FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Pemetrexed Accord 100 mg infusioonlahuse kontsentraadi pulber.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.
Estonian: Pemetrexed Accord 1000 mg infusioonlahuse kontsentraadi pulber.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 500 mg of pemetrexed.
Estonian: I tüüpi klaasist ja halli bromobutüül kummikorgiga ning sinise kinnitiga suletud viaal sisaldab 500 mg pemetrekseedi.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95 % CI= 0.64-0.96).
Estonian: Alates pemetrekseed/tsisplatiin esimese rea induktsioonravist oli OS mediaan pemetrekseedi grupis 16,9 kuud ja platseebogrupis 14,0 kuud (riskisuhe = 0,78, 95% CI= 0,64...0,96).
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 1000 mg of pemetrexed.
Estonian: I tüüpi klaasist ja halli bromobutüül kummikorgiga ning sinise kinnitiga suletud viaal sisaldab 1000 mg pemetrekseedi.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.
Estonian: RAVIMPREPARAADI NIMETUS Pemetrexed Accord 100 mg infusioonilahuse kontsentraadi pulber.
English: Pemetrexed Accord is a powder for concentrate for solution for infusion in a glass vial.
Estonian: Pemetrexed Accord on viaalis infusioonilahuse kontsentraadi pulber.
English: Breast-feeding must be discontinued during pemetrexed therapy (see section
Estonian: Pemetrekseedravi ajaks tuleb imetamine lõpetada (vt lõik 4.3).
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS Pemetrexed Accord 100 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 500 mg viaali sisu 20 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.
Estonian: Pemetrexed Accord 500 mg infusioonlahuse kontsentraadi pulber.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95 % CI = 0.56-0.88, p = 0.002).
Estonian: Kui induktsioonfaas kaasa arvata, oli muu kui prevaleeruvalt lamerakulise histoloogiaga mitteväikerakk-kopsuvähiga patsientidel üldise elulemuse mediaan 18,6 kuud pemetrekseedi rühmas ja 13,6 kuud platseeborühmas (riskisuhe = 0,71, 95 % CI = 0,56…0,88, p = 0,002).
English: For precautions to be taken before handling or administering Pemetrexed Accord, see section 6.6.
Estonian: Pemetrexed Accord'i käsitlemiseelsed ettevaatusabinõud vt lõik 6.6.
English: Preparation and administration precautions
Estonian: Ettevaatusabinõud valmistamisel ja manustamisel:
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI= 0.56-0.88, p = 0.002).
Estonian: Muu kui prevaleeruvalt lamerakulise histoloogiaga mitteväikerakkkopsuvähiga patsientidel (n = 481) oli üldise elulemuse mediaan 15,5 kuud pemetrekseedi rühmas ja 10,3 kuud platseeborühmas (riskisuhe = 0,70, 95 % CI = 0,56…0,88, p = 0,002).
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Accord.
Estonian: Enne Pemetrexed Accord'i esimest annust peate seitsme päeva jooksul võtma vähemalt 5 annust.
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 100 mg viaali sisu 4,2 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 1000 mg viaali sisu 40 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving Pemetrexed Accord usually in combination with another anticancer therapy.
Estonian: Mõnedel patsientidel on Pemetrexed Accord'i ravi ajal esinenud südameatakke, insulti või „mikroinsulti“, enamasti kombineerimise korral teiste kasvajavastaste ravimitega.
English: Clinically relevant toxicity that was reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Estonian: Kliiniliselt oluliste toksilisuse juhtumitena, mida täheldati sagedusega < 1 % patsientidest, kes olid randomiseeritud tsisplatiini ja pemetrekseedi rühma, olid GGT tõus, rindkerevalu, arütmia ja motoorne neuropaatia.
English: 50 % of previous dose (both Pemetrexed Accord and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Estonian: a Need kriteeriumid vastavad National Cancer Institute (NCI) toksilisuse üldiste kriteeriumide
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Estonian: *Toksilisuse erinevate astmete kohta vt NCI CTC 2. versiooni, v.a. terminit “kreatiniini kliirensi vähenemine,” ** mis on tuletatud terminist “neerude- ja kuseteede häired” ***Vastavalt NCI CTC-le (v2,0; NCI 1998) tuleb maitsetundlikkuse häiret ja alopeetsiat registreerida ainult 1. või 2. astmena.
English: Hypernatraemia - increased sodium in blood Inflammation of the skin, mainly of the lower limb with swelling, pain and redness
Estonian: Nahapõletik, peamiselt alajäsemetel koos turse, valu ja punetusega
English: You must tell your doctor as soon as possible when you start experiencing any of these side effects.
Estonian: Pöörduge kohe arsti poole, kui täheldate endal mõnda järgmistest toimetest:
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Estonian: Histoloogiliste alamgruppide lõikes ei täheldatud pemetrekseedi koos tsisplatiiniga ohutusprofiilide kliiniliselt olulisi erinevusi.
English: What Pemetrexed Accord contains
Estonian: Mida Pemetrexed Accord sisaldab:
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Estonian: Iga viaal sisaldab ligikaudu 108 mg naatriumi Pärast lahustamist (vt lõik 6.6) sisaldab iga viaal 25 mg/ml pemetrekseedi.
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with lavender flip-off seal containing 100 mg of pemetrexed.
Estonian: I tüüpi klaasist ja halli bromobutüül kummikorgiga ning lilla kinnitiga suletud viaal sisaldab 100 mg pemetrekseedi.
English: Nausea
Estonian: Stomatiit/
English: Stomatitis/ Pharyngitis Diarrhoea without colostomy
Estonian: Kõhulahtisus ilma kolostoomita
English: Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Estonian: Normaalse neerufunktsiooniga patsientidel (kreatiniini kliirens ≥ 80 ml/min), kellele manustatakse pemetrekseedi, tuleb ettevaatusega kasutada MSPVR-eid või atsetüülsalitsüülhappe suuremates annustes.
English: CLASSIFICATION FOR SUPPLY
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED
English: Diarrhoea
Estonian: Kõhukinnisus
English: Common Neuropathy-Sensory
Estonian: Väga sage Sensoorne neuropaatia
English: Low haemoglobin level (anaemia) Low platelet count
Estonian: Valgete vererakkude arvu langus Madal hemoglobiini tase (aneemia) Madal trombotsüütide arv Kõhulahtisus
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Accord/ radiation therapy.
Estonian: Pemetrexed Accord'i / kiiritusravi ajal on täheldatud söögitoru sisepinna põletikku.
English: Women must use effective contraception during treatment with Pemetrexed Accord.
Estonian: Pemetrexed Accord'i ravi ajal peavad naised rakendama tõhusat kontratseptsiooni.
English: Time to treatment failure (months)
Estonian: OS Time (Months)
English: Adjusted Hazard
Estonian: Iiveldus Isutus
English: Edema
Estonian: Dotsetakseel
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Estonian: Pemetrexed Accord 100 mg infusioonilahuse kontsentraadi pulber.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion
Estonian: Pemetrexed Accord 500 mg infusioonilahuse kontsentraadi pulber.
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Estonian: Kliiniliste uuringute ajal pemetrekseediga on sageli teatatud sepsisest, mis mõnel juhul on surmaga lõppenud.
English: Gastrointestinal disorders
Estonian: Trombotsüütide vähenemine
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion
Estonian: Pemetrexed Accord 100 mg infusioonlahuse kontsentraadi pulber.
English: Pemetrexed Accord.
Estonian: Pemetrexed Accord monoteraapiana
English: Very
Estonian: Sage
English: VIAL
Estonian: Iiveldus
English: Strength Pharmaceutical Form Route of Administration Packaging
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus Pakendi suurus
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Estonian: Vaktsiin hakkab toimima 7 päeva pärast vaktsineerimist ja kaitse kestab 21 päeva jooksul pärast vaktsineerimist.
English: This is a summary of the European public assessment report.
Estonian: Käesolev dokument on veterinaarvaktsiini Euroopa avaliku hindamisaruande kokkuvõte.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs.
Estonian: Vaktsiini efektiivsust sigadel uuriti kõigepealt mitmes laboriuuringus.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom defences) how to defend itself against a disease.
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: In case of accidental ingestion and/or spillage onto skin, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Estonian: Ravimi juhusliku neelamise ja/või nahale sattumise korral tuleb otsekohe pöörduda arsti poole ja näidata talle pakendi infolehte või etiketti.
English: In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
Estonian: Kummaski uuringus vaktsineeriti 350 siga vaktsiiniga Coliprotec F4 ja 350 siga jäeti vaktsineerimata.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015.
Estonian: Euroopa Komisjon andis Coliprotec F4 müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16.03.2015.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Estonian: Keeluaeg on ravimi manustamisele järgnev periood, mille jooksul ei tohi looma tappa ega tema liha toiduks tarvitada.
English: The strain of bacteria in the vaccine have this protein but do not produce the toxin that causes the disease.
Estonian: Vaktsiini bakteritüvel on see valk olemas, kuid need ei tekita haigust põhjustavat toksiini.
English: This will help protect the pigs against E. coli infection and disease.
Estonian: Vaktsiin aitab kaitsta sigu E. coli põhjustatud infektsiooni ja haiguse eest.
English: The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
Estonian: Uuringute eesmärk oli leida, kui kiiresti tekib sigadel täielik kaitse E. coli vastu ja kui kaua see püsib.
English: The main measure of effectiveness was the number of pigs developing diarrhoea.
Estonian: Efektiivsuse põhinäitaja oli kõhulahtisusse haigestunud sigade arv.
English: Although E.coli is naturally found in the gut, some strains (known as enterotoxigenic strains) produce a toxin that causes diarrhoea, and can result in dehydration, weight loss and occasionally death of the animal.
Estonian: Kuigi bakterit E. coli leidub normaalses sooleflooras, tekitab selle mõni tüvi (enterotoksigeensed tüved) toksiini, mis põhjustab kõhulahtisust ning võib põhjustada dehüdratsiooni, kaalukaotust ja mõnikord looma surma.
English: Vaccines work by ‘teaching' the immune system (the body's natural
Estonian: Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi looduslikke kaitsemehhanisme) kaitsma organismi haiguse eest.
English: The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et Coliprotec F4 kasulikkus kasutamisel heakskiidetud näidustusel on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Estonian: Vaktsiini kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu jaotises.
English: It contains live Escherichia coli (E.coli) bacteria of a strain (O8:K87) that does not produce toxins that cause disease.
Estonian: Vaktsiin sisaldab tüve O8:K87 Escherichia coli (E. coli) elusbaktereid), mis ei tekita haigust põhjustavaid toksiine.
English: Shivering may be seen in more than 1 in 10 pigs after vaccination.
Estonian: Pärast vaktsineerimist võib rohkem kui 1 seal 10st esineda värinat.
English: Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea.
Estonian: Vaktsiini Coliprotec F4 manustatakse alates 18-päevastele sigadele, et vähendada võõrutusjärgse mõõduka kuni raske E.coli põhjustatud kõhulahtisuse esinemust.
English: The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of post-weaning diarrhoea.
Estonian: Vaktsiini Coliprotec F4 efektiivsust uuriti kahes väliuuringus, milles kasutati sigu sellistest sigalatest, kus oli esinenud võõrutusjärgset kõhulahtisust.
English: Coliprotec F4 is a vaccine that is available as a lyophilisate (a freeze-dried pellet) which is made up into an oral suspension with water.
Estonian: Vaktsiini Coliprotec F4 turustatakse lüofilisaadina (külmkuivatatud graanulitena), millest valmistatakse veega suukaudne suspensioon.
English: Coliprotec F4 is given orally to pigs as a single dose either as a drench or by addition to the drinking water.
Estonian: Vaktsiini Coliprotec F4 manustatakse sigadele suu kaudu ühekordse annusena kas jootmisvahendi kaudu või lisatuna joogiveele.
English: The withdrawal period for Coliprotec F4 for pigs is zero days.
Estonian: Coliprotec F4 keeluaeg sigadel on 0 päeva.
English: In the future, if the animals are exposed to disease-causing bacteria with the F4 protein, the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad hiljem haigust põhjustavate F4 valguga bakteritega uuesti kokku, tekivad antikehad kiiremini.
English: Both field studies showed that vaccination with Coliprotec F4 reduced the number of pigs with moderate to severe diarrhoea.
Estonian: Mõlemad väliuuringud tõestasid, et vaktsiiniga Coliprotec F4 vaktsineerimine vähendas mõõduka kuni raske kõhulahtisuse esinemust sigadel.
English: Coliprotec F4 is a vaccine.
Estonian: Coliprotec F4 on vaktsiin.
English: When Coliprotec F4 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Estonian: Kui sigadele manustatakse vaktsiini Coliprotec F4, peab immuunsüsteem vaktsiinis sisalduvaid baktereid võõraks ja tekitab nende vastu antikehi.
English: The types of E.coli associated with post-weaning diarrhoea often produce a protein called F4 on their outer coat that allows them to attach to the cells of the gut.
Estonian: Võõrutusjärgse kõhulahtisusega seotud E.coli tüvede väliskestal tekib sageli valk F4, mis võimaldab neil kinnituda soolerakkudele.
English: Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Estonian: Vaktsiini käsitsemisel tuleb kanda isikukaitsevahendeid: ühekordseid kaitsekindaid ja kaitseprille.
English: What is Coliprotec F4?
Estonian: Mis on Coliprotec F4?
English: Other information about Coliprotec F4:
Estonian: Muu teave Coliprotec F4 kohta
English: Why has Coliprotec F4 been approved?
Estonian: Miks Coliprotec F4 heaks kiideti?
English: What is the risk associated with Coliprotec F4?
Estonian: Mis riskid vaktsiiniga Coliprotec F4 kaasnevad?
English: How does Coliprotec F4 work?
Estonian: Kuidas Coliprotec F4 toimib?
English: How has Coliprotec F4 been studied?
Estonian: Kuidas vaktsiini Coliprotec F4 uuriti?
English: What is Coliprotec F4 used for?
Estonian: Milleks vaktsiini Coliprotec F4 kasutatakse?
English: What benefit has Coliprotec F4 shown during the studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini Coliprotec F4 kasulikkus?
English: 10 (2 x 5 ) prefilled pens (multipack)
Estonian: 10 (2 x 5)
English: Strength Pharmaceutical Form Route of Administration Packaging
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Estonian: Direktiivi 2001/82/EÜ artikli 35 (EMEA/V/A/089) kohase esildismenetluse järelhindamine
English: What are the conclusions of the CVMP after the follow-up assessment?
Estonian: Mis on veterinaarravimite komitee järeldused pärast järelhindamist?
English: EMA/184512/2018
Estonian: märts 2018
English: What is enrofloxacin?
Estonian: Mis on enrofloksatsiin?
English: It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.
Estonian: Sellel on antibakteriaalne toime paljude grampositiivsete ja gramnegatiivsete bakterite, samuti Mycoplasma spp vastu.
English: Enrofloxacin is for veterinary use only.
Estonian: Enrofloksatsiin on ette nähtud üksnes veterinaarseks kasutamiseks.
English: Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved.
Estonian: Olles läbi vaadanud 2013. aastal (esildismenetluse algetapis) esitatud asjakohase teabe ja müügiloa hoidjatelt komisjoni rakendusotsuse (C(2014) 1484) alusel saadud täiendavad andmed, järeldas veterinaarravimite komitee 2018. aasta veebruaris, et Escherichia coli infektsioonide ravi jaoks soovitatava annustamisskeemi optimeerimisega seotud probleemi ei ole lahendatud.
English: Enrofloxacin is an antibiotic belonging to class ‘fluoroquinolones'.
Estonian: Enrofloksatsiin on fluorokinoloonide klassi kuuluv antibiootikum.
English: The CVMP has now reviewed these data and has updated its recommendations on the use of enrofloxacin in chickens and turkeys.
Estonian: Nüüdseks on veterinaarravimite komitee need andmed läbi vaadanud ja ajakohastanud oma soovitusi enrofloksatsiini kasutamise kohta kanadel ja kalkunitel.
English: The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.
Estonian: Müügiloa hoidjatel paluti ühendust võtta liikmesriikide pädevate asutustega, et arutada, kuidas rakendada veterinaarravimite komitee soovitatud muudatusi ravimiteabes.
English: On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacincontaining medicines administered via drinking water to chickens and turkeys.
Estonian: 14. veebruaril 2018 ajakohastas Euroopa Ravimiamet oma soovitusi kanadele ja kalkunitele joogiveega manustatavate enrofloksatsiini sisaldavate ravimite kohta.
English: Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?
Estonian: Miks kanadele ja kalkunitele joogiveega manustatavad enrofloksatsiini sisaldavad veterinaarravimid uuesti läbi vaadati?
English: In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin.
Estonian: 2013. aasta novembris esitas veterinaarravimite komitee kõnealuste ravimite kohta soovitused, et tagada nende õige kasutamine kanadel ja kalkunitel ning vähendada riski, et bakterid muutuvad enrofloksatsiini suhtes resistentseks.
English: The CVMP noted that the marketing authorisation holders had not demonstrated that the current dosage regimen for Escherichia coli in chickens and turkeys is optimal from a clinical perspective nor proposed a new dosage regimen.
Estonian: Veterinaarravimite komitee andmete kohaselt ei olnud müügiloa hoidjad tõendanud, et Escherichia coli ravis kanadel ja kalkunitel kehtiv annustamisskeem on kliinilisest seisukohast optimaalne, ega välja pakkunud uut annustamisskeemi.
English: The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry.
Estonian: Veterinaarravimite komitee järeldas, et kehtiv annustamisskeem võib soodustada bakterite resistentsuse teket enrofloksatsiini suhtes ning seeläbi piirata enrofloksatsiini kasutamist kolibatsilloosi viimase ravivõimalusena kodulindudel.
English: The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin.
Estonian: Veterinaarravimite komitee vaatas läbi enrofloksatsiini kohta kättesaadavad prekliinilised (laborikatsete) andmed ja kliinilised andmed (kanadel ja kalkunitel), sealhulgas andmed ettevõtetelt ja avaldatud kirjandusest.