Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glyceryl trinitrate
Beaumont Pharma Ltd
C01DA02
Glyceryl trinitrate
1mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5013675000584
PACKAGE LEAFLET: INFORMATION FOR THE USER GLYCERYL TRINITRATE Read all of this leaflet carefully before you start taking this medicine. – 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. 223050025/10 GI Nitronal / 148 x 320 / LC 7954 / England / fub Nitronal ® 1 mg/ml solution for infusion In this leaflet: 1. What Nitronal ® is and what it is used for 2. Before you take Nitronal ® 3. How to take Nitronal ® 4. Possible side effects 5. How to store Nitronal ® 6. Further information 1. WHAT NITRONAL ® IS AND WHAT IT IS USED FOR Nitronal ® contains glyceryl trinitrate (GTN). GTN belongs to a group of medicines called nitrates, which relax the muscle around blood vessels and make the heart’s work easier. Nitronal ® is a medicine which is only used in hospitals. It is used in three conditions: – in heart failure – in angina – to lower the blood pressure during surgery. All patients given Nitronal ® are monitored very carefully. 2. BEFORE YOU TAKE NITRONAL ® Do not take Nitronal ® if you – are ALLERGIC (hypersensitive) to NITRATES or ANY OF THE OTHER INGREDIENTS of Nitronal ® (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. – are taking VIAGRA (sildenafil) or similar products for the treatment of erectile dysfunction or hypertension of arterial lung vessels. If you take these products and Nitronal ® , a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, uncon- sciousness and could be fatal. – are suffering from: – acute circulatory failure – shock – low blood pressure – a condition c Lesen Sie das vollständige Dokument
OBJECT 1 NITRONAL Summary of Product Characteristics Updated 08-May-2018 | Intrapharm Laboratories Limited 1. Name of the medicinal product Nitronal ® 2. Qualitative and quantitative composition Glyceryl trinitrate 1 mg/ml. 3. Pharmaceutical form Solution for infusion. 4. Clinical particulars 4.1 Therapeutic indications (1) Unresponsive congestive heart failure, including that secondary to acute myocardial infarction. (2) Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetal's angina. (3) Control of hypertensive episodes and / or myocardial ischaemia during and after cardiac surgery. For the induction of controlled hypotension for surgery. 4.2 Posology and method of administration For intravenous use. Nitronal® should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate. _Adults and the elderly _- the dose should be titrated against the individual clinical response. (1) Unresponsive congestive heart failure. The normal dose range is 10-100 micrograms / minute administered as a continuous intravenous infusion with frequent monitoring of blood pressure and heart rate. The infusion should be started at the lower rate and increased cautiously until the desired clinical response is achieved. Other haemodynamic measurements are extremely important in monitoring response to the drug: These may include pulmonary capillary wedge pressure, cardiac output and precordial electrocardiogram depending on the clinical picture. (2) Refractory unstable angina pectoris. An initial infusion rate of 10-15 micrograms / minute is recommended; this may be increased cautiously in increments of 5-10 micrograms until either relief of angina is achieved, headache prevents further increase in dose, or the mean arterial pressure falls by more than 20 mm Hg. (3) Use in surgery. An initial infusion rate of 25 micrograms / minute is recommended; this should be increased gradually until the desired systolic arterial pressure is attained. T Lesen Sie das vollständige Dokument