Myoview^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

GE Healthcare, AS (Norway)

ATC Code

V09GA02 (Technetium (99mTc) Tetrofosmin)

Active Substance

Tetrofosmin (Rec.INN registered by WHO)

Dosage Form

Myoview®

Lyophilizate for the preparation of solution for intravenous administration 0.23 mg: fl. 3.38 mg 2 or 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intravenous administration in the form of a white powder.

Excipients: disodium sulfosalicylate – 0.32 mg, stannous chloride dihydrate – 0.03 mg, sodium gluconate – 1 mg, sodium bicarbonate – 1.8 mg.

The finished preparation of ^99mTc-tetrofosmin is a colorless, transparent solution.

Excipients: tin (II) – 0.9-4.0 µg, disodium sulfosalicylate – 0.032-0.088 mg, sodium D-gluconate – 0.125-0.25 mg, sodium bicarbonate – 0.225-0.45 mg, water for injections – up to 1 ml.

The reconstituted injection solution contains 3.6-3.7 mg/ml of sodium.

3.38 mg – vials of colorless glass with a capacity of 10 ml (2) complete with stickers (2 pcs.) – cardboard boxes.
3.38 mg – vials of colorless glass with a capacity of 10 ml (5) complete with stickers (5 pcs.) – cardboard boxes.

Clinical-Pharmacological Group

Diagnostic agent for performing myocardial perfusion scintigraphy

Pharmacotherapeutic Group

Radiopharmaceutical diagnostic agent, cardiovascular system

Pharmacological Action

Diagnostic agent for determining myocardial blood supply. No pharmacological effects are expected after intravenous administration at the recommended dose.

Pharmacokinetics

Maximum accumulation in the myocardium is noted after 5 minutes (amounting to 1.2% of the administered activity) and persists for up to 4 hours. It is excreted by the kidneys (40%) and through the intestines (26%), 66% of the administered drug – within 48 hours.

Indications

Assessment of myocardial perfusion in the diagnosis of myocardial ischemia and infarction.

ICD codes

Dosage Regimen

Planar or SPECT (single-photon emission computed tomography) study begins 15 minutes after injection. For the diagnosis and determination of the localization of myocardial ischemia, a double administration is recommended. For adults, 185-250 MBq is administered at the peak of stress, then after 4 hours – 500-750 MBq at rest. The administered activity should not exceed 1000 MBq within one day. For the diagnosis of the localization of myocardial infarction, 185-250 MBq at rest (1 injection) is sufficient.

Adverse Reactions

Possible allergic reactions, fever, nausea, metallic taste in the mouth, impaired sense of smell, burning sensation in the mouth; leukocytosis (transient).

Contraindications

Pregnancy, hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

Pediatric Use

Use with caution in children.

Special Precautions

Use is possible only by qualified personnel in a specialized department under antiseptic conditions.

Use with caution in children.

Drug Interactions

When used against the background of treatment with beta-blockers, slow calcium channel blockers, false-negative study results are possible.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.