Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL SULPHATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
SALBUTAMOL SULPHATE
1units Units
AEROPHARM GMBH
SALBUTAMOL SANDOZ PRESSURISED INHALATION Salbutamol (100 micrograms/actuation) 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET: 1. What Salbutamol Sandoz MDI is used for 2. How Salbutamol Sandoz MDI works 3. Before you use Salbutamol Sandoz MDI 4. How to use Salbutamol Sandoz MDI 5. While you are using it 6. Side effects 7. Storage and disposal of Salbutamol Sandoz MDI 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SALBUTAMOL SANDOZ MDI IS USED FOR Salbutamol Sandoz is used to treat asthma. It can also be used to prevent asthma caused by exercise or asthma caused by a reaction to allergens (substances to which you are allergic to e.g. house dust, pollen, dog hair, cat hair, cigarette smoke, etc.) or to treat breathing difficulties associated with reversible airways obstruction (e.g. chronic bronchitis). This type of medicine is known as a ‘reliever’. You may be using another medicine to prevent you from having an asthma attack (“preventer”). You can safely use your preventer with this medicine. HOW SALBUTAMOL SANDOZ MDI WORKS Salbutamol expands the airways, allowing the air to flow more freely. Salbutamol should primarily be used to relieve symptoms rather than as a regular treatment. BEFORE YOU USE SALBUTAMOL SANDOZ MDI - _When you must not use it _ • if you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of Salbutamol. - _Before you start to use it _ Ask your doctor for advice before using Salbutamol, if any of the following conditions apply to you: • severe heart disease • severe and untreated high blood pressure • enlarged artery (aneurysm) • diabetes (extra checks of blood glucose levels are recommended when beginning treatment with Salbutamol) • tumour of the adrenal medulla (pheochromocytoma). The adrenal medulla are two glands situated above the kidneys. • an overactive thyroid gland • too little potassium in the blood _PREGNANCY AND BREAST-FEEDING _ Limited knowledge Lesen Sie das vollständige Dokument
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Salbutamol Sandoz 100 micrograms/dose pressurised inhalation. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 120 micrograms of salbutamol sulphate equivalent to 100 micrograms of salbutamol. The delivered dose through the mouthpiece contains 108 micrograms of salbutamol sulphate equivalent to 90 micrograms of salbutamol (as sulphate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Preparation for inhalation in form of pressurised metered-dose inhaler. Pressurised inhalation, white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic relief of bronchospasm in bronchial asthma and in other respiratory conditions. Prophylaxis of exercise and allergen induced asthma. Salbutamol is particularly useful for the relief symptoms of asthma, providing it does not delay the introduction and regular use of inhaled corticosteroid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Salbutamol Sandoz is intended for inhalation only. For relief of acute episodes of bronchospasm Adult: 1 to 2 inhalations every four hours as necessary to obtain relief of bronchospasm up to maximum of 8 inhalations per day. If dose at this rate is not effective or if previously effective doses do not provide relief, other treatment should be instituted promptly. Children: As for adults. Elderly: Dosage should at first be lower than for younger adults but may be increased gradually to the usual adult level if necessary. To prevent allergen- or exercise-induced bronchospasm Adults: 2 inhalations should be taken 10-15 minutes before challenge. Children: 1-2 inhalations should be taken 10-15 minutes before challenge. Method of administration _Handling _ A faulty inhalation technique with pressurised inhalers is very common. It is therefore important that the patient be instructed in the correct inhalation technique. The patient’s inhalation technique should be checked at visits. Salbutamol Sandoz may be used with a Vortex ® or AeroCh Lesen Sie das vollständige Dokument