Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Vilanterol trifenatate; Umeclidinium bromide
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
Vilanterol trifenatate; Umeclidinium bromide
30units Units; 7units Units
GLAXOSMITHKLINE LLC
_Consumer Medication Information Leaflet (RiMUP) _ 1 ANORO ELLIPTA INHALATION POWDER, PRE-DISPENSED Umeclidinium/vilanterol (62.5 micrograms/25 micrograms) WHAT IS IN THIS LEAFLET 1. What ANORO is used for 2. How ANORO works 3. Before you use ANORO 4. How to use ANORO 5. While you are using it 6. Side Effects 7. Storage and Disposal of ANORO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ANORO IS USED FOR ANORO is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long- term condition characterized by breathing difficulties that slowly get worse. If you think this applies to you, don’t use this medicine until you have checked with your doctor. _Children and adolescents _ This medicine should not be given to children or adolescents below the age of 18 years. _Pregnancy, breast-feeding and _ _fertility_ _ _ If you are pregnant or breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Don’t use this medicine if you are pregnant unless your doctor tells you that you can. It is not known whether the ingredients of ANORO can pass into breast milk. If you are breast- _ANORO contains lactose_ _ _ If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine. - _Taking other medicines_ _ _ Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may affect how this medicine works, or make it more likely that you’ll have side effects. These include: - Medicines called beta blockers (such as propanolol), to treat high blood pressure or other heart problems - Ketoconazole or itraconazole , to treat fungal infections - Clarithromycin or telithromycin, ANORO contains two active doctor before you use ANORO. - Ritonavir, to treat HIV infection substances called umeclidinium and Don’t use this medicine if you are - Medicines that lower the amo Lesen Sie das vollständige Dokument
CONFIDENTIAL 1 (GSK logo) 1. NAME OF THE MEDICINAL PRODUCT ANORO Ellipta 62.5/25 micrograms inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate). Excipient with known effect Each delivered dose contains approximately 25 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed (inhalation powder). White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANORO is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _Adults _ The recommended dose is one inhalation of ANORO 62.5/25 micrograms once daily. ANORO should be administered once daily at the same time of the day each day to maintain bronchodilation. The maximum dose is one inhalation of ANORO 62.5/25 micrograms once daily. _Special populations _ Elderly patients No dosage adjustment is required in patients over 65 years. Renal impairment No dosage adjustment is required in patients with renal impairment. Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment. The use of ANORO has not been studied in patients with severe hepatic impairment and should be used with caution. _ _ CONFIDENTIAL 2 _Paediatric population _ There is no relevant use of ANORO in the paediatric population (under 18 years of age) for the indication of COPD. _ _ Method of administration ANORO is for inhalation use only. Instruction Lesen Sie das vollständige Dokument