Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Noradrenaline tartrate
Pinewood Laboratories Ltd,
C01CA; C01CA03
Noradrenaline tartrate
1 milligram(s)/millilitre
Concentrate for solution for infusion
Adrenergic and dopaminergic agents; norepinephrine
Not marketed
2015-04-17
PACKAGE LEAFLET: INFORMATION FOR THE USER NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION NORADRENALINE (AS NORADRENALINE TARTRATE) _ _ WHAT IS IN THIS LEAFLET: 1. What Noradrenaline solution is and what it is used for 2. What you need to know before you use Noradrenaline solution 3. How to use Noradrenaline solution 4. Possible side effects 5. How to store Noradrenaline solution 6. Contents of the pack and other information 1. WHAT NORADRENALINE SOLUTION IS AND WHAT IT IS USED FOR Noradrenaline is used in an emergency to increase blood pressure to normal levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU START TO USE NORADRENALINE SOLUTION YOU WILL NOT BE GIVEN NORADRENALINE 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 pharmacist before using Noradrenaline if you: have diabetes suffer from high blood pressure have an over-active thyroid have low levels of oxygen in the blood have high levels of carbon dioxide in the blood have clots or obstructions in the blood vessels supplying the heart, intestines, or other parts of the body have low blood pressure following a heart attack have a type of angina (chest pain) called Prinzmetal’s angina are elderly are hypotensive (have a low blood pressure) that has been caused by hypovolaemia (low blood volume) are taking some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat). OTHER MEDICINES AND NORADRENALINE Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. A number of medicines are known to increase the toxic effects of Noradrenaline, such as: monoamine oxidase inhibitors (antidepressants) tricyclic antidepressants linezolid (an antibiotic) anaesthetics (especially anaesthetic gases) adrenergic-serotoninergic medicines, e.g. used in the treatment of asthma and heart conditions. PR Read the complete document
Health Products Regulatory Authority 08 January 2021 CRN009L7N Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 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. 1 vial of 20 ml contains 40 mg noradrenaline tartrate equivalent to 20 mg noradrenaline base. When diluted as recommended, each ml contains 80 micrograms noradrenaline tartrate equivalent to 40 micrograms noradrenaline base. Excipients: 1 ampoule of 2 ml contains 0.29 mmol (or 6.6 mg) sodium. 1 ampoule of 4 ml contains 0.58 mmol (or 13.2 mg) sodium. 1 vial of 20 ml contains 2.90 mmol (or 66.1 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 – 4.5 Osmolality: 280 – 320 mosmol/Kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Noradrenaline (Norepinephrine) Concentrate 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. _Method of administration:_ Administer as a diluted solution via a central venous catheter. The infusion should be at a controlled rate using either a syringe pump or an infusion pump or a drip counter. For dilution instructions see section 6.6. _Dosage:_ Adults _Initial rate of infusion:_ Health Products Regulatory Authority 08 January 2021 CRN009L7N Page 2 of 6 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 b Read the complete document