FrancophonIA/ELRC3.0 huggingface dataset:
English: For type 3 Gaucher disease, which is extremely rare, the company presented data from published articles and from a special register of Gaucher disease patients.
Slovenian: Za uporabo zdravila pri Gaucherjevi bolezni tipa 3, ki je izredno redka, je družba predstavila podatke iz objavljenih člankov in posebnega registra bolnikov z Gaucherjevo boleznijo.
English: It has also been shown that patients may safely switch from alglucerase to Cerezyme treatment.
Slovenian: Prav tako je bilo dokazano, da lahko bolniki varno preidejo z zdravljenja z alglucerazo na zdravljenje z zdravilom Cerezyme.
English: Patients can develop antibodies (proteins that are produced in response to Cerezyme and can affect treatment) and they should be monitored for any allergic reactions to Cerezyme.
Slovenian: Bolniki lahko razvijejo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Cerezyme ter lahko vplivajo na zdravljenje), zato jih je treba nadzorovati, ali prihaja do morebitnih alergijskih reakcij na zdravilo Cerezyme.
English: It contains the active substance imiglucerase.
Slovenian: Vsebuje zdravilno učinkovino imiglucerazo.
English: What benefit has Cerezyme shown during the studies?
Slovenian: Kakšne koristi je zdravilo Cerezyme izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cerezyme.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Cerezyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Cerezyme should not be used in people who may be hypersensitive (allergic) to imiglucerase or any of the other ingredients.
Slovenian: Zdravila Cerezyme ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) imiglucerazo ali katero koli drugo sestavino zdravila.
English: For type 1 Gaucher disease, Cerezyme has been studied in three studies involving a total of 40 patients.
Slovenian: Za uporabo pri Gaucherjevi bolezni tipa 1 so zdravilo Cerezyme proučevali v okviru treh študij, v katerih je sodelovalo skupno 40 bolnikov.
English: • thrombocytopenia (low blood platelet counts);
Slovenian: • trombocitopenijo (znižano število trombocitov v krvi);
English: Cerezyme is used for the long-term treatment of patients with Gaucher disease.
Slovenian: Zdravilo Cerezyme se uporablja za dolgotrajno zdravljenje bolnikov z Gaucherjevo boleznijo.
English: Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA), which enables it to produce the enzyme.
Slovenian: Zdravilna učinkovina v zdravilu Cerezyme, imigluceraza, je kopija tega encima, ki ga proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori ta encim.
English: Imiglucerase replaces the missing enzyme in Gaucher disease, helping to break down glucosylceramide and stopping it building up in the body.
Slovenian: Imigluceraza nadomesti manjkajoči encim pri Gaucherjevi bolezni tako, da pomaga razgraditi glukozilceramid in zaustavi njegovo kopičenje v telesu.
English: Cerezyme is used in patients who have type 1 Gaucher disease, which does not affect the nerve cells, or type 3 Gaucher disease, which progresses slowly and affects the nerve cells.
Slovenian: Zdravilo Cerezyme se uporablja pri bolnikih, ki imajo Gaucherjevo bolezen tipa 1, ki ne prizadene živčnih celic, ali Gaucherjevo boleznijo tipa 3, ki napreduje postopoma in prizadene živčne celice.
English: • bone disease;
Slovenian: • boleznijo kosti;
English: • anaemia;
Slovenian: • anemijo;
English: The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), coughing, urticaria (hives) or angioedema (swelling beneath the skin), pruritus (itching), rash and hypersensitivity (allergic) reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Cerezyme (opaženi pri 1 do 10 bolnikov izmed 100) so dispneja (oteženo dihanje), kašljanje, urtikarija (koprivnica) ali angioedem (podkožna oteklina), pruritus (srbenje), izpuščaji in preobčutljivostne (alergijske) reakcije.
English: Patients with Gaucher disease should be managed by doctors who are knowledgeable about the disease's treatment.
Slovenian: Bolnike z Gaucherjevo boleznijo mora zdraviti zdravnik, ki ima izkušnje z zdravljenjem te bolezni.
English: The studies compared the ability of Cerezyme and alglucerase to control the symptoms of the disease, such as increasing the number of red blood cells and platelets in the blood, and decreasing the size of the liver and spleen.
Slovenian: V študijah so primerjali učinkovitost zdravila Cerezyme in algluceraze pri nadzoru simptomov bolezni, kot so povečanje števila rdečih krvničk in trombocitov v krvi ter zmanjšanje velikosti jeter in vranice.
English: What is the risk associated with Cerezyme?
Slovenian: Kakšna tveganja so povezana z zdravilom Cerezyme?
English: For the full list of all side effects reported with Cerezyme, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cerezyme, glejte navodilo za uporabo.
English: The studies have shown that Cerezyme is as safe and effective as alglucerase in controlling the symptoms of Gaucher disease.
Slovenian: Študije so pokazale, da je zdravilo Cerezyme enako varno in učinkovito pri nadzoru simptomov Gaucherjeve bolezni kot algluceraza.
English: Gaucher disease has previously been treated using an enzyme called alglucerase, which was prepared from human placentas.
Slovenian: Gaucherjevo bolezen so v preteklosti zdravili z encimom alglucerazo, pridobljenim iz človeške posteljice.
English: Without the enzyme, glucosylceramide builds up in the body, typically in the liver, spleen and bone marrow, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Slovenian: Ob odsotnosti encima se glukozilceramid kopiči v telesu, običajno v jetrih, vranici in kostnem mozgu, kar povzroči simptome bolezni: anemijo (znižane koncentracije rdečih krvničk), utrujenost, povečano verjetnost za nastanek hematomov in nagnjenost h krvavitvam, povečano vranico in jetra ter bolečine v kosteh in zlome kosti.
English: The CHMP decided that Cerezyme gives effective control of the non-neurological symptoms of types 1 and 3 Gaucher disease.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da zdravilo Cerezyme zagotavlja učinkovit nadzor nad nenevrološkimi simptomi Gaucherjeve bolezni tipa 1 in 3.
English: Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product called glucosylceramide.
Slovenian: Gaucherjeva bolezen je redka dedna napaka, pri kateri bolniku primanjkuje encima kisla betaglukozidaza, ki razgrajuje maščobni odpadni produkt, imenovan glukozilceramid.
English: Why has Cerezyme been approved?
Slovenian: Zakaj je bilo zdravilo Cerezyme odobreno?
English: Cerezyme is a powder that is made up into a solution for infusion (a drip into a vein).
Slovenian: Zdravilo Cerezyme je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: The full EPAR for Cerezyme can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cerezyme je na voljo tukaj.
English: What is Cerezyme used for?
Slovenian: Za kaj se zdravilo Cerezyme uporablja?
English: What is Cerezyme?
Slovenian: Kaj je zdravilo Cerezyme?
English: How has Cerezyme been studied?
Slovenian: Kako je bilo zdravilo Cerezyme raziskano?
English: How is Cerezyme used?
Slovenian: Kako se zdravilo Cerezyme uporablja?
English: How does Cerezyme work?
Slovenian: Kako zdravilo Cerezyme deluje?
English: 1 bottle
Slovenian: 1 steklenica
English: EU/1/11/692/001 Yellox
Slovenian: EU/1/11/692/001
English: Ocular use bottle (PE) 5 ml
Slovenian: Yellox mg/ml kapljice za oko, raztopina okularna uporaba steklenica (PE)
English: 0.9 mg/ml
Slovenian: 5 ml
English: Packaging Content (concentration)
Slovenian: (izmišljeno) ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: EU Number Invented Name
Slovenian: EU Number Ime
English: Content Package size Withdrawal Period
Slovenian: Vsebina Način pakiranja
English: This summary was last updated in 11-2013.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2013.
English: It is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Slovenian: Navadno se daje enkrat ali dvakrat dnevno, kadar je zaželen hiter začetni učinek ob hkratnem dolgotrajnejšem učinku.
English: The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Slovenian: Običajni odmerek znaša od 0,3 do 1,0 mednarodnih enot (i.e.) na kilogram telesne mase na dan.
English: Mixtard human insulin
Slovenian: Mixtard humani insulin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mixtard on 7 October 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Mixtard, veljavno po vsej Evropski uniji, odobrila 7. oktobra 2002.
English: Mixtard is given 30 minutes before a meal.
Slovenian: Zdravilo Mixtard se daje 30 minut pred obrokom.
English: The full EPAR for Mixtard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mixtard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Mixtard?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mixtard?
English: Other information about Mixtard
Slovenian: Druge informacije o zdravilu Mixtard
English: This is a summary of the European public assessment report (EPAR) for Mixtard.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mixtard.
English: A risk management plan has been developed to ensure that Mixtard is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Mixtard je bil pripravljen načrt obvladovanja tveganj.
English: By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Slovenian: Z uravnavanjem glukoze v krvi se zmanjšajo simptomi in zapleti, povezani s sladkorno boleznijo.
English: For more information about treatment with Mixtard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Mixtard preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Slovenian: Raven glukoze (sladkorja) v krvi bolnika je treba redno preverjati, da se določi najmanjši učinkoviti odmerek.
English: The CHMP decided that Mixtard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Mixtard večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What benefit has Mixtard shown during the studies?
Slovenian: Kakšne koristi je zdravilo Mixtard izkazalo med študijami?
English: The most common side effect with Mixtard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Slovenian: Najpogostejši neželeni učinek zdravila Mixtard (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Mixtard, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Mixtard in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The injection site should be changed for each injection.
Slovenian: Mesto injiciranja mora biti pri vsaki vnovični injekciji drugačno od prejšnjega.
English: Mixtard contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an ‘isophane', form which is absorbed much more slowly during the day.
Slovenian: Zdravilo Mixtard vsebuje insulin v dveh oblikah: v topni obliki, ki začne učinkovati hitro (v 30 minutah po injiciranju), ter v obliki izofan, ki se čez dan absorbira veliko počasneje.
English: Mixtard has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Slovenian: Zdravilo Mixtard so preučili pri skupno 294 bolnikih s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina, in s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mixtard.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mixtard, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Slovenian: Nadomestni insulin deluje enako kot naravno proizvedeni insulin in omogoča, da lahko glukoza iz krvi vstopi v celice.
English: About onethird of the patients had type 1 diabetes and the remainder had type 2 diabetes.
Slovenian: Približno tretjina bolnikov je imela sladkorno bolezen tipa 1, ostali pa so imeli sladkorno bolezen tipa 2.
English: Mixtard is used to treat diabetes.
Slovenian: Zdravilo Mixtard se uporablja za zdravljenje sladkorne bolezni.
English: The active substance in Mixtard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Slovenian: Zdravilna učinkovina v zdravilu Mixtard, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
English: What is the risk associated with Mixtard?
Slovenian: Kakšna tveganja so povezana z zdravilom Mixtard?
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
English: Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Slovenian: Zdravilo Mixtard je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kot pri drugih humanih insulinih.
English: Mixtard is a suspension for injection that contains the active substance human insulin.
Slovenian: Zdravilo Mixtard je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
English: It is available as vials, cartridges (Penfill) or pre-filled pens (InnoLet or FlexPen).
Slovenian: Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet ali FlexPen).
English: The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Slovenian: V študiji so zdravilo Mixtard 30 primerjali s podobno mešanico, ki pa je vsebovala analog insulina (insulin aspart).
English: Mixtard was effective for both type 1 and type 2 diabetes.
Slovenian: Zdravilo Mixtard se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot pri sladkorni bolezni tipa 2.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Slovenian: HbA1c kaže, kako dobro je raven glukoze v krvi uravnana.
English: The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, which is the percentage of haemoglobin in the blood that has glucose attached.
Slovenian: V njej so po 12 tednih merili raven glikoziliranega hemoglobina (HbA1c), ki predstavlja delež hemoglobina v krvi, na katerega se je vezala glukoza.
English: This gives Mixtard a longer duration of action.
Slovenian: To podaljša čas delovanja zdravila Mixtard.
English: Why has Mixtard been approved?
Slovenian: Zakaj je bilo zdravilo Mixtard odobreno?
English: Mixtard is given by injection under the skin, in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Slovenian: Zdravilo Mixtard se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).
English: Mixtard is a replacement insulin which is very similar to the insulin made by the pancreas.
Slovenian: Zdravilo Mixtard je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
English: Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:
Slovenian: Zdravilo Mixtard vsebuje tako hitrodelujoči (topni) kot tudi dolgodelujoči (izofan) insulin:
English: How does Mixtard work?
Slovenian: Kako zdravilo Mixtard deluje?
English: What is Mixtard used for?
Slovenian: Za kaj se zdravilo Mixtard uporablja?
English: How has Mixtard been studied?
Slovenian: Kako je bilo zdravilo Mixtard raziskano?
English: What is Mixtard?
Slovenian: Kaj je zdravilo Mixtard?
English: How is Mixtard used?
Slovenian: Kako se zdravilo Mixtard uporablja?
English: What is tylosin?
Slovenian: Kaj je tilozin?
English: 10 July 2017
Slovenian: 10. julij 2017
English: The European Commission issued a decision on 10 July 2017.
Slovenian: Evropska komisija je sklep izdala 10. julija 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/121)
Slovenian: Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/121)
English: On 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Slovenian: Finska je 22. junija 2016 v skladu s členom 35 Direktive 2001/82/ES sprožila postopek za zgoraj navedena zdravila za uporabo v veterinarski medicini.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for treatment of conditions caused by sensitive organisms.
Slovenian: Tilozin in njegove fosfatne in tartratne soli se uporabljajo v veterinarski medicini za zdravljenje stanj, ki jih povzročajo občutljivi organizmi.
English: Finland considered that ineffective treatment of mycoplasma mastitis with tylosin presents a serious concern to animal and public health as it delays the correct diagnosis, enables spread of the pathogen to other cows, impedes efficient/prudent control measures and increases risk for the development of antimicrobial resistance due to unnecessary use of antimicrobials.
Slovenian: Finska je menila, da neučinkovito zdravljenje mikoplazmatskega mastitisa s tilozinom predstavlja resno zaskrbljenost za zdravje živali in javno zdravje, saj povzroča zamude pri postavljanju pravilne diagnoze, omogoča širjenje patogena na druge krave, ovira učinkovite/preudarne ukrepe za nadzor in povečuje tveganje za razvoj protimikrobne odpornosti zaradi nepotrebne uporabe protimikrobnih zdravil.
English: Tylosin is a macrolide antibiotic and is active mostly against Gram-positive bacteria and mycoplasmas.
Slovenian: Tilozin je makrolidni antibiotik, ki deluje predvsem proti po Gramu pozitivnim bakterijam in mikoplazmam.
English: In the absence of submitted proprietary pre-clinical or clinical data for the products in the scope of this referral in support of the respective indication, the CVMP considered scientific references on efficacy.
Slovenian: Ker lastniški predklinični in klinični podatki za zdravila, zajeta v to napotitev, v podporo ustrezni indikaciji niso bila predložena, je odbor CVMP preučil znanstvene navedbe o učinkovitosti.
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the effectiveness of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Evropska agencija za zdravila (agencija) je 16. marca 2017 zaključila pregled učinkovitosti zdravil za uporabo v veterinarski medicini, ki vsebujejo tilozin, se dajejo parenteralno in so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
English: Why were veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin, se dajejo parenteralno in so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
English: Based on the evaluation of the currently-available data, the CVMP concluded that, in the absence of specific pre-clinical or clinical data, and in light of the current scientific knowledge, the indication for treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP presodil, da zaradi odsotnosti specifičnih predkliničnih ali kliničnih podatkov in na podlagi sedanjih znanstvenih dognanj indikacija za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp., z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo parenteralno, ni podprta.
English: The Committee recommended variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products in order to remove the indications ‘bovine mastitis caused by Mycoplasma spp.'
Slovenian: Odbor je priporočil spremembo pogojev dovoljenj za promet z zdravilom za omenjena zdravila za uporabo v veterinarski medicini, tako da se iz informacij o zdravilu odstrani indikacija „goveji mastitis, ki ga povzroča bakterija Mycoplasma spp.“ oziroma „goveji mastitis, ki ga povzroča bakterija Mycoplasma bovis“.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of pre-clinical or clinical data, treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da zaradi odsotnosti predkliničnih in kliničnih podatkov zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp., z omenjenimi zdravili za uporabo v veterinarski medicini ni učinkovito.
English: The CVMP was requested to review all available data and to provide its opinion on whether the indication related to 'bovine mastitis caused by Mycoplasma spp.'
Slovenian: razpoložljive podatke in poda mnenje o tem, ali je indikacija, povezana z „govejim mastitisom, ki ga povzroča bakterija Mycoplasma spp.“, utemeljena.