FrancophonIA/ELRC3.0 huggingface dataset:
English: Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Estonian: Zenapax´i kasutatakse koos teiste immunosupressiivsete ravimitega, sh tsüklosporiini ja kortikosteroididega.
English: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.
Estonian: Enne manustamist tuleb parenteraalselt manustatavaid ravimeid visuaalselt kontrollida osakeste ja värvimuutuse suhtes.
English: Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection.
Estonian: Zenapax´i kasutamine koos teise lümfotsüütide vastaseid antikehi sisaldavate ravimitega intensiivse immunosupressiooni foonil tsüklosporiini, mükofenolaatmofetiili ja kortikosteroididega võib olla faktoriks, mis viib fataalse infektsiooni tekkeni.
English: Impaired healing (without infection) Chest pain
Estonian: Haavaparanemise häired (ilma infektsioonita)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, for infusion after dilution Read the package leaflet before use
Estonian: MANUSTAMISVIIS JA -TEE Intravenoosseks manustamiseks pärast lahjendamist Enne ravimi kasutamist lugege pakendi infolehte
English: Tell your doctor straightaway if you are pregnant, breast-feeding, become pregnant or plan to start a family in the near future.
Estonian: Kui te olete rase, toidate last rinnaga, rasestute või planeerite lähiajal rasestuda, teavitage sellest kohe oma arsti.
English: No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells.
Estonian: Tsirkuleerivate lümfotsüütide arvu või raku fenotüübi suuri muutusi (fluorestsents-aktiveeritud raku sorteri analüüsil (FACS) ei tekkinud, välja arvatud Tac-positiivsete rakkude arvu mööduv vähenemine.
English: The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids.
Estonian: Kliinilistes uuringutes manustati Zenapax´i ilma koostoimete tekketa koos järgmiste transplantatsiooni ravimitega: tsüklosporiin, mükofenolaatmofetiil, gantsükloviir, atsükloviir, takrolimus, asatiopriin, tümotsüütide vastane immunoglobuliin, muromonab-CD3 (OKT3) ja kortikosteroidid.
English: METHOD OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Estonian: Intravenoosseks manustamiseks pärast lahjendamist Enne ravimi kasutamist lugege pakendi infolehte
English: In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax.
Estonian: Puuduvad kogemused teise või järgnevate Zenapax-ravikuuride kohta transplantaadi saajatel.
English: A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.
Estonian: Luuüdi transplantatsiooniga patsientidele manustati 1,5 mg/kg ilma kõrvalnähtude tekketa.
English: Patients with severe hepatic impairment
Estonian: Raske neerupuudulikkusega patsiendid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/1/99/098/001
English: Fasting blood glucose was measured in a small number of placebo- and Zenapax-treated patients.
Estonian: Tühja-kõhu glükoosisisaldust määrati väikesel hulgal platseeborühma ja Zenapax´i rühma patsientidel.
English: There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery.
Estonian: Autojuhtimine ja masinatega töötamine Puuduvad andmed selle kohta, et Zenapax mõjutaks autojuhtimise või masinate käsitsemise võimet.
English: However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the 37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Estonian: Siiski suri 40-st nii Zenapax´i kui ka lümfotsüütide vastast ravi saanud patsiendist 8 (20%) ja 37-st nii platseebot kui ka lümfotsüütide vastast ravi saanud patsiendist 2 (5,4%).
English: HOW TO USE ZENAPAX
Estonian: KUIDAS ZENAPAX´I KASUTADA
English: Serum levels of 0.5 to 0.9 µg/ml are needed to saturate the IL-2 receptor and levels of 5-10 µg/ml are needed to inhibit IL-2 mediated biologic activity.
Estonian: IL-2 retseptori küllastamiseks vajalik kontsentratsioon seerumis on 0,5...0,9 µg/ml ja IL-2 poolt vahendatud bioloogilise aktiivsuse inhibeerimiseks vajalik kontsentratsioon on 5...10 µg/ml.
English: Daclizumab saturates the Tac receptor for approximately 90 days at the recommended dosage regimen for the majority of patients.
Estonian: Soovitatud annuste manustamisel küllastab daklitsumab Tac retseptori enamusel patsientidest umbes 90 päevaks.
English: The mean ± standard deviation trough serum concentration prior to fifth dose was 7.6 ± 4.0 µg/ml.
Estonian: Madalaim kontsentratsioon seerumis enne viiendat annust oli 7,6 ± 4,0 µg/ml.
English: Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys.
Estonian: Pärast ühekordset intravenoosset boolussüsti või subkutaanset manustamist annustes 50...125 mg/kg hiirtele, rottidele ja küülikutele ning 28-päevast manustamist annuses 15 mg/kg ahvidele oli daklitsumabi talutavus hea.
English: A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILISE TOIMEAINE TOOTJA(D) JA TOOTMISLOA HOIDJA(D), KES VASTUTAB RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST
English: The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil.
Estonian: Zenapax´i ohutusprofiili uuriti platseebokontrolliga uuringutes, kus patsiendid said samaaegselt immunosupressiivset ravi, mis sisaldas ainult tsüklosporiini ja kortikosteroidi, või lisaks asatiopriini või mükofenolaatmofetiili.
English: No incompatibility between Zenapax and polyvinyl chloride bags or infusion sets has been observed.
Estonian: Zenapax´i ja polüvinüülkloriidist infusioonikottide vahel ei ole sobimatust täheldatud.
English: One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
Estonian: Üks viaal 5 ml infusioonilahuse kontsentraadiga sisaldab 25 mg daklitsumabi.
English: A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values.
Estonian: Platseeborühmas esines 16% (10-l patsiendil 64-st) ja Zenapax´i rühmas 32% (28-l patsiendil 88-st) tühja-kõhu glükoosisisalduse kõrget taset.
English: In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4).
Estonian: Harvadel juhtudel tekkisid Zenapax´i manustamise järgselt rasked ülitundlikkusreaktsioonid (vt lõik
English: No dosage adjustment is necessary for patients with severe renal impairment.
Estonian: Raske neerupuudulikkusega patsientidel ei ole vaja annust muuta.
English: Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ml) and the fifth dose (21 + 14 µg/ml).
Estonian: Maksimaalne kontsentratsioon seerumis (keskmine ± standardhälve) suurenes esimese (16 ± 12 µg/ml) ja viienda annuse (21 ± 14 µg/ml) vahel.
English: No dosage adjustments based on other identified covariates (gender, proteinuria, race and age) are required for renal allograft patients.
Estonian: Neeru transplantaadiga patsientide puhul ei ole vaja annuse kohandamisel teiste näitajatega (sugu, proteinuuria, rass ja vanus) arvestada.
English: In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating cynomolgus monkeys given a 5 - 10 fold multiple (10 mg/kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 - 0.28% of maternal serum levels) in breast milk.
Estonian: Samas daklitsumabi mittekliinilises reproduktsioonitoksilisuse uuringus leiti neljal lakteerival makaagil seitsmest, kes said inimese terapeutilisest annusest 5...10 korda suuremaid annuseid (10 mg/kg), piimast väikeses koguses daklitsumabi (mis moodustas 0,17...0,28% ravimi sisaldusest emaslooma seerumis).
English: No data are available for patients with severe hepatic impairment.
Estonian: Raske maksapuudulikkusega patsientide kohta andmed puuduvad.
English: Pack sizes of 1 or 3.
Estonian: Pakendid sisaldavad 1 või 3 viaali.
English: The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups.
Estonian: Surnultsündide, keiserlõike ja tuharseisus sündimise esinemissagedus oli võrreldav kontrollja ravigruppides.
English: Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Estonian: Surmajuhte registreeriti esimese 6 siirdamisjärgse kuu jooksul platseeborühmas 3,4% ja Zenapax´i rühmas 0,6%.
English: Abdominal pain upper (epigastric pain) Haemorrhoids
Estonian: Ülakõhuvalu (valu epigastriumis) Hemorroidid
English: There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept).
Estonian: Zenapax´i ja mükofenolaatmofetiili (CellCept) aktiivse metaboliidi mükofenoolhappe vahel ei esine farmakokineetilisi koostoimeid.
English: The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus.
Estonian: Ülitundlikkusreaktsioonide kliinilised sümptomid on hüpotensioon, tahhükardia, hüpoksia, düspnoe, vilistav hingamine, kõriturse, kopsuturse, kuumahood, diaforees, kehatemperatuuri tõus, lööve ja sügelus.
English: Severe, acute (onset within 24 hours) hypersensitivity reactions on both initial and subsequent exposure to Zenapax have been reported rarely.
Estonian: Zenapax´i manustamise järgselt on harva kirjeldatud nii esmaseid kui korduvaid raskekujulisi ägedaid ülitundlikkusreaktsioone (algus 24 tunni jooksul).
English: * Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Estonian: *Rekombinantne humaniseeritud lgG1 anti-Tac antikeha, mis on toodetud hiire NSO müeloomirakkudes kasutades glutamiinsüntetaasi (GS) ekspressiooni süsteemi (NS GSO) rekombinantse DNA tehnoloogia abil.
English: The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period.
Estonian: Vajalik annus Zenapax´i lisatakse 50 ml steriilsele 0,9% naatriumkloriidi lahusele ja manustatakse veeni 15-minutilise infusioonina.
English: The three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs. 84%) or the double immunosuppressant trial (78% Vs. 82%).
Estonian: Siirdatud elundi püsimises kolme aasta jooksul ei olnud kolme immunosupressandiga uuringus (83% vs. 84%) ega kahe immunosupressandiga uuringus platseebo ja daklitsumabi vahel olulisi erinevusi (78% vs. 82%).
English: Patients with severe renal impairment
Estonian: Raske maksapuudulikkusega patsiendid
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 5 ml
Estonian: RAVIMVORM JA PAKENDI SUURUS Üks 5 ml viaal
English: - difficulty breathing - constipation; diarrhoea; vomiting; nausea; or heartburn - pain in joints and muscles - excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema) - problems with wound healing
Estonian: - liiges- ja lihasvalu - vedeliku kogunemine organismis (tursed); käte ja jalgade tursed (perifeersed tursed) - haavaparanemise häired
English: Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection.
Estonian: Polüsorbaat 80, naatriumkloriid, veevaba naatriumdivesinikfosfaat, veevaba dinaatriumfosfaat, kontsentreeritud vesinikkloriidhape, naatriumhüdroksiid, süstevesi.
English: Zenapax is a colourless solution provided as a single use vial.
Estonian: Zenapax on värvitu lahus ühekordseks kasutamiseks mõeldud viaalis.
English: HOW TO STORE ZENAPAX
Estonian: KUIDAS ZENAPAX´I SÄILITADA
English: Clear to slightly opalescent, colourless to slightly yellowish liquid.
Estonian: Selge või kergelt opalestseeruv, värvitu või kergelt kollakas vedelik.
English: Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria
Estonian: Külmavärinad Neerupuudulikkus Neerutorukeste nekroos Hüdronefroos Neerukahjustus Kuseteede verejooks Uriinipeetus Kuseteede kahjustus Oliguuria
English: Very common side effects (occurring in 1 or more patients out of 10) are: - difficulty sleeping - shaking (tremor) - headache - high blood pressure (hypertension)
Estonian: Väga sageli esinevad kõrvaltoimed (ühel või enamal patsiendil 10-st) on: - unehäired - värisemine (treemor) - peavalu - kõrge vererõhk (hüpertensioon) - hingamisraskus - kõhukinnisus; kõhulahtisus; oksendamine; iiveldus või kõrvetised
English: - The other ingredients are polysorbate 80, sodium chloride, sodium dihydrogen phosphate, anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injections.
Estonian: - Abiained on polüsorbaat 80, naatriumkloriid, veevaba naatriumdivesinikfosfaat, veevaba dinaatriumfosfaat, kontsentreeritud vesinikkloriidhape, naatriumhüdroksiid, süstevesi.
English: PHARMACEUTICAL FORM AND CONTENTS 3 vials of 5 ml each
Estonian: RAVIMVORM JA PAKENDI SUURUS Kolm 5 ml viaali
English: Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Estonian: Zenapax on näidustatud ägeda äratõukereaktsiooni profülaktikaks de novo allogeense neerutransplantatsiooni korral koos immunosupressiivse raviga, mh tsüklosporiin ja kortikosteroidid madalalt immuniseeritud patsientidel.
English: Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Estonian: Daklitsumab on humaniseeritud monoklonaalne antikeha, mis on toodetud hiire NSO müeloomirakkudes kasutades glutamiinsüntetaasi (GS) ekspressiooni süsteemi (NS GSO) rekombinantse DNA tehnoloogia abil.
English: Paediatric patients: The safety profile for the use of Zenapax in paediatric patients was shown to be comparable to that in adult patients.
Estonian: Lapsed: Zenapax´i ohutusprofiil oli lastel ja täiskasvanutel võrreldav.
English: It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients.
Estonian: Enne manustamist tuleb see lahjendada 50 ml steriilses 0,9% naatriumkloriidi lahuses.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Daclizumab*…………5 mg per 1 ml infusion
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Daklitsumab*............5 mg 1 ml lahuse kohta Üks viaal sisaldab 25 mg daklitsumabi* 5 ml lahuses (5 mg/ml).
English: pyrosis) Abdominal distension Gastritis
Estonian: Düspepsia (sh kõrvetised) Pingetunne kõhus Gastriit
English: Zenapax is used to prevent your body from rejecting transplanted kidneys.
Estonian: Zenapax´i kasutatakse siirdatud neerude äratõukereaktsiooni vältimiseks.
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide
Estonian: Veevaba naatriumdivesinikfosfaat Veevaba dinaatriumfosfaat Kontsentreeritud vesinikkloriidhape Naatriumhüdroksiid Süstevesi
English: One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml).
Estonian: Daklitsumab*............5 mg 1 ml lahuse kohta Üks viaal sisaldab 25 mg daklitsumabi* 5 ml lahuses (5 mg/ml).
English: aggravated) Hypotension
Estonian: Hüpertensioon (sh hüpertensiooni süvenemine)
English: A maximum tolerated dose has not been determined in patients and could not be achieved in animals that received Zenapax.
Estonian: Zenapax´i maksimaalset talutavat annust ei ole patsientidel kindlaks tehtud.
English: Anxiety Tremor
Estonian: Ärevus Treemor
English: In total you should receive 5 doses of Zenapax for a complete treatment course.
Estonian: Kokku koosneb Zenapax´i ravikuur 5 annusest.
English: The identified body weight influence on systemic clearance supports the dosing of Zenapax on a mg/kg basis and maintains drug exposure within 30% of the reference exposure for patient groups with wide range of demographic characteristics.
Estonian: Soovitatud annustamisskeemide kasutamisel jääb erinevate demograafiliste näitajatega patsiendigruppidel ravimi kontsentratsioon 30% piiresse võrreldes referentsgrupiga.
English: Appreciable daclizumab serum levels were maintained except in 2 out of 18 monkeys that developed anti-daclizumab antibodies.
Estonian: Kahel ahvil tekkisid daklitsumabivastased antikehad.
English: Zenapax is NOT for direct injection.
Estonian: Zenapax´i kontsentraati EI TOHI kohe süstida.
English: Very common Insomnia Depression
Estonian: Unetus Depressioon
English: NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Zenapax 5 mg/ml infusioonilahuse kontsentraat
English: Combination Therapy in Renal Allograft Recipients
Estonian: Kombinatsioonravi neerutransplantaadiga patsientidel
English: Diabetes mellitus Fluid overload
Estonian: Lihas-skeleti valu Seljavalu Lihasspasmid Liigesvalu
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Zenapax 5 mg/ml infusioonilahuse kontsentraat Daklitsumab
English: NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Estonian: RAVIMPREPARAADI NIMETUS Zenapax 5 mg/ml infusioonilahuse kontsentraat Daklitsumab
English: This activity suppresses the body's natural immune response which otherwise might cause transplant rejection.
Estonian: Daklitsumab seondub spetsiifiliste vere valgeliblede - T-lümfotsüütide - pinnal leiduvate antigeenidega, mille tulemusena surutakse maha organismi loomulik immuunvastus, mis muidu võib põhjustada siirdatud organi äratõukereaktsiooni.
English: After dilution an immediate use is recommended.
Estonian: Ravimit tuleks kasutada koheselt pärast lahjendamist.
English: Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Estonian: Zenapax 5 mg/ml infusioonilahuse kontsentraat Daklitsumab
English: ● CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Estonian: ● MÜÜGILOA HOIDJALE ESITATUD HANKE- JA KASUTUSTINGIMUSED JA
English: It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before intravenous administration to the patients.
Estonian: Enne süstimist tuleb Zenapax´i infusioonilahuse kontsentraat lahjendada 50 ml-s steriilses 0,9% naatriumkloriidi lahuses.
English: BEFORE YOU USE ZENAPAX
Estonian: MIDA ON VAJA TEADA ENNE ZENAPAX´I KASUTAMIST
English: For mixing the solution, do not shake, gently invert the bag in order to avoid foaming.
Estonian: Lahuse valmistamisel ei tohi vahu tekkimise vältimiseks infusioonikotti raputada.
English: Store in a refrigerator (2 °C - 8 °C) Do not freeze
Estonian: Hoida külmkapis (2°C...8°C) Mitte hoida sügavkülmas Hoida originaalpakendis valguse eest kaitstult
English: Gastrointestinal disorders
Estonian: Lümfotseele Tromboos
English: Haemorrhage
Estonian: Farüngiit
English: The type of infections reported was similar in both the Zenapax- and the placebo-treated groups.
Estonian: Infektsioonide tüüp oli mõlemas rühmas sarnane.
English: These points were addressed together.
Estonian: Neid küsimusi vaadeldi koos.
English: In conclusion, the applicant's arguments are not well set out.
Estonian: Kokkuvõttes ei ole taotleja argumendid hästi esitatud.
English: This justification is based on the following arguments:
Estonian: Nimetatud tõendus põhineb järgmistel argumentidel.
English: The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 29 June 2012.
Estonian: Asjaomased liikmesriigid ei jõudnud ravimi osas kokkuleppele ja küsimus suunati 29. juunil 2012 edasi veterinaarravimite komiteele.
English: However, the difference in concentration of the active substance also needs to be considered.
Estonian: Siiski tuleb arvesse võtta ka toimeaine kontsentratsiooni erinevust.
English: The reference Member State (RMS) is the Netherlands and 12 concerned Member States (CMS) are involved: Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom.
Estonian: Viiteliikmesriik on Madalmaad ja asjaomased liikmesriigid on Austria, Belgia, Hispaania, Iirimaa, Itaalia, Poola, Prantsusmaa, Saksamaa, Taani, Tšehhi Vabariik, Ungari ja Ühendkuningriik.
English: This was clear from the variability shown in the data and referred to by the applicant.
Estonian: See ilmnes andmete varieeruvusest ja sellele viitas ka taotleja.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation
Estonian: Teaduslikud järeldused ja müügiloa andmisest keeldumise alused
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Netherlands.
Estonian: Kaaludes esitatud andmeid, tegi komitee Madalmaade saadetud teatises tõstatatud probleemide kohta järgmised järeldused.
English: The provided data are not sufficient to assure that study conditions have negligible influence on the data to the level required for this type of regulatory submission.
Estonian: Esitatud andmed ei ole piisavad selle tagamiseks, et uuringu tingimused ei mõjutaks andmeid sel tasemel, mis on nõutav seda tüüpi õigusliku esildise jaoks.
English: Some differences in pharmacokinetic parameters are attributed to different size/age of animal.
Estonian: Mõned erinevused farmakokineetilistes parameetrites on omistatud looma erinevale suurusele/vanusele.
English: Having considered all data submitted the CVMP concluded that:
Estonian: Olles kaalunud kõiki esitatud andmeid, otsustas veterinaarravimite komitee, et:
English: An insufficient number of animals was used in each of the residues studies to achieve the required precision.
Estonian: Kõigis ravimijääkide uuringutes kasutati vajaliku täpsuse saavutamiseks ebapiisavat loomade arvu.
English: This is the standard that has been generally requested from applicants seeking to change the strength of an injectable formulation (other than for intravenous route).
Estonian: Selline on standard, mida üldiselt nõutakse taotlejatelt, kes soovivad muuta süstitava ravimvormi (muul viisil kui intravenoosselt manustatava) tugevust.
English: For horses and cattle the aqueous solution is administered via the intravenous route, therefore bioequivalence can be accepted as self-evident.
Estonian: Hobustele ja veistele manustatakse vesilahust intravenoossel teel, seetõttu saab bioekvivalentsust aktsepteerida iseenesestmõistetavana.
English: Agreement was reached during the decentralised procedure with regard to data submitted to support the safety and the efficacy concerning target species cattle and horses.
Estonian: Detsentraliseeritud menetluse käigus jõuti kokkuleppele esitatud andmetes, mis toetavad ohutust ja efektiivsust asjaomastel sihtloomaliikidel veistel ning hobustel.