OSTEOCIS Kit for radiopharmaceutical preparation Ref.[27900] Active ingredients: Technetium ⁹⁹ᵐTc oxidronic acid

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.

An interval of at least 2 days must be observed between any previous scintigraphy with other technetium (^99mTc)labelled agents and administration of technetium (^99mTc)- oxidronate.

Renal impairment

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible (see section 11).

Patients with high bone uptake and/or severe renal impairment

Careful consideration of the indication is required since an increased exposure is possible in these patients. This must be taken into account when calculating the activity to be administered (see section 11).

Paediatric population

For information on the use in paediatric population, see section 4.2.

In infants and children particular attention should be paid to the relatively higher radiation exposure of the epiphyses in growing bone.

Careful consideration of the indications 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 before scanning and as often as possible during the first hours after the study in order to reduce radiation to the bladder wall

To avoid accumulation of tracer in the musculature it is advised that strenuous exercise be discouraged immediately after injection until satisfactory bone imaging has been effected.

Inadvertent or accidental subcutaneous administration of technetium (^99mTc) oxidronate should be avoided as perivascular inflammation has been described.

After the procedure

Close contact with infants and pregnant women should be restricted during 4 h.

Specific warnings

This medicinal product contains 4.5 mg of sodium per vial. 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 (23 mg) per dose. This should be taken into account in patients in low sodium diet.

Precautions with respect to environmental hazard are in section 6.6.

The accumulation of technetium (^99mTc) oxidronate in the skeleton, and thus the quality of the scintigraphic procedure, may be decreased after medication with:

• chelates,
• diphosphonates,
• tetracycline or
• iron containing drugs.

Regular medication with aluminium containing drugs (notably antacids) may lead to abnormal high accumulation of technetium (^99mTc) in the liver, presumably caused by formation of labelled colloids

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 any) should be offered to the patient.

Pregnancy

Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by mother and foetus.

Administration of 700 MBq technetium (^99mTc) oxidronate to a patient with normal bone uptake results in an absorbed dose to the uterus of 4.41 mGy. The dose decreases to 2.03 mGy in patients with high bone uptake and/or severely impaired kidney function.

Breastfeeding

Before administering radiopharmaceuticals to a mother who is breastfeeding 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, one breast feed should be banked prior to injection and the subsequent one discarded after injection. Breast feeding can be restarted 4 hours post injection. Close contact with infants should be restricted during this period.

Osteocis 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).

In this table the undesirable effects are classified in accordance with the MedDRA SOCs.

Adverse drug effects are extremely rare following administration of technetium (^99mTc) oxidronate injection. Reports suggest an incidence of not more than one in 200,000 administrations. Symptoms of anaphylactoid reactions are rash, nausea, hypotension and sometimes arthralgia. Onset of symptoms may be delayed 4 to 24 hours after administration.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose equivalent is 5.6 mSv when the maximal recommended activity of 700 MBq is administered these adverse events 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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance.

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