Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TERBUTALINE SULFATE
AstraZeneca UK Limited
R03CC03
TERBUTALINE SULFATE
500 Microgram/ML
Solution for Injection
Product subject to prescription which may not be renewed (A)
terbutaline
Not Marketed
1979-04-01
PIL IR Bricanyl Injection RSP 14 0060a (based on RSP 13 0026) 16/03/2015 SP Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER BRICANYL 500 MICROGRAMS/ML, SOLUTION FOR INJECTION OR INFUSION 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bricanyl Injection is and what it is used for 2. What you need to know before you use Bricanyl Injection 3. How to use Bricanyl Injection 4. Possible side effects 5. How to store Bricanyl Injection 6. Contents of the pack and other information 1. WHAT BRICANYL INJECTION IS AND WHAT IT IS USED FOR Bricanyl Injection contains a medicine called terbutaline sulfate. This belongs to a group of medicines called beta-agonists. These work by relaxing certain muscles. For example, they open up the airways in the lungs or relax the muscles of the womb (uterus) during pregnancy. Bricanyl Injection is used for breathing disorders such as asthma. It helps to relieve tightening of the chest and difficulty breathing (bronchospasm). Bricanyl Injection is also used 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 Bricanyl Injection 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 BRICANYL INJECTION DO NOT USE BRICANYL INJECTION: If you are allergic Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bricanyl 500 micrograms/ml solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 500 micrograms Terbutaline sulfate. Excipient(s) with known effect: 1 ml also contains sodium (<1 mmol/ml), as sodium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion A clear aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bronchodilation Terbutaline is a selective beta 2 -adrenergic agonist recommended for the relief of bronchospasm in bronchial asthma and other bronchopulmonary disorders in which bronchospasm is a complicating factor. For the short term management of uncomplicated premature labour 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 POSOLOGY The dosage should be individualised. FOR BRONCHODILATION When a rapid therapeutic response is required, Bricanyl can be administered by any of the three standard parenteral routes: subcutaneous, intramuscular, or i.v. bolus. The preferred routes will usually be subcutaneous or intramuscular. When given as an i.v. bolus the injection must be made slowly noting patient response. Adults 0.5 -1 ml (0.25 - 0.5 mg) up to four times a day. Paediatric population 2 -15 years: 0.01 mg/kg body weight to a maximum of 0.3 mg total. Age Average weight mg ml kg (lb) terbutaline volume <3 10 (22) 0.1 0.2 3 15 (33) 0.15 0.3 6 20 (44) 0.2 0.4 8 25 (55) 0.25 0.5 10+ 30+ (66+) 0.3 0.6 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document