מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE
ASTRAZENECA (ISRAEL) LTD
R03AK07
POWDER FOR INHALATION
BUDESONIDE MICRONIZED 160 MCG/DOSE; FORMOTEROL FUMARATE 4.5 MCG/DOSE
INHALATION
Required
ASTRA ZENECA AB., SWEDEN
FORMOTEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
FORMOTEROL AND BUDESONIDE
AsthmaSymbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations.Chronic Obstructive Pulmonary Disease (COPD)Symbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults, aged 18 years and older, for the Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.
2021-10-31
BODY TEXT SIZE 7.0 pt SMALLEST TEXT SIZE 7.0 pt Profile Technical Info N/A 5749 AZL030I PS23054 10-11-2022 107674972/403011024 0180 Symbicort Leaflet patient 160mcg/4.5mcg IL SGK is a Matthews International Corporation Black P485 Patient Package Insert in Accordance With the Pharmacists’ Regulations (Preparations) – 1986 The medicine is dispensed with a doctor’s prescription only Symbicort ® Turbuhaler ® 160/4.5 mcg/dose Inhalation powder Each inhalation contains: Budesonide micronized 160 micrograms Formoterol fumarate dihydrate 4.5 micrograms For inactive ingredients, please refer to Section 6 - “Further Information”. See also “Important information about some of the ingredients in this medicine” in section 2. Each inhaler contains either 60 or 120 inhalations. 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 doctor or pharmacist. Keep this leaflet; you may need it again. 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. The medicine is not intended for children and adolescents below the age of 12. The treatment with Symbicort Turbuhaler 160/4.5 mcg/dose for patients who have chronic obstructive pulmonary disease (COPD) is only intended for adult patients (aged 18 years and older). 1. WHAT IS THIS MEDICINE INTENDED FOR? Symbicort Turbuhaler 160/4.5 mcg/dose is an inhaler indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations. This medicine is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older only. COPD is a chronic disease characterized by constant disturbance of airflow into and out of the lungs, which is often caused by cigarette smoking. The קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT Symbicort Turbuhaler 160/4.5 micrograms/inhalation, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide micronized 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. EXCIPIENTS WITH KNOWN EFFECT: Lactose monohydrate 730 micrograms per delivered dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Symbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Posology and Method of administration). CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Symbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV 1 )< 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For inhalation use. POSOLOGY ASTHMA Symbicort Turbuhaler can be used according to different treatment approaches: A. Symbicort anti-inflammatory reliever therapy (patients with mild disease). B. Symbicort maintenance therapy (fixed dose). C. Symbicort anti-inflammatory reliever plus maintenance therapy. A. SYMBICORT ANTI-INFLAMMATORY RELIEVER THERAPY (PATIENTS WITH MILD DISEASE) Symbicort Turbuhaler 160/4.5 is taken as needed for the relief of asthma symptoms when they occur, and as a preventative treatment of symptoms in those circumstances recognised by the patient to precipitate an asthma attack. Patients should be advised to always have Symbicort Turbuhaler 160/4.5 available for relief of symptoms. Preventative use קרא את המסמך השלם