FrancophonIA/ELRC3.0 huggingface dataset:
English: After this a single injection should be given each year as a booster.
Slovenian: Nato je vsako leto treba dati enkratno injekcijo obnovitvenega odmerka.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo‟, kako naj se brani pred boleznijo.
English: The duration of protection was 12 months after primary vaccination as well as after the yearly single booster vaccination.
Slovenian: Zaščita je trajala 12 mesecev tako po osnovnem cepljenju kot tudi po letnem enkratnem obnovitvenem odmerku.
English: The first involved 128 pregnant mares of mixed breeds and the second involved 41 pregnant thoroughbred mares.
Slovenian: V prvo je bilo vključenih 128 brejih kobil mešanih pasem, v drugo pa 41 brejih čistokrvnih kobil.
English: The effectiveness of Equilis West Nile was first studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination, and how long the protection lasted.
Slovenian: Učinkovitost cepiva Equilis West Nile so najprej raziskali v več laboratorijskih študijah, v katerih so proučevali, koliko časa je trajalo, da se je po cepljenju razvila zaščita in kako dolgo je trajala.
English: The vaccine was also compared with placebo in two other field studies involving pregnant mares.
Slovenian: Cepivo so s placebom primerjali tudi v drugih dveh terenskih študijah, v katerih so bile vključene breje kobile.
English: It contains a strain called Yellow Fever-West Nile (YF-WN).
Slovenian: Vsebuje sev, imenovan rumena mrzlica-West Nile (Yellow Fewer-West Nile - YF-WN).
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 or milk used for human consumption.
Slovenian: Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Slovenian: Virus West Nile je okužba, ki jo prenašajo komarji in lahko pri okuženih konjih povzroči resno bolezen ter smrtne okužbe možganov.
English: The first of these involved 173 horses at least six months of age, in which vaccination with Equilis West Nile was compared with a placebo (dummy injection).
Slovenian: V prvo je bilo vključenih 173 konjev, starih najmanj šest mesecev, pri katerih so cepivo Equilis West Nile primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
Slovenian: Merilo učinkovitosti v vseh terenskih študijah je bilo število konjev, ki so razvili zadostne ravni protiteles za zaščito proti virusu West Nile.
English: The vaccine is initially given to horses over six months of age as two injections into the muscle, three to five weeks apart.
Slovenian: Najprej se konjem, starejšim od šestih mesecev, v mišico vbrizga dve injekciji cepiva v razmiku od treh do petih tednov.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis West Nile exceed the risks for the treatment of the approved indication and recommended that Equilis West Nile be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi cepiva Equilis West Nile za zdravljenje odobrene indikacije večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Equilis West Nile contains small amounts of West Nile virus that has been inactivated (killed) so that it can no longer cause disease.
Slovenian: Cepivo Equilis West Nile vsebuje majhne količine virusa West Nile, ki je bil inaktiviran (uničen), tako da ne more več povzročati bolezni.
English: A mild short-lived swelling may develop at the injection site which resolves in one to five days.
Slovenian: Na mestu injiciranja se lahko pojavi rahla prehodna oteklina, ki izgine po enem do petih dneh.
English: Other information about Equilis West Nile:
Slovenian: Druge informacije o zdravilu Equilis West Nile:
English: In future if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi virusu West Nile v prihodnosti se bo imunski sistem tako hitreje odzval.
English: Flavivirus strain YF-WN
Slovenian: Equilis West Nile sev flavivirusa YF-WN
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis West Nile on 6 June 2013.
Slovenian: Evropska komisija je dovoljenje za promet s cepivom Equilis West Nile, veljavno po vsej Evropski uniji, odobrila dne 06/06/2013.
English: The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi v tem povzetku.
English: Equilis West Nile contains an adjuvant to enhance the immune response.
Slovenian: Cepivo Equilis West Nile vsebuje adjuvans za povečanje imunskega odziva.
English: The main field study showed that vaccination with Equilis West Nile when given as recommended produced protective antibody levels in 94% of the vaccinated horses at day 42 of the study.
Slovenian: Glavna terenska študija je pokazala, da je imelo po cepljenju s cepivom Equilis West Nile po priporočeni shemi na 42. dan študije zadostne ravni protiteles za zaščito 94 % cepljenih konjev.
English: When Equilis West Nile is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Slovenian: Ko konji prejmejo cepivo Equilis West Nile, njihov imunski sistem prepozna virus v cepivu kot „tujek‟ in proti njemu tvoriti protitelesa.
English: Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Slovenian: Cepivo Equilis West Nile se uporablja za cepljenje konjev, starejših od šestih mesecev, proti virusu West Nile.
English: The studies in pregnant mares showed that 89% of the vaccinated mixed-breed mares and 95% of the vaccinated thoroughbred mares produced protective antibody levels.
Slovenian: Študiji pri brejih kobilah sta pokazali, da je zadostne ravni protiteles za zaščito tvorilo 89 % cepljenih kobil mešanih pasem in 95 % cepljenih čistokrvnih kobil.
English: Equilis West Nile was also studied in three field studies.
Slovenian: Cepivo Equilis West Nile so raziskali tudi v treh terenskih študijah.
English: If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega samoinjiciranja cepiva se je treba takoj posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
English: Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Slovenian: Equilis West Nile je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktiviran (uničen) virus West Nile.
English: What benefit has Equilis West Nile shown during the studies?
Slovenian: Kakšne koristi je zdravilo Equilis West Nile izkazalo med študijami?
English: What is the risk associated with Equilis West Nile?
Slovenian: Kakšna tveganja so povezana z zdravilom Equilis West Nile?
English: Why has Equilis West Nile been approved?
Slovenian: Zakaj je bilo zdravilo Equilis West Nile odobreno?
English: The withdrawal period for Equilis West Nile is zero days.
Slovenian: Obdobje karence za cepivo Equilis West Nile je nič dni.
English: How has Equilis West Nile been studied?
Slovenian: Kako je bilo zdravilo Equilis West Nile raziskano?
English: What is Equilis West Nile?
Slovenian: Kaj je zdravilo Equilis West Nile?
English: How does Equilis West Nile work?
Slovenian: Kako zdravilo Equilis West Nile deluje?
English: What is Equilis West Nile used for?
Slovenian: Za kaj se zdravilo Equilis West Nile uporablja?
English: EMA/CHMP/800908/2012 EMEA/H/C/002609
Slovenian: 13. december 2012 EMA/130454/2013 EMEA/H/C/002609
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da naj bi bilo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: It was to be available as a suspension for injection.
Slovenian: Na voljo naj bi bilo v obliki suspenzije za injiciranje.
English: The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Slovenian: Pregled, ki so ga opravile agencije za zdravila iz Nemčije, Švedske in Združenega kraljestva, je prinesel številne kritične in pomembne ugotovitve, ki so razkrile, da študije niso bile izvedene v skladu z dobro klinično prakso, in je povzročil resne pomisleke glede zanesljivosti podatkov iz študij.
English: The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Slovenian: CHMP je odkril tudi pomanjkljivosti v zvezi s podatki iz študij, ki jih je predložila družba, vključno s statističnimi napakami in manjkajočimi informacijami.
English: While the CHMP was awaiting the company's response to the questions, it requested an inspection of the site where studies with the medicine had taken place.
Slovenian: Medtem ko je CHMP čakal, da družba odgovori na vprašanja, je zahteval pregled lokacije, kjer so potekale študije z zdravilom.
English: The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
Slovenian: Opažene pomanjkljivosti so bile tako velike, da podatkov, ki jih je predložila družba, ni bilo mogoče uporabiti za presojo vloge za odobritev dovoljenja za promet z zdravilom.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zato, da bi ponovila študije pri priznani pogodbeni raziskovalni organizaciji in predložila dodatne podatke.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja dovolj insulina za uravnavanje ravni krvnega sladkorja ali pri kateri telo insulina ne more učinkovito izrabiti.
English: The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Slovenian: Zaradi pomislekov glede podatkov je CHMP zahteval pregled Bombajskega centra za biološke raziskave (BBRC) v Indiji, kjer so opravljali študije za družbo Marvel LifeSciences (sponzorja študij), ter tudi prostorov družbe Marvel LifeSciences v Združenem kraljestvu.
English: In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Slovenian: Poleg tega je družba predložila tudi rezultate glavne študije pri 432 bolnikih s sladkorno boleznijo, v kateri so primerjali varnost in učinkovitost treh zdravil družbe Marvel LifeSciences z ustreznimi referenčnimi zdravili.
English: The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Slovenian: Insulin v zdravilu Combimarv se pridobiva z metodo, imenovano „tehnologija rekombinantne DNK“: izdela ga bakterija, ki je prejela gen (DNK), s pomočjo katerega lahko tvori insulin.
English: The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
Slovenian: Prvotni pomisleki so bili v glavnem povezani s proizvodnjo zdravila in z vprašanjem, ali je zdravilo Combimarv dovolj podobno referenčnemu zdravilu.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Slovenian: Družba Marvel LifeSciences Ltd je dne 15. novembra 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Combimarv, namenjenim zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze v krvi.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
Slovenian: Družba je CHMP obvestila, da v času umika vloge ni bilo bolnikov, ki bi v kliničnih študijah prejemali zdravilo Combimarv.
English: Withdrawal of the marketing authorisation application for Combimarv (human insulin)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Combimarv (humani insulin)
English: Combimarv is a medicine that contains the active substance human insulin.
Slovenian: Combimarv je zdravilo, ki vsebuje zdravilno učinkovino humani insulin.
English: Among these were results from studies that looked at how the body handles Combimarv compared with Humulin M3 and how these insulins affect blood sugar levels.
Slovenian: Med rezultati so bili tudi rezultati študij, v katerih so proučevali, kako se telo odziva na zdravilo Combimarv v primerjavi z zdravilom Humulin M3, in kako omenjena insulina vplivata na ravni krvnega sladkorja.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Slovenian: Po oceni začetne dokumentacije je CHMP izrazil velike zadržke in je začasno menil, da zdravila Combimarv ni mogoče odobriti.
English: What is Combimarv?
Slovenian: Kaj je zdravilo Combimarv?
English: Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Slovenian: Zdravilo Combimarv naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo, ki potrebujejo insulin za uravnavanje glukoze (sladkorja) v krvi.
English: The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Slovenian: Vloga, ki jo je predložila družba Marvel LifeSciences, je bila skupna vloga za zdravilo Combimarv in dve drugi zdravili (Solumarv in Combimarv, ki sta bili prav tako razviti kot podobni biološki zdravili).
English: Combimarv was developed as a biosimilar medicine.
Slovenian: Zdravilo Combimarv je bilo razvito kot biološko podobno zdravilo.
English: What was Combimarv expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Combimarv uporabljalo?
English: Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Slovenian: Zdravilo Combimarv naj bi bilo nadomestni insulin, ki je podoben insulinu, ki nastaja v telesu.
English: The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Slovenian: Družba je predložila rezultate študij, ki naj bi dokazale, da je zdravilo Combimarv po svoji sestavi, biološki aktivnosti in klinični učinkovitosti podobno referenčnemu zdravilu Humulin M3.
English: Withdrawal of the marketing authorisation application for Combimarv (human insulin) EMA/CHMP/800908/2012
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Combimarv (humani insulin) EMA/130454/2013
English: How is Combimarv expected to work?
Slovenian: Kako naj bi zdravilo Combimarv delovalo?
English: The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
Slovenian: Za več informacij o biološko podobnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
English: London, 19 November 2009 Doc.
Slovenian: London, 19. novembra 2009 Sklic dok.
English: There was also a lack of data on the long-term effects in a European population.
Slovenian: Na voljo je bilo tudi premalo podatkov o dolgoročnih učinkih v evropski populaciji.
English: Ref.: EMA/814249/2009 EMEA/H/C/1034 EMEA/H/C/1122
Slovenian: : EMA/64551/2010 EMEA/H/C/1034 EMEA/H/C/1122
English: The applicant requested a re-examination of the opinion.
Slovenian: Predlagatelj je zahteval ponovno presojo mnenja.
English: The cause of fibromyalgia is not known.
Slovenian: Vzrok fibromialgije ni znan.
English: The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Slovenian: Glavna merila učinkovitosti so temeljila na izboljšanju simptomov, kot so jih dojemali bolniki, zlasti stopnje bolečine in njihovega splošnega počutja.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Slovenian: Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 19. novembra 2009 potrdil zavrnitev vloge za dovoljenje za promet.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Živčni prenašalci so kemijske spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
English: Since these neurotransmitters are involved in reducing the sensation of pain, it was expected that blocking their re-uptake into nerve cells would improve the symptoms of fibromyalgia.
Slovenian: Ker ti živčni prenašalci sodelujejo pri zmanjšanju občutka bolečine, je bilo pričakovati, da bo zaviranje njihovega ponovnega privzema v živčne celice izboljšalo simptome fibromialgije.
English: Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Slovenian: Fibromialgija lahko povzroči tudi druge simptome, kot so občutljivost, otrdelost, utrujenost, anksioznost in spremembe bolnikovih vzorcev spanja, čustvovanja in mišljenja.
English: The CHMP was of the opinion that the effect of the medicine was marginal.
Slovenian: CHMP je menil, da so učinki zdravila obrobnega pomena.
English: By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Slovenian: Z zaviranjem njihovega ponovnega privzema naj bi milnacipran povečal stopnjo sporazumevanja med temi živčnimi celicami.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je CHMP predlagal zavrnitev dovoljenja za promet?
English: The CHMP refusal was confirmed after re-examination.
Slovenian: Zavrnitev, ki jo je priporočil CHMP, je bila po ponovni presoji mnenja potrjena.
English: It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deloval naj bi tako, da bi preprečeval ponovni privzem živčnih prenašalcev 5-hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjačo.
English: Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Slovenian: Zdravilo Milnacipran Pierre Fabre Médicament/Impulsor naj bi se uporabljalo za zdravljenje odraslih s fibromialgijo, boleznijo, ki povzroča dolgotrajno, obsežno bolečino in boleče odzive na dotik.
English: In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
Slovenian: V treh glavnih študijah je 2 960 odraslih bolnikov s fibromialgijo približno štiri do sedem mesecev prejemalo zdravilo Milnacipran Pierre Fabre Médicament/Impulsor ali placebo (zdravilo brez zdravilne učinkovine).
English: The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Milnacipran Pierre Fabre Médicament/Impulsor so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Slovenian: Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za dovoljenje za promet z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 23. julija 2009 priporočil zavrnitev vloge za dovoljenja za promet z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor, namenjenim zdravljenju fibromialgije pri odraslih.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Milnacipran Pierre Fabre Médicament/Impulsor?
English: The company that applied for authorisation is Pierre Fabre Medicament.
Slovenian: Vlogo za dovoljenje je vložila družba Pierre Fabre Medicament.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Slovenian: Družba je obvestila CHMP, da klinična preskušanja z zdravilom Milnacipran Pierre Fabre Médicament/Impulsor pri bolnikih s fibromialgijo v Evropi trenutno ne potekajo.
English: Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Slovenian: Milnacipran Pierre Fabre Médicament/Impulsor je zdravilo, ki vsebuje zdravilno učinkovino milnacipran.
English: The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Slovenian: Zdravilna učinkovina zdravila Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, je „zaviralec ponovnega privzema serotonina in noradrenalina“.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
Slovenian: CHMP je zato takrat menil, da koristi zdravila Milnacipran Pierre Fabre Médicament/Impulsor pri zdravljenju fibromialgije ne odtehtajo z njim povezanih tveganj.
English: What is Milnacipran Pierre Fabre Médicament/Impulsor?
Slovenian: Kaj je zdravilo Milnacipran Pierre Fabre Médicament/Impulsor?