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)

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: water for injections; trisodium caloxetate; trometamol; hydrochloric acid; sodium hydroxide - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: trometamol; sodium hydroxide; hydrochloric acid; water for injections; trisodium caloxetate - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; trisodium caloxetate; water for injections; sodium hydroxide; trometamol - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: trisodium caloxetate; sodium hydroxide; trometamol; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: water for injections; hydrochloric acid; trisodium caloxetate; trometamol; sodium hydroxide - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

bayer australia ltd - disodium gadoxetate, quantity: 181.43 mg/ml - injection, solution - excipient ingredients: water for injections; trometamol; trisodium caloxetate; hydrochloric acid; sodium hydroxide - this medicinal product is for diagnostic use only. primovist is indicated for use in adults for the enhancement of magnetic resonance imaging (mri) of focal liver lesion

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

fresenius kabi usa, llc - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium injection, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.  patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium.  vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 l/day throughout treatment.  mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics).  patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided.  diuretic therapy should not be employed prior to correction of hypovolemia.  the safety and efficacy of pamidronate disodium injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-

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

teva parenteral medicines, inc. - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium injection is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. pamidronate disodium injection is indicated for the treatment of patients with moderate to severe paget’s disease of bone. pamidronate disodium injection is indicated in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma [see clinical studies (14.3)] . the safety and efficacy of pamidronate disodium injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. pamidronate disodium is contraindicated in patients with hypersensitivity to pamidronate disodium, other bisphosphonates, or mannitol. reactions to pamidronate disodium injection and to mannitol have included anaphylaxis. pregnancy category d [see warnings and precautions (5.2)] risk summary there are no ad

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

avkare - 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,