מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Noradrenaline acid tartrate
base) 4mg/4ml concentrate for solution for infusion ampoules (Aguettant Ltd
C01CA03
Noradrenaline acid tartrate
1mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02070200; GTIN: 5060238380003
Nom du laboratoire : Nom du document : Ro ou Ro/Vo : Code article : Couleurs : BAT N° : Edition du : Format ouvert : Format plié : NORADRENALINE 1MG/ML Recto/Verso 102563 NOIR 1 07/10/14 420 x 297 mm 148,5 x 36 mm Laboratoire AGUETTANT sas PRODUIT : Noradrenaline (Norepinephrine) 1 mg/ml, concentrate for solution for infusion NOM DE FICHIER ET N° DE VERSION : Notice-Noradrenaline 1mgml-GB-Adresse-DEF.indd ARTICLE DE CONDITIONNEMENT : Notice Page 4 Fabrication Aguettant PAYS : Royaume-Uni - Changement d’adresse de la filiale POLICE : Times New Roman TAILLE POLICE : Texte : 10 pts Sous-titres : 11 pts Titre : 15 pts CODE ARTICLE : 102563 09/14 DIMENSIONS : A plat 210x297mm - Plié 148,5x36mm ECHELLE D’IMPRESSION : 100% sur A3 DATE DE CRÉATION : 6 décembre 2013 DATE DE LA VERSION : 18 septembre 2014 Noir Caractères Gris Découpe Combinations requiring precautions for use + NON-SELECTIVE MAO INHIBITORS: increase in the pressor action of the sympathomimetic which is usually moderate. Should only be used under close medical supervision. + SELECTIVE MAO-A INHIBITORS: by extrapolation from non-selective MAO inhibitors, risk of increase in the pressor action. Should only be used under close medical supervision. + LINEZOLID: by extrapolation from non-selective MAO inhibitors: risk of increase in the pressor action. Should only be used under close medical supervision. Caution is required when using Noradrenaline with alpha and beta blockers as severe hypertension may result. Caution is required when using Noradrenaline with the following drugs as they may cause increased cardiac effects : Thyroid hormones, Cardiac glycosides, Anti-arrhythmics. Ergot alkaloids or oxytocin may enhance the vasopressor and vasoconstrictive effects. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Noradrenaline may impair placental perfusion and induce fetal bradycardia. It may also exert a contractile effect on the pregnant uterus and lead to fetal asphyxia in late pregnancy. These possible risks to the fetus should therefore קרא את המסמך השלם
OBJECT 1 NORADRENALINE (NOREPINEPHRINE) 1 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 11-Jun-2018 | Aguettant Ltd 1. Name of the medicinal product NORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for infusion 2. Qualitative and quantitative composition Each ml of concentrate for solution for infusion contains 2 mg Noradrenaline tartrate, equivalent to 1 mg Noradrenaline base Each 4ml ampoule contains 8mg Noradrenaline tartrate equivalent to 4mg Noradrenaline base. Each 8ml ampoule contains 16mg Noradrenaline tartrate equivalent to 8mg Noradrenaline base. This medicinal product contains sodium. Each ml of concentrate for solution for infusion contains 3.3 mg equivalent to 0.14 mmol of sodium Each 4ml ampoule contains 13.2 mg equivalent to 0.57 mmol of sodium Each 8ml ampoule contains 26.4 mg equivalent to 1.14 mmol of sodium To be taken into consideration by patients on a controlled sodium diet. For full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion Clear, colourless liquid pH = 3.0 to 4.0 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 Posology _Adults: _ Initial rate of infusion: The initial rate of infusion should be between 10 ml/hour and 20 ml/hour (0.16 ml/min to 0.33 ml/min). This is equivalent to 0.8 mg/hr to 1.6 mg/hr noradrenaline tartrate (or 0.4 mg/hr to 0.8 mg/hr noradrenaline base). Titration of dose: Once an infusion of noradrenaline has been established the dose should be titrated according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension. The aim should be to establish a low normal systolic blood pressure (100-120 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 65 to 80 mm Hg – depending on the patient's condition). Noradrenaline ta קרא את המסמך השלם