Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
SALBUTAMOL AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03AC
SOLUTION FOR NEBULISATION
SALBUTAMOL AS SULFATE 5 MG/ML
INHALATION WITH NEBULISER
Required
GLAXO OPERATIONS (UK) LIMITED
SELECTIVE BETA-2 ADRENORECEPTOR AGONISTS
Ventolin Respirator Solution is indicated in adults, adolescents and children.Ventolin Respirator Solution is indicated as a rescue treatment of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma.
2021-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only Ventolin Respirator Solution Active substance: Salbutamol (as Sulfate) 5 mg/ml 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 Respirator Solution is used to treat severe attacks of asthma and other forms of bronchospasm. Therapeutic group: Fast-acting bronchodilators, short-acting selective agonist to beta-2 receptors. 2. BEFORE USING THE MEDICINE Do not use the medicine: • if you are sensitive (allergic) to salbutamol sulfate or to any of the additional ingredients contained in this medicine (listed in section 6). • non-I.V. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. Special warnings regarding use of the medicine Before the treatment with Ventolin Respirator Solution, tell the physician if: • your asthma is active (for example, you have frequent flare-ups or symptoms 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 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 use another nebuliser solution, e.g., ipratropium bromide; make sure that the mist does not get in your eyes. This can be prevented b Aqra d-dokument sħiħ
1 _ _ VENTOLIN RESPIRATOR SOLUTION 1. NAME OF THE MEDICINAL PRODUCT Ventolin Respirator Solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aqueous, colourless to light yellow solution, pH 3.5, providing 0.5% w/v (5mg/ml) of salbutamol (as Salbutamol Sulfate BP). Excipients with known effect: Benzalkonium chloride solution (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for nebulisation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Respirator Solution is indicated in adults, adolescents and children (for paediatric population see Section 4.2). Ventolin Respirator Solution is indicated as a rescue treatment of chronic bronchospasm unresponsive to conventional therapy, and in the treatment of acute severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ventolin Respirator Solution is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed. Ventolin Respirator Solution may be administered intermittently or continuously. Salbutamol has a duration of action of 4 to 6 hours in most patients. Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended. The treating physician can initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents. 2 Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult. Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed nebulised medication. Intermittent administration _Adults: _Ventolin Respirator solution 0.5 ml (2.5 mg of salbutamol) should be diluted to a final volume of 2 ml with sterile normal saline. This m Aqra d-dokument sħiħ