Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Noradrenaline tartrate
Sintetica GmbH
C01CA; C01CA03
Noradrenaline tartrate
Solution for infusion
Adrenergic and dopaminergic agents; norepinephrine
Not marketed
2020-08-14
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SINORA 0.1 mg/ml solution for infusion 0.2 mg/ml solution for infusion Noradrenaline (as noradrenaline tartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 pharmacist. - 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What SINORA is and what it is used for 2. What you need to know before SINORA is given to you 3. How to use SINORA 4. Possible side effects 5. How to store SINORA 6. Contents of the pack and other information 1. WHAT SINORA IS AND WHAT IT IS USED FOR SINORA contains the active substance noradrenaline and act as a vasoconstrictor. SINORA is used for the emergency restoration of blood pressure in cases of suddenly decreased blood pressure (acute hypotension). 2. WHAT YOU NEED TO KNOW BEFORE SINORA IS GIVEN TO YOU DO NOT USE SINORA: - if you are allergic (hypersensitive) to noradrenaline preparations or to any of the other ingredients of this medicine (listed in section 6). _ _ - if you are hypotensive (have low blood pressure) that has been caused by hypovolaemia (low blood volume). - if you are taking some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat) WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING SINORA • if you have diabetes • if you suffer from high blood pressure • if you have an over-active thyroid • if you have low levels of oxygen in the blood • if you have high levels of carbon dioxide in the blood • if you have clots or obstructions in the blood vessels supplying the heart, intestines or other parts of Baca dokumen lengkapnya
Health Products Regulatory Authority 13 December 2022 CRN00D6K4 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sinora 0.2 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 0.4 mg noradrenaline (norepinephrine) tartrate corresponding to 0.2 mg noradrenaline (norepinephrine) base. Each 50 ml vial contains 20 mg of noradrenaline (norepinephrine) tartrate corresponding to 10 mg of noradrenaline (norepinephrine) base. Excipient with known effect: Each ml of solution for infusion contains 0.14 mmol (or 3.3 mg) sodium. Each 50 ml vial contains 7.19 mmol (or 165.3 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear colourless solution. pH 3.0-4.5. Osmolarity: 250-350 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated 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 _Route of Administration: _ For intravenous use. _Posology:_ Adults _Initial dose: _ The initial dose, at a body weight of 70 kg, should be between 0.4 mg/hour to 0.8 mg/hour noradrenaline base (0.8 mg/hour to 1.6 mg/hour noradrenaline tartrate). Some clinicians may wish to start at a lower dose of 0.2 mg/hour noradrenaline base (0.4 mg/hour noradrenaline tartrate). _Titration of dose: _ Once an infusion of noradrenaline has been established the dose should be titrated in steps of 0.05 -0.1 µg/kg/min of noradrenaline base according to the pressor effect observed. There is great individual variation in the dose required to attain and maintain normotension. The aim should be to establish a low normal systolic blood pressure (100 - 120 mm Hg) or to achieve an adequate mean arterial blood pressure (greater than 65 - 80 mm Hg - depending on the patient's condition). NORADRENALINE 0.2 MG/ML SOLUTION FOR INFUSION 50 ML VIAL CONTAINING 10 MG OF NORADRENALINE BASE PATIENT’S WEIGHT POSOLOGY ( Baca dokumen lengkapnya