Therapeutic indications:

Radiation therapy of tumour-tissue that is capable of retaining iobenguane.

These are tumours arising from cells originating embryologically from the neural crest: pheochromocytomas, neuroblastomas, carcinoids and medullary carcinomas of the thyroid gland (MCT).

Qualitative and quantitative compositions:

Iobenguane (¹³¹I): 370–740 MBq/mL

Excipients with known effect:

Benzyl alcohol – 10 mg/mL

Sodium chloride – 0.026–9 mg/mL.

Pharmaceutical form:

Solution for injection.

Clear, colourless or light yellow solution.

List of excipients:

Sodium metabisulphite

Copper(II) sulphate pentahydrate

Sodium acetate trihydrate

Acetic acid

Benzyl alcohol

Sodium chloride

Water for injection

Posology and method of administration:

There is two-way selection of therapeutic activity of iobenguane (¹³¹I).

Iobenguane (131I) can be administered:

• • • Therapeutic dose with an amount of iobenguane (¹³¹I) individually
      tailored on the basis of a dosimetric study. The dose as well as the interval(s) between possible multiple administrations are mainly determined by haematological radio-toxicity and the kind of tumour. The more rapid the rate of progression of the tumour, the shorter the interval.
    • The „fixed” therapeutic dose (usually 3.7–11.1 GBq).

These recommended dosages are identical for children (must not be given to premature babies or neonates) and adults.

No special dosage scheme is required for the elderly patient.

The therapeutic dose is administered intravenously, generally as an infusion over a period 1.5–4 hours. About 1 hour prior to administration the vial of iobenguane (¹³¹I) contained within its lead shield should be thawed by placing it in a water bath at temperature not exceeding 50°C. It is recommended that after thawing immediately prior to administration by intravenous infusion, the dose be diluted with 50 mL sterile physiological saline for infusion.

For detailed information on dosage and method of administration please refer to the Summary of Product Characteristics.

Shelf life:

4 days from the manufacturing date (expiry date is stated on the label).

Special precautions for storage:

Store in original at the temperature below [-15°C] in accordance with regulations for radiation safety (Atomic Low).

Protect from light.

After defrosting store below 25°C for up to 2 hours.

Transport in dry ice.

Storage should be in accordance with national regulations for radioactive materials.

Nature and content of container:

The product is supplied in 10 mL glass vials, with a possibility of drawing multidoses in an aseptic way. The vials are capped with rubber stoppers and aluminium caps and placed inside a shielded lead container. The outer transport packaging is a metal tin with styrofoam insert.

Every source is accompanied with a certificate of radioactivity.