Therapeutic indications:

This medicinal product is for diagnostic use only.

After radiolabelling with sodium pertechnetate (^99mTc) solution, the solution of ^99mTc-Tektrotyd obtained is indicated for use in adults as adjunct in the diagnosis and management of somatostatin receptor bearing neuroendocrine tumours (NET), by aiding their localization.

Tumours which do not bear somatostatin receptors will not be visualised.

Qualitative and quantitative compositions:

Vial I contains:

• • • 20 micrograms of HYNIC-[D-Phe¹,Tyr³-Octreotide] trifluoroacetate.

The radionuclide is not part of the kit.

Pharmaceutical form:

Kit for radiopharmaceutical preparation.

White or almost white lyophilisates.

For radiolabelling with sodium pertechnetate (^99mTc) solution.

List of excipients:

Vial I:

N-[tris(hydroxymethyl)methyl]glycine (Tricine)

Stannous chloride dihydrate

Mannitol

Sodium hydroxide for pH adjustment

Hydrochloric acid for pH adjustment

Nitrogen (protective gas)

Vial II: Ethylenediamine-N,N’-diacetic acid (EDDA)

Disodium phosphate dodecahydrate

Sodium hydroxide

Sodium hydroxide for pH adjustment

Hydrochloric acid for pH adjustment

Nitrogen (protective gas)

Posology and method of administration:

Adults

The suggested activity range is 370 to 740 MBq in one single intravenous injection. The activity to be administered depends on the available equipment.

Elderly population (above 65 years)

No dose adjustment is required for elderly.

Renal impairment

Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Hepatic impairment

Dosage reduction in hepatic impairment is not necessary. 

Paediatric population

There are no data on safety and efficacy of ^99mTc-Tektrotyd for the use in paediatric patients.

If alternative techniques not using ionising radiation are not available, the use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. Because of the potential hazard of ionising radiation, ^99mTc-Tektrotyd should not be used in children under 18 years of age, unless the value of the expected clinical information is considered to outweigh the possible risk from radiation.

^99mTc-Tektrotyd is administered intravenously in a single dose. This medicinal product should be radiolabelled before administration to the patient.

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

Shelf life:

1 year.

After reconstitution and radiolabelling 4 hours when stored below 25°C.

Special precautions for storage:

Store in a refrigerator at 2–8°C.

During transportation (not longer than 5 days) up to 35°C.

After radiolabelling of the medicinal product, at a temperature below 25°C in a suitable radiation lead shield.

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

Nature and content of container:

Glass vials of 10 mL nominal capacity, sealed with a bromobutyl stopper and an aluminium cap.

The aluminium cap for vial I is blue and the aluminium cap for vial II is white in order to distinguish vial I from vial II during the reconstitution/ radiolabelling procedure.

Vials I and II contain components for the radiopharmaceutical preparation of ^99mTc-Tektrotyd. Each vial contains a white or nearly white lyophilisate for preparation of a solution for injection.

Vial I

active substance: HYNIC-[D-Phe¹,Tyr³-Octreotide] trifluoroacetate, excipients: stannous chloride dihydrate, N-[Tris(hydroxymethyl)methyl] glycine (tricine), mannitol, sodium hydroxide or hydrochloric acid for pH adjustment, nitrogen

Vial II

excipients: ethylenediamine-N,N’-diacetic acid (EDDA), disodium phosphate dodecahydrate, sodium hydroxide, sodium hydroxide or hydrochloric acid for pH adjustment, nitrogen

Pack size: 2 vials.