FrancophonIA/ELRC3.0 huggingface dataset:
English: • Dairy farm calves: Italy - 28.9% (Makoshey et al, 20086).
Estonian: • piimafarmi vasikad: Itaalia - 28,9% (Makoshey jt, 20086).
English: Section 4.2 of the SPC and Section 4 of the Package Leaflet:
Estonian: Ravimi omaduste kokkuvõtte lõik 4.2 ja pakendi infolehe lõik 4:
English: The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC) provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Estonian: Esildismenetluse käigus esitatud toimik vastab keskkonnaohu hindamise suhtes kohaldatavatele nõuetele (mis on sätestatud direktiivi 2001/82/EÜ (muudetud direktiiviga 2004/28/EÜ) artikli 12 lõike 3 punktis j) tingimusel, et ravimpreparaati kasutatakse üksnes bakterite Mannheimia haemolytica, Pasteurella multocida ja Histophilus somni põhjustatud veiste hingamisteede infektsioonide terapeutiliseks raviks.
English: This overall process is described in VICH Phase I and Phase II guidelines (VICH Topic GL6 (Ecotoxicity Phase I; Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL) and VICH GL 38 (Environmental impact assessment for veterinary medicinal products - Phase II (CVMP/VICH/790/03-FINAL)).
Estonian: Kogu seda protsessi kirjeldatakse VICH esimese ja teise faasi suunistes - VICH teema GL6 (ökotoksilisus, I faas; suunis veterinaarravimite keskkonnamõju hindamise kohta - I faas (CVMP/VICH/592/98-FINAL)) ja VICH teema GL38 (veterinaarravimite keskkonnamõju hindamine - II faas (CVMP/VICH/790/03-FINAL)).
English: In this instance a number of publications were provided to substantiate the proportion of animals treated for BRD within a herd.
Estonian: Kõnealusel juhul esitati mitu väljaannet, et kinnitada veiste hingamisteede haiguse ravi saavate loomade osakaalu karjas.
English: • Dairy calves: Sweden - 2.2-53.3% (Svensson et al 20064).
Estonian: • piimakarja vasikad: Rootsi - 2,2-53,3% (Svensson jt, 20064);
English: 2.1 Incidence of BRD (Bovine Respiratory Disease)
Estonian: 2.1 Veiste hingamisteede haiguse esinemissagedus
English: • Commercial veal unit: UK - 75% (Miller et al, 19802).
Estonian: • vasikaliha tootmisüksus: Ühendkuningriik - 75% (Miller jt, 19802);
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Estonian: III LISA RAVIMI OMADUSTE KOKKUVÕTE JA PAKENDI INFOLEHT
English: • Veal calves: The Netherlands - 19.8%, Belgium - 13.3% (Catry et al, 20091).
Estonian: • lihavasikad: Madalmaad - 19,8%, Belgia - 13,3% (Catry jt, 20091);
English: • Beef calves: Spain - 31.5%, UK - 13-15% (Martin et al, 20073).
Estonian: • lihakarja vasikad: Hispaania - 31,5%, Ühendkuningriik - 13-15% (Martin jt, 20073);
English: 2.2 PECsoil CALCULATION
Estonian: 2.2 PROGNOOSITAVA SISALDUSE PINNASES (PECsoil) ARVUTAMINE
English: The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1).
Estonian: Müügiloa hoidja esitas andmed eesmärgiga näidata, et veiste hingamisteede haiguse ravi saavate loomade osakaal karjas on väiksem kui veterinaarravimite komitee ülalnimetatud suunises (EMEA/CVMP/ERA/418282/2005-Rev.1) esitatud vaikeväärtus 50%.
English: The PECsoil for each cattle type (calves, dairy cows, cattle 0-1 year, cattle over 2 years) has been calculated using 38% as the proportion of the herd treated, according to the following formula (from the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
Estonian: Kõikide veiste (vasikad, piimalehmad, 0-1-aastased veised, üle 2-aastased veised) puhul arvutati prognoositav sisaldus pinnases, kasutades ravi saavate loomade osakaaluna karjas näitajat 38%, järgmise valemi järgi (allikas: veterinaarravimite komitee suunis veterinaarravimite keskkonnamõju hindamise kohta, mis toetab VICH suuniseid GL6 ja GL38 - EMEA/CVMP/ERA/418282/2005Rev.1).
English: The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil.
Estonian: Veterinaarravimite komitee otsustas, et esitatud tõendid olid adekvaatsed, näitamaks, et bakterite Mannheimia haemolytica, Pasteurella multocida ja Histophilus somni põhjustatud veiste hingamisteede infektsioonide terapeutilist ravi saavate loomade osakaal karjas ei ole suurem kui 38%, ja et selle näitaja (38%) võrdsustamine ravi saavate loomade arvuga karjas, selleks et arvutada prognoositavat sisaldust pinnases, oli andmetega põhjendatud.
English: The product is presented as a solution for injection containing 300 mg of florfenicol per ml solution for injection and it is intended for the therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Estonian: Ravimit turustatakse süstelahusena, mis sisaldab 300 mg florfenikooli süstelahuse milliliitri kohta ja on näidustatud bakterite Mannheimia haemolytica, Pasteurella multocida ja Histophilus somni põhjustatud hingamisteede infektsioonide terapeutiliseks raviks veistel.
English: “Diseases caused by florfenicol susceptible bacteria: therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni”.
Estonian: „Florfenikoolile tundlike bakterite põhjustatud haigused: bakterite Mannheimia haemolytica, Pasteurella multocida ja Histophilus somni põhjustatud veiste hingamisteede infektsioonide terapeutiline ravi.“
English: When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Aassessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Estonian: Kui sellised andmed ei ole kättesaadavad, tuleb kasutada vaikeväärtusi, mis on esitatud veterinaarravimite komitee VICHsuuniseid toetava suunise (suunis veterinaarravimite keskkonnamõju hindamise kohta, mis toetab VICH-suuniseid GL6 ja GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1; tuntud ka tehnilise juhenddokumendina) tabelis 2.
English: According to the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guideline GL6 and GL38 (EMEA/CVMP/ERA/418282/2005Rev.1), complete degradation has to be demonstrated either by total mineralisation or by the presence of degradation products all representing 5% or less of the total dose.
Estonian: Vastavalt veterinaarravimite komitee suunisele veterinaarravimite keskkonnamõju hindamise kohta, mis toetab VICH-suuniseid GL6 ja GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1), tuleb ravimijääkide täielikku lagunemist tõendada kas täieliku mineraliseerumise kaudu või siis lagunemissaaduste olemasolu kaudu, mis moodustavad kokku 5% koguannusest või vähem.
English: In this case a number of studies were provided to demonstrate that the proportion of treated animals in a herd would not be greater than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Estonian: Kõnealusel juhul esitati mitu uuringut, näitamaks, et bakterite Mannheimia haemolytica, Pasteurella multocida ja Histophilus somni põhjustatud veiste hingamisteede infektsioonide terapeutilist ravi saavate loomade osakaal karjas ei ole suurem kui 38%.
English: Invented name Pharmaceutical form
Estonian: Ravimvorm Tugevus
English: = Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline) = Bulk density of dry soil [kg.m-3]
Estonian: = ravi saav osa karjast [näitaja jääb 0 ja 1 vahele] (vt suunise tabelit 2) = kuiva pinnase mahumass [kg.m-3] 10000 = 1-hektariline maa-ala [m2 .ha-1]
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Estonian: Veterinaarravimite komitee suunises veterinaarravimite keskkonnamõju hindamise kohta, mis toetab VICH suuniseid GL8 ja GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1), on esitatud vaikeväärtused ravi saavate loomade osakaalu kohta karjas, mida kasutatakse PECsoil väärtuse arvutamisel.
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Estonian: Veterinaarravimite komitee suunis veterinaarravimite keskkonnamõju hindamise kohta, mis toetab veterinaarravimite registreerimise tehniliste nõuete ühtlustamise alase rahvusvahelise koostöö (VICH) suuniseid GL6 ja GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1), viidatakse asjaolule, et andmed ravi saavate loomade osakaalu kohta karjas võivad olla olemas toimikus, näiteks välitingimustes tehtud uuringute andmed, või siis võib need leida teaduslikust kirjandusest.
English: In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Estonian: Eelkõige tekitas kahtlusi, kas müügiloa hoidja esitatud andmed veiste hingamisteede haiguse esinemissageduse kohta nakatunud karjas on asjakohased ja sellest tulenevalt oldi vastu ettepanekule mitte kasutada näitaja PECsoil (prognoositav sisaldus pinnases) arvutamisel nakatunud loomade arvuna vaikeväärtust 50%, mis on kindlaks määratud veterinaarravimite komitee suunises veterinaarravimite keskkonnamõju hindamise kohta, mis toetab veterinaarravimite registreerimise tehniliste nõuete ühtlustamise alase rahvusvahelise koostöö (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, VICH) suuniseid GL6 ja GL38 (EMEA/CVMP/ERA/418282/2005Rev.1).
English: = Number of days of treatment [d] BW = Animal body weight [kgbw] (see Table 3 of the guideline.)
Estonian: BW = looma kehamass [kgbw] (vt suunise tabelit 3) P
English: Calf
Estonian: Vasikas
English: = Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline) = EU nitrogen spreading limit [kg N.ha-1]
Estonian: (vt suunise tabelit 3) = ELi lämmastiku sisalduse piirnorm [kg N.ha-1]
English: 1500 x 10000 x 0.05 x 35 x 0.5 Dairy cow PECsoil = 40 x 1 x 425 x 1 x 170 x 0.38 x 1000=
Estonian: PECsoil = 40 x 1 x 425 x 1 x 170 x 0,38 x 1000= 48,8 µg/kg 1500 x 10 000 x 0,05 x 60 x 0,5
English: 1500 x 10000 x 0.05 x 18 x 0.5 Cattle (> 2 years) PECsoil = 40 x 1 x 450 x 1 x 170 x 0.38 x 1000=
Estonian: Veis (> 2-aastane) PECsoil = 40 x 1 x 450 x 1 x 170 x 0,38 x 1000= 88,6 µg/kg 1500 x 10 000 x 0,05 x 35 x 0,5
English: 1500 x 10000 x 0.05 x 10 x 1 Cattle (0 - 1 year) PECsoil = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
Estonian: PECsoil = 40 x 1 x 200 x 1 x 170 x 0,38 x 1000 = 76,6 µg/kg 1500 x 10 000 x 0,05 x 18 x 0,5
English: Marixino should be given once a day at the same time every day.
Estonian: Marixinot peab võtma üks kord ööpäevas, iga päev samal kellaajal.
English: The name of the medicine was changed to Marixino on 9 August 2013.
Estonian: Ravimi nimetus muudeti Marixino ks 9 augustil 2013.
English: The full EPAR for Marixino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Marixino kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee recommended that Marixino be approved for use in the EU.
Estonian: Komitee soovitas Marixino kasutamise Euroopa Liidus heaks kiita.
English: Other information about Marixino
Estonian: Muu teave Marixino kohta
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.
Estonian: Ravi tohib alustada vaid juhul, kui on olemas hooldaja, kes jälgib regulaarselt, kuidas patsient Marixinot kasutab.
English: 1 Previously known as Maruxa.
Estonian: Varasem nimetus Maruxa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Estonian: Euroopa Komisjon andis Marixino müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 29. aprillil 2013.
English: Marixino memantine
Estonian: Marixino memantiin
English: To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Estonian: Kõrvalnähtude ennetamiseks suurendatakse Marixino annust esimese kolme ravinädala jooksul järk-järgult: esimesel nädalal on annus 5 mg, teisel 10 mg ja kolmandal 15 mg.
English: Why is Marixino approved?
Estonian: Miks Marixino heaks kiideti?
English: What is Marixino and what is it used for?
Estonian: Mis on Marixino ja milleks seda kasutatakse
English: It contains the active substance memantine hydrochloride.
Estonian: Ravim sisaldab toimeainena memantiinhüdrokloriidi.
English: Marixino is a ‘generic medicine'.
Estonian: Marixino on geneeriline ravim.
English: This is a summary of the European public assessment report (EPAR) for Marixino.
Estonian: See on ravimi Marixino Euroopa avaliku hindamisaruande kokkuvõte.
English: What measures are being taken to ensure the safe and effective use of Marixino?
Estonian: Mis meetmed võetakse, et tagada Marixino kasutamise efektiivsus js ohutus?
English: Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Marixino on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Estonian: Marixino on retseptiravim ja seda turustatakse 10 mg ja 20 mg tablettidena.
English: This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Estonian: See tähendab, et Marixino on sarnane võrdlusravimiga Ebixa, millel juba on Euroopa Liidus müügiluba.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing
Estonian: Ravimi taluvust ja annust tuleb hinnata 3 kuu jooksul alates ravi algusest, seejärel tuleb Marixinoga toimuva ravi jätkamist regulaarselt uuesti hinnata.
English: The company provided data on the medicine's solubility, composition and absorption in the body.
Estonian: Ettevõte esitas Marixino lahustuvuse, koostise ja organismis imendumise andmed.
English: Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Estonian: Alzheimeri tõbi on dementsuse (teatud ajuhäire) liik, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Marixino ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavate ettevaatusmeetmete teave.
English: ‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Estonian: Kaks ravimit on bioekvivalentsed, kui mõlemad tekitavad organismis sama toimeainesisalduse.
English: For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Marixinoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Marixino võrdväärne kvaliteet ja bioekvivalentsus ravimiga Ebixa.
English: The active substance in Marixino, memantine, is an antidementia medicine.
Estonian: Marixino toimeaine memantiin on dementsuse ravim.
English: What are the benefits and risks of Marixino?
Estonian: Milles seisneb Marixino kasulikkus ja mis riskid ravimiga kaasnevad?
English: How does Marixino work?
Estonian: Kuidas Marixino toimib?
English: No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa.
Estonian: Lisauuringuid patsientidel ei vajatud, sest oli tõendatud Marixino võrdväärne kvaliteet ja bioekvivalentsus võrdlusravimiga Exiba.
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Ebixa korral, ületab ravimi Marixino kasulikkus sellega kaasnevad riskid.
English: How is Marixino used?
Estonian: Kuidas Marixinot kasutatakse?
English: For practical information about using Marixino, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Hindamisaruandes ei anta Marixino kasutamise praktilisi nõuandeid.Kui vajate Marixino kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How has Marixino been studied?
Estonian: Kuidas Marixinot uuriti?
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Estonian: Ravi Marixinoga tohib alustada üksnes Alzheimeri tõvega patsientide diagnoosimises ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
English: The company requested a re-examination of the opinion.
Estonian: Taotleja nõudis arvamuse taasläbivaatamist.
English: How does the medicine work?
Estonian: Kuidas ravim toimib?
English: During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine.
Estonian: Taasläbivaatamisel veendus komitee, et ravimiga ei näi vahetult olevat seotud ühtki sageli teatatud kõrvalnähtu.
English: The company that applied for authorisation is XBiotech Germany GmbH.
Estonian: Müügiluba taotles XBiotech Germany GmbH.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Estonian: Pärast taotluse põhjenduste arutamist vaatas inimravimite komitee oma algse arvamuse uuesti läbi ja kinnitas müügiloa andmisest keeldumist 22. septembril 2014.
English: The medicine was compared with placebo (a dummy treatment).
Estonian: Ravimit võrreldi platseeboga (näiv ravim).
English: However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine's benefits and manufacturing controls.
Estonian: Samas puudub piisav ohutusteave, et nõuetekohaselt hinnata üldriske, ning komitee nägi ikka põhjust ettevaatlikkuseks seoses ravimi kasulikkuse ja tootmiskontrolliga.
English: At the time of the initial review, the CHMP had a number of concerns.
Estonian: Esialgse läbivaatamise ajal nägi inimravimite komitee mitu põhjust ettevaatlikkuseks.
English: Firstly, the study did not show clear improvements in either lean body mass or quality of life.
Estonian: Esiteks ei tõendatud uuringus lihasemassi ega elukvaliteedi selget paranemist.
English: What was the medicine expected to be used for?
Estonian: Milleks kavatseti ravimit kasutada?
English: The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Estonian: Inimravimite komitee oli seepärast endiselt arvamusel, et ravimi kasulikkus ei ole suurem kui sellega kaasnevad riskid, ja soovitas müügiloa andmisest keelduda.
English: The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life.
Estonian: Ettevõte esitas andmed põhiuuringust (333 patsienti), milles vaadeldi ravimi toimet lihasemassile (kehamass ilma rasvkoeta) ja elukvaliteedile.
English: Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Estonian: Teiseks näis ravimit kasutanud patsientidel olevat suurem infektsioonirisk, mida peeti infektsioonide suhtes vastuvõtlike palliatiivse ravi patsientide jaoks vastuvõetamatuks.
English: The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.
Estonian: Ettevõte teatas inimravimite komiteele, et tagab kõikidele praegu kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele ravimi kättesaadavuse.
English: Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Estonian: Märgiti ka, et kontroll tootmisprotsessi üle, mille eesmärk on tagada ravimi võrdväärne kvaliteet kliinilistes uuringutes kasutatud ravimi kvaliteediga, oli puudulik.
English: By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Estonian: Inimese IL-1α toimet blokeerides aeglustab ravim eeldatavasti vähi edasiarenemist, leevendades patsientide sümptomeid.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Estonian: 18. mail 2017 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades kaugelearenenud kolorektaalvähi kurnavate sümptomite raviks kasutada kavatsetava inimese IL-1α suhtes spetsiifilise inimese IgG1 monoklonaalse antikeha XBiotech müügiloa andmisest keelduda.