Cold kits for radiopharmaceutical preparation with sodium pertechnetate (Tc-99m) injection for diagnosis
For Renal Studies
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndicationsActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPCSPC/RU
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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 -
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 -
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 Charasteristics24 months after radiolabelling: 8 h2-8°C after radiolabelling: ≤ 25°C
For Blood Pool
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndicationsActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPCSPC/RU
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PYRON 25 mgTc-IK-5V09BA03OGYI-T9246/01Technetium (99mTc) tin pyrophosphate injectionSodium pyrophosphate25.0 mg
- Stannous chloride dihydrate
- Sodium chloride
- Bone and acute myocardial infarct scintigraphy
- Blood pool scintigraphy
- Spleen scintigraphy
1.3–3.0 GBq6 injection vialsSee in the Summary of Product Charasteristics12 months after radiolabelling: 3 h≤ 25°C after radiolabelling: ≤ 25°C
For Bone Scintigraphy
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndicationsActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPCSPC/RU
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MDP 5 mgTc-IK-10V09BA02OGYI-T9702/01Technetium (99mTc) medronate injectionMedronic acid5.0 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 GBq6 injection vialsSee in the Summary of Product Charasteristics12 months after radiolabelling: 6 h2-8°C after radiolabelling: ≤ 25°C
For Myocardial Perfusion Scintigraphy
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndications/PosologyActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPCSPC/RU
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MIBITop 1 mgTc-IK-81V09GA01OGYI-T-23814/01Technetium (99mTc) sestamibi injection[tetrakis (1-isocyanide-2-methoxy-2-methylpropyl-)copper(I)] tetrafluoroborate1.0 mg
- Cysteine hydrochloride monohydrate
- Sodium citrate
- Stannous chloride dihydrate
- D-Mannitol
- Diagnosis of reduced coronary perfusion and myocardial infarction: 400 – 900 MBq
- Diagnosis of ischaemic heart disease:
- Two-day protocol: 600 – 900 MBq /study
- One-day protocol: 400 – 500 MBq for the first injection, three times more for the second injection
- Assessment of global ventricular function: 600 – 800 MBq injected as a bolus
- Scintimammography: 700 – 1000 MBq injected as a bolus
- Localisation of hyperfunctioning parathyroid tissue: 200 – 700 MBq injected as a bolus
max. 15.0 GBq6 injection vialsSee in the Summary of Product Charasteristics24 months after radiolabelling: 16 h2-8°C after radiolabelling: ≤ 25°C
For Examination of the Liver- and Hepatobiliary System
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In vivo kitProduct CodeATC codeMarketing Authorisation No.For preparation ofActive ingredientContent/vialExcipientsIndicationsActivity for labelling vialVials per kitRecommended dosesShelf lifeStorageSPCSPC/RU
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FYTON 15 mgTc-IK-2V09DB07OGYI-T9288/01Technetium (99mTc) phytate injectionSodium phytate15.0 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
0.8–1.6 GBq6 injection vialsSee in the Summary of Product Charasteristics12 months after radiolabelling: 3 h≤ 25°C after radiolabelling: ≤ 25°C -
TECHIDA 30 mgTc-IK-6V09DA02OGYI-T-9210/01Technetium (99mTc) etifenin injectionDiethyl-acetanilid-imino diacetic acid30.0 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
- Verification of focal nodular hyperplasia
0.8–1.6 GBq6 injection vialsSee in the Summary of Product Charasteristics24 months after radiolabelling: 6 h2-8°C after radiolabelling: 2-8°C