EU Binding Tariff Information
HS Code : | 3006.30 | |
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CN Code : | 3006.30.••.•• | |
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BTI Reference :
Issuing Country :
SLOVENIA
Date Of Issue : 05.Nov.2026 - 04.Nov.2029
Diagnostic agent for use in patients, packaged as a kit. Used in nuclear medicine as a radiotracer for positron emission tomography (PET) imaging to localize neuroendocrine tumors (NET) in adults and children. Contains lyophilized powder with oxodotreotide, which is radiolabeled with gallium-68 in the laboratory prior to use. After intravenous injection of the prepared solution, the radiolabeled compound selectively binds to neuroendocrine tumors, enabling clear visualization during PET scans. Packaged as a kit containing one vial of lyophilized powder and one vial of buffer solution.
Description auto translated : Diagnostic agent intended for use in patients, supplied in a kit format. This diagnostic agent is used in nuclear medicine as a radiotracer for positron emission tomography (PET) imaging. It is indicated for the localization of neuroendocrine tumors (NET) in adults and children. The lyophilized powder contains the active ingredient dotatate (oxodotreotide), which is radioactively labeled with gallium-68 isotope prior to use in the laboratory. After intravenous injection of the prepared solution, the radiolabeled agent selectively binds to neuroendocrine tumors, enabling their clear visualization during PET imaging. Supplied in a kit format containing one vial of lyophilized powder and one vial of buffer solution.
Original Description: Diagnostično sredstvo, namenjeno uporabi na bolniku, pakirano v kompletu.
Diagnostično sredstvo se v nuklearni medicini uporablja kot označevalec pri slikanju s pozitronsko emisijsko tomografijo (PET scans). Namenjeno je lokalizaciji nevroendokrinih tumorjev (NET) pri odraslih in otrocih.
Liofiliziran prah vsebuje učinkovino dotatat (oxodotreotide), ki se ga pred uporabo v laboratoriju radioaktivno označi z izotopom galij-68 . Po intravenskem vbrizganju pripravljene raztopine se radiooznačena učinkovina selektivno veže na nevroendokrine tumorje, kar omogoča njihovo jasno prikazovanje pri PET-preiskavi.
Pakirano v obliki kompleta, ki vsebuje eno vialo z liofiliziranim prahom ter eno vialo s pufersko raztopino.
Source : EU Binding Tariff Information
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