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. Advanced life support facilities should be readily available.

Paediatric population
Paediatric population, see section 4.2.

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.

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.

Breast lesions less than 1 cm in diameter may not all be detected with scintimammography as the sensitivity of Myoview for the detection of these lesions is 36% (n=5 of 14, 95% CI 13% to 65%) relative to histological diagnosis. A negative examination does not exclude breast cancer especially in such a small lesion.

Efficacy in the identification of axillary lesions has not been proven; consequently scintimammography is not indicated for staging breast cancer.

In myocardial scintigraphy investigations under stress conditions, the contraindications associated with the induction of stress should be considered.

Precautions with respect to environmental hazard see section 6.6

Specific warnings
This medicinal product contains 15 – 29 mg sodium per reconstituted vial, equivalent to 0.7 – 1.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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.