Land: Israel
Språk: engelska
Källa: Ministry of Health
SALBUTAMOL AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03AC02
POWDER FOR INHALATION
SALBUTAMOL AS SULFATE 200 MCG/DOSE
INHALATION
Required
GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND
SALBUTAMOL
SALBUTAMOL
Relief of bronchospasm in broncial asthma of all types, chronic, bronchitis and emphysema.
2022-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician's prescription only Ventolin Diskus Powder for Inhalation Each metered dose contains: salbutamol (as sulfate) 200 mcg Ventolin Diskus contains 60 metered doses. For the list of the inactive and allergenic ingredients in the medicine, see section 2 – Important information about some of the ingredients in the medicine and section 6 – Additional information . Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Ventolin Diskus is used to treat breathing problems in people with asthma and similar conditions. This includes relieving and preventing asthma brought on by exercise or other triggers, such as dust, pollen, cats, dogs and cigarette smoke. Therapeutic group: Selective beta-2 adrenoceptor agonist. Ventolin Diskus contains a medicine called salbutamol. It belongs to a group of medicines called fast-acting bronchodilators. • Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. • They help to relieve chest tightness, wheezing and cough. 2. BEFORE USING THE MEDICINE Special warnings regarding use of the medicine Before the treatment with Ventolin Diskus, tell the physician if: • your asthma is active (for example, you have frequent symptoms or flare ups or limited physical ability). Your physician may start or increase a medicine to control your asthma such as an inhaled corticosteroid. • you have high blood pressure. • you have an overactive thyroid gland. • you have a history of heart problems, such as an irregular or fast heartbeat or angina. • you are taking xant Läs hela dokumentet
Page 1 of 6 VENTOLIN DISKUS 1. NAME OF THE MEDICINAL PRODUCT Ventolin Diskus 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ventolin Diskus is a plastic inhaler device containing a foil strip with 60 regularly spaced blisters each containing a mixture of 200 micrograms of microfine salbutamol (as sulfate) and larger particle lactose. Excipients with known effect: Contains Lactose monohydrate (which contains milk protein) 12.5 mg/blister (see section 4.4). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Multi-dose dry powder inhalation device. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Diskus is indicated in adults, adolescents and children. Ventolin Diskus can be used for relief of bronchospasm in broncial asthma of all types, chronic bronchitis and emphysema. Ventolin Diskus is particularly suitable for the relief of asthma symptoms. It should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). Ventolin Diskus is particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults (including the elderly)_ _ For the relief of acute asthma symptoms including bronchospasm, 100 micrograms may be administered (with Ventolin Inhaler CFC Free) as a single minimum starting dose. This may be increased to 200 mcg if necessary. To prevent allergen or exercise-induced symptoms, 200 mcg should be taken 10-15 minutes before challenge. For chronic therapy, 200 mcg up to four times a day. Page 2 of 6 Children For the relief_ of acute _asthma symptoms including _bronchospasm_, or before _allergen _exposure _or _ _exercise_, 100 mcg (with Ventolin Inhaler CFC Free), or 200 mcg if necessary._ _ For chronic_ therapy_, 200 mcg up to four times a day. _ _ On-demand use o Läs hela dokumentet