Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Ipratropium bromide; SALBUTAMOL SULFATE
Pharma Stulln GmbH
R03AL; R03AL02
Ipratropium bromide; SALBUTAMOL SULFATE
0.5 mg/2.5 milligram(s)
Nebuliser solution
Product subject to prescription which may be renewed (B)
Adrenergics in combination with anticholinergics; salbutamol and ipratropium bromide
Marketed
2014-01-10
2 PACKAGE LEAFLET: INFORMATION FOR THE USER COMBIPRASAL 0.5 MG / 2.5 MG PER 2.5 ML NEBULISER SOLUTION IPRATROPIUM BROMIDE AND SALBUTAMOL 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What COMBIPRASAL is and what it is used for 2. What you need to know before you use COMBIPRASAL 3. How to use COMBIPRASAL 4. Possible side effects 5. How to store COMBIPRASAL 6. Contents of the pack and other information 1. WHAT COMBIPRASAL IS AND WHAT IT IS USED FOR The name of your medicine is COMBIPRASAL. You use it with a device called a ‘nebuliser’. This changes your medicine into a mist for you to breathe in. The active substances are ipratropium bromide and salbutamol. Both belong to a group of medicines called bronchodilators. They work by opening up your airways and therefore making breathing easier. COMBIPRASAL is used in adults and children over 12 years to treat long term breathing problems (e.g. chronic bronchitis and emphysema). COMBIPRASAL alleviates wheezing when breathing, shortness of breath and tightness in the chest. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COMBIPRASAL DO NOT USE COMBIPRASAL - if you are allergic to salbutamol, ipratropium bromide or atropine (including medicines similar to atropine) or any of the other ingredients of this medicine (listed in section 6). - if you have heart rhythm disorder including a very fast heart beat. - if you know that your heart is enlarged or if you have a heart problem called ‘hypertrophic obstructive cardiomyopathy’. This is where the wall bet Perskaitykite visą dokumentą
Health Products Regulatory Authority 07 October 2021 CRN00CGHS Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Combiprasal 0.5 mg / 2.5 mg per 2.5 ml nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose container (2.5 ml) contains 0.5 mg ipratropium bromide (as monohydrate) and 2.5 mg salbutamol (as salbutamol sulfate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless solution (pH approx. 3.5, osmolality approx. 300 mOsm/kg). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Combiprasal is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD) who require regular treatment with both ipratropium bromide and salbutamol. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is: _Adults (including elderly patients and children over 12 years)_ The content of one single-dose container three or four times daily. _Paediatric population (under 12 years)_ The safety and efficacy of Combiprasal in children aged under 12 years have not been established. Combiprasal is not recommended in children below 12 years of age. Method of administration Inhalation use. Drug delivery characteristics were studied _in vitro_ using an eFlow rapid electronic nebuliser and a PARI LC Sprint nebuliser: NEBULISER DROPLET SIZE DISTRIBUTION [micrometer] DRUG DELIVERY RATE [microgram/minute] TOTAL DRUG DELIVERED [microgram] D10 D50* D90 eFlow rapid electronic nebuliser 2.5 4.7 10.4 Salbutamol: 361.2 Ipratropium: 73.6 Salbutamol: 1185.7 Ipratropium: 240.6 PARI LC Sprint nebuliser (used with PARI Boy SX compressor) 1.4 4.2 13.2 Salbutamol: 137.9 Ipratropium: 28.1 Salbutamol: 1031.7 Ipratropium: 206.7 * Median Mass Diameter Health Products Regulatory Authority 07 October 2021 CRN00CGHS Page 2 of 10 No information is available in respect of pulmonary inhalation and deposition patterns across nebuliser systems that have not been studied. The use of an al Perskaitykite visą dokumentą