Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbutaline sulfate
AstraZeneca UK Ltd
R03AC03
Terbutaline sulfate
2.5mg/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5014162002418
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER BRICANYL RESPULES ® 2.5 MG/ML NEBULISER SOLUTION terbutaline sulfate 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. 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 Bricanyl Respules are and what they are used for 2. What you need to know before you use Bricanyl Respules 3. How to use Bricanyl Respules 4. Possible side effects 5. How to store Bricanyl Respules 6. Contents of the pack and other information 1. WHAT BRICANYL RESPULES ARE AND WHAT THEY ARE USED FOR Bricanyl Respules contain a medicine called terbutaline. This belongs to a group of medicines called ‘beta-agonists’. These work by relaxing certain muscles and opening up the airways in the lungs. Bricanyl Respules are used for asthma and other breathing problems where you have a tight chest and difficulty breathing. Bricanyl should not be used alone for the regular treatment of asthma or other breathing conditions. If you are using Bricanyl every day then your doctor should have also prescribed you another type of medication such as an “inhaled corticosteroid”, which helps reduce the swelling and inflammation in your lungs. A Respule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRICANYL RESPULES DO NOT USE BRICANYL RESPULES: If you are allergic to terbutaline or any of the other ingredients of Přečtěte si celý dokument
OBJECT 1 BRICANYL RESPULES 2.5 MG/ML NEBULISER SOLUTION Summary of Product Characteristics Updated 02-May-2017 | AstraZeneca UK Limited 1. Name of the medicinal product Bricanyl Respules 2.5 mg/ml Nebuliser Solution 2. Qualitative and quantitative composition Terbutaline sulfate 2.5mg/ml. Each single dose respule contains 2ml (5mg). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sterile nebuliser solution. A clear, aqueous, isotonic solution. 4. Clinical particulars 4.1 Therapeutic indications Terbutaline is a selective beta 2 -adrenergic agonist recommended for the relief of severe bronchospasm in bronchial asthma and in chronic bronchitis and other bronchopulmonary disorders in which bronchospasm is a complicating factor. 4.2 Posology and method of administration Posology When used as maintenance therapy the patient should also receive optimal anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene receptor antagonists. In most patients, the use of terbutaline sulfate, based on the doses below, given 2-4 times daily will be sufficient to relieve bronchospasm. In acute, severe asthma, additional doses may be necessary. Bricanyl Respules: Adults: Children: Children: 1 or 2 Respules (5 or 10mg) (>25kg) 1 Respule (5mg) (<25kg) use multidose bottles. Multidose Bottles: Adults: 0.5 to 1 ml (5 to 10mg) diluted to required nebuliser volume with sterile physiological saline. Children: 0.2 to 0.5ml (2 to 5mg), see table, diluted to required nebuliser volume with sterile physiological saline. Table illustrating ml undiluted solution from multidose bottle required for administration to children Age Average kg weight lb mg terbutaline ml undiluted solution <3 10 22 2.0 0.2 3 15 33 3.0 0.3 6 20 44 4.0 0.4 8+ 25+ 55+ 5.0 0.5 Elderly: Dosage as for adults. Method of administration Instructions for use and cleaning are provided in the Patient Information Leaflet which can be found in each pack. 4.3 Contraindications Hypersensitivity to the active substance(s) or to any of the excipients li Přečtěte si celý dokument