Tektrotyd, 20 micrograms

Specyfikacja
Expiration: 

 

1 year.

 

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

 

Storage: 

 

Store in a refrigerator at 2°C - 8°C. During transportation (not longer than 5 days) up to 35°C.

 

For storage conditions after radiolabelling of the medicinal product. Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

 

Pharmaceutical form: 

 

Kit for radiopharmaceutical preparation

 

White or almost white lyophilisates

 

For radiolabelling with sodium pertechnetate (99mTc) solution

 

Active substance: 

 

Vial I contains 20 micrograms of

 

HYNIC-[D-Phe1,Tyr3-Octreotide] trifluoroacetate

 

The radionuclide is not part of the kit.

 

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)

 

Package: 

 

Glass vials (Type I Ph. Eur.) 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

 

Range of activity: 

 

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.

 

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