Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - radium (223ra) dichloride, quantity: 6600 kbq - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; sodium citrate dihydrate - xofigo is indicated for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastatic disease.

European Union - English - EMA (European Medicines Agency)

bayer ag - radium (223ra) dichloride - prostatic neoplasms - therapeutic radiopharmaceuticals - xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - radium ra-223 dichloride (unii: rj00kv3vtg) (radium ra-223 cation - unii:9h414a99md) - radium ra-223 dichloride 30 uci in 1 ml - xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. none. the safety and efficacy of xofigo have not been established in females. based on mechanism of action, xofigo can cause fetal harm when administered to a pregnant female [see clinical pharmacology ( 12.1)] . while there are no human or animal data on the use of xofigo in pregnancy, maternal use of a radioactive therapeutic agent could affect development of a fetus. advise pregnant females and females of reproductive potential of the potential risk to a fetus. risk summary the safety and efficacy of xofigo have not been established in females. there is no data on the presence of radium-223 dichloride in human milk, the effects on the breastfed child, or the effects on milk production. males because of potential effects on spermatogenesis associated with radiation, advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with xofigo [see use in specific populations (8.1)] . males based on mechanism of action, xofigo may impair fertility in males of reproductive potential [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . the safety and efficacy of xofigo in pediatric patients have not been established. in single- and repeat-dose toxicity studies in rats, findings in the bones (depletion of osteocytes, osteoblasts, osteoclasts, fibro-osseous lesions, disruption/disorganization of the physis/growth line) and teeth (missing, irregular growth, fibro-osseous lesions in bone socket) correlated with a reduction of osteogenesis that occurred at clinically relevant doses beginning in the range of 22 – 88 kbq (0.59 - 2.38 microcurie) per kg body weight. of the 600 patients treated with xofigo in the randomized trial, 75% were 65 years of age and over and while 33% were 75 years of age and over. no dosage adjustment is considered necessary in elderly patients. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dedicated hepatic impairment trial for xofigo has been conducted. since radium-223 is neither metabolized by the liver nor eliminated via the bile, hepatic impairment is unlikely to affect the pharmacokinetics of radium-223 dichloride [see clinical pharmacology (12.3)] . based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with mild hepatic impairment. no dose adjustments can be recommended for patients with moderate or severe hepatic impairment due to lack of clinical data. no dedicated renal impairment trial for xofigo has been conducted. based on subgroup analyses in the randomized clinical trial, dose adjustment is not needed in patients with existing mild (creatinine clearance [crcl] 60 to 89 ml/min) or moderate (crcl 30 to 59 ml/min) renal impairment. no dose adjustment can be recommended for patients with severe renal impairment (crcl less than 30 ml/min) due to limited data available (n = 2) [see clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

cardinal health 414, llc - radium ra-223 dichloride (unii: rj00kv3vtg) (radium ra-223 cation - unii:9h414a99md) - radium ra-223 dichloride 90 uci in 1 ml

Canada - English - Health Canada

seroyal international inc. - radium bromide - globules - 8x - radium bromide 8x - homeopathic products

Canada - English - Health Canada

dolisos canada inc. - radium bromide - globules - 8x - radium bromide 8x - homeopathic products

Canada - English - Health Canada

bayer inc - radium ra-223 dichloride - solution - 1100kbq - radium ra-223 dichloride 1100kbq - radioactive agents

United States - English - NLM (National Library of Medicine)

washington homeopathic products - radium brom - to relieve the symptoms of itching. indications: radium brom   itching if symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

United States - English - NLM (National Library of Medicine)

washington homeopathic products - radium brom - to relieve the symptoms of itching. indications:  radium brom   itching if symptoms persist/worsen or if pregnant/nursing, consult your practitioner.

United States - English - NLM (National Library of Medicine)

silver star brands - radium bromide (unii: r74o7t8569) (radium cation - unii:05456mvl7t), arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av), calcium sulfide (unii: 1mbw07j51q) (calcium sulfide - unii:1mbw07j51q), graphite (unii: 4qqn74lh4o) (graphite - unii:4qqn74lh4o), viola tricolor (unii: 9q24rai43v) (viola tricolor - unii:9q24rai43v) - radium bromide 30 [hp_c] in 59 ml - soothes transient itching and weeping of skin during an eczema 'flare up'. this statement has not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure or prevent any disease. soothes symptoms of transient skin flare-ups in children with eczema or atopic dermatitis