Kits for radiopharmaceutical preparation with sodium pertechnetate (Tc-99m) injection for diagnosis
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndicationsActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPC
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DMSA 1.5 mgTc-IK-7V09CA02OGYI-T9245/01Technetium (99mTc) succimer injectionDimercaptosuccinic acid1.5 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 GBq6 injection vialsSee in the Summary of Product Charasteristics24 months after radiolabelling: 8 h2-8°C after radiolabelling: ≤ 25°C
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DTPA 9 mgTc-IK-8V09CA01OGYI-T-9244/01Technetium (99mTc) pentate injectionDiethylenetriamino pentaacetic acid9.0 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 GBq6 injection vialsSee in the Summary of Product Charasteristics12 months after radiolabelling: 8 h≤ 25°C after radiolabelling: ≤ 25°C
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EC 2 mgTc-IK-25V09CAOGYI-T-9141/01Technetium (99mTc) EC injectionEthylene-dicysteine2.0 mgVial A
- Disodium hydrogen phosphate dihydrate
- Mannitol
- Ascorbic acid
- Sodium edetate
- Stannous chloride dihydrate
- Ascorbic acid
- Tartaric acid
- Potassium dihydrogen phosphate
- Ascorbic acid
- Dynamic studies of kidney for renal tubular function
0.8–1.6 GBq3 x 4 injection vialsSee in the Summary of Product Charasteristics12 months after radiolabelling: 8 h2-8°C after radiolabelling: ≤ 25°C
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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
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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
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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
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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 h2-8°C
after radiolabelling: ≤ 25°C
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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
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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 h2-8°C
after radiolabelling: ≤ 25°C
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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
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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 h2-8°C
after radiolabelling: 2-8°C