GalliaPharm · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100457 · has-adverse-reaction-information · PDF-Seite 6

Possible adverse reactions following the use of a 68Ga-labelled radiopharmaceutical will be dependent on the specific kit for radiopharmaceutical preparation being used. Such information will be supplied in the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled. Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 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 system listed in Appendix V.

HOS-100453 · has-contraindication-information · PDF-Seite 4

Gallium (68Ga) chloride solution should not be administered directly to the patient. The use of 68Ga-labelled medicinal products is contraindicated in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. For information on contraindications to particular 68Ga-labelled radiopharmaceuticals prepared by radiolabelling with gallium (68Ga) chloride solution, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

HOS-100452 · has-indication-information · PDF-Seite 3

This radionuclide generator is not intended for direct use in patients. 3 The sterile eluate (gallium (68Ga) chloride solution) from the radionuclide generator GalliaPharm is indicated for in vitro radiolabelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such eluate, to be used for positron emission tomography (PET) imaging.

HOS-100455 · has-interaction-information · PDF-Seite 5

No interaction studies of the gallium (68Ga) chloride solution for radiolabelling with other medicinal products have been performed, because it is used for in vitro radiolabelling of medicinal products. For information concerning interactions associated with the use of 68Ga-labelled radiopharmaceuticals, refer to the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled.

HOS-100456 · has-pregnancy-information · PDF-Seite 5

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 the foetus. Breast-feeding Before administering a radiopharmaceutical to a mother who is breast-feeding, consideration should be given to whether the investigation could be reasonably delayed until the mother has ceased breast- feeding. If the administration is considered necessary, breast-feeding should be interrupted, and the expressed feeds discarded. Further information concerning the use of a 68Ga-labelled radiopharmaceutical in pregnancy and breast-feeding is specified in the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled. Fertility 5 Further information concerning the use of a 68Ga-labelled radiopharmaceutical concerning fertility is specified in the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled.

HOS-100454 · has-warning-information · PDF-Seite 4

Gallium (68Ga) chloride solution for radiolabelling is not to be administered directly to the patient but is used for in vitro radiolabelling of various kits for radiopharmaceutical preparation. Unintended direct administration of gallium (68Ga) chloride solution may lead to increased radiation exposure to patients (see sections 4.9, 5.2, and 11). Accidental administration of gallium (68Ga) chloride solution for radiolabelling containing 0.1 mol/l hydrochloric acid may also cause local venous irritation and, in case of paravenous injection, tissue necrosis. The catheter or affected area should be irrigated with 9 mg/ml (0.9 %) sodium chloride solution for injection. Safe handling of GalliaPharm and its eluate in accordance with the instructions in this document should be permanently ensured to protect patients and healthcare professionals from unintentional excess radiation exposure (see sections 6 and 12). 4 68 Ge breakthrough can increase in the eluate above 0.001 % if the radionuclide generator is not eluted for several days (see section 12). All instructions provided in section 12 should be strictly followed to avoid the risk of excess exposure to 68Ge. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The radioactivity administered should in every case be as low as reasonably achievable to obtain the required information. General warnings For information concerning special warnings and special precautions for use of 68Ga-labelled radiopharmaceuticals refer to the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled. Precautions with respect to environmental hazard are included in section 6.6.