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 Charasteristics12 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/vialExcipientsIndicationsActivity 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
- 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 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
- Dynamic examination of flow disorders in the hepatobiliary system (blockage in the biliary duct, etc.)
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
- Diagnosis of focalis 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