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Γλώσσα: Αγγλικά
Πηγή: myHealthbox
noradrenaline tartrate
FARMA MEDITERRANIA S.L.
C01CA03
noradrenaline tartrate
2mg/ml
Concentrate for solution for infusion
intravenous use
5 ampoules of 2 ml in a pack 5 ampoules of 4 ml in a pack 5 vials of 20 ml in a pack
POM - Prescription Only Medicine
NOVOCAT FARMA, S.A
Adrenergic and dopaminergic agents
Noradrenaline (Norepinephrine) Concentrate is indicated for the emergency restoration of blood pressure in cases of acute hypotension.
Authorised
2015-03-31
PATIENT INFORMATION LEAFLET NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION NORADRENALINE (AS NORADRENALINE TARTRATE) IN THIS LEAFLET: 1. What NORADRENALINE (NOREPINEPHRINE) CONCENTRATE is and what it is used for 2. Things to consider before you start to use NORADRENALINE (NOREPINEPHRINE) CONCENTRATE 3. How to use NORADRENALINE (NOREPINEPHRINE) CONCENTRATE 4. Possible side effects 5. How to store NORADRENALINE (NOREPINEPHRINE) CONCENTRATE 6. Further information 1. WHAT NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IS AND WHAT IT IS USED FOR Noradrenaline (Norepinephrine) Concentrate is used in an emergency to increase blood pressure to normal levels. 2. THINGS TO CONSIDER BEFORE YOU START TO USE NORADRENALINE (NOREPINEPHRINE) CONCENTRATE YOU WILL NOT BE GIVEN NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IF You are allergic (hypersensitive) to Noradrenaline preparations or to any of the other ingredients of this medicine (see section 6). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE EVEN IF YOU HAVE ALREADY USED NORADRENALINE OR A SIMILAR MEDICINE BEFORE, WE ADVISE YOU TO READ THIS TEXT CAREFULLY. THE INFORMATION MAY HAVE BEEN CHANGED. - Keep this leaflet. You may need to read it again. . - If you have any further questions, 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 symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. - The name of this medicinal product is Noradrenaline (Norepinephrine) Διαβάστε το πλήρες έγγραφο
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: _ When diluted as recommended in section 6.6 (the concentration of the prepared infusion is 40 mg/litre noradrenaline base (80 m Διαβάστε το πλήρες έγγραφο