Gadotheric acid (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

V08CA02 (Gadoteric acid)

Active Substance

Gadoteric acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Contrast diagnostic agent for magnetic resonance imaging

Pharmacotherapeutic Group

Contrast agents; magnetic resonance imaging contrast agents; paramagnetic contrast agents

Pharmacological Action

Contrast agent for MRI. Gadoteric acid has paramagnetic properties that allow for enhancing image contrast in magnetic resonance diagnostics.

It does not exert a specific pharmacodynamic action and exhibits biological inertness.

Indications

Use for image acquisition during magnetic resonance imaging (MRI) in the following clinical areas.

In neuroradiology for the detection and evaluation of intracranial space-occupying lesions, tumors of the spine, and meningeal tumors.
In abdominal radiology for the visualization of primary liver tumors and secondary metastatic liver lesions.
In musculoskeletal imaging for the assessment of primary tumor pathology affecting bones and soft tissues.

ICD codes

Open the list of 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.

Administer as a single intravenous bolus injection at the recommended dose of 0.1 mmol per kilogram of body weight, which is equivalent to 0.2 mL/kg.

This dosage is standardized for both adult and pediatric patient populations. Flush the intravenous line with sterile sodium chloride solution 0.9% after administration to ensure complete delivery of the dose.

Adverse Reactions

The most frequently reported adverse reactions are nausea and vomiting.

Other possible reactions include skin reactions such as rash, urticaria, and pruritus. Pain and localized reactions may occur at the injection site, particularly in cases of extravasation into the subcutaneous tissue.

Monitor the patient for signs of hypersensitivity reactions, which can range from mild to severe, including anaphylactoid and anaphylactic events.

Contraindications

Do not use in patients with known hypersensitivity to gadoteric acid or any of the excipients in the formulation.
Administration is contraindicated in patients with certain implanted devices, specifically those with a functioning artificial pacemaker or a non-MRI compatible vascular stent.
Contraindicated during pregnancy due to a lack of sufficient safety data to prove its safe use.

Use in Pregnancy and Lactation

The safety of use during pregnancy has not been proven.

Use in Renal Impairment

Should be used with caution in patients with severe renal failure.

Special Precautions

Should be used with caution in patients with severe renal failure.

The injection must be performed strictly intravenously; in case of extravasation, local reactions may develop (appropriate local treatment is necessary).

Throughout the entire study, medical supervision of the patient’s condition is necessary, as well as constant venous access for symptomatic therapy if needed.

Do not administer subarachnoidally (or epidurally).

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

Gadotheric acid J [Jodas Expoim, LLC (Russia)]
Solution for intravenous administration 0.5 mmol/1 mL: 5 mL, 10 mL, 15 mL, or 20 mL fl., 15 mL or 20 mL syringes

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Gadoteric acid J

Solution for intravenous administration 0.5 mmol/1 mL: 5 mL, 10 mL, 15 mL, or 20 mL fl., 15 mL or 20 mL syringes

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, from colorless to light yellow.

	1 ml
Gadoteric acid (as gadoterate meglumine)	0.5 mmol (279.32 mg)
Corresponding to the content of DOTA¹	202.46 mg
Gadolinium oxide	90.62 mg

¹1,4,7,10-tetraazacyclododecane-N,N’,N”,N”’-tetraacetic acid

Excipients : meglumine – 97.6 mg, water for injections – up to 1 ml.

5 ml – vials (1) – cardboard boxes.
10 ml – vials (1) – cardboard boxes.
15 ml – vials (1) – cardboard boxes.
20 ml – vials (1) – cardboard boxes.
15 ml – 20 ml syringes with a Luer lock needle tip (1) – cardboard boxes.
20 ml – 20 ml syringes with a Luer lock needle tip (1) – cardboard boxes.

Gadotheric acid-TL [R-Pharm JSC (Russia)]
Solution for intravenous administration 0.5 mmol/mL: 10 mL, 15 mL, or 20 mL fl.