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Radiopharmaceutical Business Unit

 

Introduction film

Virtual tour

Export Production Schedule 2017 for Radiopharmaceutical products

Product catalogue 2017

 

In Vivo Products for Human Diagnosis and Therapy

(See Product List below)

IZOTOP’s facility licensed for operating at a high level of radioactivity is located near to the Budapest research reactor. The level “A” isotope laboratory includes hot cell lines for the chemical and pharmaceutical processing of radionuclides. In addition, clean-room facilities in the radioactive and non-radioactive zones are available for production of radiopharmaceuticals and cold-kits, respectively. IZOTOP is a licensed company, possessing a GMP Certificate for pharmaceutical preparation as well. IZOTOP is licensed also for manufacturing of active pharmaceutical ingredients as well as investigational products for clinical trials.

Production of Radioisotopes

Radionuclides from neutron irradiation are mainly produced as raw materials for radiopharmaceutical preparations or as radiochemicals. The regularly prepared radioisotopes for in vivo use are 90Y, 131I and 153Sm while 125I is manufactured for labelling of various tracers used in life sciences or by „in vitro diagnostic products”. Furthermore 166Ho and 177Lu are also manufactured for labelling novel compounds. Certain reactor isotopes are available on request from time to time.

In Vivo Radiopharmaceuticals

99mTc Radiopharmaceutical Kits

cold_kit

Cold kits for 99mTc-labelling fully meet the clinical requirements for studying renal, bone and hepatobiliary systems. DMSA provides excellent renal imaging as well as a possibility to determine the the functional mass of kidneys. DTPA and EC (Ethylene-L, L-dicysteine) are used for studying the dynamics of the glomerular and tubular function, respectively. DTPA can also be used for liquor circulation studies.

MDP is the most commonly used bone-seeking agent. Using IZOTOP’s FYTON kit, the colloid forming under in vivo conditions is suitable for both liver scintigraphy and for the detection of internal bleeding. TECHIDA is available for dynamic studies of the liver cell function and hepatobiliary excretion; PYRON in an agent for labeling red blood cells for blood-pool or spleen scintigraphy.

Palliative Therapy

EDTMP (MULTIBONE) kit is manufactured for labelling either with 90Y or with 153Sm-precursors to obtain agents for palliative therapy of painful bone metastases.

131I Radiopharmaceutical

131I sodium-iodide is formulated in solution and is available as „ThyroTop” capsules.
131I-MIBG is produced for imaging and the therapeutic treatment of neuroendocrine tumors.

Radiopharmaceutical Products

SYNOPHYT (sodium phytate) kit for radiopharmaceutical preparation HO-IK-27

In Vivo Kits (Powders for Solution for Injection)

Code

Renal Studies

DMSA (dimercapto succinic acid) Tc-Kit Tc-IK-7
DTPA (diethylenetriamine pentaacetate) Tc-Kit Tc-IK-8
EC (ethylenedicysteine) Tc-Kit Tc-IK-25

cold_kits

Bloodpool Scintigraphy

PYRON (sodium pyrophosphate) Tc-Kit Tc-IK-5

Examination of the Liver and Hepatobiliary System

FYTON (sodium phytate) Tc-Kit Tc-IK-2
TECHIDA Tc-Kit Tc-IK-6

Bone Scintigraphy

MDP (methylene diphosphonate) Tc-Kit Tc-IK-10

Bone Scintigraphy / Palliative Treatment of Bone Metastases

Sm-MULTIBONE (EDTMP) Kit Sm-IK-26
Y-MULTIBONE (EDTMP) Kit
for Labelling with Sm-153 or Y-90 Radionuclides
Y-IK-26
Multibone Information for Doctors
Multibone Information for Patients
Isotope Treatment and Bone Pain (downloadable in a PDF-file / 269 Kb)

Preparations for Labelling in Vivo Kits

Sm-153 Samarium Chloride Radioactive Precursor for labelling MULTIBONE kit Sm-RA-26
Y-90 Yttrium Chloride Precursor Y-RA-26
Ho-166 holmium chloride radioactive precursor for labelling SYNOPHYT kit HO-RA-27

Radioactive Drug Substances

I-131 Sodium Iodide Non-Sterile Solution, Drug Substance I-RA-5
I-131 Sodium Iodide Sterile Solution Drug Substance I-RA-7

Radiopharmaceuticals

I-131 Sodium Iodide 20 MBq/ml Oral Solution I-RA-6
ThyroTop I-131 Sodium Iodide Hard Capsules / Diagnostic I-RA-7/D
ThyroTop I-131 Sodium Iodide Hard Capsules / Therapeutic I-RA-7/k
Applicator for Removing I-131 Capsule from Container
I-131 MIBG 20 MBq/ml Injection for Diagnostic Use I-RAO-1
I-131 MIBG 370 MBq/ml Injection for Therapy I-RAO-2

Radiochemicals

I-125 Sodium Iodide Solution for Labelling I-RB-4
High Purity I-125 Sodium-Iodide Solution for Labelling I-RB-41

HeliCap

Diagnosis of Helicobacter Pylori
(See: www.kibion.com)

Presentation of the Packaging of Our Radiopharmaceutical Products:

PDF version (615 KB)                Presentation (3,12 MB)

NEW LABELS (product label samples) according to the EU template:

DMSA Tc-kit box label

DMSA Tc-kit vial label

DTPA Tc-kit box label

DTPA Tc-kit vial label

EC Tc-kit box label

EC Tc-kit vial A label

EC Tc-kit vial B label

EC Tc-kit vial C label

Pyron Tc-kit box label

Pyron Tc-kit vial label

Fyton Tc-kit box label

Fyton Tc-kit vial label

Techida Tc-kit box label

Techida Tc-kit vial label

MDP Tc-kit box label

MDP Tc-kit vial label

Sm-MULTIBONE kit box label

Sm-MULTIBONE kit vial label

Y-MULTIBONE kit box label

Y-MULTIBONE kit vial label

Empty vial label concerning in vivo kits

Sm-153 precursor box label

Sm-153 precursor lead container label

Sm-153 precursor vial label

Y-90 precursor box label

Y-90 precursor lead container label

Y-90 precursor vial label

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ThyroTop (4.00 MBq) box label

ThyroTop (4.00 MBq)lead container label

ThyroTop (1110.00 MBq) lead container label

I-131 MIBG injection for diagnostic use (20 MBq) box label

I-131 MIBG injection for diagnostic use (20 MBq) lead container label

I-131 MIBG injection for diagnostic use (20 MBq) vial label

I-131 MIBG injection for diagnostic use (40 MBq) box label

I-131 MIBG injection for diagnostic use (40 MBq) lead container label

I-131 MIBG injection for diagnostic use (40 MBq) vial label

I-131 MIBG injection for diagnostic use (80 MBq) box label

I-131 MIBG injection for diagnostic use (80 MBq) lead container label

I-131 MIBG injection for diagnostic use (80 MBq) vial label

I-131 MIBG injection for therapy box label

I-131 MIBG injection for therapy lead container label

I-131 MIBG injection for therapy vial label

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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