RENOCIS

Posology Adults The recommended activity is 30 to 120 MBq for a patient of 70 kg bodyweight. Renal impairment Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Paediatric population The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. 5 MBq should be used in order to obtain images of sufficient quality.

Method of administration For intravenous use. For multidose use. Precautions to be taken before handling or administration of the medicinal product This medicinal product should be radiolabelled before administration to the patient. For instructions on radiolabelling and control of the radiochemical purity of the medicinal product before administration, see section 12.

For patient preparation, see section

The adverse events are presented in the table below by the MedDRA System Organ Class and with a not known frequency (cannot be estimated from the available data): MedDRA Body system SOCs Preferred term Frequency Immune system disorders Hypersensitivity Not known Allergic reactions have been reported in the literature.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 06 mSv when the maximal recommended activity of 120 MBq is administered these adverse reactions are expected to occur with a 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Image acquisition The images can be obtained by static (planar or tomographic) acquisitions between 1 to 3 hours post-injection. Where there is renal impairment or obstruction, delayed views may be needed (6 to 24 hours respectively).

1 or to any of the components of the labelled radiopharmaceutical. 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. 2). 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. After the procedure Close contact with infants and pregnant women should be restricted during 4 hours.

e. is essentially ‘sodium- free’. 6.

1 or to any of the components of the labelled radiopharmaceutical.