Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Noradrenaline
AS Kalceks
C01CA03
Noradrenaline
1 milligram(s)/millilitre
Concentrate for solution for infusion
norepinephrine
Marketed
2020-05-01
PACKAGE LEAFLET: INFORMATION FOR THE USER NOREPINEPHRINE KALCEKS 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION norepinephrine 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. ‒ 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 Norepinephrine Kalceks is and what it is used for 2. What you need to know before you are given Norepinephrine Kalceks 3. How Norepinephrine Kalceks will be given 4. Possible side effects 5. How to store Norepinephrine Kalceks 6. Contents of the pack and other information 1. WHAT NOREPINEPHRINE KALCEKS IS AND WHAT IT IS USED FOR Norepinephrine Kalceks contains the active substance norepinephrine and act as a vasoconstrictor (causes narrowing of blood vessels). Norepinephrine Kalceks is used in adults in an emergency to increase blood pressure to normal levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NOREPINEPHRINE KALCEKS YOU SHOULD NOT BE GIVEN NOREPINEPHRINE KALCEKS • if you are allergic to norepinephrine or any of the other ingredients of this medicine (listed in section 6) • if you have low blood pressure that has been caused by low blood volume • if you receive some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat). WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given norepinephrine if you: • have diabetes • have liver failure • have severe kidney disorders • suffer from high blood pressure • have an over-active thyroid gland • have low levels of oxygen in the blood • have high levels of carbon dioxide in the blood • have elevated pressure inside the skull (intracranial pressure) • have clots or obstructions in the blood vessels supplying the heart, intestines, or other pa Lire le document complet
Health Products Regulatory Authority 07 July 2022 CRN00CV0Q Page 1 of 9 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 Each 1 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 1 mg noradrenaline. Each ampoule containing 2 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 2 mg noradrenaline. Each ampoule containing 4 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 4 mg noradrenaline. Each ampoule containing 5 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 5 mg noradrenaline. Each ampoule containing 8 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 8 mg noradrenaline. Each ampoule containing 10 ml of concentrate for solution for infusion contains noradrenaline tartrate equivalent to 10 mg noradrenaline. When diluted as recommended, each ml contains noradrenaline tartrate equivalent to 40 micrograms noradrenaline. Excipient with known effect 8 ml of concentrate for solution for infusion contains 26.4 mg (or 1.12 mmol) sodium. 10 ml of concentrate for solution for infusion contains 33 mg (or 1.40 mmol) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless or yellowish solution, practically free from visible particles. pH ranges between 3.0 and 4.0. Osmolality 260‑310 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion is recommended in adults 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_ Add 2 ml of Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion t Lire le document complet