Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Noradrenaline acid tartrate monohydrate 2 mg/mL equivalent to Noradrenaline base 1 mg/mL
Pfizer New Zealand Limited
Noradrenaline acid tartrate monohydrate 2 mg/mL (equivalent to Noradrenaline base 1 mg/mL)
1 mg/mL
Concentrate for injection
Active: Noradrenaline acid tartrate monohydrate 2 mg/mL equivalent to Noradrenaline base 1 mg/mL Excipient: Sodium chloride Sodium metabisulfite Water for injection
Prescription
Cambrex Profarmaco Milano Srl
For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusions and drug reactions). As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means.
Package - Contents - Shelf Life: Vial, glass, Type 1 amber glass with rubber stopper & aluminium seal 4mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.
2013-12-04
Version: pfdlevoi10822 Supersedes: pfdlevoi10720 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ LEVOPHED TM 1:1000 Concentrate for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains noradrenaline (norepinephrine) 4 mg in 4 mL (1:1000), present as 8 mg of noradrenaline (norepinephrine) acid tartrate in 4 mL. Excipient(s) with known effects: • Sodium metabisulfite For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM LEVOPHED TM 1:1000 is a sterile colourless (or practically colourless), concentrated solution for injection. It has a pH of 3.0 to 4.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means. 4.2 DOSE AND METHOD OF ADMINISTRATION LEVOPHED TM 1:1000 contains noradrenaline (norepinephrine) as the acid tartrate. It is a concentrated, potent injection which must be diluted in dextrose containing solutions prior to infusion. An infusion of noradrenaline (norepinephrine) should be given into a large vein (see Section 4.4). LEVOPHED TM 1:1000 contains no antimicrobial preservative. It is for single use in one patient only. Discard any residue. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to use, whenever solution and container permit. Discoloured solutions or those containing a precipitate should not be used. Avoid contact with iron salts, alkalis, or oxidising agents. Version: pfdlevoi10822 Supersedes: pfdlevoi10720 RESTORATION OF BLOOD PRESSURE IN ACUTE HYPOTENSIVE STATES Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, Izlasiet visu dokumentu