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

ax pharmaceutical corp - lead acetate (unii: rx077p88ry) (lead - unii:2p299v784p) - lead acetate 495 g in 500 g

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostatic neoplasms - endocrine therapy - erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt).

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

janssen products, lp - apalutamide (unii: 4t36h88ua7) (apalutamide - unii:4t36h88ua7) - erleada is indicated for the treatment of patients with - metastatic castration-sensitive prostate cancer (mcspc) - non-metastatic castration-resistant prostate cancer (nmcrpc) none. risk summary the safety and efficacy of erleada have not been established in females. based on findings from animals and its mechanism of action, erleada can cause fetal harm and loss of pregnancy when administered to a pregnant female [see clinical pharmacology (12.1)] . there are no available data on erleada use in pregnant women to inform a drug-associated risk. in an animal reproduction study, oral administration of apalutamide to pregnant rats during and after organogenesis resulted in fetal abnormalities and embryo-fetal lethality at maternal exposures ≥ 2 times the human clinical exposure (auc) at the recommended dose (see data) . data animal data in a pilot embryo-fetal developmental toxicity study in rats, apalutamide caused developmental toxicity when administered at oral doses of 25, 50 or 100 mg/kg/day throughout and after the period of organogenesis (gestational days 6–20). findings included embryo-fetal lethality (resorptions) at doses ≥50 mg/kg/day, decreased fetal anogenital distance, misshapen pituitary gland, and skeletal variations (unossified phalanges, supernumerary short thoracolumbar rib(s), and small, incomplete ossification, and/or misshapen hyoid bone) at ≥25 mg/kg/day. a dose of 100 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 2, 4 and 6 times, respectively, the auc in patients. risk summary the safety and efficacy of erleada have not been established in females. there are no data on the presence of apalutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production. contraception males based on the mechanism of action and findings in an animal reproduction study, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of erleada [see use in specific populations (8.1)] . infertility males based on animal studies, erleada may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of erleada in pediatric patients have not been established. of the 1327 patients who received erleada in clinical studies, 19% of patients were less than 65 years, 41% of patients were 65 years to 74 years, and 40% were 75 years and over. no overall differences in effectiveness were observed between older and younger patients. of patients treated with erleada (n=1073), grade 3–4 adverse reactions occurred in 39% of patients younger than 65 years, 41% of patients 65–74 years, and 49% of patients 75 years or older. falls in patients receiving erleada with androgen deprivation therapy was elevated in the elderly, occurring in 8% of patients younger than 65 years, 10% of patients 65–74 years, and 19% of patients 75 years or older. - erleada comes in 2 different strengths, 60 mg tablets and 240 mg tablets. please find the instructions below that refer to your prescribed erleada strength for how to prepare and take erleada tablets if you cannot swallow tablets whole. - erleada 240 mg tablet can be prepared and given through a feeding tube 8 french or larger. - store erleada at room temperature between 68 °f to 77 °f (20 °c to 25 °c). - erleada comes in a child-resistant bottle. - store erleada in the original package to protect from light and moisture. - the bottle of erleada contains a desiccant packet to help keep your medicine dry (protect it from moisture). do not throw away (discard) the desiccant.

Israel - English - Ministry of Health

j-c health care ltd - apalutamide - film coated tablets - apalutamide 60 mg - apalutamide - "erleada is indicated in adult men for the treatment of• metastatic hormone‐sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt)• non-metastatic castration-resistant prostate cancer (nm-crpc)."

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ranvet pty. limited - lead acetate - unknown - lead acetate mineral-lead active 0.0 - active constituent

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

seroyal usa - lead (unii: 2p299v784p) (lead - unii:2p299v784p) - lead 6 [hp_x] - indications helps to support normal musclo-nervous functions indications helps to support normal musclo-nervous functions directions adults: take five granules three times daily or as recommended by your healthcare practitioner. children: take three granules and follow adult directions.

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

leaders cosmetics co.,ltd. - homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox) - purpose: sunscreen

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

leaders cosmetics co.,ltd. - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox) - purpose: sunscreen

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

leaders cosmetics co.,ltd. - octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w) - purpose: sunscreen

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

leader - mineral oil (unii: t5l8t28fgp) (mineral oil - unii:t5l8t28fgp), petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - uses - for the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun. - may be used as a protectant against further irritation stop use and ask a doctor if: - you experience eye pain, changes in vision, continued redness or irritation of the eye. - the condition worsens or persists for more than 72 hours. . directions • wash your hands. • pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.