Cold kits with Tc-99m labelling for diagnosis

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

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

For Blood Pool
  • In vivo kit

    Product Code

    ATC code

    Marketing Authorisation No.

    For preparation of

    Active ingredient

    Content/vial

    Excipients

    Indications

    Activity for labelling vial

    Vials per kit

    Recommended doses

    Shelf life

    Storage

    SPC

  • PYRON 25 mg

    Tc-IK-5

    V09BA03

    OGYI-T9246/01

    Technetium (99mTc) tin pyrophosphate injection

    Sodium pyrophosphate

    25.0 mg

    • Stannous chloride dihydrate
    • Sodium chloride
    • Bone and acute myocardial infarct scintigraphy
    • Blood pool scintigraphy
    • Spleen scintigraphy

    1.3–3.0 GBq

    6 injection vials

    See in the Summary of Product Charasteristics

    12 months
    after radiolabelling: 3 h

    ≤ 25°C
    after radiolabelling: ≤ 25°C


For Bone Scintigraphy
  • In vivo kit

    Product Code

    ATC code

    Marketing Authorisation No.

    For preparation of

    Active ingredient

    Content/vial

    Excipients

    Indications

    Activity for labelling vial

    Vials per kit

    Recommended doses

    Shelf life

    Storage

    SPC

  • MDP 5 mg

    Tc-IK-10

    V09BA02

    OGYI-T9702/01

    Technetium (99mTc) medronate injection

    Medronic acid

    5.0 mg

    • Stannous chloride dihydrate
    • Ascorbic acid
    • Urea

    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

    3.0–6.0 GBq

    6 injection vials

    See in the Summary of Product Charasteristics

    12 months
    after radiolabelling: 6 h

    2-8°C
    after radiolabelling: ≤ 25°C


For Myocardial Perfusion Scintigraphy
  • In vivo kit

    Product Code

    ATC code

    Marketing Authorisation No.

    For preparation of

    Active ingredient

    Content/vial

    Excipients

    Indications

    Activity for labelling vial

    Vials per kit

    Recommended doses

    Shelf life

    Storage

    SPC

  • MIBITop 1 mg

    Tc-IK-81

    V09GA01

    OGYI-T-23814/01

    Technetium (99mTc) sestamibi injection

    [tetrakis (1-isocyanide-2-methoxy-2-methylpropyl-)copper(I)] tetrafluoroborate

    1.0 mg

    • Cysteine hydrochloride monohydrate
    • Sodium citrate
    • Stannous chloride dihydrate
    • D-Mannitol
    • 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.

    max. 15.0 GBq

    6 injection vials

    See in the Summary of Product Charasteristics

    24 months
    after radiolabelling: 16 h

    2-8°C
    after radiolabelling: ≤ 25°C


For Examination of the Liver- and Hepatobiliary System
  • In vivo kit

    Product Code

    ATC code

    Marketing Authorisation No.

    For preparation of

    Active ingredient

    Content/vial

    Excipients

    Indications

    Activity for labelling vial

    Vials per kit

    Recommended doses

    Shelf life

    Storage

    SPC

  • FYTON 15 mg

    Tc-IK-2

    V09DB07

    OGYI-T9288/01

    Technetium (99mTc) phytate injection

    Sodium phytate

    15.0 mg

    • Stannous chloride dihydrate
    • Sodium chloride
    • 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.)

    0.8–1.6 GBq

    6 injection vials

    See in the Summary of Product Charasteristics

    12 months
    after radiolabelling: 3 h

    ≤ 25°C
    after radiolabelling: ≤ 25°C

  • TECHIDA 30 mg

    Tc-IK-6

    V09DA02

    OGYI-T-9210/01

    Technetium (99mTc) etifenin injection

    Diethyl-acetanilid-imino diacetic acid

    30.0 mg

    • Stannous chloride dihydrate
    • Ascorbic acid
    • 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

    0.8–1.6 GBq

    6 injection vials

    See in the Summary of Product Charasteristics

    24 months
    after radiolabelling: 6 h

    2-8°C
    after radiolabelling: 2-8°C

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