STABILISED CERETEC

Posology Adults 555-1110 MBq by direct intravenous injection. Normally a once-only diagnostic procedure. Paediatric population Technetium-99m exametazime with the cobalt chloride solution is not recommended for administration to children.

Safety and effectiveness of the cobalt solution has not been established in the paediatric population. 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.

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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). Congenital and familial/genetic disorders Not known Hereditary defects1 Neoplasms benign and malignant (including cysts and polyps) Not known Cancer induction1 Immune system disorders Hypersensitivity including rash, Not known erythema, urticaria, angiooedema, pruritus.

, malaise, fatigue) 1 Linked with ionising radiation Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 3 mSv these adverse events are expected to occur with 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. Individual benefit/risk justification For each patient, exposure to ionising radiation must be justifiable on the basis of 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.

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