FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you are given ZINPLAVA
Estonian: Mida on vaja teada enne ZINPLAVA manustamist
English: Frequency Adverse Reaction(s)
Estonian: Esinemissagedus Kõrvaltoime(d)
English: The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours.
Estonian: Lahjendatud ZINPLAVA lahust tohib säilitada kas toatemperatuuril kuni 16 tundi või külmkapis temperatuuril 2°C kuni 8°C kuni 24 tundi.
English: ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode.
Estonian: ZINPLAVA ei ole ette nähtud CDI raviks ega mõjuta käesolevat CDI episoodi.
English: Although ZINPLAVA is intended for single dose administration, the immunogenicity of bezlotoxumab following a second administration of 10 mg/kg, 12 weeks after the first dose, was assessed in 29 healthy subjects.
Estonian: Ehkki ZINPLAVA on ette nähtud manustamiseks ühekordse annusena, hinnati 29 tervel isikul bezlotoksumabi immunogeensust ka pärast ravimi teistkordset manustamist annuses 10 mg/kg, mis toimus 12 nädalat pärast esimese annuse manustamist.
English: Table 3 shows the results of a prospectively planned combined analysis of the CDI recurrence rates in pre-specified subgroups of patients at high risk for CDI recurrence across the two Phase 3 Trials.
Estonian: Tabelis 3 on esitatud prospektiivselt plaanitud kombineeritud analüüsi tulemusena CDI retsidiivide määrad eelnevalt määratletud patsientide, kellel oli kõrge risk CDI retsidiivi tekkeks, alarühmades, kahes III faasi uuringus.
English: Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Estonian: Abiained: sidrunhappe monohüdraat, dietüleentriamiinpenta-äädikhape, polüsorbaat 80, naatriumkloriid, naatriumtsitraatdihüdraat, süstevesi, naatriumhüdroksiid.
English: Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433)
Estonian: Sidrunhappe monohüdraat (E330) Dietüleentriamiinpenta-äädikhape Polüsorbaat 80 (E443)
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Estonian: ZINPLAVAt manustatakse CDI-vastase antibakteriaalse ravi kuuri ajal (vt lõigud 4.4 ja 5.1).
English: No clinical data are available on the possible effects of bezlotoxumab on fertility.
Estonian: Puuduvad kliinilised andmed bezlotoksumabi võimalike toimete kohta fertiilsusele.
English: These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients.
Estonian: Neist kõrvaltoimetest teatati sarnaste esinemissagedustega nii platseeboravi saanud kui ka ZINPLAVAga ravitud patsientidel.
English: Patients on oral vancomycin or oral fidaxomicin could have also received IV metronidazole.
Estonian: Suukaudset vankomütsiini või suukaudset fidaksomitsiini saanud patsiendid võisid olla saanud ka i.v.
English: Sodium citrate dihydrate (E331) Water for injections
Estonian: Naatriumtsitraatdihüdraat (E331) Süstevesi
English: The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe
Estonian: Neerukahjustuse mõju bezlotoksumabi farmakokineetikale hinnati kerge (eGFR 60 kuni < 90 ml/min/1,73 m 2), mõõduka (eGFR 30 kuni < 60 ml/min/1,73 m 2) ja raske (eGFR 15 kuni
English: The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Estonian: ZINPLAVA patsientidel kasutamise kogemus piirdub ühekordse manustamisega ühekordse CDI episoodi korral (vt lõik 4.4).
English: Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable.
Estonian: tee kaudu ning seega on biosaadavus kohene ja täielik.
English: Keep vial in the outer carton in order to protect from light.
Estonian: Hoida originaalpakendis, valguse eest kaitstult.
English: In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
Estonian: Kliinilistes uuringutes manustati CDI patsientidele vaid üks ZINPLAVA annus (vt lõik 5.1).
English: Infusion related reactions
Estonian: Infusioonireaktsioonid
English: Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class
Estonian: Tabel 1: ZINPLAVA kõrvaltoimed
English: ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
Estonian: ZINPLAVAt manustatakse teile koos antibiootikumiga, mida te saate CDI raviks.
English: There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3).
Estonian: Kudede ristreaktiivsuse uuringutes ei seondunud bezlotoksumab reproduktiivkudedega ning korduvtoksilisuse uuringutes hiirtel ei esinenud märkimisväärseid toimeid isas- ja emasloomade reproduktiivorganitele (vt lõik 5.3).
English: There were no notable effects in the male and female reproductive organs in mice based on repeat dose toxicity studies and no binding to reproductive tissues was observed in tissue cross-reactivity studies.
Estonian: Korduvtoksilisuse uuringutes ei esinenud märkimisväärset mõju isaste ja emaste hiirte reproduktiivorganitele ning kudede ristreaktiivsuse uuringutes ei täheldatud seondumist reproduktiivkudedesse.
English: The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.
Estonian: Bezlotoksumabi kliirens suurenes koos kehakaalu suurenemisega; tulemuseks olid kontsentratsioonide erinevused, mida saab vältida kehakaalupõhiste annuste manustamise teel.
English: There is no experience with repeat administration of ZINPLAVA in patients with CDI.
Estonian: Puudub kogemus ZINPLAVA korduva manustamisega CDI patsientidele.
English: Infusion related reactions†
Estonian: Infusioonireaktsioonid†
English: A single infusion of ZINPLAVA or placebo was administered prior to completion of antibacterial therapy and patients were followed for 12 weeks following the infusion.
Estonian: Enne antibakteriaalse ravikuuri lõppu manustati ühekordse infusioonina ZINPLAVAt või platseebot ning patsiente jälgiti 12 infusioonile järgnenud nädala jooksul.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion
Estonian: ZINPLAVA 25 mg/ml infusioonilahuse kontsentraat
English: Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
Estonian: Tabelis 1 on esitatud kõrvaltoimed, millest teatati ZINPLAVA-ravi saanud patsientidel 4 nädala jooksul pärast infusiooni.
English: Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Estonian: Bezlotoksumab ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: What ZINPLAVA contains - The active substance is bezlotoxumab.
Estonian: Mida ZINPLAVA sisaldab - Toimeaine on bezlotoksumab.
English: • Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Estonian: kotti, mis sisaldab kas 0,9% naatriumkloriidi süstelahust või 5% dekstroosi süstelahust, et saada manustamiskõlblik lahus lõppkontsentratsiooniga vahemikus 1 kuni 10 mg/ml.
English: In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks.
Estonian: I faasi kliinilises uuringus manustati tervetele isikutele 12-nädalase vahega kaks järjestikust 10 mg/kg bezlotoksumabi annust.
English: Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins.
Estonian: Farmakoterapeutiline rühm: infektsioonivastased ained süsteemseks kasutamiseks, spetsiifilised immunoglobuliinid, ATC-kood: J06BB21
English: There are no data on repeated administration of bezlotoxumab in patients with CDI.
Estonian: Puuduvad andmed bezlotoksumabi korduva manustamise kohta CDI-ga patsientidele.
English: Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Estonian: Uuringutes MODIFY I ja MODIFY II hinnati ZINPLAVA immunogeensust elektrokemiluminestsentsuuringu (ECL) abil.
English: Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab.
Estonian: Bezlotoksumabiga ei ole läbi viidud reproduktsiooni- või arengutoksilisuse mittekliinilisi uuringuid loomadel.
English: ZINPLAVA has no effect on the CDI you have now.
Estonian: ZINPLAVA ei mõjuta teie praegust CDI nakkust.
English: • Discard vial(s) and all unused contents.
Estonian: • Visake ära viaal(id) koos kasutamata jäänud ravimiga.
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI.
Estonian: ZINPLAVAt tuleb manustada CDI-vastase antibakteriaalse ravi kuuri ajal.
English: Clear to moderately opalescent, colourless to pale yellow liquid.
Estonian: Selge kuni mõõdukalt opalestseeruv, värvitu kuni kahvatukollane vedelik.
English: Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Estonian: Eakad 65-aastastel ja vanematel patsientidel ei ole vaja annuseid kohandada (vt lõik 5.2).
English: How to store ZINPLAVA
Estonian: Kuidas ZINPLAVAt säilitada
English: • Inspect vial contents for discoloration and particulate matter prior to dilution.
Estonian: • Enne lahjendamist kontrollige viaali sisu värvuse muutuse ja võõrosakeste esinemise suhtes.
English: • feeling sick (nausea)
Estonian: • iiveldus (süda paha)
English: - The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment).
Estonian: polüsorbaat 80 (E443), naatriumkloriid, naatriumtsitraatdihüdraat (E331), süstevesi ja naatriumhüdroksiid (E524) (pH reguleerimiseks).
English: • Do not freeze the diluted solution.
Estonian: • Pärast lahjendamist ei tohi lasta lahusel külmuda.
English: If refrigerated, allow the IV bag to come to room temperature prior to use.
Estonian: kotil tuleb enne kasutamist lasta soojeneda toatemperatuurini.
English: (eGFR < 15 mL/min/1.73 m 2), as compared to patients demonstrating normal (eGFR
Estonian: < 30 ml/min/1,73 m 2) neerukahjustusega või lõppstaadiumis neeruhaigusega (eGFR < 15 ml/min/1,73 m 2) patsientidel võrreldes normaalse neerufunktsiooniga patsientidega (eGFR ≥ 90 ml/min/1,73 m 2).
English: The effects of various covariates on the pharmacokinetics of bezlotoxumab were assessed in a population pharmacokinetic analysis.
Estonian: Populatsiooni farmakokineetika analüüsis hinnati mitmesuguste kaasmuutujate mõju bezlotoksumabi farmakokineetikale.
English: One 40 mL vial contains 1,000 mg of bezlotoxumab.
Estonian: Üks 40 ml viaal sisaldab 1000 mg bezlotoksumabi.
English: ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid.
Estonian: ZINPLAVA on selge kuni mõõdukalt opalestseeruv, värvitu kuni kahvatukollane vedelik.
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between elderly patients 65 years and older and patients under 65 years of age.
Estonian: 65-aastaste ja vanemate patsientide võrdlemisel alla 65-aastaste patsientidega ei leitud kliiniliselt olulisi erinevusi bezlotoksumabi kontsentratsioonides.
English: All patients received concomitant standard of care antibacterial therapy for CDI.
Estonian: Kõik patsiendid said samaaegselt CDI-vastast antibakteriaalset standardravi (SoC, standard oral care).
English: Talk to your doctor before you are given ZINPLAVA.
Estonian: Enne ZINPLAVA manustamist pidage nõu oma arstiga.
English: Mix diluted solution by gentle inversion.
Estonian: Segage saadud lahust, pöörates kotti ettevaatlikult ümber.
English: You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teavitada riikliku teavitussüsteemi, mis on loetletud V lisas, kaudu.
English: Adult patients had a confirmed diagnosis of CDI, which was defined as diarrhoea (passage of 3 or more loose bowel movements as defined in the Bristol stool chart as types 5 through 7 in 24 or fewer hours) and a positive stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.
Estonian: Täiskasvanud patsientidel oli kinnitatud CDI diagnoos, mis defineeriti kui kõhulahtisus (vedela konsistentsiga iste, mis vastab Bristoli roojakaardi tüüpidele 5 kuni 7, vähemalt
English: Bezlotoxumab has limited extravascular distribution.
Estonian: Bezlotoksumabi ekstravaskulaarne jaotumine on piiratud.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
Estonian: ZINPLAVA 25 mg/ml infusioonilahuse kontsentraat bezlotoksumab
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Estonian: Neerukahjustus Neerukahjustusega patsientidel ei ole vaja annuseid kohandada (vt lõik 5.2).
English: Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) Based on the Miettinen and Nurminen method without stratification Based on medical conditions or medications received that may result in immunosuppression Zar score ≥ 2
Estonian: Kõigi andmete analüüs = kõigi randomiseeritud patsientide alarühm, kust arvati välja järgmised patsiendid: (i) kes ei saanud uuringuravimi infusiooni; (ii) kelle kohalikus laboris teostatud rooja analüüs ei olnud toksigeense C. difficile suhtes positiivne; (iii) kes ei saanud protokollis defineeritud standardravi 1 päeva jooksul enne või pärast infusiooni toimumist; (iiii) mittevastavus heale kliinilisele tavale
English: Each mL of concentrate contains 25 mg of bezlotoxumab.
Estonian: Üks ml kontsentraati sisaldab 25 mg bezlotoksumabi.
English: See leaflet.
Estonian: Lugege infolehte.
English: Each mL contains 25 mg bezlotoxumab.
Estonian: Üks ml sisaldab 25 mg bezlotoksumabi.
English: ZINPLAVA with SoC Percent (n/m)
Estonian: ZINPLAVA koos suukaudse standardravimiga protsent (n/m)
English: Each vial contains 1,000 mg bezlotoxumab.
Estonian: Üks viaal sisaldab 1000 mg bezlotoksumabi.
English: How you are given ZINPLAVA
Estonian: Kuidas ZINPLAVAt teile manustatakse
English: ZINPLAVA contains the active substance bezlotoxumab.
Estonian: Bezlotoksumabi manustatakse i.v.
English: What ZINPLAVA looks like and contents of the pack The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid.
Estonian: Infusioonilahuse kontsentraat on selge kuni mõõdukalt veiklev, värvitu kuni kahvatukollane vedelik.
English: ZINPLAVA with SoC Percent (n/N)
Estonian: ZINPLAVA koos suukaudse standardravimiga protsent (n/N)
English: No anti-bezlotoxumab antibodies were detected after the second dose.
Estonian: Ka pärast teise annuse manustamist ei leitud ühelgi patsiendil bezlotoksumabi-vastaseid antikehasid.
English: Placebo with SoC Percent (n/m) Difference (95% CI)
Estonian: Erinevus (95% CI)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Estonian: Korduvtoksilisuse konventsionaalsed mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic impairment and patients with normal hepatic function.
Estonian: Neerukahjustusega ja tervetel patsientidel ei leitud kliiniliselt olulisi erinevusi bezlotoksumabi kontsentratsioonides.
English: Placebo with SoC Percent (n/N)
Estonian: Platseebo koos suukaudse standardravimiga protsent (n/N)
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with renal impairment and patients with normal renal function.
Estonian: Maksakahjustusega ja tervetel patsientidel ei leitud kliiniliselt olulisi erinevusi bezlotoksumabi kontsentratsioonides.
English: It is unknown whether bezlotoxumab is secreted in human milk.
Estonian: Ei ole teada, kas bezlotoksumab eritub inimese rinnapiima.
English: p-value n = Number of patients in the analysis population meeting the criteria for endpoint N = Number of patients included in the analysis population Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion; (iiii) GCP non-compliance SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) One sided p-value based on the Miettinen and Nurminen method stratified by protocol (MODIFY I and MODIFY II), SoC antibacterial (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)
Estonian: Suukaudse standardravi antibakteriaalne aine (metronidasool või vankomütsiin või fidaksomitsiin) Ühepoolne p-väärtus põhineb protokolli järgi stratifitseeritud Miettineni ja Nurmineni meetodil (MODIFY I ja MODIFY II), suukaudse standardravi antibakteriaalsel ainel (metronidasool vs. vankomütsiin vs. fidaksomitsiin) ja hospitaliseerimise staatusel (haigla- vs. ambulatoorne patsient)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: Kuidas ZINPLAVA välja näeb ja pakendi sisu
English: Posology
Estonian: Püreksia
English: 7 May 2015
Estonian: 7. mai 2015
English: In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Estonian: Lisaks esinesid probleemid seoses sellega, et ravimi ohutust ei olnud täielikult näidatud, ja esines üks lahendamata kvaliteediprobleem.
English: What is Lodipressin?
Estonian: Mis on Lodipressin?
English: The company that applied for authorisation is Le Vet Beheer B.V.
Estonian: Müügiluba taotles ettevõte Le Vet Beheer B.V.
English: This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Estonian: See tähendab, et ta blokeerib rakupinnal olevaid kanaleid, mille kaudu kaltsium tavaliselt rakku siseneb.
English: Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Estonian: Lodipressin on veterinaarravim, mis sisaldab toimeainena amlodipiinbesilaati.
English: After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Estonian: Pärast taotluse põhjenduste arutamist vaatas veterinaarravimite komitee oma algse arvamuse uuesti läbi ja 7. mail 2015 kinnitas müügiloa andmisest keeldumist.
English: On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Estonian: 15. jaanuaril 2015 võttis veterinaarravimite komitee vastu negatiivse arvamuse, soovitades süsteemse arteriaalse hüpertensiooni raviks kassidel kasutatava ravimi Lodipressin müügiloa andmisest keelduda.
English: The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Estonian: Uuringul oli kaks osa: esimene tehti 19 kassil, kellest kahe nädala jooksul 11 raviti Lodipressiniga ja 8 said platseebot (toimeaineta ravim).
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Estonian: Lodipressini (amlodipiinbesilaat) müügiloa andmisest keeldumine EMA/55773/2016
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Estonian: Lodipressini (amlodipiinbesilaat) müügiloa andmisest keeldumine
English: In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
Estonian: Teises osas said 23 kassi Lodipressinit 16 nädala jooksul, platseeborühm puudus.
English: This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
Estonian: See tähendas, et kuigi olid mõned tõendid, et Lodipressin on vererõhu alandamisel efektiivne, ei saanud teha kindlaid järeldusi selle efektiivsuse kohta kasside kõrge vererõhu ravis.
English: By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Estonian: Vähendades kaltsiumi sisenemist rakkudesse, väldib amlodipiin veresoonte kokkutõmbumist, alandades seeläbi vererõhku.
English: When calcium enters the cells in the blood vessel walls this causes contraction.
Estonian: Kui kaltsium siseneb veresoonte seinte rakkudesse, põhjustab see nende kokkutõmbumise.
English: At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
Estonian: Esmase hindamise ajal leidis veterinaarravimite komitee, et väliuuringu ülesehituses ja läbiviimises ning tulemuste esitamise viisis esinesid puudujäägid.
English: The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Estonian: Eksperdirühm leidis, et kuigi väliuuringus näidati teatud tõendeid vererõhu vähenemise kohta, ei lasknud uuringu paljud puudujäägid järeldada, et Lodipressini kasulikkus kõrge vererõhu ravis kassidel ületaks selle riske.
English: Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Estonian: Lodipressinit kavatseti kasutada süsteemse arteriaalse hüpertensiooniga (kõrge vererõhuga) kasside raviks.
English: The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
Estonian: Seetõttu jäi veterinaarravimite komitee oma soovituse juurde keelduda müügiloa andmisest.
English: It was to be available as tablets.
Estonian: Lodipressinit kavatseti turustada tablettidena.
English: As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Estonian: Ettevõte esitas osana oma taotlusest kassidel vererõhuga vähemalt 160 mmHg tehtud väliuuringu tulemused.
English: During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Estonian: Taasläbivaatamise ajal arutas veterinaarravimite komitee kassimeditsiini eksperdirühma arvamust.
English: How is Lodipressin expected to work?
Estonian: Milline on Lodipressini eeldatav toime?
English: What were the CVMP's main concerns that led to the refusal?
Estonian: Mis olid peamised põhjused, mille tõttu soovitas veterinaarravimite komitee müügiloa andmisest keelduda?
English: What was Lodipressin expected to be used for?
Estonian: Milleks kavatseti Lodipressinit kasutada?
English: Invented name
Estonian: Ravimi (väljamõeldud) nimetus
English: All patients were clinically cured.
Estonian: Kõik patsiendid paranesid kliiniliselt.
English: PC: {number} [product code]
Estonian: PC: {number} [tootekood]
English: Take one dose on each day.
Estonian: Võtke iga päev üks annus.