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

clinect pty ltd - methylene blue, quantity: 50 mg - injection - excipient ingredients: water for injections - proveblue is indicated: for the treatment of drug-induced methaemoglobinaemia. for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobulin is not present). as a bacterial stain. as a dye in diagnostic procedures such as fistula detection. for the delineation of certain body tissues during surgery.

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

phebra pty ltd - methylene blue, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - methylene blue injection usp is indicated: for the treatment of drug-induced methaemoglobinaemia; for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobin is not present); as a bacteriological strain as a dye in diagnostic procedures such as fistula detection; for the delineation of certain body tissues during surgery.

Singapore - English - HSA (Health Sciences Authority)

pharm-d singapore private limited - methylthioninium chloride trihydrate (methylene blue) - injection, solution - methylthioninium chloride trihydrate (methylene blue) 5mg/ml

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

zydus pharmaceuticals usa inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. methylene blue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary methylene blue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of methylene blue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions, including genotoxicity discontinue breast-feeding during and for up to 8 days after treatment with methylene blue [see clinical pharmacology (12.3)] . the safety and effectiveness of methylene blue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of methylene blue is supported by two retrospective case series that included 2 pediatric patients treated with methylene blue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)] . clinical studies of methylene blue did not include sufficient numbers 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 the elderly and younger patients. methylene blue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)]. methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73 m2 ) significantly [see clinical pharmacology (12.3)]. adjust methylene blue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)]. no dose adjustment is recommended in patients with mild renal impairment (egfr 60-89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with methylene blue.

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

martindale pharmaceuticals ltd - methylthioninium chloride - solution for injection - 5mg/1ml

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

american regent, inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 5 mg in 1 ml - provayblue is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. provayblue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary provayblue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of provayblue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions including genotoxicity, discontinue breast-feeding during and for up to 8 days after treatment with provayblue [see clinical pharmacology (12.3)] . the safety and effectiveness of provayblue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of provayblue is supported by two retrospective case series that included 2 pediatric patients treated with provayblue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)]. clinical studies of provayblue did not include sufficient numbers 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 the elderly and younger patients. provayblue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)] . methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73m2 ) significantly [see clinical pharmacology (12.3)] . adjust provayblue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)] . no dose adjustment is recommended in patients with mild renal impairment (egfr 60 – 89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with provayblue.

Egypt - English - EDA (Egyptian Drug Authority)

t3a pharma - injection - 640 mg

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

bio-practica pty ltd - magnesium citrate, quantity: 468.727 mg/g (equivalent: magnesium, qty 72.727 mg/g) - powder, oral - excipient ingredients: potassium bicarbonate; citric acid; steviol glycosides; beet red; xylitol; riboflavin; flavour - maintain/support energy levels ; maintain/support energy production ; maintain/support body electrolyte balance ; maintain/support general health and wellbeing ; maintain/support healthy teeth ; maintain/support bone health ; maintain/support cardiovascular system health ; maintain/support healthy cardiovascular system function ; maintain/support heart health ; maintain/support healthy immune system function ; decrease/reduce/relieve muscle cramps ; helps decrease/reduce/relieve mild muscle spasms/twitches ; maintain/support healthy muscle contraction function ; maintain/support muscle function ; maintain/support healthy neuromuscular system/function ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral) within normal range ; decrease/reduce/relieve symptoms of mild anxiety ; decrease/reduce/relieve mild migraine symptoms ; maintain/support nerve conduction ; maintain/support nervous system health ; maintain/support nervous system function ; decrease/reduce/relieve menstrual spasms/cramps ; decrease/reduce/relieve symptoms of premenstrual tension

New Zealand - English - Medsafe (Medicines Safety Authority)

clinect nz pty limited - methylthioninium chloride hydrate 5 mg/ml equivalent to methylthioninium chloride trihydrate 5 mg/ml (methylthioninium chloride anhydrous 4.27) - solution for injection - 50 mg/10ml - active: methylthioninium chloride hydrate 5 mg/ml equivalent to methylthioninium chloride trihydrate 5 mg/ml (methylthioninium chloride anhydrous 4.27) excipient: water for injection - for the treatment of methaemoglobinaemia. for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobin is not present).

India - English - Central Drugs Standard Control Organization

nicholas - rosiglitazone,metformin,glibenclamide - tab - 2,500,5;mg - 10