cardiovascular insufficiency, severe cerebral vascular atherosclerosis, decompensated diabetes mellitus, hyperthyroidism, nodular goiter, plasmocytoma, pregnancy.

Use in Pregnancy and Lactation

During pregnancy, the drug is prescribed only in cases where the attending physician considers it absolutely necessary, taking into account the possible risk to the fetus. Hysterosalpingography is prohibited during pregnancy.

Excretion of the drug in breast milk is insignificant and, according to available experience, the likelihood of harm to the child is low; however, before prescribing the drug during lactation, the potential danger to the child must be considered.

Use in Hepatic Impairment

With caution, the drug should be used in cases of impaired hepatic function.

Use in Renal Impairment

With caution, the drug should be used in cases of impaired renal function.

Pediatric Use

In children, due to the physiologically reduced concentrating capacity of the still immature kidney nephron, relatively high doses of Trazograph^® 76% are required: up to 1 year – 6 ml, from 1 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.

Special Precautions

Crystallization may occur during storage of the drug. In such cases, the ampoule should be heated in a water bath (at a temperature of about 60°C (140°F)), shaking periodically. If the crystals disappear and do not reappear upon cooling to 33-37°C (91.4-98.6°F), the solution is suitable for use.

Effect on ability to drive vehicles and machinery

In rare cases, there is a possibility of slowed reaction time, which may impair the ability to drive vehicles and operate other machinery.

Overdose

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

Drug Interactions

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

In patients with diabetic nephropathy taking biguanides, the administration of contrast medium may lead to the development of lactic acidosis. To prevent this complication, it is necessary to stop taking biguanides 48 hours before the procedure. To resume taking biguanides, it is necessary to ensure the absence of impaired renal function.

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

In patients taking interleukin, delayed reactions (e.g., fever, rash, itching, joint pain) and flu-like symptoms occur more frequently.

Storage Conditions

Store at a temperature not exceeding 30°C (86°F). Do not freeze! Protect from light and secondary X-rays. Keep out of reach of children.

Shelf Life

Shelf life – 5 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.