Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
SALBUTAMOL AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03AC02
SYRUP
SALBUTAMOL AS SULFATE 2 MG / 5 ML
PER OS
Required
FARMACLAIR, FRANCE
SALBUTAMOL
SALBUTAMOL
Relief of bronchospasm in bronchial asthma of all types,chronic bronchitis,efmphysema.
2014-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician's prescription only Ventolin Syrup Each teaspoon (5 ml) contains: Salbutamol (as Sulfate) 2 mg 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 Syrup is intended for the relief of bronchospasm related to asthma, chronic bronchitis and emphysema. Therapeutic group: Selective beta-2 adrenoceptor agonist. Ventolin Syrup contains a medicine called salbutamol. It belongs to a group of medicines called 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. Ventolin Syrup is used when children and adults cannot use an inhaler device. 2. BEFORE USING THE MEDICINE Special warnings regarding use of the medicine Before the treatment with Ventolin Syrup, tell the physician if: • you have high blood pressure • you are diabetic • 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 xanthine derivatives (such as theophylline) or steroids to treat asthma • you are taking diuretics, sometimes used to treat high blood pressure or a heart condition. Children and adolescents Ventolin Syrup is not intended for children and babies below the age of 2 years. Drug interactions If you are taking, or have rece Διαβάστε το πλήρες έγγραφο
Page 1 of 9 VENTOLIN SYRUP 1. NAME OF THE MEDICINAL PRODUCT Ventolin Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 2 mg Salbutamol (as Sulfate). Excipient with known effect: 5.6 mg sodium per 5 ml dose, 10.0 mg sodium benzoate per 5 ml dose, 1.9 mg propylene glycol per 5 ml dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Syrup is indicated for the relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral Ventolin syrup is suitable oral therapy for children and adults who are unable to use an inhaler device. Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require a high dose inhaled (e.g. >1mg/day) beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increase costicosteroid dosage which should be administered under urgent medical supervision. Adults The minimum starting dose is 2 mg three times a day given as 5 ml syrup. The Page 2 of 9 usual effective dose is 4 mg (10 ml syrup) three or four times a day, which may be increased to a maximum of 8 mg (20 ml syrup) three or four times a day if adequate bronchodilation is not obtained. Elderly In elderly patients or in those known to be unusually sensitive to beta- adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose. Paediatric Population 2 - 6 years: the minimum starting dose is 1 mg as 2.5 ml of syrup three times daily. This may be increased to 2 mg as 5 ml o Διαβάστε το πλήρες έγγραφο