Cardiogen-82 is a radionuclide generator of rubidium-82 (Rb-82) containing strontium-82 (Sr-82) adsorbed on stannic oxide in a chromatography column. It provides a means of obtaining, via elution, a sterile, non-pyrogenic injectable solution of rubidium-82 (Rb-82) chloride. The activity of the generator is between 3.3 and 5.6 gigabecquerel (GBq) Sr-82 at calibration time. The activity of the rubidium-82 (Rb-82) chloride solution obtained from each elution depends on the elution capacity of the generator. The specifications can be found in the SmPC. On each use, when eluted at a rate of no more than 50 mL/minute, each generator eluate should contain no more than 1x10-5 megabecquerel (MBq) of strontium-82 (Sr-82) and no more than 1x10-4 MBq of strontium-85 (Sr-85) per MBq of injectable solution of rubidium-82 (Rb-82) chloride. 1 mL of solution contains 9 mg of sodium chloride.

This medicinal product is for diagnostic use only. The generator eluate (solution of rubidium-82 (Rb-82) chloride for injection) is used for Positron Emission Tomography (PET) imaging of the myocardium at rest or under pharmacologic stress conditions to evaluate regional myocardial perfusion in adults with suspected or known coronary artery disease.

Rubidium-82 (Rb-82) chloride solution for injection is intended only for intravenous administration. Recommended adult and elderly dose: 1100 to 2220 MBq (adjusted according to patient’s body size, PET equipment used, and imaging technique employed) by intravenous infusion. Cardiogen-82 should be used with an appropriate infusion system designed specifically for use with the Cardiogen-82 generator, e.g., Cardiogen-82 Infusion System Model 510 or Model 1701. Refer to the SmPC for product preparation instructions before administration. This radiopharmaceutical should be administered at a rate of 50 mL/minute (Model 510 or Model 1701) or 20 mL/minute (Model 1701 only) through a catheter inserted into a large peripheral vein, with the maximum volume per infusion of 100 mL, and a total volume not exceeding 200 mL. The elution rate should never exceed 50 mL/minute, as this could lead to breakthrough of strontium-82 (Sr-82). Image acquisition: In general, two doses should be administered in order to carry out both a rest imaging and a pharmacological stress imaging session. See SmPC for full details.

Pregnancy. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of SmPC.

No undesirable effects associated with Cardiogen-82 were observed during clinical studies. The application of vasodilator pharmacologic stress may cause serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, broncho-constriction, and cerebrovascular events. Perform testing only in settings where cardiac resuscitation equipment and trained staff are readily available.

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, personnel and equipment such as endotracheal tube and ventilator must be immediately available.

For each patient, the ionising 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.

Unintended patient exposure to ionising radiation due to contamination with strontium can occur in patients receiving rubidium-82 (Rb-82) chloride from the Cardiogen-82 generator at clinical sites where quality control is not carried out correctly. Strict adherence to the instructions regarding quality control at clinical sites is required. The eluate must not be used if the specified generator eluate limits have been exceeded.

High level radiation exposure to the bone marrow has occurred in some patients due to strontium-82 (Sr-82) and/or strontium-85 (Sr-85) breakthrough in the eluate when an incorrect solution was used to elute the Cardiogen-82 generator. Use only pharmacopeial grade additive-free NaCl 9 mg/mL solution to elute the generator.

Heart failure patients: Rubidium-82 (Rb-82) chloride solution contains sodium. According to the time of injection, the content of sodium administered may in some cases be greater than 1 mmol. This should be taken into account in patients on strict low sodium diets. Patients with congestive heart failure should be monitored particularly carefully during infusion because of the transitory nature increase in blood volume.

Patient preparation: Patient should fast for at least 6 hours and should be well hydrated, before the start
of the examination. In addition, the patient should not consume food products that contain caffeine and/
or other xanthine derivatives (e.g., coffee, tea, chocolate, cola and other soft drinks, maté, guarana) for at least 12 hours before the examination. The intake of medicinal products which could affect the results of the pharmacologic stress imaging should be avoided/stopped at least one day before the start of the examination based on the opinion of the attending nuclear physician/expert and the indication of the examination.

In order to avoid administration of a large quantity of strontium-82 (Sr-82) and/or strontium-85 (Sr-85) (breakthrough), the instructions for use should be strictly adhered to and the maximum elution rate should not exceed 50 mL/minute.

Consult the SmPC for further information relating to adverse reactions, warnings and precautions.

Denmark 68262