Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate
Mawdsley-Brooks & Company Ltd
R03AC02
Salbutamol sulfate
2mg/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101
PACKAGE LEAFLET: INFORMATION FOR THE USER NEBULES 2.5 MG AND 5 MG SALBUTAMOL 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, 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 Nebules are and what they are used for 2 What you need to know before you use Ventolin Nebules 3 How to use Ventolin Nebules 4 Possible side effects 5 How to store Ventolin Nebules 6 Contents of the pack and other information 1 WHAT VENTOLIN NEBULES ARE AND WHAT THEY ARE USED FOR Ventolin Nebules contain a medicine called salbutamol. This belongs to a group of medicines called fast-acting bronchodilators. • Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. • They help to relieve chest tightness, wheezing and cough. Ventolin Nebules are used to treat breathing problems in people with asthma and other chest illnesses. They are usually given to people who suffer quite badly from these conditions when other forms of treatment do not help enough. Ventolin Nebules are also given to treat severe attacks of asthma. A Nebule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine makes a fine mist for you to breathe in through a face mask. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN NEBULES DO NOT USE VENTOLIN NEBULES IF: • you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in Section 6). • you unexpectedly go into early labour (premature labour) or threatened abortion Preberite celoten dokument
1. NAME OF THE MEDICINAL PRODUCT Ventolin Nebules 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Plastic ampoule containing 2.5 ml of a sterile 0.2% w/v solution of salbutamol (as Salbutamol Sulfate BP) in normal saline. 3. PHARMACEUTICAL FORM Solution for inhalation via a nebuliser. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Nebules are indicated in adults, adolescents and children, see Section 4.2. Salbutamol is a selective β 2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. Ventolin Nebules are indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ventolin Nebules are for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed. _Adults (including the elderly):_ 2.5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital. _Paediatric Population _ Children aged 12 years and over: Dose as per adult population. Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old. Infants under 18 months old: Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered. Ventolin Nebules are intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. 4.4 SPECIAL WARNINGS AND PRECAUTIONS Preberite celoten dokument