البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
FLUTICASONE FUROATE; VILANTEROL AS TRIFENATATE
GLAXO SMITH KLINE (ISRAEL) LTD
R01AD12
POWDER FOR INHALATION
VILANTEROL AS TRIFENATATE 22 MCG; FLUTICASONE FUROATE 92 MCG
INHALATION
Required
GLAXO OPERATIONS UK LIMITED ( TRADING AS GLAXO WELLCOME OPERATIONS)
FLUTICASONE FUROATE
AsthmaRelvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:• patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonists.• patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.COPD (Chronic Obstructive Pulmonary Disease)Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
2019-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician s prescription only Relvar Ellipta 92/22 mcg, powder for inhalation Each dose released from the Ellipta inhaler contains: 92 mcg Fluticasone furoate/22 mcg Vilanterol (as trifenatate). Relvar Ellipta 184/22 mcg, powder for inhalation Each dose released from the Ellipta inhaler contains: 184 mcg Fluticasone furoate/22 mcg Vilanterol (as trifenatate). 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? Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms. The 92/22 mcg strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and asthma in adults and adolescents aged 12 years and older. The 184/22 mcg strength is used to treat asthma in adults and adolescents aged 12 years and older. The 184/22 mcg strength is not approved for the treatment of chronic obstructive pulmonary disease (COPD). Relvar Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack, you must use a quick-acting inhaler (such as salbutamol). If you do not hav اقرأ الوثيقة كاملة
1 RELVAR ELLIPTA 92/22 MCG RELVAR ELLIPTA 184/22 MCG 1. NAME OF THE MEDICINAL PRODU CT RELVAR ELLIPTA 92/22 MCG. RELVAR ELLIPTA 184/22 MCG. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Relvar Ellipta 92/22 mcg: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). Relvar Ellipta 184/22 mcg: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 200 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). Excipient with known effect Each delivered dose contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White powder in a light grey inhaler (Ellipta) with a pale blue mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asthma Relvar Ellipta 92/22 mcg and Relvar Ellipta 184/22 mcg is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta 2 -agonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta 2 -agonists. • patients already adequately controlled on both inhaled corticosteroid and long-acting beta 2 -agonist. COPD (Chronic Obstructive Pulmonary Disease) Relvar Ellipta 92/22 mcg is indicated for the symptomatic treatment of adults with COPD with a FEV 1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Asthma _ Patients with asthma should b اقرأ الوثيقة كاملة