Clariscan (Solution) Instructions for Use

Marketing Authorization Holder

GE Healthcare, AS (Norway)

ATC Code

V08CA02 (Gadoteric acid)

Active Substance

Gadoteric acid (Rec.INN registered by WHO)

Dosage Form

Clariscan

Intravenous solution 0.5 mmol/ml: 5 ml, 10 ml, 15 ml, 20 ml, 50 ml or 100 ml fl. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, colorless or slightly yellowish.

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

5 ml – vials (10) – carton packs.
10 ml – vials (10) – carton packs.
15 ml – vials (10) – carton packs.
20 ml – vials (10) – carton packs.
50 ml – vials (10) – carton packs.
100 ml – vials (10) – carton packs.

Clinical-Pharmacological Group

Contrast diagnostic agent for magnetic resonance imaging

Pharmacotherapeutic Group

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

Pharmacological Action

MRI contrast agent. Gadoteric acid has paramagnetic properties that allow it to enhance image contrast during magnetic resonance diagnostics.

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

Indications

• Use for magnetic resonance imaging (MRI) to enhance contrast in neuroradiology for the detection and evaluation of intracranial space-occupying lesions, tumors of the spine, and meningeal tumors.
• Employ in abdominal radiology for the visualization and characterization of primary and secondary liver tumors.
• Utilize for the diagnostic assessment of primary tumor pathology affecting bones and soft tissues.

ICD codes

Dosage Regimen

Administer as a single intravenous bolus injection. Calculate the volume based on the patient’s body weight.

The standard diagnostic dose for adults and pediatric patients is 0.1 mmol per kilogram of body weight, which corresponds to 0.2 ml/kg.

Flush the intravenous line with sterile sodium chloride solution 0.9% after administration to ensure complete delivery of the dose. Initiate the MRI procedure promptly following the injection.

Adverse Reactions

Monitor for immediate hypersensitivity reactions, including anaphylactoid and anaphylactic reactions, which can be life-threatening. These may present with cardiovascular, respiratory, and/or cutaneous symptoms.

Common adverse reactions include nausea, vomiting, headache, and dizziness. Localized reactions such as injection site pain, cold sensation, or warmth are also possible.

Observe for skin reactions, including rash, urticaria, and pruritus. Extravasation during injection may cause transient local tissue reactions such as pain and inflammation.

Contraindications

• Do not use in patients with known hypersensitivity to gadoteric acid or any of the excipients in the formulation.
• Contraindicated in patients with severe, acute, or chronic renal impairment (GFR < 30 mL/min/1.73m²) due to the elevated risk of nephrogenic systemic fibrosis (NSF).
• Avoid use in patients who are pregnant or breastfeeding, as the safety profile has not been established.

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 continuous venous access for symptomatic therapy if needed.

Do not administer subarachnoidally (or epidurally).

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.