ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
AMBROXOL HYDROCHLORIDE
Boehringer Ingelheim Limited
R02AD
AMBROXOL HYDROCHLORIDE
17.86 Mg/Ml
Oromucosal Spray
Product not subject to medical prescription
ANESTHETICS, LOCAL
Authorised
2014-02-14
1. WHAT LYSOPADOL SPRAY IS AND WHAT IT IS USED FOR t-ZTPQBEPM4QSBZDPOUBJOTUIFBDUJWFTVCTUBODFBNCSPYPM IZESPDIMPSJEF5IFBDUJWFTVCTUBODFJTUIFQBSUPGUIFTQSBZ UIBUHJWFTUIFUIFSBQFVUJDFGGFDUZPVOFFE t-ZTPQBEPM4QSBZIBTBMPDBMBOBFTUIFUJDFGGFDUXIJDISFMJFWFT UIFQBJOJOBDVUFTPSFUISPBU t-ZTPQBEPM4QSBZJTVTFEUPSFMJFWFUIFQBJOJOBDVUFTPSF UISPBUGPSBEVMUTBOEDIJMESFOPWFSZFBSTPGBHF t:PVNVTUUBMLUPBEPDUPSJGZPVEPOPUGFFMCFUUFSPSJGZPV GFFMXPSTFBGUFSEBZT 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSOPADOL SPRAY DO NOT TAKE LYSOPADOL SPRAY: t*GZPVBSFBMMFSHJDUPBNCSPYPMIZESPDIMPSJEFPSBOZPGUIF PUIFSJOHSFEJFOUTPGUIJTNFEJDJOF MJTUFEJOTFDUJPO WARNINGS AND PRECAUTIONS 5BMLUPZPVSEPDUPSPSQIBSNBDJTUCFGPSFUBLJOH-ZTPQBEPM 4QSBZ t:PVTIPVMEOPUVTF-ZTPQBEPM4QSBZGPSNPSFUIBOEBZT*G ZPVTUJMMIBWFTZNQUPNTBGUFSEBZTPSJGZPVIBWFBIJHI GFWFSQMFBTFDPOTVMUBEPDUPS t*GZPVIBWFMJWFSPSLJEOFZQSPCMFNTBTLZPVSEPDUPSCFGPSF VTJOH-ZTPQBEPM4QSBZ t-ZTPQBEPM4QSBZJTOPUTVJUBCMFGPSUIFUSFBUNFOUPGQBJOGVM MFTJPOTJOUIFNPVUI FHVMDFSTPSTPSFT t*GZPVIBWFNPVUIVMDFSTQMFBTFDPOTVMUBEPDUPS t4IPSUOFTTPGCSFBUI EZTQOPFB NBZCFPCTFSWFEEVFUPBO VOEFSMZJOHDPOEJUJPO FHTXPMMFOUISPBU "OPUIFSSFBTPO DPVMECFBGFFMJOHPGUJHIUOFTTJOUIFUISPBUEVFUPUIFMPDBM BOBFTUIFUJDFGGFDUPG-ZTPQBEPM4QSBZ"GVSUIFSDBVTFDPVME CFBOBMMFSHJDSFBDUJPOXIJDINBZBMTPDBVTFZPVSNPVUI BOEUISPBUUPTXFMM t:PVSUISPBUBOENPVUINBZGFFMMFTTTFOTJUJWFUIBOVTVBM OVNC t5IFSFIBWFCFFOSFQPSUTPGTFWFSFTLJOSFBDUJPOTBTTPDJBUFE XJUIUIFBENJOJTUSBUJPOPGBNCSPYPMIZESPDIMPSJEF*GZPV EFWFMPQBTLJOSBTI JODMVEJOHMFTJPOTPGUIFNVDPVT NFNCSBOFTTVDIBTNPVUIUISPBUOPTFFZFTHFOJUBMT TUPQ VTJOH-ZTPQBEPM4QSBZBOEDPOUBDUZPVSEPDUPSJNNFEJBUFMZ CHILDREN %POPUHJWFUIJTNFEJDJOFUPDIJMESFOVOEFSZFBSTPGBHF OTHER MEDICINES AND LYSOPADOL SPRAY 5FMMZPVSEPDUPSPSQ อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lysopadol 17.86 mg/ml Oromucosal Spray, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One actuation of the spray contains 2.5 mg of ambroxol hydrochloride. One ml of the spray contains 17.86 mg of ambroxol hydrochloride. Excipient(s) with known effect: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose (4 actuations) and very small amounts of propylene glycol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution Clear and almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pain relief in acute sore throat for adults and children over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years of age: one dose of 10 mg (4 actuations) to be sprayed into the back of the throat up to 6 times per day. Lysopadol 17.86 mg/ml Oromucosal Spray can be used for up to 3 days. In case of persistent symptoms or high fever, the patient should consult a doctor. _Paediatric population_ Lysopadol 17.86 mg/ml Oromucosal Spray should not be used in children under 12 years of age (see section 4.4). Method of administration Oromucosal use Prior to use, the pump should be actuated 5 times so that an even spray mist is released. After not having used the spray for a long time, the pump should be actuated once before applying the product again. For application the spray bottle should be used in an upright position with the nozzle targeted at the back of the throat whilst pushing down the pump head completely. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance (ambroxol) or to any of the excipients listed in section 6.1. HEALTH PRODUCTS REGULATORY A อ่านเอกสารฉบับเต็ม