Australie - anglais - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - indium (111in) chloride, quantity: 370 mbq/ml - injection, solution - excipient ingredients: hydrochloric acid - for the radiolabelling of approved polyaminocarboxylic acid derivatised monoclonal antibody preparations for in vivo diagnostic imaging procedures.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: sodium acetate; hydrochloric acid; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: hydrochloric acid; sodium acetate; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

États-Unis - anglais - NLM (National Library of Medicine)

telix pharmaceuticals (us) inc. - gozetotide (unii: 9ag41l3aoq) (gozetotide - unii:9ag41l3aoq) - illuccix, after radiolabeling with ga 68, is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer: - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. - for selection of patients with metastatic prostate cancer, for whom lutetium lu 177 vipivotide tetraxetan psma-directed therapy is indicated. none risk summary illuccix is not indicated for use in females. there are no available data with gallium ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. all radiopharmaceuticals, including illuccix, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide. ri