Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Sodium medronate
laboratory: GE Healthcare Sas
IM Injectable Solution
Kit of 5 Vials of 8.59 mg Powder
This medicine is for diagnostic use only.
After reconstitution with sodium pertechnetate solution ( 99m Tc), this product can detect areas of abnormal osteogenesis by bone scintigraphy.
Dosage AMERSCAN MEDRONATE II IM Injectable Solution Kit of 5 vials of 8.59 mg powder
Strict intravenous administration.
In adults, the recommended activity is 500 MBq.
Different activities can be justified (300 to 700 MBq).
The images obtained immediately after the injection (for example in the so-called "3-phase bone scintigraphy" protocol) only partially reflect the bone metabolic activity. Late static scintigraphy is performed at least 2 hours after the injection. The patient must urinate before acquiring the scintigraphic images.
In children, the activity to be injected is a fraction of that recommended in adults, fraction obtained by applying the coefficients below according to body mass.
3kg = 0.1
22kg = 0.50
42kg = 0.78
4kg = 0.14
24kg = 0.53
44kg = 0.80
6kg = 0.19
26kg = 0.56
46kg = 0.82
8kg = 0.23
28kg = 0.58
48kg = 0.85
10kg = 0.27
30kg = 0.62
50kg = 0.88
12kg = 0.32
32kg = 0.65
52-54kg = 0.90
14kg = 0.36
34kg = 0.68
56-58kg = 0.92
16kg = 0.40
36kg = 0.71
60-62kg = 0.96
18kg = 0.44
38kg = 0.73
64-66kg = 0.98
20kg = 0.46
40kg = 0.76
68kg = 0.99
In very young children (up to 1 year old) a minimum activity of 40 MBq is required to obtain images of satisfactory quality.
Known hypersensitivity to the active substance or to any of the excipients.
Adverse effects Amerscan Medronate II
For each patient, exposure to ionizing radiation must be justified by the expected benefit. The administered activity should correspond to the lowest possible dose of radiation compatible with obtaining the expected diagnostic information.
Exposure to ionizing radiation can theoretically induce cancer and / or hereditary abnormalities. In the case of a diagnostic nuclear medicine examination, it is generally considered that the frequency of these risks is negligible due to the low doses of radiation delivered.
For most diagnostic nuclear medicine examinations, the radiation dose delivered (E: effective dose) is less than 20 mSv. Higher doses may be medically justified in some cases.
Hypersensitivity reactions, including very rare potentially life-threatening anaphylaxis, may occasionally occur during intravenous administration of technetium ( 99m Tc) medronate (approximately 0.5 per 100, 000 tests). Cases of local or general erythema with itching and skin irritation have been observed; usually beginning a few hours after the injection and can last up to 48 hours. Treatment with non-sedating anti-histamine H1 may provide an improvement.
Other reactions have been reported such as drop in blood pressure and symptoms of hypotension, nausea, vomiting, cutaneous vasodilatation, headache, malaise, extremity edema and arthralgia.