Medicinal Products

ELUMATIC III

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active Ingredients: Molybdenum Generator [99Mo] / Technetium [99mTc], Technetium-99m
laboratory: Cis Bio International

Radiopharmaceutical generator
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Indication

- This medicine is for diagnostic use only.
- The eluate of the generator, solution for injection of sodium pertechnetate [99mTc] (Ph.Eur.), Can be used as a precursor for the labeling of various compounds supplied in the form of kits, or be administered directly such as:
at. When intravenously injected, sodium pertechnetate [99mTc] injection may be used in the following diagnostic indications:
. Thyroid scintigraphy : imaging and measurement of thyroid fixation to obtain information on the presence of nodules, their size and position as well as the anatomical and functional study of the thyroid.
. Scintigraphy of the salivary glands : anatomic and functional examination.
. Scintigraphy of the ectopic gastric mucosa : Meckel's diverticulum.
. Cerebral scintigraphy : evidence of the involvement of the blood-brain barrier in relation to the presence of tumor, infarction, haemorrhage or edema, when no other method is available.
b. When used for the labeling of red blood cells by technetium-99m after the administration of a reducing agent:
. Cardiovascular scintigraphy : angioscintigraphy for:
* evaluation of the ventricular ejection fraction,
* global or regional evaluation of motility of the cardiac wall,
* Imaging myocardial phases,
* organ perfusion imaging or vascular abnormality.
. Diagnosis and localization of gastrointestinal occult bleeding.
c. After instillation of the sterile solution of sodium pertechnetate [99mTc] in the eye: Scintigraphy of the lacrimal ducts .

Dosage ELUMATIC III Radiopharmaceutical Generator of 0

Injectable solution of sodium pertechnetate [99mTc] is normally administered intravenously. The activities used vary widely according to the clinical information sought and the equipment used. Pretreatment of patients with thyroid blocking agents or reducing agents may be necessary for some indications.
The recommended radioactivities are:
ADULTS AND PEOPLE :
- Thyroid scintigraphy: 20-80 MBq.
Images are acquired 20 minutes after intravenous injection.
- Scintigraphy of the salivary glands: 40 MBq.
Images are acquired immediately after intravenous injection and at regular intervals up to 15 minutes.
- Scintigraphy of Meckel diverticula: 400 MBq.
Images are acquired immediately after intravenous injection and at regular intervals up to 30 minutes.
- Brain scintigraphy: 350-800 MBq.
Successive images of short duration are acquired immediately in the first minute after intravenous administration; static images are acquired 1 to 4 hours later. The thyroid and choroid plexuses will be blocked to avoid nonspecific uptake of technetium-99m.
- Cardiac and vascular scintigraphy: 750-950 MBq.
Red blood cells are labeled in vivo or in vitro after pretreatment with a reducing agent. Images of the first cardiovascular passage are acquired at equilibrium the first minute after administration; they will be followed by pictures for 30 minutes.
- Gastrointestinal haemorrhage: 750-950 MBq.
Red blood cells are labeled in vivo or in vitro after pretreatment with a reducing agent. The images are acquired in the first minute after administration. They are followed by images acquired at regular intervals, possibly up to 24 hours.
- Scintigraphy of the lacrimal ducts: 2-4 MBq in each eye.
Drops are instilled into each eye and a series of images are acquired within 2 minutes, during the next 20 minutes static images are acquired at regular intervals.
CHILDREN :
- The activity to be administered to the child can be calculated from the radioactivities recommended in the adult according to the mass or the surface area of ​​the body.
However, the EANM Pediatric Working Group recommends that the child's activity be calculated based on body weight using the factors presented in the following table:
Correction coefficient to apply to activity in adults :
3 kg = 0.10 / 4 kg = 0.14 / 6 kg = 0.19 / 8 kg = 0.23 / 10 kg = 0.27 /
12 kg = 0.32 / 14 kg = 0.36 / 16 kg = 0.40 / 18 kg = 0.44 / 20 kg = 0.46 /
22 kg = 0.50 / 24 kg = 0.53 / 26 kg = 0.56 / 28 kg = 0.58 / 30 kg = 0.62 /
32 kg = 0.65 / 34 kg = 0.68 / 36 kg = 0.71 / 38 kg = 0.73 / 40 kg = 0.76 /
42 kg = 0.78 / 44 kg = 0.80 / 46 kg = 0.82 / 48 kg = 0.85 / 50 kg = 0.88 /
52-54 kg = 0.90 / 56-58 kg = 0.92 / 60-62 kg = 0.96 / 64-66 kg = 0.98 / 68 kg = 0.99.
- For very young children (less than 1 year old), a minimum activity of 20 MBq (10 MBq for thyroid scintigraphy) for direct administration, and 80 MBq for labeling of red blood cells, are necessary to obtain images of satisfactory quality.

Against indications

- None known to date.
Pregnancy: Technetium-99m, in the form of pertechnetate, has been shown to pass through the placental barrier. Radionuclide tests in pregnant women cause a certain amount of radiation for the fetus. They are therefore achieved during pregnancy only for imperative reasons and after evaluating the expected benefit in relation to the risks incurred by the mother and the fetus. The direct administration of 800 MBq of sodium pertechnetate [99mTc] to a patient results in a uterine irradiation dose of 6.5 mGy. When a thyroid blocking agent is administered to the patient, administration of 800 MBq of sodium pertechnetate [99mTc] results in a 5.3 mGy uterine irradiation dose. The administration of 925 MBq of technetium-99m-labeled red blood cells results in a radiation dose of 4.3 mGy of the uterus.
- Breast-feeding: Before administering a radiopharmaceutical to a woman during breastfeeding, consideration should be given to whether the examination can be reasonably postponed until the end of breastfeeding or, if not, to ensure that the radiopharmaceutical chosen is the most appropriate given the possible passage of the radioactivity in the milk. If administration is essential, breastfeeding should be discontinued and milk produced for the next 12 hours should be eliminated. Breastfeeding may be resumed when the activity rate in the milk will no longer give rise to a dose of radiation delivered greater than 1 mSv.

Elumatic Iii side effects

- Allergic reactions have been reported after injection of sodium pertechnetate [99mTc]; they include urticaria, facial edema, vasodilatation, pruritus, cardiac arrhythmias and coma.
- For any patient, exposure to ionizing radiation must be justified by the expected diagnostic benefit. The radioactivity administered should be such that the resulting irradiation is as low as possible, bearing in mind the need to obtain the required diagnosis. - Exposure to ionizing radiation may eventually induce cancer or develop hereditary deficiencies. Experience shows that, for diagnostic tests in nuclear medicine, the frequency of these adverse effects is very low because of the low activity used.
- For most nuclear medicine examinations, the radiation dose delivered (Effective Dose) is less than 20 mSv. The use of stronger activities, such as tomoscintigraphy, is justified in certain clinical circumstances.

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