Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: Calcium pentetate
laboratory: Cis Bio International

Powder for solution for injection
Box of 5 multidose vials of 15 ml
All forms

Indication

This medicine is for diagnostic use only.

After reconstitution with sodium pertechnetate solution ( 99m Tc) this product can be used for:

a) Intravenously:

· Dynamic renal scintigraphy for the study of perfusion, renal function and urinary tract.

· Determination of glomerular filtration rate.

· Dynamic (angioscintigraphy) and static brain scans where CT and / or nuclear magnetic resonance imaging are not available.

(b) Inhalation as an aerosol:

· Pulmonary ventilation scintigraphy.

c) Orally:

· Research of gastroesophageal reflux and exploration of gastric emptying.

Dosage PENTACIS Powder for solution for injection Box of 5 multidose vials of 15 ml

In adults, the recommended activities are as follows (other activities may be justified):

Intravenous injection:

· Determination of Glomerular Filtration Rate from Plasma Samples: 1.8 to 3.7 MBq.

· Dynamic renal scintigraphy that can be combined with determination of glomerular filtration rate: 37 to 370 MBq.

Dynamic sequential imaging should begin immediately after injection. Static imaging can be done 1 hour after injection.

· Brain scintigraphy: 185 to 750 MBq.

Dynamic sequential imaging should begin immediately after injection and static images can be obtained 1 hour, and if necessary a few hours after injection.

Inhalation:

· Pulmonary ventilatory scintigraphy: 500 to 1000 MBq in the nebulizer, to obtain an activity of 50 to 100 MBq in the lungs.

Oral way:

· Research of gastroesophageal reflux and exploration of gastric emptying: 10 to 20 MBq.

Pediatric dosage:

Calculated as a function of body mass according to the following formula:

Pediatric activity (MBq) = [adult activity (MBq) x body mass of the child (kg)] / 70.
In some cases, calculation based on body surface area is more appropriate:
Pediatric activity (MBq) = [adult activity (MBq) x body surface area of ​​the child (m²)] / 1.73.
In very young children (up to 1 year) when technetium pentetate ( 99m Tc) is used for renal scintigraphy, a minimum activity of 20 MBq is required to obtain images of sufficient quality.

Against indications

Hypersensitivity to the active substance or to any of the excipients.

Pentacis 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 inherited 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 (E effective dose) is less than 20 mSv.

Some cases of side reactions have been reported: redness, dizziness, dyspnea, itching, hives and hypotension

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