Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
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.

Paediatric population
Paediatric population, see section 4.2

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.

Precautions with respect to environmental hazard see section 6.6.

Effects on Driving

4.7   Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.