Special Warning : אזהרת שימוש

4.4   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 be immediately available.

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 or hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible (see section 4.2).


Paediatric population
For information on the use in paediatric population, see section 4.2.
Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).

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.

Cardiac imaging
If possible, patients should fast for at least four hours prior to the study. It is recommended that patients eat a light fatty meal or drink a glass or two of milk after each injection, prior to imaging. This will promote rapid hepatobiliary clearance of technetium (99mTc) sestamibi resulting in less liver activity in the image.

Interpretation of technetium (99mTc) sestamibi images
Interpretation of scintimammography
Breast lesions less than 1 cm in diameter may not all be detected with scintimammography as the sensitivity of technetium (99mTc) sestamibi for the detection of these lesions is low. A negative examination does not exclude breast cancer especially in such a small lesion.

After the procedure
Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.

Specific warnings
In myocardial scintigraphy investigations under stress conditions, the general contraindications and precautions associated with the induction of ergometric or pharmacological stress should be considered.

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free’.

For precautions with respect to environmental hazard see section 6.6.

Effects on Driving

4.7    Effects on ability to drive and use machines

STAMICIS has no or negligible influence on the ability to drive and use machines.