Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate
Viatris UK Healthcare Ltd
R03AC02
Salbutamol sulfate
100microgram/1dose
Inhalation powder
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5060035241903
T5008758 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 SALBULIN MDPI NOVOLIZER IS AND WHAT IT IS USED FOR. 2. WHAT YOU NEED TO KNOW BEFORE USING SALBULIN MDPI NOVOLIZER. 3. HOW TO USE SALBULIN MDPI NOVOLIZER. 4. POSSIBLE SIDE-EFFECTS. 5. HOW TO STORE SALBULIN MDPI NOVOLIZER. 6. CONTENTS OF THE PACK AND OTHER INFORMATION. 7. INSTRUCTIONS FOR USING THE NOVOLIZER DEVICE. 1. WHAT SALBULIN MDPI NOVOLIZER IS AND WHAT IT IS USED FOR Salbulin MDPI Novolizer is indicated in adults, adolescents and children aged 6 to 12 years. Salbulin MDPI Novolizer is a powder for inhalation containing the active substance salbutamol. Salbutamol belongs to a group of anti-asthmatic drugs known as bronchodilators which are used to relieve symptoms such as chest tightness, wheezing or cough caused by asthma or other conditions. Salbutamol can also be used to prevent asthma symptoms brought on by exercise and other 'triggers' such as pollen. For instructions for using the Novolizer Inhaler Device, see section 7 on the reverse side of this leaflet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALBULIN MDPI NOVOLIZER DO NOT take Salbulin MDPI Novolizer if: • you are allergic (hypersensitive) to salbutamol, lactose or milk protein Warnings and precautions Talk to your doctor before using Salbulin MDPI Novolizer if you can answer ‘yes’ to any of the following questions: • do you have any heart or circulatory problems, particularly a recent heart attack or angina? • do you suffer from high blood pressure? • have Pročitajte cijeli dokument
OBJECT 1 SALBULIN MDPI NOVOLIZER 100MCG INHALATION POWDER Summary of Product Characteristics Updated 02-Feb-2018 | Meda Pharmaceuticals 1. Name of the medicinal product Salbulin MDPI Novolizer 100 micrograms / dose inhalation powder 2. Qualitative and quantitative composition One delivered dose contains 100 micrograms of salbutamol equivalent to 120 micrograms of salbutamol sulphate. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipient: 11.42 milligrams mg of lactose monohydrate/delivered dose. 3. Pharmaceutical form Inhalation powder White powder 4. Clinical particulars 4.1 Therapeutic indications Salbulin MDPI Novolizer 100 micrograms is indicated in adults, adolescents and children aged 6 to 12 years. Salbulin MDPI Novolizer 100 micrograms is recommended for use in patients with reversible airways obstruction such as asthma for relief and prevention of asthma symptoms. It should be used to relieve asthma symptoms when they occur and to prevent symptoms in circumstances known by the patient to precipitate symptoms, for example prior to exercise or allergen exposure. Salbulin MDPI Novolizer 100 micrograms is particularly useful for the relief of symptoms of asthma, providing it does not delay the introduction and regular use of inhaled corticosteroid therapy. 4.2 Posology and method of administration _Posology_ The dose depends on the type, severity, and course of the disorder. Adults (including older people and adolescents) For the relief of acute asthma symptoms including bronchospasm a starting dose of one inhalation (100 micrograms) is recommended for adults; this dose may be increased to two inhalations if necessary. For prevention of exercise-induced or allergen induced symptoms two inhalations (200 micrograms) should be taken 10-15 minutes prior to challenge. The maximum on-demand use in any 24 hours should not exceed 8 inhalations (equivalent to 800 micrograms). Children (aged 6 to 12 years) For the relief of acute asthma symptoms including bronchospas Pročitajte cijeli dokument