FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Giotrif and what is it used for?
Estonian: Mis on Giotrif ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Giotrif.
Estonian: Hindamisaruandes ei anta Giotrifi kasutamise praktilisi nõuandeid.
English: Why is Giotrif approved?
Estonian: Miks Giotrif heaks kiideti?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU.
Estonian: Inimravimite komitee otsustas, et Giotrifi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: This is a summary of the European public assessment report (EPAR) for Giotrif.
Estonian: See on ravimi Giotrif Euroopa avaliku hindamisaruande kokkuvõte.
English: Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.
Estonian: Ravi Giotrifiga peab alustama ja jälgima vähiravis kogenud arst.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Giotrifi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription.
Estonian: Giotrif on retseptiravim ja seda turustatakse tablettidena (20 mg, 30 mg, 40 mg ja 50 mg).
English: • when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.
Estonian: • kui vähkkasvaja on lamerakuline (tekib kopsu lamerakkudes) ja on süvenenud plaatinapõhisele keemiaravile vaatamata.
English: Giotrif contains the active substance afatinib.
Estonian: Giotrif sisaldab toimeainena afatiniibi.
English: Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer.
Estonian: Giotrif on ravim, mida kasutatakse teatud tüüpi kopsuvähi, nimelt mitteväikerakk-kopsuvähi raviks.
English: For the full list of all side effects and restrictions with Giotrif, see the package leaflet.
Estonian: Giotrifi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.
Estonian: ErbB-rühma valke blokeerides aitab afatiniib piirata rakkude jagunemist, aeglustades nii mitteväikerakk-kopsuvähi kasvu ja levikut organismis.
English: What are the risks associated with Giotrif?
Estonian: Mis riskid Giotrifiga kaasnevad?
English: The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects.
Estonian: Seda annust taluvatel patsientidel tohib annust suurendada kuni 50 mg-ni üks kord ööpäevas, kuid kõrvalnähtude tekkimisel tuleb ravi katkestada või annust vähendada.
English: • when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
Estonian: • kui vähkkasvajal on EGFR-valgu geenis teatud mutatsioon ja kasvajat ei ole varem ravitud türosiinkinaasiinhibiitoritega;
English: For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Giotrifi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: EGFR proteins are part of the ErbB family.
Estonian: EGFR-valgud kuuluvad ErbB-rühma.
English: For more information about treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Giotrifiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.
Estonian: Teises uuringus, milles osales 795 lamerakulise vähiga patsienti, oli patsientide keskmine progresseerumiseta elumus Giotrifi rühmas 2,6 kuud ja muu vähiravimi (erlotiniib) ravirühmas 1,9 kuud.
English: Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.
Estonian: Giotrif aeglustab mitteväikerakk-kopsuvähiga patsientidel oluliselt haiguse süvenemist.
English: How is Giotrif used?
Estonian: Kuidas Giotrifi kasutatakse?
English: How does Giotrif work?
Estonian: Kuidas Giotrif toimib?
English: In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.
Estonian: Ühes põhiuuringus, milles osales 345 EGFR-geeni mutatsiooniga patsienti, oli patsientide keskmine progresseerumiseta elumus (kui kaua patsiendid elasid haiguse süvenemiseta) Giotrifi rühmas 11 kuud ja kahe muu vähiravimi (pemetrekseed ja tsisplatiin) rühmas 7 kuud.
English: What benefits of Giotrif have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Giotrifi kasulikkus?
English: The active substance in Giotrif, afatinib, is an ErbB family blocker.
Estonian: Giotrifi toimeaine afatiniib on ErbB-rühma valkude blokaator, mis blokeerib vähirakkude pinnal leiduvate teatud valkude (ErbB-rühma valkude) toime.
English: The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients.
Estonian: Inimravimite komitee leidis, et Giotrifiga ravitud patsientide progresseerumiseta elumuse pikenemine on mitteväikerakk-kopsuvähiga patsientidele oluliselt kasulik.
English: EMA/CVMP/19896/2007 EMEA/V/C/000082
Estonian: EMA/67099/2007 EMEA/V/C/000082
English: Avoid contact with eyes and skin.
Estonian: Hoiduda kontaktist silmade ja nahaga.
English: This summary was last updated in April 2012.
Estonian: Kokkuvõtte viimane uuendus: aprill 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Previcox on 13 September 2004.
Estonian: Euroopa Komisjon andis Previcox müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, on 13. september 2004.
English: Horse:
Estonian: Hobune
English: Wash hands after use of the product.
Estonian: Pärast ravimi kasutamist pesta käed.
English: Other information about Previcox:
Estonian: Muu teave Previcoxi kohta
English: These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Estonian: Need reaktsioonid on üldjuhul mööduvad ja lõpevad ravi lõpetamisel.
English: Dog:
Estonian: Koer
English: Previcox is presented as chewable tablets for dogs (57 mg and 227 mg) and as an oral paste for horses (8.2 mg/g).
Estonian: Previcox on saadaval närimistablettidena koertele (57 mg ja 227 mg) ning on saanud müügiloa ka suukaudse pastana hobustele (8,2 mg/g).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Previcox are greater than any risks of treatment and they recommended that Previcox should be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Previcox kasulikkus ületab ravimi kasutamisega kaasnevad ohud, ning soovitas anda Previcox müügiloa.
English: Previcox chewable tablets for dogs were studied in two large European field studies in dogs for a period of up to 90 days.
Estonian: Previcoxi närimistablette koertele uuriti Euroopa kahes suures väliuuringus koertega, mille kestus oli kuni 90 päeva.
English: If it occurs, rinse affected area immediately with water.
Estonian: Kontakti korral loputada koheselt rohke veega.
English: The use of Previcox is not permitted in mares producing milk for human consumption.
Estonian: Previcoxi ei ole lubatud kasutada märadel, kelle piim on ette nähtud inimtoiduks.
English: Two multi-centre studies were conducted (one in the US and one in Europe) to investigate the efficacy, safety and acceptability of firocoxib under field conditions when administered to horses orally once daily for 14 days at a dose of 0.1 mg/kg.
Estonian: Viidi läbi kaks mitmekeskuselist uuringut (üks USAs ja teine Euroopas) firokoksiibi efektiivsuse, ohutuse ja vastuvõetavuse uurimiseks välitingimustes selle suukaudsel manustamisel hobustele üks kord päevas 14 päeva jooksul annuses 0,1 mg/kg.
English: Previcox has been studied in laboratory animals, as well as in dogs and horses that were treated in various veterinary practices/clinics across Europe (“clinical studies”).
Estonian: Previcoxi uuriti laboriloomadel, samuti koertel ja hobustel, keda on ravitud Euroopa paljudes loomakliinikutes (kliinilised uuringud).
English: The product was shown to be comparable to other reference products (carprofen and meloxicam, respectively).
Estonian: Tõestati ravimi võrreldavust teiste võrdlusravimitega (vastavalt karprofeen ja meloksikaam).
English: In case of accidental ingestion, it is necessary to seek medical advice immediately and show the package leaflet or the label to the physician.
Estonian: Juhuslikul ravimi allaneelamisel pöörduda viivitamatult arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Estonian: Rasedad naised peaks hoiduma kontaktist ravimiga või kandma preparaadi manustamisel ühekordseid kindaid.
English: Previcox oral paste administered once daily for 14 days at a dose of 0.1 mg/kg improved clinical scores for lameness and soft tissue injuries in horses and also helped alleviate pain and inflammation associated with osteoarthritis in horses.
Estonian: Previcoxi suukaudse pasta manustamisel üks kord päevas 14 päeva jooksul annuses 0,1 mg/kg paranesid kliinilised lonkamistulemused ja pehmete kudede vigastused hobustel ning see aitas ka leevendada hobustel osteoartriidiga seotud valu ja põletikku.
English: Previcox tablets for dogs improved the scores for the relief of pain and inflammation.
Estonian: Previcoxi tabletid koertele parandasid koertel valu ja põletiku vähenemise tulemusi.
English: What is Previcox?
Estonian: Mis on Previcox?
English: Previcox contains firocoxib, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2).
Estonian: Previcox sisaldab firokoksiibi, mis kuulub mittesteroidsete põletikuvastaste ravimite klassi koksiibide rühma, mille toime seisneb tsüklooksügenaas-2 (COX-2) selektiivses pärssimises.
English: The dose, duration of treatment and frequency will depend on the weight and type of animal and condition to be treated.
Estonian: Ravi annus, kestus ja sagedus olenevad looma kehamassist ja liigist ning ravitavast seisundist.
English: Firocoxib blocks the enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins.
Estonian: Firokoksiib blokeerib ensüümi (tsüklooksügenaas), mis osaleb prostaglandiinide tekkel.
English: As the prostaglandins are substances that trigger pain, inflammation and fever, Previcox, therefore, reduces those responses.
Estonian: Prostaglandiinid on ained, mis vallandavad valu, eritisi ja põletikku, ning Previcoxi toimel need reaktsioonid vähenevad.
English: After the last day of treatment with Previcox, horses should not be slaughtered for 26 days (when treated with the oral paste).
Estonian: Ravitud hobuseid ei tohi tappa 26 päeva jooksul pärast viimast ravipäeva Previcoxiga (suukaudne pasta).
English: Return halved tablets to the blister and keep out of the reach of children.
Estonian: Poolitatud tabletid asetada tagasi müügipakendisse ja hoida lastele kättesaamatus kohas.
English: What is the risk associated with Previcox?
Estonian: Mis riskid Previcoxi kaasnevad?
English: The results showed an improvement in lameness score in dogs with established osteoarthritis.
Estonian: Tulemused näitasid lonkamise vähenemist väljakujunenud osteoartriidiga koertel.
English: Previcox must not be administered with corticosteroids or other NSAIDs.
Estonian: Previcoxi ei tohi manustada koos kortikosteroidide ega teiste mittesteroidsete põletikuvastaste ravimitega.
English: Administration of the product in accordance with the recommended dosing schedule for a period of up to 90 days resulted in an improvement in lameness score in dogs with established osteoarthritis.
Estonian: Ravimi manustamisel soovitusliku annustamisskeemi kohaselt kuni 90 päeva jooksul paranes väljakujunenud osteoartriidiga koertel lonkamistulemus.
English: Coxibs display pain relief, anti-inflammatory and antipyretic properties.
Estonian: Koksiibidel on valuvaigistavad, põletikuvastased ja palavikuvastased omadused.
English: How does Previcox work?
Estonian: Kuidas Previcox toimib?
English: Why has Previcox been approved?
Estonian: Miks Previcox heaks kiideti?
English: What is Previcox used for?
Estonian: Milleks Previcoxi kasutatakse?
English: Firocoxib
Estonian: Firokoksiib
English: Previcox is used for a relief of pain and inflammation associated with osteoarthritis, soft-tissue, orthopaedic and dental surgery in dogs and for the alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Estonian: Previcoxi kasutatakse osteoartriidiga seonduva, pehmete kudede-ortopeediliste- ja hambaopeoperatsioonidega kaasneva operatsioonijärgse valu ja põletiku leevendamiseks koertel ning osteoartriidiga seonduva valu ja põletiku leevendamiseks ja selle haigusega seonduva lonkamise vähendamiseks hobustel.
English: What benefit has Previcox shown during the studies?
Estonian: Milles seisneb uuringute põhjal Previcoxi kasulikkus?
English: The side effects of Previcox are typical for those seen with other medicines in this product class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/diarrhoea or lethargy.
Estonian: Previcoxil on tüüpilised sama klassi (mittesteroidsed põletikuvastased ravimid) ravimite kõrvaltoimed, näiteks suu koekahjustused hobustel, pehme väljaheide või kõhulahtisus või letargia.
English: Information on the prescription status of this product may be found on the label of the carton.
Estonian: Teave selle kohta, kas toode on retseptiravim, on esitatud etiketil/välispakendil.
English: Care should also be taken when used with molecules displaying action on renal flow e.g. diuretics.
Estonian: Ettevaatlik tuleb olla selle kasutamisel koos vedelikuvoolu neerudes mõjutavate ainetega, näiteks diureetikumidega.
English: Previcox contains the active substance firocoxib, which belongs to a class of medicines having antiinflammatory action.
Estonian: Previcoxi toimeaine firokoksiib kuulub põletikuvastase toimega ravimite klassi.
English: The CVMP concluded that Previcox oral paste was as effective as other authorised products (phenylbutazone and vedaprofen) in the alleviation of pain and inflammation associated with osteoarthritis and the reduction of associated lameness in horses.
Estonian: Veterinaarravimite komitee jõudis otsusele, et Previcoxi suukaudne pasta on osteoartriidiga seotud valu ja põletiku leevendamisel ning selle haigusega seotud lonkamise vähendamisel hobustel sama efektiivne kui teised müügiloa saanud ravimid (fenüülbutasoon ja vedaprofeen).
English: For details, please see the Package Leaflet.
Estonian: Täpsemad andmed leiate pakendi infolehelt.
English: This might potentially lead to problems of animal welfare.
Estonian: See võib kaasa tuua loomade heaoluga seotud probleeme.
English: No data from other European countries/regions have been submitted, so it could not been evaluated if this situation is representative of the whole EU.
Estonian: Teistest Euroopa riikidest/piirkondadest andmeid ei esitatud, seega ei ole võimalik hinnata, kas see olukord esindab kogu ELi.
English: The animals were split into four groups.
Estonian: Loomad jagati nelja rühma.
English: Types and mechanisms of resistance
Estonian: Resistentsuse tüübid ja mehhanismid
English: from the period 2004-2006 until the period 2008-2009 in the isolates tested in Germany.
Estonian: puhul alates ajavahemikust 2004-2006 kuni ajavahemikuni 2008-2009 Saksamaal katsetatud isolaatides.
English: It represents a practical approach in line with the aims of this procedure and is appropriate for the protection of consumer safety.
Estonian: See esindab praktilist käsitlusviisi kooskõlas käeoleva menetlusega ja see sobib tarbijaohutuse kaitsmiseks.
English: The overall recovery rate was 46.7%.
Estonian: Paranemise üldmäär oli 46,7%.
English: 1123 Budapest Hungary
Estonian: 1123 Budapest Ungari
English: These data come from different bibliographic publications as well as publicly available reports from European monitoring programs and cover the period between 1998 and 2009.
Estonian: Need andmed on pärit erinevatest bibliograafilistest publikatsioonidest ning samuti Euroopa seireprogrammide avalikult kättesaadavatest aruannetest ja need hõlmavad ajavahemikku 1998-2009.
English: The clinical response rate was 92%.
Estonian: Kliinilise ravivastuse määr oli 92%.
English: Most of the animals recovered within 2-3 days.
Estonian: Enamik loomi paranes 2-3 päevaga.
English: These data are supported by published literature.
Estonian: Neid andmeid toetab avaldatud kirjandus.
English: are also appropriate for Grampositive infection in both species as well.
Estonian: puhul on asjakohased ka grampositiivsete infektsioonide puhul mõlemal liigil.
English: The withdrawal period was derived from the first study, but also bearing in mind the results of the second (confirmatory) study.
Estonian: Keeluaeg tuletati esimesest uuringust, kuid pidades ka meeles teise (kinnitava) uuringu tulemusi.
English: Data were available from two studies.
Estonian: Kättesaadavad olid kahe uuringu andmed.
English: These extrapolations were considered acceptable as goats are considered as minor species.
Estonian: Nimetatud ekstrapolatsioone peeti vastuvõetavaks, kuna kitsi peetakse vähelevinud liigiks.
English: Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Estonian: Seega tuleb siinseid soovitusi kasutada ainult konkreetse annuse määramise lähtealusena.
English: The highest success rate was observed in calves ≤ 2 years old (71.4%), but it decreased in older animals.
Estonian: Suurimat edukust täheldati ≤ 2 aasta vanuste vasikate puhul (71,4%), kuid see vähenes vanemate loomade puhul.
English: No mortality was observed in the treatment groups.
Estonian: Suremust ravirühmades ei täheldatud.
English: As regards to Mycoplasma bovis, this microorganism is difficult to be identified and assessed since it is often involved in mixed infections.
Estonian: Mis puutub tüve Mycoplasma bovis, siis seda mikroorganismi on raske tuvastada ja hinnata, sest see on sageli seotud segainfektsioonidega.
English: 949 01, Nitra Slovakia
Estonian: 949 01, Nitra Slovakkia
English: Via Emilia, 285 Ozzano Emilia (BO) Italy
Estonian: Via Emilia, 285 Ozzano Emilia (BO) Itaalia
English: At the European level, different actions and activities are constantly taken in order to maintain the efficacy of fluoroquinolone-containing veterinary medicinal products.
Estonian: Euroopa tasandil on pidevalt võetud erinevaid meetmeid ja tehtud toiminguid fluorokinolooni sisaldavate veterinaarravimite efektiivsuse säilitamiseks.
English: 20037 Paderno Dugnano (MI) Italy
Estonian: 20037 Paderno Dugnano (MI) Itaalia
English: Friulchem via San Marco, 23 33099 Vivaro (PN) Italy
Estonian: Friulchem via San Marco, 23 33099 Vivaro (PN) Itaalia
English: Thus, it was considered that for consistency the target animal species for both strengths should harmonised to “Sheep” and “Goats”.
Estonian: Seega leiti, et järjepidevuse huvides tuleks sihtloomade liigid mõlema tugevuse puhul ühtlustada „lammasteks” ja „kitsedeks”.
English: Litvínovská 609/3 190 21 Praha 9
Estonian: Litvínovská 609/3 190 21 Praha 9 Tšehhi
English: The bacteriological success was the first criteria of efficacy.
Estonian: Efektiivsuse esimene kriteerium oli bakterioloogiline edukus.
English: The provided data on efficacy are adequate to demonstrate efficacy against this bacteria.
Estonian: Efektiivsuse kohta esitatud andmed on selle bakteri vastase efektiivsuse tõestamiseks piisavad.
English: - In another study 56 Staph.
Estonian: - Teises uuringus isoleeriti 56 Staph.
English: 8501 Novo Mesto Slovenia
Estonian: 8501 Novo Mesto Sloveenia
English: The risk on individual level might be increased for rabbit as compared to other species.
Estonian: Võrreldes teiste liikidega võib küülikute puhul suureneda risk indiviidi tasandil.
English: and Proteus spp.
Estonian: ja Proteus spp.
English: The clinical parameters improved.
Estonian: Kliinilised näitajad paranesid.
English: Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Estonian: Küülikuid kasvatatakse pidevsüsteemides, kus resistentsed bakterid võivad pikka aega püsida, kuid üldine risk jääks küülikuliha vähese tarbimise tõttu siiski väikeseks.
English: It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Estonian: Ei ole selge, kas kinoloonresistentene Campylo-bakteri infektsioon on seotud halbade tagajärgedega inimtervisele.
English: aureus, together with a bacteriological cure of 66.67%.
Estonian: aureus'ega seotud infektsioonide puhul koos bakterioloogilise paranemise määraga 66,67%.
English: Following intravenous injection:
Estonian: Pärast intravenoosset süsti:
English: Burgos Spain
Estonian: Burgos Hispaania
English: Bravničarjeva 13 Ljubljana Slovenia
Estonian: Bravničarjeva 13 Ljubljana Sloveenia
English: The available data does fully demonstrate the efficacy of this veterinary medicinal product for the treatment of septicaemia.
Estonian: Olemasolevad andmed tõestavad täielikult selle veterinaarravimi efektiivsust septitseemia ravis.
English: Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia
Estonian: Novo mesto Smarjeska cesta 6 8501 Novo Mesto Sloveenia
English: Several controlled experimental studies were conducted with induced infection (all of them together with M. haemolytica).
Estonian: Mitmed kontrollitud katseuuringud viidi läbi esilekutsutud nakkusega (kõik neist koos tüvega M. haemolytica).
English: Clinical and bacteriological cure were obtained.
Estonian: Saavutati kliiniline ja bakterioloogiline tervenemine.
English: All available clinical data referred to pet rabbits only.
Estonian: Kõik olemasolevad kliinilised andmed viitasid ainult lemmikloomadena peetavatele küülikutele.
English: In other cases, a combination of parenteral and oral administration or the parenteral route alone was used.
Estonian: Muudel juhtudel kasutati parenteraalse ja suukaudse manustamise kombinatsiooni või ainult parenteraalset manustamist.
English: Although the scientific justification for this indication is not as robust as desirable, a clinical cure (response to treatment) of 87.5% was obtained in infections involving Staph.
Estonian: Kuigi selle näidustuse teaduslik põhjendus ei ole nii tugev kui oleks soovitav, täheldati kliinilist paranemist (ravivastust) 87,5% Staph.