FrancophonIA/ELRC3.0 huggingface dataset:
English: TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Estonian: Raske maksakahjustusega patsientidel ei ole TESAVELi kasutamist uuritud ja tuleb olla hoolikas (vt lõik 5.2).
English: When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Estonian: Kui TESAVELi kasutatakse kombinatsioonis sulfonüüluurea või insuliiniga, võib kaaluda väiksemat sulfonüüluurea või insuliini annust, et vähendada sulfonüüluurea poolt indutseeritud hüpoglükeemia riski (vt lõik 4.4).
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Estonian: Hüpoglükeemia kombinatsioonis teiste hüperglükeemia vastaste ravimitega Kliinilistes uuringutes, mille käigus TESAVELi kasutati monoteraapiana ja osana kombinatsioonravist ravimitega, mis teadaolevalt ei põhjusta hüpoglükeemiat (st metformiin ja/või PPAR agonist), oli sitagliptiini puhul kirjeldatud hüpoglükeemia esinemissagedus sarnane esinemissagedusega platseebot saanud patsientidel.
English: It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL.
Estonian: TESAVELi võtmise ajal on tähtis järgida arsti poolt soovitatud dieedi ja füüsilise koormuse programmi.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4).
Estonian: TESAVELi saavatel patsientidel on kirjeldatud kõhunäärmepõletiku (pankreatiidi) juhtusid (vt lõik 4).
English: How to store TESAVEL
Estonian: Kuidas TESAVELi säilitada
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and TESAVEL administered concomitantly.
Estonian: Kasutamisel kombinatsioonis metformiini ja/või PPAR agonistiga ei muudeta metformiini ega PPAR agonisti annust ja TESAVELi manustatakse samaaegselt.
English: TESAVEL should not be used during breast-feeding.
Estonian: TESAVELi ei tohi imetamise ajal kasutada.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
Estonian: Mõõduka neerukahjustusega patsientidel (GFR  30 kuni < 45 ml/min) on TESAVELi annus 50 mg üks kord ööpäevas.
English: TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Estonian: TESAVEL on näidustatud ka täiendava ravina lisaks insuliinile (koos metformiiniga või ilma), kui dieedi ja füüsilise koormuse ning insuliini stabiilsete annustega ei ole saavutatud veresuhkrusisalduse piisavat vähenemist.
English: TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Estonian: TESAVEL kuulub suukaudsete antihüperglükeemiliste ravimite rühma, mida nimetatakse dipeptidüülpeptidaas-4 (DPP-4) inhibiitoriteks.
English: Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Estonian: Esinemissagedus teadmata eksfoliatiivsed nahareaktsioonid, sh Stevensi
English: If bullous pemphigoid is suspected, TESAVEL should be discontinued.
Estonian: Kui kahtlustatakse bulloosset pemfigoidi, tuleb ravi TESAVELiga lõpetada.
English: After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (PerProtocol Analysis).
Estonian: 54 nädala pärast oli algse HbA1c keskmine vähenemine -0,76% sitagliptiini puhul ja -0,64% glipisiidi puhul (protokollijärgne analüüs).
English: No dose adjustment for TESAVEL is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Estonian: Kerge või mõõduka maksakahjustusega patsientidel (Child-Pugh' skoor ≤ 9) ei ole vaja TESAVELi annust muuta.
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Estonian: Et saavutada sitagliptiini puhul sarnaseid plasmakontsentratsioone kui normaalse neerufunktsiooniga patsientidel, soovitatakse patsientidel, kelle GFR < 45 ml/min, sh lõppstaadiumis neeruhaigusega patsientidel, kes vajavad hemodialüüsi või peritoneaaldialüüsi, kasutada väiksemaid annuseid (vt lõigud 4.2 ja 5.2).
English: How to take TESAVEL
Estonian: Kuidas TESAVELi võtta
English: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Estonian: CYP3A4 kaudu toimuval) vaid vähene roll sitagliptiini kliirensis.
English: TESAVEL 25 mg tablets Sitagliptin
Estonian: TESAVEL 25 mg tabletid Sitagliptiin
English: TESAVEL 100 mg tablets Sitagliptin
Estonian: TESAVEL 100 mg tabletid Sitagliptiin
English: TESAVEL 50 mg tablets Sitagliptin
Estonian: TESAVEL 50 mg tabletid Sitagliptiin
English: EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
Estonian: EU/1/07/435/013 14 õhukese polümeerikattega tabletti EU/1/07/435/014 28 õhukese polümeerikattega tabletti EU/1/07/435/023 30 õhukese polümeerikattega tabletti EU/1/07/435/015 56 õhukese polümeerikattega tabletti EU/1/07/435/016 84 õhukese polümeerikattega tabletti EU/1/07/435/024 90 õhukese polümeerikattega tabletti EU/1/07/435/017 98 õhukese polümeerikattega tabletti EU/1/07/435/018 50 × 1 õhukese polümeerikattega tabletti
English: EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
Estonian: EU/1/07/435/001 14 õhukese polümeerikattega tabletti EU/1/07/435/002 28 õhukese polümeerikattega tabletti EU/1/07/435/019 30 õhukese polümeerikattega tabletti EU/1/07/435/003 56 õhukese polümeerikattega tabletti EU/1/07/435/004 84 õhukese polümeerikattega tabletti EU/1/07/435/020 90 õhukese polümeerikattega tabletti EU/1/07/435/005 98 õhukese polümeerikattega tabletti EU/1/07/435/006 50 x 1 õhukese polümeerikattega tabletti
English: EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
Estonian: EU/1/07/435/007 14 õhukese polümeerikattega tabletti EU/1/07/435/008 28 õhukese polümeerikattega tabletti EU/1/07/435/021 30 õhukese polümeerikattega tabletti EU/1/07/435/009 56 õhukese polümeerikattega tabletti EU/1/07/435/010 84 õhukese polümeerikattega tabletti EU/1/07/435/022 90 õhukese polümeerikattega tabletti EU/1/07/435/011 98 õhukese polümeerikattega tabletti EU/1/07/435/012 50 x 1 õhukese polümeerikattega tabletti
English: 1 vial + 6 injection syringes with attached needle + 12 cleansing swabs
Estonian: 1 viaal + 6 kinnitatud nõelaga süstalt + 12 puhastustampooni
English: 2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
Estonian: 2 viaali + 12 kinnitatud nõelaga süstalt + 24 puhastustampooni
English: Pharmaceutical form
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: 12 vials + 72 injection syringes + 72 injection needles +
Estonian: 72 kinnitatud nõelaga süstalt +
English: 1 150 mg indoxacarb + 480 mg permethrin/ml
Estonian: 1 150 mg indoksakarbi + 480 mg permetriini/ml
English: Strength Pharmaceutical Form
Estonian: Nimetus Tugevus Ravimvorm Loomaliigid
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
Estonian: Gripiviiruse pinnaantigeenid (hemaglutiniin ja neuraminidaas), inaktiveeritud, sisaldavad järgmisi tüvesid*: A/Brisbane/02/2018 (H1N1)pdm09 sarnane tüvi (A/Idaho/07/2018) 15 mikrogrammi HA** A/Kansas/14/2017 (H3N2) sarnane tüvi (A/Indiana/08/2018) 15 mikrogrammi HA** B/Colorado/06/2017 sarnane tüvi (B/Iowa/06/2017) 15 mikrogrammi HA** B/Phuket/3073/2013 sarnane tüvi (B/Singapore/INFTT-16-0610/2016) 15 mikrogrammi HA** 0,5 ml annuses
English: --¹ 1 Each 0.5 ml dose contains:
Estonian: --¹ Üks 0,5 ml annus sisaldab:
English: * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Estonian: * kultiveeritud Madin Darby koera neeru (Madin Darby Canine Kidney, MDCK) rakkudes ** hemaglutiniin
English: Intramuscular use Pre-filled syringe (glass) without needle
Estonian: Süstesuspensioon Intramuskulaarne Süstlis (klaas) ilma nõelata
English: The full EPAR and risk management plan summary for Aripiprazole Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Aripiprazole Zentiva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Aripiprazole Zentiva aripiprazole
Estonian: Aripiprazole Zentiva aripiprasool
English: A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Aripiprazole Zentiva võimalikult ohutu kasutamine.
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Estonian: • Skisofreenia - vaimuhaigus, millel on mitmesuguseid sümptomeid, sealhulgas mõtlemis- ja kõnehäired, hallutsinatsioonid (tegelikult mitte olemasolevate asjade kuulmine või nägemine), kahtlustamine ja luulud (eksiarvamused).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Estonian: Euroopa Komisjon andis Aripiprazole Zentiva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. juunil 2015.
English: The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Estonian: Komitee soovitas Aripiprazole Zentiva kasutamise Euroopa Liidus heaks kiita.
English: Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Estonian: Aripiprazole Zentivat turustatakse tablettidena (5, 10, 15 ja 30 mg) ja suus dispergeeruvate (lahustuvate) tablettidena (10, 15 ja 30 mg).
English: Other information about Aripiprazole Zentiva
Estonian: Muu teave Aripiprazole Zentiva kohta
English: The orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Estonian: Suus dispergeeruvaid tablette tohib kasutada patsientidel, kellel on tablette raske neelata.
English: The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.
Estonian: Annust tuleb kohandada nende patsientide korral, kes võtavad teisi ravimeid, mis mõjutavad Aripiprazole Zentiva lagunemist organismis.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Estonian: • I tüüpi bipolaarne meeleoluhäire - vaimuhaigus, mille korral patsientide maniakaalsed episoodid (meeleolu äärmuslik tõus) vahelduvad normaalse meeleolu perioodidega.
English: To prevent manic episodes in adults, the same dose should be continued.
Estonian: Maniakaalsete episoodide ennetamiseks täiskasvanutel peab ravi jätkama sama annusega.
English: Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Estonian: Aripiprazole Zentivat kasutatakse mõõdukate ja raskete maniakaalsete episoodide raviks täiskasvanutel ja uute maniakaalsete episoodide ennetamiseks täiskasvanutel, kellel on varem tekkinud sellele ravimile ravivastus.
English: Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Aripiprazole Zentiva on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Aripiprazole Zentivaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Estonian: Aripiprazole Zentiva tootja varustab ka patsiendid, nende hooldajad ja arstid teabepakmega, mis selgitab ravimi ohutut kasutamist 13-17-aastastel patsientidel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Aripiprazole Zentiva omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Estonian: Aripiprazole Zentivat kasutatakse ka kuni 12 nädalat mõõdukate ja raskete maniakaalsete episoodide raviks patsientidel vanuses 13 aastat ja vanemad.
English: This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Estonian: See tähendab, et Aripiprazole Zentiva on sarnane võrdlusravimiga Abilify, millel juba on Euroopa Liidus müügiluba.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Aripiprazole Zentiva võrreldav kvaliteet ja bioekvivalentsus ravimiga Abilify.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Estonian: Bipolaarse meeleoluhäirega kaasnevate maniakaalsete episoodide korral on täiskasvanute soovitatav algannus suukaudsel manustamisel 15 mg üks kord ööpäevas ainsa ravimina või kombinatsioonis teiste ravimitega.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Abilify korral, ületab ravimi Aripiprazole Zentiva kasulikkus sellega kaasnevad riskid.
English: Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Estonian: Et Aripiprazole Zentiva on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati Aripiprazole Zentiva bioekvivalentsust võrdlusravimiga Abilify.
English: Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Estonian: Aripiprazole Zentiva sisaldab toimeainena aripiprasooli ja see on geneeriline ravim.
English: Aripiprazole Zentiva is used in patients aged 15 years or over;
Estonian: Aripiprazole Zentivat kasutatakse vähemalt 15-aastastel patsientidel.
English: Aripiprazole Zentiva is used in patients with the following mental illnesses:
Estonian: Aripiprazole Zentivat kasutatakse järgmiste vaimuhaigustega patsientide raviks.
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Estonian: Algannus 15-17-aastastel patsientidel on 2 mg ööpäevas (kasutatakse vedelikuna turustatavat aripiprasooli ravimpreparaati), mida suurendatakse järk-järgult kuni soovitusliku annuseni 10 mg üks kord ööpäevas.
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Estonian: Maniakaalsete episoodide ravi algannus 13-17-aastastel patsientidel on 2 mg ööpäevas (kasutatakse vedelikuna turustatavat aripiprasooli ravimpreparaati), mida suurendatakse järk-järgult kuni soovitusliku annuseni 10 mg üks kord ööpäevas.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Estonian: Soovitatav algannus täiskasvanutel skisofreenia ravis suukaudsel manustamisel on 10 või 15 mg ööpäevas, millele järgneb säilitusannus 15 mg üks kord ööpäevas.
English: The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Estonian: Aripiprazole Zentiva toimeaine aripiprasool on antipsühhootikum.
English: How is Aripiprazole Zentiva used?
Estonian: Aripiprazole Zentiva on retseptiravim.
English: The amended information to healthcare professionals and patients is available here.
Estonian: Muudetud teave tervishoiutöötajatele ja patsientidele on siin.
English: The company wanted the authorisation to be recognised in Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom (the ‘concerned Member States').
Estonian: Ettevõte soovis müügiloa tunnustamist Küprosel, Tšehhi Vabariigis, Prantsusmaal, Itaalias, Poolas, Portugalis, Hispaanias ja Ühendkuningriigis (asjaomased liikmesriigid).
English: Ref. EMEA/CHMP/150446/2009 rev.1 EMEA/H/A-29/1082
Estonian: London, 2. oktoober 2009 Viide EMEA/CHMP/150446/2009 rev.1 EMEA/H/A-29/1082
English: Bayer Vital GmbH submitted Avalox solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Estonian: Bayer Vital GmbH esitas infusioonilahuse Avalox vastastikuse tunnustamise menetluseks Saksamaa 30. aprillil 2002 antud algse müügiloa põhjal.
English: Complicated means that the infection is difficult to treat because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Estonian: Komplitseeritud tähendab, et nakkus allub halvasti ravile, kuna see on levinud sügavale nahaalustesse kudedesse, ning võib olla vajalik kirurgiline ravi või et patsiendil esineb teisi haigusi, mis võivad ravivastust mõjutada.
English: The grounds for the referral were concerns expressed by the United Kingdom that the use of intravenous moxifloxacin in community acquired pneumonia and complicated skin and soft tissues infections should be limited to when the standard treatments for these infections are not appropriate, and concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Estonian: Esildise aluseks oli Ühendkuningriigi arvamus, et moksifloksatsiini intravenoosne kasutamine keskkonnatekkese pneumoonia ning naha- ja nahaaluskoe komplitseeritud infektsioonide korral peaks olema näidustatud vaid juhul, kui nende infektsioonide tavapärane ravi ei sobi patsiendile, ja Prantsusmaa mure seoses ravimi põhjustatud südame rütmihäirete (QT-intervalli pikenemise) riskiga.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Avalox solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom.
Estonian: Inimravimite komitee otsustas, et Avaloxi infusioonilahuse kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimile võib anda müügiloa lisaks Saksamaale ka järgmistes ELi liikmesriikides: Küpros, Tšehhi Vabariik, Prantsusmaa, Itaalia, Poola, Portugal, Hispaania ja Ühendkuningriik.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Avalox solution for infusion outweigh its risks, and therefore the marketing authorisation for Avalox solution for infusion should be granted in all concerned Member States.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule otsustas inimravimite komitee, et infusioonilahuse Avalox kasulikkus on suurem kui sellega kaasnevad riskid ning seetõttu tuleks ravimile anda müügiluba kõikides asjaomastes liikmesriikides.
English: Avalox solution for infusion is an antibiotic given by infusion (drip into a vein).
Estonian: Infusioonilahus Avalox on antibiootikum, mida manustatakse infusioonina (tilgutatakse veeni).
English: The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.
Estonian: Inimravimite komitee soovitas samuti muuta ravimiteavet kõigis liikmesriikides, kus ravimile on müügiluba antud.
English: Questions and answers on the referral for Avalox solution for infusion containing moxifloxacin 400 mg/250 ml
Estonian: Teave järgmise ravimi esildise kohta: Avalox infusioonilahus, 400 mg/250 ml moksifloksatsiini
English: It is used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Estonian: Seda kasutatakse järgmiste bakteriaalsete infektsioonide raviks: - keskkonnatekkene pneumoonia (kopsupõletik, millesse nakatutakse väljaspool haiglat); - naha- ja nahaaluskoe komplitseeritud infektsioonid.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Avalox solution for infusion.
Estonian: Euroopa Ravimiamet on lõpetanud vahekohtumenetluse, mis algatati pärast seda kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele infusioonilahusele Avalox müügiloa andmises.
English: The active substance in Avalox solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Estonian: Infusioonilahus Avalox sisaldab toimeainena moksifloksatsiini, mis kuulub fluorokinoloonide rühma.
English: However, the prescribing information for Avalox solution for infusion should be amended in all the Member States where it is authorised.
Estonian: Infusioonilahuse Avalox määramise teavet tuleb aga muuta kõigis liikmesriikides, kus ravimile on müügiluba antud.
English: What is Avalox solution for infusion?
Estonian: Mis on infusioonilahus Avalox?