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Generators & Kits

SAM Nordic provides several generators and kits for the preparation of radiopharmaceuticals.

SOMAKIT TOC

SomaKit TOC is the first ever approved kit for preparation of a PET radiopharmaceutical.

After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.

Gallium (68Ga) edotreotide binds to somatostatin receptors. In vitro, this radiopharmaceutical binds with high affinity mainly to SSTR2 but also, to a lesser extent, to SSTR5.

The kit reduce the preparation time substantially as well as the time for the quality control compared to production of Ga-68 Dotatoc.

SomaKit TOC was approved by the European Medicines Agency in December 2016 and was placed on the Scandinavian market the 1st of September 2017.

 

For more information see Summary of product characteristics (SmPC).

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004140/human_med_002038.jsp&mid=WC0b01ac058001d124

 

SAMMIBI

Kit for the preparation of 99mTc-MIBI used for intravenous injection after radiolabelling with sodium 99mTc pertechnetate solution and is indicated for:

  • Diagnosis of ischaemic heart disease.
  • Diagnosis and localisation of myocardial infarction.
  • Assessment of global ventricular function.
  • Diagnostic aid for detection of hyperparathyroidism.

 

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Sammibi

NephroMAG

This is a kit for the preparation of a radioactive solution for injection. After radiolabelling with sodium pertechnetate( 99mTc) solution, the solution of technetium-( 99mTc) mertiatide, is used for the evaluation of nephrological and urological disorders in particular for the study of function, morphology and perfusion of the kidneys and characterisation of urinary outflow.

Preparation time approximately15 minutes.
No boiling needed on preparation of this product.

 

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NephroMAG

NanoHSA / Nanotop

Used for scintigraphic imaging examination (by means of a radioactive tracer and a special camera) and assessment of

  • Sentinel lymph nodes in tumor diseases (Sentinel Node Mapping).
  • Lymphatic system integrity and to distinguish venous from lymphatic obstruction(blockage in the venous and lymphatic flow of the bone marrow.
  • Inflammation scanning.

Preparation time approximately 10 minutes.

 

TEKTROTYD

Kit for the preparation of 99mTc-TEKTROTYD used for intravenous injection after radiolabelling with sodium 99mTc pertechnetate solution and is indicated for diagnostics of pathological lesions in which somatostatin receptors are overexpressed (particularly subtype 2 and, to a lesser extent, subtypes 3 and 5).

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

This kit is a registered pharmaceutical since 2016.

POLTECHNET

99Mo/99Tc Poltechnet generator. The eluate from the generator (sodium pertechnetate (99mTc) injection ).

Registered in Denmark and Sweden as a medicinal product for diagnostic use only.