Pays: Israël
Langue: anglais
Source: Ministry of Health
FLUTICASONE PROPIONATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03BA05
INHALATION SUSPENSION FOR NEBULISATION
FLUTICASONE PROPIONATE 0.5 MG / 2 ML
INHALATION
Required
GLAXO SMITH KLINE AUSTRALIA PTY LTD
FLUTICASONE
FLUTICASONE
In adults and adolescents over 16 years Flixotide Nebules can be used:For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. It reduces symptoms and exacerbations of asthma in patients previously treated with other prophylactic therapy.Children and adolescents from 4 to 16 years of age:Treatment of acute exacerbations of asthma.
2014-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a physician’s prescription only Flixotide Nebules 0.5 mg/2 ml, Inhalation Suspension for Nebulisation Each 2 ml of Flixotide Nebules contain 0.5 mg fluticasone propionate. A list of the inactive ingredients is detailed in section 6. Read this 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 the pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? In adults and adolescents over 16 years of age: For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. Children and adolescents from 4 to 16 years of age: Treatment of acute exacerbations of asthma. Therapeutic group: corticosteroids Fluticasone propionate belongs to a group of medicines called corticosteroids (sometimes just called steroids). When taking steroids by inhalation, a very low dosage is required since the medicine goes straight to the lungs. Flixotide Nebules reduces swelling and irritation in the lungs, meaning, Flixotide Nebules has an anti-inflammatory effect. When Flixotide Nebules is used as a prophylactic treatment, it is very important to adhere to a daily treatment regimen. Flixotide Nebules is not intended to treat sudden asthma attacks where you feel breathless. There are other medicines to treat sudden attacks. If you use several medicines concomitantly, be careful not to confuse them. 2. BEFORE USING THE MEDICINE Do not use the medicine if: You are sensitive (allergic) to the active ingredient or to any of the additional ingredients contained in the medicine as detailed in section 6. Do not use Flixotide Nebules if the above applies to you. If you are not sure Lire le document complet
Page 1 of 14 FLIXOTIDE NEBULES 2 MG/2 ML 1. NAME OF THE MEDICINAL PRODUCT Flixotide Nebules 2 mg/2 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Plastic ampoules containing 2 ml of a buffered, isotonic saline suspension containing 2 mg fluticasone propionate. 3. PHARMACEUTICAL FORM Inhalation suspension for nebulisation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In adults and adolescents over 16 years Flixotide Nebules can be used: _ For prophylactic management of severe chronic asthma in patients requiring high dose inhaled or oral corticosteroid therapy. It reduces symptoms and exacerbations of asthma in patients previously treated with other prophylactic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. Page 2 of 14 Patients should be given an initial dose of nebulised fluticasone propionate which is appropriate for the severity of their disease. The dosage may be increased until control is achieved or reduced to the minimum effective dose according to the individual response. _Adults and adolescents over 16 years_ : 500-2000 micrograms twice daily. Prescribers should be aware that fluticasone propionate is as effective as other inhaled steroids approximately at half the microgram daily dose. For example, a 100 mcg of fluticasone propionate is approximately equivalent to 200 mcg dose of beclometasone dipropionate (CFC containing) or budesonide. Prescribers should be aware of the risks of systemic effects when using high doses of corticosteroids (see 4.4 special warnings and precautions for use and 4.8 undesirable effects). The dose should be titrated down to the lowest dose at which effective control of asthma is maintained. _Children 16 years and under:_ Fl Lire le document complet