Malta - English - Medicines Authority

baxter healthcare limited - mesna - solution for injection - mesna 100 mg/ml - all other therapeutic products

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

baxter healthcare corporation - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. limitation of use: mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1)]. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on use during pregnancy. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm including embryo-fetal lethality. refer to the ifosfamide prescribing information for more information on use during pregnancy. in embryo-fetal development studies, oral administration of mesna to pregnant rats (500, 1000, 1500, and 2000 mg/kg) and rabbits (500 and 1000 mg/kg) during the period of organogenesis revealed no adverse developmental outcomes at doses approximately 10 times the maximum recommended total daily human equivalent dose based on body surface area. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide is excreted in breast milk. refer to the ifosfamide prescribing information for more information on use during lactation. there are no data on the presence of mesna in human or animal milk, the effect on the breastfed child, or the effect on milk production. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see warnings and precautions (5.3) and use in specific populations (8.4)]. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for 1 week after the last dose of mesna or ifosfamide. mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on contraception and effects on fertility. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiation of mesna in combination with ifosfamide. contraception females advise females of reproductive potential to use effective contraception during treatment with mesna in combination with ifosfamide and for 6 months after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with mesna in combination with ifosfamide and for 3 months after the last dose. mesna injection contains the preservative benzyl alcohol which has been associated with serious adverse reactions and death when administered intravenously to premature neonates and low birth weight infants. avoid use of mesna injection in premature neonates and low-birth weight infants [see warnings and precautions (5.3)] . clinical studies of mesna did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. the ratio of ifosfamide to mesna should remain unchanged. no clinical studies were conducted to evaluate the effect of renal impairment on the pharmacokinetics of mesna. no clinical studies were conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of mesna.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - mesna - oral tablet - 400mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

baxter healthcare ltd - mesna - oral tablet - 600mg

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

mylan institutional llc - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna 100 mg in 1 ml

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

sagent pharmaceuticals - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. limitation of use: mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1)]. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on use during pregnancy. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all

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

hikma pharmaceuticals usa inc. - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis l imitation of use: mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1 )]. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on use during pregnancy. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see warnings and precautions (5.3) and use in specific populations (8.4)].   the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

Israel - English - Ministry of Health

mbi pharma ltd., israel - mesna - solution for injection - mesna 100 mg / 1 ml - mesna - prevention of urinary tract toxicity of oxazaphosphorines (the active components of ifosfamide, cyclophosphamide , trofosfamide) in particular in high-risk patients with previous radiation therapy in the area of the lesser pelvis, cystitis with previous ifosfamide, cyclophosphamide or trofosfamide, urinary passage diseases in anamnesis.

Israel - English - Ministry of Health

mbi pharma ltd., israel - mesna - solution for injection - mesna 100 mg / 1 ml - mesna - prevention of urinary tract toxicity of oxazaphosphorines (ifosfamide, cyclophosphamide or trofosfamide) in particular patients at risk. risks are in particular previous radiation therapy in the area of the true pelvis, cystitis following previous therapy with ifosfamide, cyclophosphamide or trofosfamide and a history of uropathy.

Canada - English - Health Canada

fresenius kabi canada ltd - mesna - solution - 100mg - mesna 100mg - protective agents