Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate
Arrow Generics Ltd
R03AC02
Salbutamol sulfate
2mg/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5060034833017
Salbutamol 2.5mg/2.5ml & 5mg/2.5ml PIL - UK item no: AAAI7544 print proof no: 2 origination date: 11.02.16 originated by: S.Anson revision date: 10.03.16 revised by: S.Anson dimensions: 200 x 280 pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. 2. 3. date sent: 11.02.16 supplier: Laboratoire Unither technically app. date: 16.02.16 min pt size: 9 TECHNICAL APPROVAL IN THIS LEAFLET: 1. What Salbutamol Nebuliser Solution is and what it is used for 2. Before you take Salbutamol Nebuliser Solution 3. How to take Salbutamol Nebuliser Solution 4. Possible side effects 5. How to store Salbutamol Nebuliser Solution 6. Further information _1 WHAT SALBUTAMOL NEBULISER SOLUTION IS AND WHAT IT _ _IS USED FOR_ Salbutamol 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. Salbutamol Nebuliser Solution helps to make breathing easier in patients who have long-standing breathing difficulties. It is also given to treat severe attacks of asthma. _2 BEFORE YOU TAKE SALBUTAMOL NEBULISER SOLUTION_ DO NOT TAKE SALBUTAMOL NEBULISER SOLUTION • If you are allergic (hypersensitive) to salbutamol • If you are allergic to any of the other ingredients (see section 6 Further Information) Some forms of Salbutamol are used to help control premature labour. Salbutamol Nebuliser Solution is not to be used for this purpose. TAKE SPECIAL CARE WITH SALBUTAMOL NEBULISER SOLUTION Talk to your doctor if any of the following apply to you: • if you have diabetes • if you have a heart condition or have recently had a heart attack • if you have high blood pressure • if you have an overactive thyroid gland • if you have a history of heart disease, irregular heartbeat/rhythm including a very fast pulse or angina • if you have an aneurysm (a widening of the wall of a blood vessel) • if you suffer from glaucoma (excessive pressure inside your eyes) • if you have ever been told that you suffer from ph Lue koko asiakirja
OBJECT 1 SALBUTAMOL 5MG/2.5ML NEBULISER SOLUTION (ARROW) Summary of Product Characteristics Updated 09-Jun-2016 | Accord-UK Ltd 1. Name of the medicinal product Salbutamol 5mg/2.5ml Nebuliser Solution 2. Qualitative and quantitative composition Each ampoule contains 5 mg salbutamol (as sulfate). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Nebuliser Solution A clear, colourless to pale yellow solution in a clear, plastic single dose ampoule. 4. Clinical particulars 4.1 Therapeutic indications Salbutamol Nebuliser Solution are indicated in adults, adolescents and children aged 4 years and above, see section 4.2. Salbutamol Nebuliser Solution is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma. 4.2 Posology and method of administration Salbutamol Nebuliser Solution should be administered by a suitable nebuliser, via a face mask or T piece or via an endotracheal tube. To open the plastic ampoule, take a strip of ampoules from the foil pack, remove one ampoule, replacing the rest back in the foil pack, and replace the foil pack back in the carton. Hold the ampoule upright and open it by twisting off the top. Squeeze the liquid into the solution holder of the machine. DOSAGE: _ADULTS _ The usual starting dose is 2.5mg as a single dose. This may be increased to 5mg. Treatment may be repeated up to four times a day. For the treatment of severe airways obstruction in adult hospitalised patients, higher doses up to 40mg per day can be given under strict medical supervision. In domiciliary practice the benefits of increasing the dosage should be weighed against the risk that a deterioration in the patient's underlying condition may be masked. In this case a medical assessment should be considered and alternative therapy instituted where indicated. _PAEDIATRIC POPULATION_ Children aged 12 years and over: Dose as per adult population. Children aged 4 to 11 years: 2.5mg to 5mg up to four times a day. Othe Lue koko asiakirja