Publisher: ROTOP Pharmaka GmbH, Bautzner Landstrasse 400, 01328 Dresden, Germany, Phone: +49 351 26 31 02 10, Fax: +49 351 26 31 03 13, e-mail: service@rotop-pharmaka.de
TEKTROTYD 16 micrograms kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
|
Kit for radiopharmaceutical preparation. White or almost white lyophilisates. For radiolabelling with sodium pertechnetate (99mTc) solution. |
Vial I contains 16 µg of HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt.
Vial II contains 10 mg of EDDA (Etylenediamine-N,N'-diacetic acid).
For a full list of excipients, see section 6.1.
The radionuclide is not part of the kit.
| Active Ingredient | Description | |
|---|---|---|
| Technetium ⁹⁹ᵐTc hynic-octreotide |
Technetium ⁹⁹ᵐTc hynic-octreotide is for diagnostic use only. Technetium (99mTc) labelled EDDA/HYNIC-TOC binds with high affinity to somatostatin receptor subtypes 2 and 5, also to subtype 3 but with lesser affinity. |
| List of Excipients |
|---|
|
Vial I: Tricine (N-[tris(hydroxymethyl)methyl]glycine) Vial II: Disodium hydrogen phosphatedodecahydrate |
Glass vials (Type I Ph. Eur.) of 10 mL nominal capacity, sealed with a rubber stopper and an aluminium cap with flip off seal.
Vials I and II contain components for the radiopharmaceutical preparation of 99mTcEDDA/HYNIC-TOC.
Each vial contains a white or nearly white lyophilisate for preparation of a solution for injection.
Vial I: active substance: HYNIC-[D-Phe1, Tyr3octreotide] TFA salt, excipients: stannous chloride dihydrate, tricine (N[Tris(hydroxymethyl)methyl]glycine), mannitol, nitrogen
Vial II: active substance: EDDA (ethylenediamine-N,N'-diacetic acid), excipients: disodium hydrogen phosphate dodecahydrate, sodium hydroxide, nitrogen
Pack size: 2 vials.
ROTOP Pharmaka GmbH, Bautzner Landstrasse 400, 01328 Dresden, Germany, Phone: +49 351 26 31 02 10, Fax: +49 351 26 31 03 13, e-mail: service@rotop-pharmaka.de
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