Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate
GlaxoSmithKline UK Ltd
R03CC02
Salbutamol sulfate
1mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5000124415709
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VENTOLIN ® SOLUTION FOR INTRAVENOUS INFUSION 1 mg/ml SALBUTAMOL SULFATE 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 What Ventolin Infusion is and what it is used for 2 What you need to know before you use Ventolin Infusion 3 How to use Ventolin Infusion 4 Possible side effects 5 How to store Ventolin Infusion 6 Contents of the pack and other information 1 WHAT VENTOLIN INFUSION IS AND WHAT IT IS USED FOR Ventolin Solution for Intravenous Infusion (called ‘Ventolin Infusion’ in this leaflet) contains a medicine called salbutamol. This belongs to a group of medicines called ‘beta-agonists’. It acts on special receptor sites in the lungs and in the uterus (in women) to: help the airways in your lungs to stay open. This makes it easier for air to get in and out. It helps to relieve chest tightness, wheezing and cough relax the muscles in the walls of the uterus. This may stop the contractions associated with labour. Ventolin Infusion is used: to treat severe breathing problems in people with asthma and similar conditions in women who have unexpectedly gone into early labour (premature labour) between the 22 nd and 37 th week of gestation, to provide a short delay in the early delivery of the baby. You will receive Ventolin Infusion for a maximum of 48 hours. This will give your doctor or midwife time to take extra measures that will improve the health of your baby. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN INFUSION DO NOT USE VENTOLIN INFUSION IF: yo Pročitajte cijeli dokument
OBJECT 1 VENTOLIN SOLUTION FOR IV INFUSION Summary of Product Characteristics Updated 13-Feb-2015 | GlaxoSmithKline UK 1. Name of the medicinal product Ventolin ® Solution for Intravenous Infusion 5mg in 5ml (1mg/ml). 2. Qualitative and quantitative composition Ventolin Solution for Intravenous Infusion 5mg in 5ml (1mg/ml) is presented as ampoules of 5ml, each containing 5mg salbutamol as Salbutamol Sulfate BP in a sterile isotonic solution. 3. Pharmaceutical form Clear, colourless or pale straw-coloured solution for intravenous infusion. 4. Clinical particulars 4.1 Therapeutic indications Ventolin Solution for Intravenous Infusion is indicated in adults and adolescents. Ventolin Solution for Intravenous Infusion should be administered under the direction of a physician. It is indicated for two distinct clinical situations: a) For the relief of severe bronchospasm. b) To arrest labour between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy. 4.2 Posology and method of administration Ventolin Solution for Intravenous Infusion is used to prepare an infusion solution. It should not be injected undiluted. Ventolin Solution for Intravenous Infusion should not be administered in the same syringe or infusion as any other medication. 1. In severe bronchospasm. Adults: A suitable solution for infusion providing 10 micrograms salbutamol/ml is prepared by diluting 5ml Ventolin Solution for Intravenous Infusion to 500ml with an infusion solution such as Sodium Chloride and Dextrose Injection BP. Other suitable diluents are Water for Injections BP, Sodium Chloride Injection BP or Dextrose Injection BP. Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to 2ml/minute of the above infusion solution) are usually adequate. Higher doses have been used with success in patients with respiratory failure. _Paediatric Population_ The safety and efficacy of Ventolin Solution for Intravenous in children under the age of 12 has not been established. From the avail Pročitajte cijeli dokument