ethyol inj plv sol 3x500mg - search results

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

ethyol- amifostine injection, powder, lyophilized, for solution

cumberland pharmaceuticals inc. - amifostine (unii: m487qf2f4v) (amifostine anhydrous - unii:ila426l95o) - amifostine anhydrous 500 mg in 10 ml - ethyol (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see clinical studies (14.1)] . ethyol is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see clinical studies (14.2)] . limitation of use do not use ethyol in other settings where chemotherapy can produce a significant survival benefit or cure [see warnings and precautions (5.1)] , or in patients receiving definitive radiotherapy [see warnings and precautions (5.2)] , except in the context of a clinical study. ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. based on findings in animals, ethyol ca

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

ethyol amifostine (as trihydrate) 500mg powder for injection vial

link medical products pty ltd t/a link pharmaceuticals - amifostine, quantity: 500 mg - injection, powder for - excipient ingredients: - to decrease the incidence of neutropenia related fever and infection induced by dna-binding chemotherapeutic agents (classical alkylating agents such as cyclophosphamide and non-classical alkylating agents such as mitomycin-c and platinum-containing drugs); decrease in the incidence of acute and cumulative nephrotoxicity associated with platinum-based therapy; and the provision of better adherence to these types of chemotherapy regimens. indications as at 31 march 2000: ethyol is indicated to decrease the incidence of neutropenia-related fever and infection induced by dna-binding chemotherapeutic agents (classical alkylating agents such as cyclophosphamide and non-classical alkylating agents such as mitomycin-c and platinum containing drugs); decrease the incidence of acute and cumulative nephrotoxicity associated with platinum-based therapy; and to provide better adherence to these types of chemotherapy regimens. ethyol is also indicated to protect against acute and late xerostomia associated with standard

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

ethyol- amifostine injection, powder, lyophilized, for solution

clinigen limited - amifostine (unii: m487qf2f4v) (amifostine anhydrous - unii:ila426l95o) - ethyol (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see clinical studies (14.1)] . ethyol is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see clinical studies (14.2)] . limitation of use do not use ethyol in other settings where chemotherapy can produce a significant survival benefit or cure [see warnings and precautions (5.1)] , or in patients receiving definitive radiotherapy [see warnings and precautions (5.2)] , except in the context of a clinical study. ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. based on findings in animals, ethyol can cause fetal harm when administered to a pregnant woman. there are no available data on ethyol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of ethyol to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of the recommended dose in humans based on body surface area (see data) . advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the estimated background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies in the u.s. general population. ethyol has been shown to be embryotoxic in rabbits at intravenous doses of 50 mg/kg, approximately sixty percent of the recommended dose in humans on a body surface area basis. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for lactation information. there are no data on the presence of amifostine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with ethyol. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for contraception and infertility information. verify pregnancy status in females of reproductive potential prior to initiating ethyol. males based on findings from animal studies, ethyol may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness in pediatric patients have not been established. the clinical studies did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients.

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

ethyol

merck sharp & dohme australia pty ltd - amifostine -