ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
Noradrenaline
Laboratoire AGUETTANT
C01CA; C01CA03
Noradrenaline
0.08 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Adrenergic and dopaminergic agents; norepinephrine
Marketed
2016-02-05
106786 Package leaflet: Information for the user NORADRENALINE (NOREPINEPHRINE) 0.08 MG/ML SOLUTION FOR INFUSION noradrenaline (norepinephrine) Referred to as Noradrenaline Solution for infusion in this leaflet. 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, ask your doctor or nurse. - This medicine has been prescribed for you only. 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Noradrenaline Solution for infusion is and what it is used for 2. What you need to know before you use Noradrenaline Solution for infusion 3. How to use Noradrenaline Solution for infusion 4. Possible side effects 5. How to store Noradrenaline Solution for infusion 6. Contents of the pack and other information 1. WHAT NORADRENALINE SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR This medicine contains the active substance noradrenaline and acts as a vasoconstrictor. This medicine is only indicated for adults. This medicine is used in adults weighing over 50 kg for the treatment of hypotensive emergencies that require an immediate increase in blood pressure to a normal level. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NORADRENALINE SOLUTION FOR INFUSION DO NOT USE NORADRENALINE SOLUTION FOR INFUSION: - administered via peripheral cannula and/or peripheral vein, - if you are allergic to noradrenaline or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Noradrenaline Solution for infusion: - if you have major left ventricular dysfunction (a heart condition), - if you have recently had myocardial infarction (a heart attack), - if you have cardiac rhythm disorders (your hea อ่านเอกสารฉบับเต็ม
Health Products Regulatory Authority 02 February 2023 CRN00CW1M Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Noradrenaline (Norepinephrine) 0.08 mg/mL solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 0.16 mg noradrenaline tartrate, equivalent to 0.08 mg noradrenaline base. Each 50 mL vial contains 8 mg noradrenaline tartrate, equivalent to 4 mg noradrenaline base. Excipient with known effect: Each mL of solution for infusion contains 3.5 mg equivalent to 0.2 mmol of sodium. Each 50 mL vial contains approximately 177.3 mg equivalent to 7.7 mmol of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colourless or slightly yellow solution pH = 3.2 – 3.8 Osmolality: 260 - 320 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Noradrenaline (Norepinephrine) is indicated in adults weighing over 50kg for the treatment of hypotensive emergencies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use only. Noradrenaline (Norepinephrine) Noradrenaline (Norepinephrine) should only be administered as an intravenous infusion via a central venous catheter to minimize the risk of extravasation and subsequent tissue necrosis. Noradrenaline (Norepinephrine) should be infused at a controlled rate using an infusion pump or a syringe pump. Noradrenaline (Norepinephrine) should not be diluted before use: it is supplied ready to use. It should not be mixed with other medicines. Blood pressure control: Blood pressure should be monitored carefully for the duration of therapy, and preferably controlled by arterial blood pressure monitoring. The patient should be monitored carefully for the duration of noradrenaline (norepinephrine) therapy. Posology Initial dose: The initial dose of noradrenaline base is usually between 0.05-0.15 micrograms/kg/min. Maintenance dose range: The recommended maintenance range of noradrenaline base is between 0.05-1.5 micrograms/kg/min. Titrat อ่านเอกสารฉบับเต็ม