Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Glyceryl trinitrate
Merus Labs Luxco II S.à.R.L.
C01DA; C01DA02
Glyceryl trinitrate
1 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Organic nitrates; glyceryl trinitrate
Not marketed
1983-08-02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NITROCINE ® 1 MG/ML SOLUTION FOR INFUSION GLYCERYL TRINITRATE 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 further questions, please 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 Nitrocine is and what it is used for 2. What you need to know before you are given Nitrocine 3. How you will be given Nitrocine 4. Possible side effects 5. How to store Nitrocine 6. Contents of the pack and other information. 1. WHAT NITROCINE IS AND WHAT IT IS USED FOR Nitrocine belongs to a group of medicines called ‘nitrates’. These are used to widen your blood vessels and reduce the workload of your heart. NITROCINE IS USUALLY USED IN EMERGENCY SITUATIONS TO: Rapidly control high blood pressure during surgery, especially heart surgery Treat unstable angina. (Angina attacks feel like a tight pain in your chest, neck or arm and are a sign that your heart is not getting enough oxygen for the amount of work it is doing) Treat heart failure following a heart attack. It is very important that your doctor treats these conditions as quickly and effectively as possible, as left untreated the consequences could be fatal. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NITROCINE DO NOT USE NITROCINE: If you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6) If you are allergic to any other nitrates If you are taking medicines for failure to achieve an erection such as Viagra. Using Nitrocine with these medicines could cause a severe drop in blood pressure and c Preberite celoten dokument
Health Products Regulatory Authority 12 January 2021 CRN00C3GS Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitrocine 1 mg/ml solution for infusion, vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg glyceryl trinitrate in 50 ml (1mg/ml). For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear colourless and odourless isotonic sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Surgery_: Nitrocine is indicated for: 1.The rapid control of hypertension during cardiac surgery. 2.Reducing blood pressure and maintaining controlled hypotension during surgical procedures. 3.Controlling myocardial ischaemia during and after cardiovascular surgery. _Unresponsive congestive heart failure_: Nitrocine may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction. _Unstable angina_: Nitrocine may be used to treat unstable angina which is refractory to treatment with beta blockers and sublingual nitrates. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The dose of Nitrocine should be adjusted to meet the individual needs of the patient. The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min may be necessary during some surgical procedures. _Elderly _ There is no evidence that a posology adjustment is required in the elderly. _Paediatric population_ The safety and efficacy of Nitrocine has not yet been established in children. _Surgery_: A starting dose of 25 mcg/min is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 mcg/min at 5 minute intervals until the blood pressure is stabilized. Doses between 10 - 200 mcg/min are usually sufficient during surgery, although doses of up to 400 mcg/min have been required in some cases. The treatment of perioperative myocardial ischaemia may be started with a dose of 15 - 20 mcg/min, with subsequent increments of 10 - 15 mcg/min un Preberite celoten dokument