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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - disodium edetate, quantity: 30 mg/ml - injection, concentrated - excipient ingredients: water for injections - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. indications held in artg paper records. (old code) 1. disodium edetate is particularly effective in treating lead accumulation and lead poisoning. this is especially so where there is a concomitant hypercalcaemic problem (refer "indications (2)"). however it must be noted that disodium edetate is equally effective with calcium disodium edetate in removing heavy metals, even in the absence of hypercalcaemia. for patients with elevated serum calcium or hypermobility of their body pools of calcium where there may be transiently or prolonged raised serum calcium (see "indications (2)"), the edta of choice for removing heavy metals may be disodium edetate. there are no recognised safe limits for lead intoxication. lead poisoning may occur by ingestion or inhalation of lead dust or fumes. poisoning is manifested by a metallic taste, anorexia, irritability, apathy, abdominal colic, vomiting, diarrhoea, cons

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

orthomolecular medisearch laboratories pty ltd trading as biological therapies - sodium ascorbate, quantity: 100 mg/ml; disodium edetate, quantity: 60 mg/ml - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide - 1. disodium edetate is particularly effective in treating lead accumulation and lead poisoning. this is especially so where there is a concomitant hypercalcaemic problem (refer "indications (2)"). however it must be noted that disodium edetate is equally effective with calcium disodium edetate in removing heavy metals, even in the absence of hypercalcaemia. for patients with elevated serum calcium or hypermobility of their body pools of calcium where there may be transiently or prolonged raised serum calcium (see "indications (2)"), the edta of choice for removing heavy metals may be disodium edetate. there are no recognised safe limits for lead intoxication. lead poisoning may occur by ingestion or inhalation of lead dust or fumes. poisoning is manifested by a metallic taste, anorexia, irritability, apathy, abdominal colic, vomiting, diarrhoea, constipation, headache, leg cramps, black stools, oliguria, stupor, convulsions, palsies and coma. chronic lead poisoning causes variable involvement of the central n

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

total potassium 7.5mmol/50ml) / disodium phosphate dihydrate 667.5mg solution for infusion 50ml pre-filled syringes (special order - potassium hydroxide; disodium phosphate dihydrate; potassium dihydrogen phosphate - solution for infusion - 1.4mg/1ml ; 13.35mg/1ml ; 17.01mg/1ml

New Zealand - English - Medsafe (Medicines Safety Authority)

centre for advanced medicine - disodium edetate 150 mg/ml (added as disodium edetate hydrous 166mg) - solution for injection - 150 mg/ml - active: disodium edetate 150 mg/ml (added as disodium edetate hydrous 166mg) excipient: hydrochloric acid sodium hydroxide water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

centre for advanced medicine - disodium edetate 150 mg/ml (added as disodium edetate hydrous 166mg) - solution for injection - 150 mg/ml - active: disodium edetate 150 mg/ml (added as disodium edetate hydrous 166mg) excipient: hydrochloric acid sodium hydroxide water for injection

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

avpak - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether balsalazide disodium is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when balsalazide is administered to a nursing woman. use of balsalazide disodium in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by: - extrapolation of results from clinical studies that supported the approval of balsalazide disodium for adults. - a clinical trial of 68 patients ages 5 to 17 years comparing two doses of balsalazide disodium (6.75 g/day and 2.25 g/day), and - a pharmacokinetic study performed on a subset of the pediatric study population. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day. safety and efficacy of balsalazide disodium in pediatric patients below the age of 5 years have not been established.

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

disodium edetate; sodium ascorbate -

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

disodium edetate -

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

disodium edetate; sodium ascorbate -

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

disodium edetate -