País: Armênia
Língua: inglês
Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
noradrenaline tartrate
Kalceks JSC
C01CA03
noradrenaline tartrate
1mg/ml
concentrate for solution for infusion
(5/1x5/) ampoules 4ml in plastic liner, (10/2x5/) ampoules 4ml in plastic liner
Prescription
Registered
2022-11-03
PACKAGE LEAFLET: INFORMATION FOR THE USER NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION noradrenaline 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 Noradrenaline is and what it is used for 2. What you need to know before you are given Noradrenaline 3. How Noradrenaline will be given 4. Possible side effects 5. How to store Noradrenaline 6. Contents of the pack and other information 1. WHAT NORADRENALINE IS AND WHAT IT IS USED FOR Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion contains the active substance noradrenaline and act as a vasoconstrictor (causes narrowing of blood vessels). Noradrenaline is used in adults in an emergency to increase blood pressure to normal levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NORADRENALINE YOU SHOULD NOT BE GIVEN NORADRENALINE • if you are allergic to noradrenaline 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 noradrenaline 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 parts of the bod Leia o documento completo
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 to 48 ml 50 mg/ml (5%) glucose (or other in section 6.6 mentioned solution Leia o documento completo