Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
LTT Pharma Limited
R03AK07
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
200/6 Mcg/Dose
Powder for Inhalation
inspiratory flow-driven
Each inhaler contains 120 doses
Product subject to prescription which may be renewed (B)
AstraZeneca AB, AstraZeneca GmbH, AstraZeneca UK Limited
Adrenergics and other drugs for obstructive airway diseases
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
It is indicated in adults and adolescents aged 12 to 17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe COPD
Authorised
2015-08-07
The effects include: • changes in bone mineral density (thinning of the bones) • cataract (clouding of the lens in the eye) • glaucoma (increased pressure in the eye) • a slowing of the rate of growth of children and adolescents • an effect on the adrenal gland (a small gland next to the kidney). These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets. REPORTING OF SIDE EFFECTS If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE SYMBICORT TURBOHALER • Keep this medicine out of the sight and reach of children. • Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. • Do not store above 30°C. • Keep the container/cap tightly closed, in order to protect from moisture. • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT SYMBICORT 200/6 TURBOHALER CONTAINS The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains 160 micrograms of budesonide and 4.5 mg of formoterol fumarate dihydrate, this corresponds to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate. The other ingredient is lactose monohydrate (which contains milk proteins). WHAT SYMBICORT 200/6 TURBOHALER LOOKS LIKE AND CONTENTS OF THE PACK Symbicort 200/6 Turbohaler is an inhaler containing your medicine. The inhalation powder is white in colour. Each Turboh Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Symbicort Turbohaler, 200 micrograms/6 micrograms/inhalation, inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. Each metered dose contains: budesonide 200 micrograms / inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient with known effect: Contains Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from Slovakia_ White powder 4 CLINICAL PARTICULARS As per PA0970/028/002 5 PHARMACOLOGICAL PROPERTIES As per PA0970/028/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate (which contains milk proteins) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the inhaler and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 ° C. Keep the container tightly closed, in order to protect from moisture. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/01/2017_ _CRN 2185964_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler. The inhaler is white with a red turning grip. Each inhaler contains 120 doses. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER LTT Pharma Limited Unit 18 Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION Прочитать полный документ