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Triombrast (Solution) Instructions for Use

ATC Code

V08AA01 (Amidotrizoic acid)

Active Substance

Sodium amidotrizoate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Radiocontrast ionic diagnostic agent for intravascular and intracavitary administration

Pharmacotherapeutic Group

Radiocontrast agent

Pharmacological Action

Radiocontrast diagnostic agent containing iodine. It enhances image contrast by absorbing X-rays with iodine.

Indications

  • Perform intravenous and retrograde urography.
  • Conduct angiocoronarography.
  • Obtain images of contrasted body cavities during CT tomography and hysterosalpingography.

ICD codes

ICD-10 code Indication
Z03 Medical observation and evaluation for suspected disease or pathological condition
ICD-11 code Indication
QA02 Medical observation or examination for suspected diseases or conditions that were ruled out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Establish the dosage individually for each patient, based on the specific diagnostic procedure and the type of examination being performed.

Adjust the volume and concentration of the administered solution according to the patient’s body weight, the vascular bed under study, and the required image quality.

Solution

It is established individually, depending on the indications and the dosage form used.

Adverse Reactions

Monitor for immediate and delayed hypersensitivity reactions, including urticaria, angioedema, bronchospasm, and severe anaphylactoid or anaphylactic reactions that can progress to cardiovascular collapse and shock.

Observe for nausea, vomiting, dizziness, and transient sensations of heat, pain, or flushing at the injection site. Be aware of the potential for severe cardiovascular events, including arrhythmias, and neurological complications such as convulsions or paralysis.

Drug Interactions

Exercise caution with concurrent administration of other nephrotoxic agents, such as aminoglycosides or nonsteroidal anti-inflammatory drugs, due to an increased risk of acute renal failure.

Avoid use in patients taking metformin, as the combination elevates the risk of lactic acidosis, particularly in the setting of contrast-induced nephropathy. Discontinue metformin as per established protocols.

Be aware that interleukin-2 and beta-blockers may increase the risk and severity of anaphylactoid reactions to iodinated contrast media.

Contraindications

  • Do not administer to patients with a known hypersensitivity to the active substance, other iodinated contrast media, or any of the excipients.
  • Absolutely contraindicated in patients with overt hyperthyroidism.
  • Avoid use in patients with severe hepatic or renal insufficiency, decompensated cardiac failure, and in states of shock or collapse.
  • Contraindicated for phlebography in the presence of acute phlebitis.

Overdose

Manage overdose primarily as supportive care, focusing on the maintenance of a patent airway and ensuring adequate ventilation and circulation.

Treat cardiovascular complications, such as shock or cardiac arrest, with immediate standard resuscitative measures. Initiate rehydration and monitor renal function closely to mitigate the risk of contrast-induced nephropathy.

There is no specific antidote; treatment is directed at the presenting symptoms and complications, which may include seizures, pulmonary edema, or fluid and electrolyte imbalances.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Special Precautions

For coronary angiography, only the 76% solution is used.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Farmak, JSC (Ukraine)

Dosage Form

Bottle Rx Icon Triombrast Solution for injection 60%: amp. 20 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 60% 1 ml
Sodium amidotrizoate 600 mg

20 ml – ampoules of dark glass (5) – cardboard boxes.
20 ml – ampoules of dark glass (10) – cardboard boxes.

Marketing Authorization Holder

Farmak, JSC (Ukraine)

Dosage Form

Bottle Rx Icon Triombrast Injection solution 76%: amp. 20 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 76% 1 ml
Sodium amidotrizoate 760 mg

20 ml – ampoules of dark glass (5) – cardboard boxes.
20 ml – ampoules of dark glass (10) – cardboard boxes.

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