Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Noradrenaline acid tartrate
base) 2mg/2ml solution for infusion ampoules (Pfizer Ltd
C01CA03
Noradrenaline acid tartrate
1mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02070200; GTIN: 5013158015890
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER NORADRENALINE (NOREPINEPHRINE) 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Noradrenaline (as noradrenaline tartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The name of this medicinal product is Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion but it will be referred to as Noradrenaline (Norepinephrine) Concentrate throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Noradrenaline (Norepinephrine) Concentrate is and what it is used for 2. What you need to know before you use Noradrenaline (Norepinephrine) Concentrate 3. How to use Noradrenaline (Norepinephrine) Concentrate 4. Possible side effects 5. How to store Noradrenaline (Norepinephrine) Concentrate 6. Contents of the pack and other information 1. WHAT NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IS AND WHAT IT IS USED FOR Noradrenaline (Norepinephrine) Concentrate for Solution for Infusion is used in an emergency to increase blood pressure to normal levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NORADRENALINE (NOREPINEPHRINE) CONCENTRATE DO NOT TAKE NORADRENALINE (NOREPINEPHRINE) CONCENTRATE if you are allergic to noradrenaline preparations or to any of the other ingredients of this medicine ( listed in section 6). Tell your doctor if any of the above applies to you before this medicine is used. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IF YOU HAVE: diabetes high blood pressure Læs hele dokumentet
OBJECT 1 NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 14-May-2018 | Hospira UK Ltd 1. Name of the medicinal product Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for Infusion 2. Qualitative and quantitative composition 1 ml concentrate for solution for infusion contains 2 mg noradrenaline tartrate equivalent to 1 mg noradrenaline base. 1 ampoule of 2 ml contains 4 mg noradrenaline tartrate equivalent to 2 mg noradrenaline base. 1 ampoule of 4 ml contains 8 mg noradrenaline tartrate equivalent to 4 mg noradrenaline base. When diluted as recommended, each ml contains 80 micrograms noradrenaline tartrate equivalent to 40 micrograms noradrenaline base. Excipient(s) with known effects: 1 ampoule of 2 ml contains 0.29 mmol (or 6.7 mg) sodium. 1 ampoule of 4 ml contains 0.58 mmol (or 13.3 mg) sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion A clear colourless or yellowish solution pH: 3.0 – 4.0 Osmolarity: approximately 280 mOsm/l 4. Clinical particulars 4.1 Therapeutic indications Indicated for use as an emergency measure in the restoration of blood pressure in cases of acute hypotension. 4.2 Posology and method of administration Posology Adults _Initial rate of infusion: _ When diluted as recommended in section 6.6 (the concentration of the prepared infusion is 40 mg/litre noradrenaline base (80 mg/litre noradrenaline tartrate)) the initial rate of infusion, at a body weight of 70 kg, should be between 10 ml/hour and 20 ml/hour (0.16 to 0.33 ml/min). This is equivalent to 0.4 mg/hour to 0.8 mg/hour noradrenaline base (0.8 mg/hour to 1.6 mg/hour noradrenaline tartrate). Some clinicians may wish to start at a lower initial infusion rate of 5 ml/hour (0.08 ml/min), equivalent to 0.2 mg/hour noradrenaline base (0.4 mg/hour noradrenaline tartrate). _Titration of dose: _ Once an infusion of noradrenaline has been established the dose should be titrated in steps Læs hele dokumentet