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 impairment
Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

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
Pretreatment of patients with thyroid-blocking agents or reducing agents may be necessary for certain indications.
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.

After the procedure
Close contact with infants and pregnant women should be restricted during 12h.

Specific warnings
Sodium pertechnetate (99mTc) solution for injection contains 3.6 mg/mL of sodium.
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 patient on low sodium diet.
When labelling kit, the sodium content of the dose administered must take into account the sodium derived from the eluate and the kit. Please refer to the package leaflet of the kit considered.
In salivary gland scintigraphy a lower specificity of the method should be expected compared to MR sialography.

Precautions with respect to environmental hazard see section 6.6.

Effects on Driving