Tektrotyd, 16 micrograms

Specyfikacja
Expiration: 

Shelf life of the kit: 1 year
Labelled product must be stored at temperature below 25°C and used within 6 hours after preparation.

Storage: 

Store the kit in a refrigerator at 2°C - 8°C.
During transportation (not longer than 7 days) up to 35°C.
Expiry date is indicated on the package.
After labelling, store the medicinal product for no more than 6 hours at temperature below 25°C using appropriate radiation shielding. Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials.

Pharmaceutical form: 

Kit for radiopharmaceutical preparation.
Lyophilisate for solution for injection.

Active substance: 

Vial I contains:
HYNIC-[D-Phe1,Tyr3-Octreotide]•TFA, 16 micrograms
The radionuclide is not part of the kit.

Excipients: 

Vial I:
Tricine (N-[Tris(hydroxymethyl)methyl]glycine
Tin (II) chloride dihydrate
Mannitol
Nitrogen
Vial II:
EDDA (ethylenediamine-N,N’-diacetic acid)
Disodium hydrogen phosphate dodecahydrate
Sodium hydroxide
Nitrogen

Package: 

The kit package contains two glass vials (Vial I and Vial II) of 10 ml volume, closed with a rubber stopper and an aluminium crimp cap. The vials are supplied in cardboard boxes. Vials I and II contain components for preparation of a radiopharmaceutical 99mTc-Tektrotyd.

Indications: 

99mTc-Tektrotyd, kit for radiopharmaceutical preparation is for diagnostic use only. 99mTc-Tektrotyd is a radiopharmaceutical indicated for diagnostics of pathological lesions in which  somatostatin receptors are overexpressed (particularly subtype 2 and, to a lesser extent, subtypes 3 and 5) and which may be imaged by the labelled ligand.
In particular, these are:
- gastro-entero-pancreatic neuroendocrine tumours (GEP-NET);
- pituitary adenomas;
- tumours originating in a sympathetic system; pheochromocytoma, paraganglioma, neuroblastoma, ganglioneurinoma etc.;
- medullary thyroid carcinoma;
- the preparation may be potentially useful in the case of other tumours expressing somatostatin receptors of various intensity. Other tumours which may overexpress somatostatin receptors: breast cancer, melanoma, lymphomas, prostate cancer, NSCLC, sarcoma, renal cell carcinoma, differentiated thyroid carcinoma, astrocytoma according to WHO I-IV (including glioblastoma multiforme G-M), meningiomas, ovarian cancer.

Załączniki: 
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