FrancophonIA/ELRC3.0 huggingface dataset:
English: Cerenia is a medicine that contains the active substance maropitant.
Estonian: Cerenia on ravim, mis sisaldab toimeainena maropitanti.
English: Dogs:
Estonian: Koerad
English: Other information about Cerenia:
Estonian: Muu teave Cerenia kohta
English: What is Cerenia?
Estonian: Mis on Cerenia?
English: The measures of effectiveness were evidence of retching, vomiting, intensity of nausea and improvements in the speed of recovery by for example measuring time to sit up and stand.
Estonian: Efektiivsuse näitajad olid okserefleksi esinemine, oksendamine, iivelduse tugevus ja paranemise kiirenemine, mõõtes näiteks istuli ja püsti tõusmiseks kuluvat aega.
English: Information on the prescription status of this product can be found on the label/outer package.
Estonian: Teave selle kohta, kas toode on retseptiravim, on esitatud etiketil/välispakendil.
English: It is available as tablets (16, 24, 60 and 160 mg) for dogs, and as a solution for injection (10 mg/ml) under the skin or into a vein for dogs and cats.
Estonian: Seda turustatakse tablettidena (16, 24, 60 ja 160 mg) koerte jaoks ja süstelahusena (10 mg/ml) süstimiseks koertele ja kassidele naha alla või veeni.
English: A further study involving dogs looked at the prevention of nausea and vomiting before and after surgery.
Estonian: Täiendavas uuringus, mis hõlmas koeri, vaadeldi iivelduse ja oksendamise ennetamist enne ja pärast operatsiooni.
English: the animal owner can administer the tablets to the dog.
Estonian: Järelraviks võib koera omanik anda koerale tablette.
English: Also, the treatment of vomiting should only be together with other supportive measures or other veterinary therapy while addressing the underlying causes of the vomiting.
Estonian: Oksendamist tuleb ravida ainult koos muu toetava meetme või muu veterinaarraviga, kõrvaldades oksendamise põhjused.
English: Since this was mainly observed in dogs with an empty stomach, it is recommended to feed a light meal or snack a while before the tablets are given.
Estonian: Et seda täheldati põhiliselt tühja kõhuga koertel, on soovitav anda veidi enne tablettide manustamist kerge eine või suupiste.
English: The CVMP concluded that the benefits of Cerenia exceed its risks and recommended that Cerenia be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et Cerenia kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Only one out of 16 dogs given Cerenia vomited after receiving morphine, whilst 14 out of 15 dogs given placebo vomited, and in this group, nine of the dogs that vomited did so more than once.
Estonian: Cereniat saanud 16 koerast ainult üks oksendas pärast morfiini saamist, ent platseebot saanud 15 koerast oksendas 14 ja selles rühmas oksendas 9 koera rohkem kui üks kord.
English: What is the risk associated with Cerenia?
Estonian: Mis riskid Cereniaga kaasnevad?
English: Why has Cerenia been approved?
Estonian: Miks Cerenia heaks kiideti?
English: In case of accidental ingestion or self-injection medical advice should be sought immediately and the package leaflet or the label shown to the physician.
Estonian: Allaneelamise või iseendale süstimise korral tuleb pöörduda kohe arsti poole ja näidata ravimi pakendi infolehte või etiketti.
English: In the study looking at the effect of Cerenia before and after surgery, Cerenia was effective at preventing vomiting asociated with the use of morphine.
Estonian: Uuringus, kus vaadeldi Cerenia mõju enne ja pärast operatsiooni, oli Cerenia efektiivne morfiini kasutamisega seotud oksendamise ennetamisel.
English: Cats:
Estonian: Kassid
English: Cerenia blocks neurokinin-1 (NK1) receptors, which are found on the surface of certain cells in the part of the brain that controls nausea and vomitingand are activated by the attachment of a chemical in the body called ‘substance P'.
Estonian: Cerenia blokeerib neurokiniin-1 (NK1) retseptorid, mida leidub teatud rakkude pinnal iiveldust ja oksendamist reguleerivas ajuosas ja mille aktiveerib organismis leiduv nn P-aine neile kinnitudes.
English: Since maropitant could affect heart activity, Cerenia should be used with caution in animals with certain heart conditions.
Estonian: Maropitant võib mõjutada südametegevust, seepärast tuleb olla ettevaatlik ka Cerenia kasutamisel teatud südamehaigustega loomadel.
English: Cerenia solution for injection is used in dogs both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Estonian: Cerenia süstelahust kasutatakse koertel nii iivelduse ja oksendamise ennetamiseks enne ja pärast operatsiooni kui ka üldnarkoosist toibumise kiirendamiseks pärast morfiini kasutamist.
English: A very common side effect in cats was evidence of pain from injection under the skin and this may be reduced by injection of the product at refrigerated temperature.
Estonian: Kassidel oli tavaline kõrvalnäht valu nahaaluse süste kohal, seda saab vähendada jahutatud toote süstimisega.
English: The bioequivalence studies showed that giving the injection under the skin produced the same levels of maropitant in the body as giving the injection into a vein.
Estonian: Bioekvivalentsusuuringud näitasid, et nahaalune süst tekitas organismis samasuguse maropitanti sisalduse kui veenisüst.
English: A large number of studies with Cerenia were carried out either in laboratory dogs and cats or in animal patients at veterinary practices in several European countries and in the USA.
Estonian: Cerenia kohta on korraldatud laborikoerte ja -kasside ning loomakliinikute patsientidega rohkesti uuringuid mitmes Euroopa riigis ja USA-s.
English: Other reported side effects were decreased activity levels and tiredness.
Estonian: Muud esinenud kõrvalnähud olid loidus ja väsimus.
English: The benefit-risk balance can be found in the scientific discussion module of this EPAR.
Estonian: Ravimi kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu jaotises.
English: For dogs, the treatment of vomiting should be started with the injection, since vomiting animals might throw the intact tablet up again.
Estonian: Oksendava koera ravi tuleb alustada süstiga, sest oksendav koer võib tableti tervena välja oksendada.
English: Since Cerenia has not been studied in very young dogs or cats, or in pregnant or lactating bitches or queens, use of Cerenia in these animals should be discussed with your veterinarian.
Estonian: Et Cerenia kasutamist väga noortel, tiinetel või imetavatel koertel ega kassidel ei ole uuritud, tuleb Cerenia kasutamisel neil loomadel pidada nõu loomaarstiga.
English: How does Cerenia work?
Estonian: Kuidas Cerenia toimib?
English: In order to study the effect of Cerenia in motion sickness, dogs prone to vomiting when travelling were taken on car journeys lasting several hours for up to two consecutive days.
Estonian: Cerenia toime uurimiseks merehaiguse puhul viidi koeri, kes kaldusid reisi ajal oksendama, mitme tunni kuni 2 järjestikuse päeva pikkustele autoreisidele.
English: By preventing the attachment of substance P to the receptors, Cerenia prevents them from being activated and so reduces nausea and vomiting.
Estonian: Cerenia takistab P-aine kinnitumist retseptoreile ja retseptorite aktiveerumist ning vähendab sellega iiveldust ja oksendamist.
English: Dogs received either Cerenia soluton for injection or placebo 45 minutes before the administration of morphine for sedation and pain relief prior to anaesthesia .
Estonian: Koertele anti kas Cerenia süstelahust või platseebot 45 minutit enne rahustava morfiini manustamist ja valu leevendamiseks enne anesteesiat.
English: What benefit has Cerenia shown during the studies?
Estonian: Milles seisneb uuringute põhjal Cerenia kasulikkus?
English: In dogs the tablets can be used to prevent vomiting due to motion sickness.
Estonian: Koertel tohib tablette kasutada merehaigusest tingitud oksendamise ennetamiseks.
English: Cerenia is used to treat vomiting in dogs and cats (solution for injection) or to prevent vomiting in dogs (tablets), in combination with other supportive measures.
Estonian: Cereniat kasutatakse oksendamise ennetamiseks koertel ja kassidel (süstelahus) või oksendamise ennetamiseks koertel (tabletid) koos teiste toetavate vahenditega.
English: In cats the solution for injection is used to prevent vomiting and to reduce nausea, but is not suitable for motion (travel) sickness.
Estonian: Kassidel kasutatakse süstelahust oksendamise ennetamiseks ja iivelduse vähendamiseks, kuid mitte reisimisest põhjustatud merehaiguse ennetamiseks.
English: A common side effect of the tablets when used at a high dose of 8 mg/kg in dogs (for motion sickness) was vomiting before the car journey started.
Estonian: Merehaiguse vastu suure annusega (8 mg/kg kohta) ravi saanud koerte rühmas oli sage kõrvalnäht oksendamine enne autosõidu algust.
English: What is Cerenia used for?
Estonian: Milleks Cereniat kasutatakse?
English: Cerenia tablets are given to dogs at a dose of 2 mg maropitant per kg bodyweight once daily to prevent or treat vomiting for up to 14 days.
Estonian: Cerenia tablette antakse koertele annuses 2 mg maropitanti kehamassi 1 kg kohta üks kord ööpäevas, et ennetada või ravida oksendamist kuni 14 ööpäeva jooksul.
English: The animals received either Cerenia tablets at a dose of 8 mg/kg bodyweight or a placebo for up to two consecutive days.
Estonian: Loomad said Cerenia tablette annuses 8 mg kehamassi kg kohta või platseebot kuni 2 järjestikuse päeva jooksul.
English: Bioequivalence studies were conducted in both dogs and cats to compare giving the injection under the skin with injection into a vein.
Estonian: Nii koertel kui ka kassidel tehti bioekvivalentsuse uuringud, et võrrelda nahaalust süstimist veeni süstimisega.
English: The active substance in Cerenia, maropitant, is broken down in the liver and therefore it is recommended to be used with caution in animals with liver disease.
Estonian: Cerenia toimeaine maropitant laguneb maksas ja seepärast tuleb olla ettevaatlik selle kasutamisel maksahaigusega loomadel.
English: For the prevention of vomiting, Cerenia was studied in dogs which received either Cerenia or a placebo (a dummy tablet or injection) before another substance known to trigger vomiting (such as certain cancer medicines) was given to them.
Estonian: Oksendamise ennetamiseks uuriti Cerenia kasutamist koertel, kes said Cereniat või platseebot (näiv tablett või süst), enne kui neile anti oksendamist tekitavat ainet (nt teatud vähiravimid).
English: In cats, treatment of vomiting is with the injection only.
Estonian: Kassidel tuleb oksendamist ravida vaid süstiga.
English: For the treatment of vomiting, the effect of Cerenia compared with placebo was examined in sick cats that were vomiting for various reasons.
Estonian: Oksendamise raviks uuriti Cerenia toimet võrreldes platseeboga haigetel kassidel, kes oksendasid mitmesugustel põhjustel.
English: The results of the studies showed that Cerenia was more effective than placebo: less vomiting was seen in dogs and cats that received the medicine than in animals that received placebo, both in the treatment or in the prevention of vomiting.
Estonian: Uuringute tulemusena tõestati, et Cerenia on platseebost efektiivsem: ravimit nii oksendamise raviks kui ka ennetamiseks saanud koerad ja kassid oksendasid vähem kui platseebot saanud loomad.
English: For the treatment of vomiting, the effect of Cerenia (or a placebo) was examined in sick dogs that were vomiting for various reasons, for example because of a gastrointestinal infection.
Estonian: Oksendamise raviks uuriti Cerenia (või platseebo) toimet haigetel koertel, kes oksendasid mitmesugustel põhjustel, näiteks seedekulgla nakkuse tõttu.
English: For the prevention of vomiting, Cerenia was studied in cats which received either Cerenia or placebo before another substance known to trigger vomiting was given to them.
Estonian: Oksendamise ennetamiseks uuriti Cerenia kasutamist kassidel, kes said Cereniat või platseebot, enne kui neile anti oksendamist tekitavat ainet.
English: Cerenia tablets are given to dogs at a dose of 8 mg maropitant per kg bodyweight once daily to prevent vomiting due to motion sickness for a maximum of two consecutive days.
Estonian: Cerenia tablette antakse koertele annuses 8 mg maropitanti kehamassi 1 kg kohta üks kord ööpäevas, et ennetada merehaigusest tulenevat oksendamist kuni 2 järjestikuse ööpäeva jooksul.
English: Dogs were treated with either 1 mg/kg (injection given under the skin) or 2 mg/kg (tablet) once daily up to five days.
Estonian: Koertele anti ravimit kas 1 mg/kg (nahaalune süst) või 2 mg/kg (tabletid) üks kord ööpäevas kuni 5 päeva jooksul.
English: As injection under the skin causes pain in cats, the animal will need to be restrained when treated.
Estonian: Et nahaalune süste on kassidel valulik, tuleb tagada süstimise ajal looma liikumatus.
English: Cerenia solution for injection is given to dogs and cats once daily under the skin or into a vein (1 mg per kg bodyweight) for up to five days.
Estonian: Cerenia süstelahust manustatakse koertele ja kassidele naha alla või veeni (1 mg kehamassi 1 kg kohta) üks kord ööpäevas kuni 5 päeva jooksul.
English: Cats were treated with 1 mg/kg (injection given under the skin) once daily up to five days.
Estonian: Kassidele anti ravimit 1 mg/kg (nahaalune süst) üks kord ööpäevas kuni 5 päeva jooksul.
English: How has Cerenia been studied?
Estonian: Kuidas Cereniat uuriti?
English: Cerenia is used to prevent (tablets and solution for injection) and treat (solution for injecton) nausea caused by chemotherapy in dogs.
Estonian: Cereniat kasutatakse koertel keemiaravist põhjustatud iivelduse ennetamiseks (tabletid ja süstelahus) ning raviks (süstelahus).
English: Handling Cerenia does not represent a particular risk for people.However, maropitant can produce short lived eye irritation and in the case of accidental eye exposure, the eyes should be flushed with plenty of water and medical attention sought.
Estonian: Ravimi sattumisel silma tuleb silmi loputada rohke veega ja pöörduda arsti poole.
English: Package size
Estonian: Ravimvorm Manustamistee Pakendi iseloomustus Pakendi sisu Pakendi suurus
English: Treatment is started as soon as possible and usually within 6 days after symptoms start.
Estonian: Ravi alustatakse võimalikult kiiresti ja tavaliselt 6 päeva jooksul pärast sümptomite teket.
English: Further information on Dectova can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dectova.
Estonian: Lisateave Dectova kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/dectova.
English: When the neuraminidases are blocked, the virus cannot spread.
Estonian: Kui neuraminidaasid on blokeeritud, ei saa viirus levida.
English: Dectova (zanamivir)
Estonian: Dectova (zanamiviir)
English: What measures are being taken to ensure the safe and effective use of Dectova?
Estonian: Mis meetmed võetakse, et tagada Dectova ohutu ja efektiivne kasutamine?
English: The recommended dose for adults is 600 mg twice daily for 5 to 10 days while for children the dose is adjusted based on weight.
Estonian: Täiskasvanute soovitatav annus on 600 mg kaks korda ööpäevas 5-10 päeva jooksul, laste annust kohandatakse kehamassi alusel.
English: The European Medicines Agency therefore decided that Dectova's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Dectova kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Complicated influenza is a severe flu infection that requires hospitalisation of the patient.
Estonian: Tüsistunud gripp on raske gripiinfektsioon, mille korral vajab patsient haiglaravi.
English: Since Dectova has been authorised under exceptional circumstances, the company that markets the medicine will conduct two observational studies in patients with complicated influenza to obtain further data on the effectiveness.
Estonian: Et Dectova on saanud müügiloa erandlikel asjaoludel, korraldab selle turustaja kaks vaatlusuuringut tüsistunud gripiga patsientidel, et saada efektiivsuse kohta lisaandmeid.
English: The medicine is used when the virus is resistant to other flu treatments or when other antiviral treatments, including inhaled zanamivir are not suitable for the patient.
Estonian: Ravimit kasutatakse, kui viirus on resistentne muude gripiravimite suhtes või kui patsiendile ei sobi muud viirusvastased ravimid, sealhulgas inhaleeritav zanamiviir.
English: As for all medicines, data on the use of Dectova are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Dectova kasutamise kohta pidevat järelevalvet.
English: Other information about Dectova
Estonian: Muu teave Dectova kohta
English: Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age.
Estonian: Dectova on viirusvastane ravim, mida kasutatakse kas A- või B-gripiviiruse põhjustatud tüsistunud ja potentsiaalselt eluohtliku gripi raviks täiskasvanutel ja lastel alates 6. elukuust.
English: Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.
Estonian: Laboriuuringutest ja muudest kliinilistest uuringutest saadud tõendid kinnitasid samuti Dectova efektiivsust.
English: The most serious side effect is liver injury.
Estonian: Kõige raskem kõrvalnäht on maksakahjustus.
English: What is Dectova and what is it used for?
Estonian: Mis on Dectova ja milleks seda kasutatakse?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dectova have been included in the summary of product characteristics and the package leaflet.
Estonian: Dectova ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Dectova are carefully evaluated and any necessary action taken to protect patients.
Estonian: Dectova kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Its side effects, the most important one being liver injury, are similar to those seen with Tamiflu.
Estonian: Selle kõrvalnähud, millest olulisim on maksakahjustus, on sarnased Tamiflu kõrvalnähtudega.
English: The main measure of effectiveness was how long it took for patients to leave hospital or for 4 out of the following 5 flu symptoms to resolve: fever, decreased levels of oxygen in the blood, raised breathing rate, raised heart rate and abnormal blood pressure.
Estonian: väljakirjutamiseni või 4 gripisümptomi lahenemiseni järgmisest 5 sümptomist: palavik, vere vähenenud hapnikusisaldus, suurenenud hingamissagedus, südame suurenenud löögisagedus ja ebanormaalne vererõhk.
English: Further evidence on benefits of Dectova comes from supporting clinical studies and other laboratory studies.
Estonian: Lisatõendid Dectova kasulikkuse kohta on saadud toetavatest kliinilistest uuringutest ja muudest laboriuuringutest.
English: For more information about using Dectova, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Dectova kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.
Estonian: Ehkki võrdlusravimina kasutati Tamiflud, ei ole täiesti selge, kui efektiivne on see ravim tüsistunud gripi korral, sest seda ei ole võrreldud platseeboga (näiv ravim) hospitaliseeritud gripipatsientidel.
English: The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash.
Estonian: Dectova kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on kõhulahtisus, transaminaaside (maksaensüümid) suurenenud sisaldus, maksakahjustus ja lööve.
English: What are the risks associated with Dectova?
Estonian: Mis riskid Dectovaga kaasnevad?
English: Lower doses are given to adults and children with reduced kidney function.
Estonian: Neerutalitluse häirega täiskasvanutel ja lastel kasutatakse väiksemaid annuseid.
English: A main study showed that Dectova works as well as Tamiflu, with comparable time to discharge patients from hospital or resolution of most of the influenza symptoms.
Estonian: Põhiuuringus tõendati, et Dectova on sama efektiivne kui Tamiflu ning patsientide haiglast väljakirjutamiseni või enamiku gripisümptomite lahenemiseni kulunud aeg oli võrreldav.
English: It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.
Estonian: Dectovaga lahenesid patsientide sümptomid või nad kirjutati haiglast välja ligikaudu 5,1 päeva pärast ning Tamifluga 5,6 päeva pärast.
English: Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.
Estonian: Dectova toimib nii A- (kõige tavalisem tüüp) kui ka B-gripiviiruse neuraminidaasidele.
English: What information is still awaited for Dectova?
Estonian: Mis teavet Dectova kohta veel oodatakse?
English: The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases.
Estonian: Dectova toimeaine zanamiviir takistab gripiviiruse levikut, blokeerides viiruse pinnal leiduvate teatud ensüümide (neuraminidaaside) toime.
English: However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under ‘exceptional circumstances'.
Estonian: Et Tamiflu toime (ja sellest tulenevalt Dectova toime) ulatus ei ole endiselt selge, on Dectova saanud müügiloa erandlikel asjaoludel.
English: Dectova contains the active substance zanamivir.
Estonian: Dectova sisaldab toimeainena zanamiviiri.
English: Dectova is expected to be effective against some flu strains that do not respond to other flu treatments.
Estonian: Dectova on eeldatavasti efektiivne mõnede muudele gripiravimitele allumatute gripiviiruse tüvede korral.
English: How is Dectova used?
Estonian: Kuidas Dectovat kasutatakse?
English: How does Dectova work?
Estonian: Kuidas Dectova toimib?
English: An overview of Dectova and why it is authorised in the EU
Estonian: Ülevaade ravimist Dectova ja ELis müügiloa väljastamise põhjendus
English: Dectova can only be obtained with a prescription.
Estonian: Dectova on retseptiravim.
English: What benefits of Dectova have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Dectova kasulikkus?
English: Dectova is given as an infusion (drip) into a vein.
Estonian: Dectovat manustatakse veeniinfusioonina.
English: Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised.
Estonian: Põhiuuringus, milles osales 626 hospitaliseeritud patsienti, oli Dectova sama efektiivne kui Tamiflu (tüsistunud gripi standardravi).
English: “Paediatric patients
Estonian: "Pediaatrilised patsiendid
English: The company responded to these points on 30 November 2006.
Estonian: Ettevõte vastas neile punktidele 30. novembril 2006.
English: The Member States competent authorities will continue to keep the product under regular review.
Estonian: Liikmesriikide pädevad ametiasutused jätkavad ravimi regulaarset kontrollimist.
English: Section 4.1 (Indication):
Estonian: Lõik 4.1 (näidustus):
English: Notes:
Estonian: Märkused:
English: A Request for Supplementary Information was adopted on 16 November 2006.
Estonian: 16. novembril 2006 otsustati nõuda lisateavet.
English: BACKGROUND INFORMATION*
Estonian: TAUSTTEAVE*
English: Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Estonian: Gadografi ei soovitata kasutada populatsioonil vanuses alla 18 aasta efektiivsust ja ohutust käsitlevate andmete puudumise tõttu.