OCTREOSCAN Kit for radiopharmaceutical preparation Ref.[10963] Active ingredients: Indium ¹¹¹In pentetreotide

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 4.4.

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.

This medicinal product should be reconstituted before administration to the patient.

For instructions on reconstitution of the medicinal product before administration, see section 12.

For patient preparation see section 4.4.

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. Spot views may be repeated at 48 hours, 72 hours and/or 96 hours p.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.

The pharmaceutical form (monodose injection) makes inadvertent overdosing improbable. In the event of administration of a radiation overdose with indium(¹¹¹In)pentetreotide, the absorbed dose by the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding.

Vial A and vial B expire 24 hours after the activity reference time/date of the indium(¹¹¹In).

After reconstitution: 6 hours. Store below 25°C.

Store below 25°C.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

Octreoscan is supplied as one pack containing two vials:

Vial A: a 10 ml quartz-coated, type I glass vial with a teflon-coated bromobutyl rubber stopper and shielded with lead containing 1.1. ml of indium(¹¹¹In)chloride solution corresponding to 122 MBq at activity reference time.

Vial B: 10 mL type I glass vial closed with a bromobutyl rubber stopper and orange flip off cap, containing 10 micrograms of pentetreotide.

The vials cannot be used separately. Both vials are sealed with an aluminium crimp cap and packed in a closed, folded tin. Enclosed in the tin is a Sterican Luer Lock 0.90 × 70 mm / 20 G x 2 4/5 needle to be used for the labelling procedure.

General warning

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal is subject to the regulations and/or appropriate licences of the local competent official organisation.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.

The contents of both vials are intended only for use in the preparation of indium(¹¹¹In)Pentetreotide solution for injection and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on reconstitution of the medicinal product before administration, section 12.

If at any time in the preparation of this product the integrity of the vials is compromised they should not be used.

Administration procedures should be carried out in a way to minimise the risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Instructions for waste disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.