Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active ingredients: Sodium Pyrophosphate (EE450)
laboratory: Cis Bio International

Powder for solution for injection
Radiopharmaceutical kit of 5 vials of 15 ml
All forms

Indication

This medicine is for diagnostic use only.
In vivo labeling of red blood cells for scintigraphy of the blood compartment.
- The main indications are:
. Angiocardioscintigraphy for the study of:
* measurement of the ventricular ejection fraction,
* the kinetic, amplitude and phase analysis, global and segmental myocardium.
- Scintigraphy of perfusion of an organ or vascular malformations.
- Diagnosis and localization of occult digestive hemorrhage.

Dosage ANGIOCIS Powder for solution for injection Radiopharmaceutical kit of 5 vials of 15 ml

Dosage:
Scintigraphy of the blood compartment :
- The optimal amount of non-radioactive stannous tin for labeling red blood cells in vivo is from 0.05 μg to 1.25 μg / ml of blood. The calculation of the volume is made according to the size and weight of the patient.
- The volume of the reconstituted solution to be injected intravenously is calculated using the following formula:
[ total blood volume (ml) / 5400] x 1.5.
- The sodium pertechnetate [99mTc] is administered 30 minutes later. The average activity administered is 890 MBq (740-925 MBq).
- The examination can be performed immediately after the injection of the radioactive tracer.
- Pediatric dosage:
. In children, the activity to be injected is a fraction of that used in adults, fraction obtained by applying the coefficients below according to body mass.
Coefficients 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.
. In very young children (less than 1 year old), a minimum activity of 80 MBq is required to obtain images of satisfactory quality.
- Given the duration of fixation of stannous salts on erythrocytes, it is advisable not to repeat the examination before a period of three months.
Administration mode :
- strict intravenous administration.
- Technique for labeling red blood cells:
. Reconstitution of stannous pyrophosphate :
The lyophilizate of stannous pyrophosphate (non-radioactive compound) is initially reconstituted with an isotonic solution of sodium chloride injection.
. In vivo labeling :
Injection of the reconstituted solution of stannous pyrophosphate followed by the injection of an injection solution of sodium pertechnetate [99mTc], 30 minutes later.

Against indications

- Pregnancy: Radionuclide tests in pregnant women also involve irradiation of the fetus. In the course of pregnancy, only the absolutely necessary investigations should be carried out when the probable benefit exceeds the risks to the mother and the fetus.
- Breast-feeding: If the administration of a radioactive product is essential, the milk must be drawn before injection and kept for later use. Breastfeeding should be suspended for at least 12 hours after the injection and the milk produced during this period should be eliminated. Breastfeeding may be resumed when the activity in the milk is unlikely to result in a radiation dose for the child greater than 1 mSv.

Angiocis side effects

- For all patients, 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 can potentially 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 activities used.
- For most nuclear medicine examinations for diagnostic purposes, the radiation dose delivered (effective dose) is less than 20 mSv. The use of stronger activities is justified in certain clinical circumstances.
- Adverse reactions arising from intravenous administration of the [99mTc] -labeled or unlabeled compound have been reported in isolation (1-5 / 100, 000 administrations). The following side effects have been described: redness of the face, headache, vasodilation, nausea, dizziness, arm edema, erythema and pruritus at the injection site, sweating and tinnitus, urticaria, generalized itching, cardiac arrhythmia, facial edema, coma.

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