Medicinal Products

INMUM PENTETATE MALLINCKRODT 37 MBq / mL

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active Ingredients: Indium Pentetate [111In]
laboratory: Mallinckrodt France

Injectable solution
Multidose bottle of 10 ml
All forms

Indication

This medicine is for diagnostic use only.
- Study of cerebrospinal fluid (CSF) transit:
. obstruction diagnosis.
. differential diagnosis between normal pressure hydrocephalus and other hydrocephalic diseases.
- Cerebrospinal fluid leak detection (rhinorrhea or otorrhea).

Dosage PENTETATE INDIUM MALLINCKRODT 37 MBq / mL Solution for injection Multi-dose vial of 10 ml

- Intrathecal (lumbar or suboccipital) administration.
- The recommended activity in adults is 10 to 20 MBq.
- The activity intended for the child must be calculated according to his body mass by applying the following formula:
Pediatric activity (MBq) = [Activity in adults (MBq) x body mass of the child (kg)] / 70.
- Ten to fifteen minutes after lumbar injection, a control scintigraphy should be performed at the injection site to detect possible extra-meningeal activity, which could lead to misinterpretation.
- The first cephalic acquisitions can be made at the earliest 1 hour to 1 hour 30 minutes after the injection. Subsequent acquisitions are performed at the 3rd, 6th and 24th hours, sometimes even at the 48th and 72nd hours after the injection, depending on the diagnostic information sought. During a sub-occipital injection, the acquisition of the first images should be performed as early as the 15th minute. The acquisition schedules proposed above must be advanced from 1 to several hours for subsequent acquisitions.
- In case of otorrhea or rhinorrhea, the flow of CSF may be so low that leakage is not detectable in the images. In this case, leakage of cerebrospinal fluid can be demonstrated by measuring the activity of cotton swabs placed in the external auditory canals or nostrils.

Against indications

- Coagulation disorder and anticoagulant treatment.
- Intracranial hypertension.
- 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: Before administering a radiopharmaceutical to a woman who wants to continue breastfeeding, it should be assessed whether this examination can be postponed until the end of breastfeeding. Otherwise, it should be ensured that the chosen radiopharmaceutical is the most appropriate given the activity likely to pass into breast milk. If the administration of a radioactive product is essential, the milk will be drawn before injection and kept for later use. Breastfeeding should be suspended for at least 2 days after the injection and milk produced during this period should be eliminated. Breastfeeding may be resumed when the activity in the milk is not likely to cause a dose of radiation for the child greater than 1 mSv.

Side effects Pentetate Indium Mallinckrodt

- Intrathecal injection can cause side reactions that are usually benign in nature. The symptoms observed are headaches and signs of meningeal irritation, which usually disappear within 48 hours.
Aseptic meningitis and fevers have been reported.
- In the case of sub-occipital administration, the radiopharmaceutical product may be in the immediate vicinity of the emergence points of the cranial pairs from the brainstem. The oculomotor, facial, cochleovestibular nerves may be stimulated and may temporarily cause effects such as eyelid ptosis, tinnitus or loosening of the corner of the mouth.
- 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. For diagnostic nuclear medicine examinations, experience shows that the frequency of these adverse effects is very low due to the low activity used.
- Most nuclear medicine diagnostic tests deliver an effective dose less than 20 mSv. Higher doses may be warranted in some cases.

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