OCTREOSCAN

Posology Adults and elderly population The activity to be administered for single photon emission tomography (SPECT) depends on the available equipment. In general for an adult of 70 kg, an activity of 110 to 220 MBq in one single intravenous injection should be sufficient.

Other activities should be justifible. Renal impairment Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. In patients with significant renal failure administration of 111In-pentetreotide is not advisable because the reduced or absent function of the principal route of excretion will lead to delivery of an increased radiation dose, see section

Adverse effects attributable to the administration of Octreoscan are uncommon (≥1/1000 to <1/100). Specific effects have not been observed. The symptoms reported are suggestive of vasovagal reactions or of anaphylactoid drug effects.

The withdrawal of octreotide therapy as a preparatory step to scintigraphy might provoke severe adverse effects, generally of the nature of a return of the symptoms seen before this therapy was started. Exposure to ionising radiation is linked with cancer induction and a potential for the development of hereditary defects.

As the effective dose is 12 mSv, when the maximal recommended activity of 220 MBq is administered, these adverse events are expected to occur with a low probability. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).

4. Paediatric population The decision to administer pentetrotide (111In) to a child must be taken by a nuclear medicine specialist familiar with somatostatin receptor scintigraphy, after considering using alternative radiopharmaceuticals with a lower radiation burden (PET in particular).

Pentetreotide (111In) should only be administered to a child when alternative radiopharmaceuticals are not available or they do not yield a satisfactory performance in the clinical setting of the child. Method of administration The medicinal product is for single use.

Administration by intravenous injection. Careful administration is necessary to avoid paravasal deposition of activity. This medicinal product should be reconstituted before administration to the patient. For instructions on reconstitution of the medicinal product before administration, see section 12.

4. Image acquisition Images can be acquired at 4 and 24 hours, or 24 and 48 hours post-injection. 4 hours images may be useful for comparison and evaluation of abdominal activity imaged at 24 hours. When activity in the abdomen is observed at 24 hours which cannot be interpreted with certainty as uptake in tumour or activity in bowel contents, scintigraphy should be repeated at 48 hours.

It is important to acquire two sets of images with at least one SPECT (or SPECT/CT) acquisition. i. to allow clearance of interfering bowel radioactivity. Physiologic uptake occurs in spleen, liver, kidneys and bladder. Thyroid, pituitary and intestines are visible in most patients.

1. 4 Special warnings and precautions for use Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.

To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must immediately available. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit.

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