Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Metaraminol tartrate 0.95 mg/mL equivalent to Metaraminol 0.5 mg/mL
Phebra NZ Limited
5 mg/10mL
Solution for injection
Active: Metaraminol tartrate 0.95 mg/mL equivalent to Metaraminol 0.5 mg/mL Excipient: Sodium chloride Sodium hydroxide Sodium metabisulfite Tartaric acid Water for injection
Prescription
Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma.
Package - Contents - Shelf Life: Vial, glass, 10 mL clear type I with rubber stopper and aluminium seal - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
2017-05-18
DATA SHEET Metaraminol Phebra 0.5 mg/mL Solution for Injection Version 2.0 Page 1 of 5 1 PRODUCT NAME Metaraminol Phebra 0.5 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Metaraminol Phebra solution for injection contains metaraminol (as tartrate) 0.5 mg. Each 6 mL vial contains 3.0 mg metaraminol (as tartrate). Each 10 mL vial contains 5.0 mg metaraminol (as tartrate). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia. 4.2 Dose and method of administration Metaraminol Phebra injection is for intravenous administration only (injection or infusion) and should be used in one patient on one occasion only. It contains no antimicrobial preservative. Unused solution should be discarded. Because the maximum effect is not immediately apparent, at least ten minutes should elapse before increasing the dosage. As the effect tapers off when the vasopressor is discontinued, the patient should be carefully observed so that therapy can be reinitiated promptly if the blood pressure falls too rapidly. Patients with coexistent shock and acidosis may show a poor response to vasopressors. Established methods of shock management, such as blood or fluid replacement when indicated, and other measures directed to the specific cause of the shock also should be used. Direct intravenous injection In severe shock, when time is of great importance, it may be desirable to administer Metaraminol Phebra injection by direct intravenous injection. The suggested dose is 0.5 to 5 mg (1 to 10 mL), followed by an infusion of 15 to 95 mg in a diluent made up to a total volume of 500 Přečtěte si celý dokument