NANOSCAN Kit for radiopharmaceutical preparation Ref.[27559] Active ingredients: Technetium ⁹⁹ᵐTc nanocolloid

Potential for hypersensitivity or anaphylactic reactions

The possibility of hypersensitivity including serious, life-threatening, fatal 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.

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/Hepatic impairment

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

Paediatric population

For information on the use in paediatric population, see section 4.2. Careful consideration of the benefits and risks 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 the initial 24 hours following the injection.

Specific warnings

It is strongly recommended that every time that NanoScan is administered to a patient, the name and batch number of the product are recorded, in order to maintain a link between the patient and the batch of the product.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.

This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

Lymphoscintigraphy is not advised in patients with total lymphatic obstruction because of the potential radiation hazard at injection sites. The subcutaneous injection must be made without pressure into loose connective tissue.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. Precautions with respect to environmental hazard see section 6.6.

No interactions studies have been performed in adults or children.

Iodinated contrast media used in lymphoangiography may interfere with lymphatic scanning using nanocolloidal technetium (^99mTc) albumin.

Women of childbearing potential

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques, not using ionising radiation (if there are any) should be offered to the patient.

Pregnancy

Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus. During pregnancy, lymphoscintigraphy involving the pelvis is strictly contraindicated due to the accumulation in pelvic lymph nodes (see section 4.3).

Breast-feeding

Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breastfeeding should be interrupted for 24 hours and the expressed feeds discarded.

Close contact with infants should be restricted during the initial 24 hours following injection.

Fertility

No studies on fertility have been performed.

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

The following table presents how the frequencies are reflected in this section:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data)

Immune system disorders

Frequently not known: Protein allergic (hypersensitive) reaction, and hypersensitivity reactions (including very rare life-threatening anaphylaxis).

Very rare: local reactions, rash, itching, vertigo, hypotension

Other disorders

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 3.12mSv when the maximal recommended activity of 500 MBq is administered these adverse reactions are expected to occur with a low probability.

For safety with respect to transmissible agents, see section 4.4.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemlisted in Appendix V*.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.