Страна: Израел
Език: английски
Източник: Ministry of Health
BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE DIHYDRATE
ABIC MARKETING LTD, ISRAEL
R03AK07
POWDER FOR INHALATION
FORMOTEROL FUMARATE DIHYDRATE 9 MCG/DOSE; BUDESONIDE MICRONIZED 320 MCG/DOSE
INHALATION
Required
NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS, IRELAND
FORMOTEROL AND BUDESONIDE
DuoResp Spiromax 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.Or- Patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.Chronic Obstructive Pulmonary Disease (COPD)DuoResp Spiromax 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in I second (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy
2020-09-30
Inhaled steroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. This effect may be manifested in: • Changes in bone density )thinning of the bones( • Cataract )clouding of the lens of the eye( • Glaucoma )increased intraocular pressure( • A slowing in the rate of growth of children and adolescents, requiring monitoring by the attending doctor, who, if necessary, may refer the child to a specialist • An effect on the adrenal gland )a small gland located next to the kidney( These effects are more likely to happen with treatment with oral steroids )such as tablets( than with treatment with inhaled steroids. IF A SIDE EFFECT OCCURS, IF ONE OF THE SIDE EFFECTS WORSENS OR IF YOU SUFFER FROM A SIDE EFFECT NOT MENTIONED IN THE LEAFLET, CONSULT WITH THE DOCTOR. Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of Drug Treatment” found on the Ministry of Health homepage )www.health.gov.il( that directs you to the online form for reporting side effects, or by entering the link: https://sideeffects.health.gov.il 5. HOW SHOULD THE MEDICINE BE STORED? • Avoid poisoning! This medicine, and any other medicine, must be kept in a safe place out of the reach and sight of children and/or infants in order to avoid poisoning. Do not induce vomiting unless explicitly instructed to do so by the doctor. • Do not use the medicine after the expiry date )exp. date( that appears on the package. The expiry date refers to the last day of that month. • Store below 25°C. • Keep the mouthpiece closed after removing the aluminum wrapper. • Can be used for 6 months after removing the aluminum wrapper. It is recommended to use the sticker on the inhaler to record the opening date of the wrapper. • Do not store different medicines in the same package. • Discard the inhaler after you have used the last dose, do not discard it into the household wastebin. Please consult with your pharmacist on how to dis Прочетете целия документ