Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
NOREPINEPHRINE BITARTRATE
Sintetica GmbH
C01CA; C01CA03
NOREPINEPHRINE BITARTRATE
Solution for infusion
Adrenergic and dopaminergic agents; norepinephrine
Not marketed
2020-04-24
Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Sinora 0.08 mg/ml solution for infusion 0.16 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, pharmacist or nurse. - 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, pharmacist or nurse. 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 is a medicine that belongs to the group of adrenergic and dopaminergic agents. Sinora is indicated in adults weighing over 50 kg for the on-going treatment of hypotensive emergencies with escalating noradrenaline dose requirements. The product is for adults only. 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). Page 2 WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE 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 the body • if you have low b Lestu allt skjalið
Health Products Regulatory Authority 29 November 2023 CRN00DWHY Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sinora 0.16 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 0.32 mg noradrenaline tartrate corresponding to 0.16 mg noradrenaline base. Each 50 ml vial contains 16 mg of noradrenaline tartrate corresponding to 8 mg of noradrenaline 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 3.0-4.0. Osmolarity: 250 – 350 mOsm/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sinora solution for infusion is indicated in adults weighing over 50kg for the on-going treatment of hypotensive emergencies with escalating noradrenaline dose requirements. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of Administration:_ For intravenous use only. _Blood pressure control:_ Blood pressure should be monitored carefully for the duration of therapy, and preferably controlled by arterial blood pressure monitoring. The patient should be monitored carefully for the duration of noradrenaline therapy. _Posology:_ Sinora solution for infusion should not be used for initiating vasopressor treatment. It may be considered for use in patients already established on noradrenaline therapy whose dose requirements are clinically confirmed to be escalating, such that Sinora 0.08 mg/ml, solution for infusion may be commenced at a flow rate of 1.5 ml/h and Sinora 0.16 mg/ml, solution for infusion may be commenced at a flow rate of 0.75 ml/h. Adults _Initial dose:_ The initial dose of noradrenaline base is usually between 0.05 and 0.15 micrograms/kg/min. This initial posology should be administered using a less concentrated noradrenaline solution that permits better titration by 0.05 and 0.1 micrograms/kg/m Lestu allt skjalið