CERETEC

The route of administration is direct intravenous injection for brain scintigraphy studies and intravenous injection of labelled leucocytes post labelling in vitro. Posology Adults and the elderly population 1. for brain scintigraphy, 350-500 MBq 2.

for in vivo localisation of technetium-99m-labelled leucocytes, 200 MBq Normally a once-only diagnostic procedure. Paediatric population Technetium-99m exametazime and technetium-99m-labelled leucocytes are not recommended for administration to children.

Method of administration 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

The frequencies of undesirable effects are defined as follows:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data) Immune system disorders Not known: Hypersensitivity including rash, erythema, urticaria, angioedema, pruritus.

Re-injected Ceretec labelled leukocytes only:

Not known: Hypersensitivity including rash, erythema, urticaria, angioedema, pruritus, anaphylactoid reaction or anaphylactoid shock. , malaise, fatigue) Exposure to ionising radiation is linked with cancer induction and a potential for developing hereditary defects.

2 mSv when the maximal recommended activity of 555 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

Potential for hypersensitivity or anaphylactic reactions The possibility of hypersensitivity including anaphylactic/anaphylactoid reactions should always be considered. 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 be immediately available.

Re-injected Ceretec labelled leucocytes only:

When preparing technetium-99m-labelled leucocytes it is essential that cells are washed free of sedimentation agents before they are re-injected into the patient as materials used in cell separation may cause hypersensitivity reactions.

Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.

Renal impairment and hepatic impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. 2 Patient preparation The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.

Specific warnings Depending on the time when you administer the injection the content of sodium given to the patient may in some cases be greater than 1 mmol. This should be taken into account in patients on low sodium diet. 6.

1.