Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
NORADRENALINE ACID TARTRATE
Martindale Pharmaceuticals Ltd
NORADRENALINE ACID TARTRATE
0.1 Mg/Ml
Product subject to prescription which may not be renewed (A)
Withdrawn
2011-12-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Noradrenaline (Norepinephrine) 0.1 mg/ml Solution for Infusion in pre-filled syringe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 0.2mg Noradrenaline Tartrate, equivalent to 0.1mg Noradrenaline. Each 50ml syringe contains 10mg Noradrenaline Tartrate equivalent to 5mg Noradrenaline. For a full list of excipients see section 6.1 This medicinal product contains approximately 7.4mMol (170mg) Sodium per 50ml syringe. To be taken into consideration by patients on a controlled sodium diet. This medicinal product contains 12.5mg sodium metabisulphite per 50ml syringe. May rarely cause severe hypersensitivity reaction and bronchospasm. 3 PHARMACEUTICAL FORM Solution for Infusion in pre-filled syringe. A 50ml pre-filled syringe containing a clear, colourless solution The pH of the solution is 3.0 – 4.6 and the osmolality is 270-330 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Noradrenaline is indicated for the emergency restoration of blood pressure in cases of acute hypotension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ROUTE OF ADMINISTRATION:_ For intravenous use only. Noradrenaline should only be administered as an infusion at a controlled rate by a syringe pump. Noradrenaline should not be diluted before use; it is supplied ready for use. Site of injection: Noradrenaline is used by intravenous infusion only. Infusions of noradrenaline should be given into a large vein via a central venous catheter. Blood pressure control: Measure blood pressure every two minutes at the beginning of the infusion until the desired blood pressure is obtained. Then every five minutes when desired the blood pressure is obtained, if the administration has to be continued. The infusion flow rate mus Lire le document complet