국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
Amikacin sulfate
Insmed Netherlands B.V.
J01GB06
amikacin
Antibacterials for systemic use,
Respiratory Tract Infections
Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.
Revision: 2
Authorised
2020-10-27
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARIKAYCE LIPOSOMAL 590 MG NEBULISER DISPERSION amikacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ARIKAYCE liposomal is and what it is used for 2. What you need to know before you use ARIKAYCE liposomal 3. How to use ARIKAYCE liposomal 4. Possible side effects 5. How to store ARIKAYCE liposomal 6. Contents of the pack and other information 7. Instructions for use 1. WHAT ARIKAYCE LIPOSOMAL IS AND WHAT IT IS USED FOR ARIKAYCE liposomal is an ANTIBIOTIC that contains the active ingredient amikacin. Amikacin belongs to a group of antibiotics called aminoglycosides which stop the growth of certain bacteria that cause infections. ARIKAYCE liposomal is used by inhalation to treat LUNG INFECTION caused by _Mycobacterium avium_ Complex in adults with limited treatment options who do not have cystic fibrosis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARIKAYCE LIPOSOMAL DO NOT USE ARIKAYCE LIPOSOMAL - if you are allergic to AMIKACIN or other AMINOGLYCOSIDES , SOYA or ANY OF THE OTHER INGREDIENTS of this medicine (listed in section 6) - if you are taking any other aminoglycosides (oral or for injection) - if you have very poor kidney function WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using ARIKAYCE liposomal if: - you use a bronchodilator (“reliever”) for breathing problems, as you will be asked to use that first, before using ARIKAYCE liposomal; - you have KIDNEY PROBLEMS ; you may need to have a kidney te 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ARIKAYCE liposomal 590 mg nebuliser dispersion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains amikacin sulfate equivalent to 590 mg amikacin in a liposomal formulation. The mean delivered dose per vial is approximately 312 mg of amikacin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser dispersion White, milky, aqueous, nebuliser dispersion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARIKAYCE liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by _Mycobacterium avium_ Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ARIKAYCE liposomal treatment should be initiated and managed by physicians experienced in the treatment of non-tuberculous lung disease due to _Mycobacterium avium _ Complex. ARIKAYCE liposomal should be used in conjunction with other antibacterial agents active against _Mycobacterium avium _ Complex lung infections. Posology The recommended dose is one vial (590 mg) administered once daily, by oral inhalation. _Duration of treatment _ Treatment with inhaled liposomal amikacin, as part of a combination antibacterial regimen, should be continued for 12 months after sputum culture conversion. Treatment with inhaled liposomal amikacin should not continue beyond a maximum of 6 months if sputum culture conversion (SCC) has not been confirmed by then. The maximum duration of treatment with inhaled liposomal amikacin should not exceed 18 months. _Missed doses _ If a daily dose of amikacin is missed, the next dose should be administered the next day. A double dose should not be given to make up for the missed dose. _Elderly _ No dose adjustment is required. 3 _Hepatic impairment _ Inhaled liposomal amikacin has not 전체 문서 읽기