País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Calcium carbonate 42.4 mg/mL; Edetic acid 123.7 mg/mL; Sodium hydroxide 33.9 mg/mL
iNova Pharmaceuticals (New Zealand) Limited
Calcium carbonate 42.4 mg/mL
1g/5mL
Solution for injection
Active: Calcium carbonate 42.4 mg/mL Edetic acid 123.7 mg/mL Sodium hydroxide 33.9 mg/mL Excipient: Water for injection
Ampoule, glass, 6 x 5ml ampoule, 6 dose units
Prescription
Prescription
Hospira Inc
Package - Contents - Shelf Life: Ampoule, glass, 6 x 5ml ampoule - 6 dose units - 60 months from date of manufacture stored at or below 30°C
1969-12-31
DATA SHEET CALCIUM DISODIUM VERSENATE _EDETATE CALCIUM DISODIUM _ WARNINGS: Calcium Disodium Versenate is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in paediatric patients in whom it may be incipient and thus overlooked. The mortality rate in paediatric patients has been high. Patients with lead encephalopathy and cerebral oedema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded. NAME OF THE MEDICINE Edetate calcium disodium DESCRIPTION Calcium Disodium Versenate (edetate calcium disodium injection, USP) is a sterile, injectable, chelating agent in concentrated solution for intravenous infusion or intramuscular injection. Each 5 ml ampoule contains 1000 mg of edetate calcium disodium (equivalent to 200 mg/ml) in water for injection. Chemically, this product is called [[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)- glycinato]](4-)-N,N',O,O',O N ,O N ']-,disodium, hydrate, (OC-6-21)-Calciate(2-). STRUCTURAL FORMULA: C 10 H 10 CaN 2 Na 2 O 8 . xH 2 O Molecular weight 374.27 (anhydrous) PHARMACOLOGY The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals. A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury. The amounts of manganese and iron mobilised are not significant. Copper is not mobilised and mercury is unavailable for chelation because it is too tightly bound to body ligands or it is stored in inaccessible body compartments. The excretion of calcium by the body is not increased following intravenous a Leer el documento completo