Kits for radiopharmaceutical preparation with sodium pertechnetate (Tc-99m) injection for diagnosis

For Renal StudiesView listClose listNext group

In vivo kit DMSA 1.5 mg
DTPA 9 mg
EC 2 mg
Product Code Tc-IK-7 Tc-IK-8 Tc-IK-25
ATC code V09CA02 V09CA01 V09CA
Marketing Authorisation No. OGYI-T9245/01 OGYI-T-9244/01 OGYI-T-9141/01
For preparation of Technetium (99mTc) succimer injection Technetium (99mTc) pentate injection Technetium (99mTc) EC injection
Active ingredient Dimercaptosuccinic acid Diethylenetriamino pentaacetic acid Ethylene-dicysteine
Content/vial 1.5 mg 9.0 mg 2.0 mg
Excipients Stannous chloride dihydrate Stannous chloride dihydrate Vial A Vial B Vial C
Ascorbic acid Ascorbic acid Disodium hydrogen phosphate dihydrate Stannous chloride dihydrate Potassium dihydrogen phosphate
Calcium gluconate Sodium chloride Mannitol Ascorbic acid Ascorbic acid
Ascorbic acid Tartaric acid
Sodium edetate
Indications
  • Kidney scintigraphy, static kidney imaging, localisation of the kidneys with imaging
  • Dynamic studies of kidney, determination of kidney perfusion, glomerural filtration rate, total and partial kidney function
  • Dynamic studies of kidney for renal tubular function
  • Determination of the functional mass of the kidney
  • Examination of the cerebral blood circulation
  • Determination of the relative function ratio (percentage) of the left and right kidneys
  • Examination of the gastrointestinal tract by using labelled foodstuff or drink
  • Examination of liquor circulation
Activity for labelling vial 1.0–1.8 GBq 0.8–2.4 GBq 0.8–1.6 GBq
Vials per kit 6 injection vials 6 injection vials 3 x 4 injection vials
Recommended doses See in the Summary of Product Charasteristics
Shelf life 24 months 12 months 12 months
after radiolabelling: 8 h after radiolabelling: 8 h after radiolabelling: 8 h
Storage 2-8°C  ≤ 25°C 2-8°C
after radiolabelling: ≤ 25°C after radiolabelling: ≤ 25°C after radiolabelling: ≤ 25°C
SPC

For Blood Pool, spleen scintigraphy, imaging of acute myocardial infarct, bone scintigraphyView listClose listNext group

In vivo kit PYRON 25 mg
Product Code Tc-IK-5
ATC code V09BA03
Marketing Authorisation No. OGYI-T9246/01
For preparation of Technetium (99mTc) tin pyrophosphate injection
Active ingredient Sodium pyrophosphate
Content/vial 25.0 mg
Excipients
  • Stannous chloride dihydrate
  • Sodium chloride
Indications
  • Bone and acute myocardial infarct scintigraphy
  • Blood pool scintigraphy
  • Spleen scintigraphy
Activity for labelling vial 1.3–3.0 GBq
Vials per kit 6 injection vials
Recommended doses See in the Summary of Product Charasteristics
Shelf life 12 months
after radiolabelling:   3 h
Storage  ≤ 25°C
after radiolabelling: ≤ 25°C
SPC

For Bone ScintigraphyView listClose listNext group

In vivo kit MDP 5 mg
Product Code Tc-IK-10
ATC code V09BA02
Marketing Authorisation No. OGYI-T9702/01
For preparation of Technetium (99mTc) medronate injection
Active ingredient Medronic acid
Content/vial 5.0 mg
Excipients
  • Stannous chloride dihydrate
  • Ascorbic acid
  • Urea
Indications
  • For bone scintigraphy (diagnostic skeletal imaging)

Use of the preparation is highly recommended for:

    • Primer bone tumours
    • Metastases of other tumours, for example prostate/breast/lung cancer
    • Osteomyelitis
    • Metabolic bone diseases
    • Paget’s disease
Activity for labelling vial 3.0–6.0 GBq
Vials per kit 6 injection vials
Recommended doses See in the Summary of Product Charasteristics
Shelf life 12 months
after radiolabelling: 6 h
Storage 2-8°C
after radiolabelling: ≤ 25°C
SPC

For Myocardial Perfusion ScintigraphyView listClose listNext group

In vivo kit MIBITop 1 mg
Product Code Tc-IK-81
ATC code V09GA01
Marketing Authorisation No. OGYI-T-23814/01
For preparation of Technetium (99mTc) sestamibi injection
Active ingredient [tetrakis (1-isocyanide-2-methoxy-2-methylpropyl-)copper(I)] tetrafluoroborate
Content/vial 1.0 mg
Excipients
  • Cysteine hydrochloride monohydrate
  • Sodium citrate
  • Stannous chloride dihydrate
  • D-Mannitol
Indications
  • Myocardial perfusion scintigraphy for the detection and localisation of coronary artery disease (angina pectoris and myocardial infarction)
  • Assessment of global ventricular function.

First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion

  • Scintimammography for the detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate
  • Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands.
Activity for labelling vial max. 15.0 GBq
Vials per kit 6 injection vials
Recommended doses See in the Summary of Product Charasteristics
Shelf life 24 months
after radiolabelling: 16 h
Storage 2-8°C
after radiolabelling: ≤ 25°C
SPC

For Examination of the Liver- and Hepatobiliary SystemView listClose listNext group

 

In vivo kit FYTON 15 mg
TECHIDA 30 mg
Product Code Tc-IK-2 Tc-IK-6
ATC code V09DB07 V09DA02
Marketing Authorisation No. OGYI-T9288/01 OGYI-T-9210/01
For preparation of Technetium (99mTc) phytate injection Technetium (99mTc) etifenin injection
Active ingredient Sodium phytate Diethyl-acetanilid-imino diacetic acid
Content/vial 15.0 mg 30.0 mg
Excipients
  • Stannous chloride dihydrate
  • Sodium chloride
  • Stannous chloride dihydrate
  • Ascorbic acid
Indications
  • Morphological examination of the liver by imaging technique
  • Diagnosis of benign and malignant liver tumours and monitoring of the therapy
  • Dynamic examination of flow disorders in the hepatobiliary system (blockage in the biliary duct, etc.)
  • Dynamic examination of the function of the hepatocytes
  • Liver transplant evaluation
  • Dynamic examination of flow disorders in the hepatobiliary system (blockage in the biliary duct, etc.)
  • Examination of the acute cholecystitis
  • Diagnosis of focalis nodular hyperplasia
Activity for labelling vial 0.8–1.6 GBq 0.8–1.6 GBq
Vials per kit 6 injection vials 6 injection vials
Recommended doses See in the Summary of Product Charasteristics
Shelf life 12 months 24 months
after radiolabelling: 3 h after radiolabelling: 6 h
Storage ≤ 25°C  2-8°C
after radiolabelling: ≤ 25°C after radiolabelling:  2-8°C
SPC