Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Frusemide
Sanofi-Aventis Ireland Limited T/A SANOFI
C03CA; C03CA01
Frusemide
20 mg/2ml
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Sulfonamides, plain; furosemide
Marketed
1977-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER LASIX 20MG/2ML SOLUTION FOR INJECTION OR INFUSION _FUROSEMIDE _ SANOFI LOGO IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP 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 pharmacist. • 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 Lasix Injection is and what it is used for 2. What you need to know before you take Lasix Injection 3. How Lasix Injection is given 4. Possible side effects 5. How to store Lasix Injection 6. Contents of the pack and other information 1. WHAT LASIX INJECTION IS AND WHAT IT IS USED FOR WHAT LASIX INJECTION IS The name of your medicine is Lasix 20mg/2ml Solution for Injection or Infusion (called Lasix Injection throughout this leaflet). Lasix Injection contains a medicine called furosemide. Lasix Injection belongs to a group of medicines called diuretics (water tablets). WHAT LASIX INJECTION IS USED FOR Lasix Injection can be used to help you lose extra water in your body very quickly. It is given when you cannot take a tablet or when you have a lot of extra water in your body. Lasix Injection is often used when you have too much water around your heart, lungs, liver or kidneys. HOW LASIX INJECTION WORKS Lasix Injection works by helping you to pass more water (urine) than you usually do. If the extra water in your body is not removed, it can put extra strain on the heart, blood vessels, lungs, kidneys or liver. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LASIX INJECTION DO NOT TAKE LASIX INJECTION IF: • You are allergic (hypersensitive) to furosemide or any of the other ingredients of Lasix Injection (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, s Прочитать полный документ
Health Products Regulatory Authority 23 February 2023 CRN00CPW7 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lasix 20mg/2ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Furosemide 20mg in 2ml aqueous solution. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection or Infusion. Clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lasix is used for the management of fluid retention and for the management of mild to moderate hypertension, either alone or as an adjunct. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION General: The dose used must be the lowest that is sufficient to achieve the desired effect. Route of administration: intramuscular or intravenous Furosemide is given intravenously only when oral administration is not feasible or is ineffective (e.g. in impaired intestinal absorption) or if a rapid effect is required. If intravenous therapy is used, it is recommended that transfer to oral therapy be carried out as soon as possible. Intravenous furosemide must always be injected or infused slowly, a rate of 4mg per minute must not be exceeded. The diuretic effect of Lasix is proportional to the dosage. In patients with severe impairment of renal function (serum creatinine >5 mg/dl), it is recommended that an infusion rate of 2.5 mg per minute is not exceeded. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration are feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections. Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher Прочитать полный документ