Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate; Ipratropium bromide
Actavis UK Ltd
R03AL02
Salbutamol sulfate; Ipratropium bromide
1mg/1ml ; 200microgram/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010400; GTIN: 5012617025807
Ipratropium Salbutamol 0,5 2,5mg Nebuliser Solution PIL UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. 2. 3. 4. 5. 6. 1. 2. 3. date sent: supplier: approved: min pt size: TECHNICAL APPROVAL black AAAJ0147 3 9.5.16 db 16.5.16 db Laboratoire Unither 200 x 280 9 pt 9.5.16 10.5.16 * Please note that only Actavis Global Artwork Studios are permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. WHAT IS IN THIS LEAFLET: 1. What Salipraneb Nebuliser Solution is and what it is used for 2. What you need to know before you use Salipraneb Nebuliser Solution 3. How to use Salipraneb Nebuliser Solution 4. Possible side effects 5. How to store Salipraneb Nebuliser Solution 6. Contents of the pack and other information 1. WHAT SALIPRANEB NEBULISER SOLUTION IS AND WHAT IT IS USED FOR Salipraneb Nebuliser Solution belongs to a group of medicines called “bronchodilators” which help to open up the air passages in your lungs so that you can breathe more easily. Salipraneb Nebuliser Solution helps to make breathing easier in patients who have long-standing breathing difficulties. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALIPRANEB NEBULISER SOLUTION DO NOT USE SALIPRANEB NEBULISER SOLUTION: • If you are allergic (hypersensitive) to ipratropium bromide, salbutamol sulfate, atropine or any of the other ingredients of Salipraneb Nebuliser Solution (see section 6) • If you have a heart condition called cardiomyopathy (this is when your heart does not work properly due to inflammation of the heart muscles) • If you have a fast and irregular heartbeat (known as tachyarrhythmia) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist if any of the following apply to you: • If you are pregnant, thinking of becoming pregnant or if you are breast- feeding • If you have diabetes • If you have a heart condition Belgenin tamamını okuyun
OBJECT 1 SALIPRANEB 0.5MG / 2.5MG PER 2.5 ML NEBULISER SOLUTION Summary of Product Characteristics Updated 24-Aug-2016 | Accord-UK Ltd 1. Name of the medicinal product Salipraneb 0.5mg / 2.5mg per 2.5 ml Nebuliser Solution 2. Qualitative and quantitative composition Each 2.5 ml single dose ampoule contains 0.5mg of ipratropium bromide (as monohydrate) and 2.5mg of salbutamol (as sulfate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Nebuliser Solution. A 2.5ml ampoule containing 2.5ml of colourless nebuliser solution. 4. Clinical particulars 4.1 Therapeutic indications Salipraneb is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary diseases (COPD) who require regular treatment with both ipratropium bromide and salbutamol. 4.2 Posology and method of administration Posology For inhalation use. The recommended dose is: _Adults (including elderly patients and children over 12 years):_ 1 ampoule three or four times daily. _Paediatric population_ _Children under 12 years: _There is no experience of the use of Salipraneb in children under 12 years. Method of Administration Salipraneb may be administered from a suitable nebuliser or an intermittent positive pressure ventilator after the single dose ampoule has been opened and its contents transferred to the nebuliser chamber. Administration should be in accordance with the manufacturer's instructions for the device. The solution in the single dose ampoules is intended for inhalation use only and should not be taken orally or administered parenterally. 1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor. 2. Carefully separate a new ampoule from the strip. Never use an ampoule that has been opened already. 3. Open the ampoule by simply twisting off the top, always taking care to hold it in an upright position. 4. Unless otherwise instructed by your doctor, squeeze all the contents of the plastic ampoule into the nebuliser chamber. 5. Assemble the Belgenin tamamını okuyun