FrancophonIA/ELRC3.0 huggingface dataset:
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 Prevenar 13.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them to be recognised by the immune system.
Slovenian: Ti polisaharidi se prečistijo in nato „konjugirajo“ (vežejo) na nosilec, zaradi česar jih imunski sistem lahko prepozna.
English: In adults and the elderly, the Committee noted that community-acquired pneumonia and invasive pneumococcal disease may be an important health problem and that the benefit in terms of protection outweighed the risk of adverse reactions.
Slovenian: Pri odraslih in starejših je opozoril, da sta pljučnica, dobljena v domačem okolju, in invazivna pnevmokokna bolezen lahko velika zdravstvena težava in da so koristi zdravila z vidika zaščite večje od njegovih neželenih učinkov.
English: The fourth dose, the booster, is given between 11 and 15 months of age.
Slovenian: Cepljenje s četrtim (poživitvenim) odmerkom se opravi v starosti od 11 do 15 mesecev.
English: What benefit has Prevenar 13 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Prevenar 13 izkazalo med študijami?
English: In children, the ability of Prevenar 13 to trigger the production of antibodies (immunogenicity) was assessed in two main studies involving 1,266 healthy children who were vaccinated between the ages of two and 15 months and in a third study involving 598 children aged between five and 17 years old who had previously been vaccinated with Prevenar or who had never been vaccinated for invasive pneumococcal disease.
Slovenian: Pri otrocih so učinkovitost zdravila Prevenar 13 pri sprožanju nastajanja protiteles (imunogenosti) primerjali v dveh glavnih študijah s 1 266 zdravimi otroki, ki so bili cepljeni v starosti od dveh do 15 mesecev, in v tretji študiji, ki je vključevala 598 otrok, starih od pet do 17 let, ki so bili predhodno cepljeni z zdravilom Prevenar ali ki še nikoli niso bili cepljeni proti invazivni pnevmokokni bolezni.
English: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Slovenian: cepivo proti pnevmokokom, polisaharidno, konjugirano (13-valentno, adsorbirano)
English: • children aged between six weeks and six months are normally given four doses.
Slovenian: • otroci, stari od šest tednov do šest mesecev, običajno prejmejo štiri odmerke.
English: Where the response to Prevenar 13 was lower than the comparator, the differences were considered to be small.
Slovenian: Kadar je bil odziv na zdravilo Prevenar 13 manjši kot pri primerjalnem zdravilu, so bile razlike majhne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prevenar 13, 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 Prevenar 13 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: It is available as a suspension for injection that contains parts from 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Slovenian: Na voljo je v obliki suspenzije za injiciranje, ki vsebuje dele 13 različnih vrst bakterije Streptococcus pneumoniae (S. pneumoniae) .
English: Further information on the use of Prevenar 13 in people at increased risk of pneumococcal infections (such as patients with HIV or people who have received a haematopoietic stem cell transplant) and on how to switch from Prevenar to Prevenar 13 can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila Prevenar 13 pri osebah, ki so izpostavljene povečanemu tveganju za pnevmokokne okužbe (kot so bolniki z okužbo z virusom HIV ali osebe, pri katerih je bila izvedena presaditev hematopoetskih matičnih celic), in o prehodu s cepiva Prevenar na cepivo Prevenar 13 glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: It is also used to protect adults and the elderly against invasive disease and pneumonia caused by S. pneumoniae.
Slovenian: Uporablja se tudi za zaščito odraslih in starejših pred invazivno boleznijo in pljučnico, ki jo povzroča bakterija S. pneumoniae.
English: The main measure of effectiveness was based on the number of subjects who developed a first episode of pneumonia caused by a type of S. pneumoniae covered by Prevenar 13.
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu oseb, pri katerih se je razvila prva epizoda pljučnice, ki jo je povzročila bakterija vrste S. pneumoniae, ki je zajeta v zdravilu Prevenar 13.
English: Alternatively, when Prevenar 13 is given as part of a routine immunisation programme, two doses can be given at the ages of two and four months, followed by a booster at 11 to 15 months of age;
Slovenian: Kadar se zdravilo Prevenar 13 daje kot del rutinskega imunizacijskega programa, so lahko otroci cepljeni tudi z dvema odmerkoma, in sicer pri starosti dveh in štirih mesecev, ki jima sledi poživitveni odmerek v 11. do 15. mesecu starosti;
English: Prevenar 13 can be used in children who have started vaccination with Prevenar (another vaccine authorised in the European Union for S. pneumoniae, which contains parts of seven of the 13 types of S. pneumoniae included in Prevenar 13).
Slovenian: Zdravilo Prevenar 13 se lahko uporablja pri otrocih, ki so cepljenje začeli z zdravilom Prevenar (drugim cepivom, ki je že odobreno v Evropski uniji za zaščito pred bakterijo S. pneumoniae in ki vsebuje dele sedmih od 13 vrst bakterije S. pneumoniae, vključenih v zdravilo Prevenar 13).
English: Why has Prevenar 13 been approved?
Slovenian: Zakaj je bilo zdravilo Prevenar 13 odobreno?
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium.
Slovenian: Ko bo imunski sistem naslednjič izpostavljen bakteriji, bo lahko hitreje tvoril protitelesa.
English: In adults and the elderly, the most common side effects (seen in more than 1 patient in 10) are decreased appetite, headaches, diarrhoea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.
Slovenian: Pri odraslih in starejših so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) zmanjšan tek, glavoboli, driska, povišana telesna temperatura (zelo pogosta samo pri osebah, starih od 18 do 29 let), bruhanje (zelo pogosto samo pri odraslih, starih od 18 do 49 let), izpuščaj, reakcije na mestu injiciranja, omejitve gibanja rok, artralgija in mialgija (bolečine v sklepih in mišicah), mrzlica in utrujenost.
English: For the full list of all side effects reported with Prevenar 13, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prevenar 13, glejte navodilo za uporabo.
English: What is the risk associated with Prevenar 13?
Slovenian: Kakšna tveganja so povezana z zdravilom Prevenar 13?
English: In both studies, Prevenar 13 was compared with a similar vaccine containing the polysaccharides from 23 different types of S. pneumoniae (23-valent polysaccharide vaccine).
Slovenian: V obeh študijah so zdravilo Prevenar 13 primerjali s podobnim cepivom, ki vsebuje polisaharide 23 različnih vrst bakterije S. pneumoniae (23-valentno polisaharidno cepivo).
English: Prevenar 13 is used to protect children aged between six weeks and 17 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Slovenian: Zdravilo Prevenar 13 se uporablja za zaščito otrok, starih od šest tednov do 17 let, proti invazivni bolezni, pljučnici (okužbi pljuč) in akutnemu vnetju srednjega ušesa, ki ga povzroča bakterija S. pneumoniae.
English: The first three doses are given with an interval of one month between each dose.
Slovenian: Med prvimi tremi odmerki mora miniti en mesec.
English: • children between two and 17 years of age should receive a single dose.
Slovenian: • otroci, stari od dve leti do 17 let, morajo prejeti enojni odmerek.
English: • children aged between seven months and 11 months should first receive two doses with an interval of at least one month followed by a third dose in the second year;
Slovenian: • otroci, stari od sedem do 11 mesecev, prejmejo najprej dva odmerka, med katerima mora miniti vsaj en mesec, tretji odmerek pa morajo prejeti v drugem letu starosti;
English: Prevenar 13 contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Slovenian: Zdravilo Prevenar 13 vsebuje majhne količine polisaharidov (vrste sladkorja), pridobljenih iz „ovojnice“, ki obdaja bakterijo S. pneumoniae.
English: The Committee also noted that Prevenar 13 contains additional polysaccharides from the types of S. pneumoniae that are responsible for causing disease in children in Europe.
Slovenian: Ugotovil je tudi, da vsebuje zdravilo Prevenar 13 dodatne polisaharide iz vrst S. pneumoniae , ki v Evropi povzročajo bolezen pri otrocih.
English: All six of the additional polysaccharides in Prevenar 13 produced a response at least as good as the lowest response seen with Prevenar in the first main study.
Slovenian: Vseh šest dodatnih polisaharidov v zdravilu Prevenar 13 je povzročilo vsaj tako dober odziv, kot je bil najmanjši odziv na zdravilo Prevenar v prvi glavni študiji.
English: The most common side effects with Prevenar 13 (seen in more than 1 patient in 10) in children are decreased appetite, fever (only very common in children aged 6 weeks to 5 years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.
Slovenian: Najpogostejši neželeni učinki zdravila Prevenar 13 (opaženi pri več kot 1 bolniku od 10) pri otrocih so zmanjšan tek, povišana telesna temperatura (zelo pogosta samo pri otrocih, starih od šest tednov do pet let), razdražljivost, reakcije na mestu injiciranja (rdečina ali otrdelost kože, oteklina, bolečina ali občutljivost), zaspanost in slaba kakovost spanca.
English: Prevenar 13 was compared with Prevenar.
Slovenian: Zdravilo Prevenar 13 so primerjali z zdravilom Prevenar.
English: Additional studies in children looked at the effects of giving booster vaccinations, switching from Prevenar to Prevenar 13 and using Prevenar 13 alongside other vaccines routinely given to children.
Slovenian: V dodatnih študijah pri otrocih so raziskovali učinke poživitvenih odmerkov cepiva, prehod s cepiva Prevenar na cepivo Prevenar 13 in uporabo cepiva Prevenar 13 v kombinaciji z drugimi cepivi, ki jih rutinsko prejemajo otroci.
English: Prevenar 13 must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients or to diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Slovenian: Zdravila Prevenar 13 ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) zdravilne učinkovine, katero od drugih pomožnih sestavin zdravila ali davični toksoid (oslabljeni toksin iz bakterije, ki povzroča davico).
English: The second study involved 938 adults aged 70 years or older who had already been vaccinated against invasive disease caused by S. pneumoniae at least five years earlier.
Slovenian: V drugo študijo je bilo vključenih 938 odraslih, starih 70 let ali več, ki so pred najmanj petimi leti že bili cepljeni proti invazivni bolezni, ki jo povzroča bakterija S. pneumoniae.
English: The first study involved 835 adults aged 50 to 64 years who had not previously been vaccinated against invasive disease caused by S. pneumoniae.
Slovenian: V prvi študiji je sodelovalo 835 odraslih, starih od 50 do 64 let, ki predhodno niso bili cepljeni proti invazivni bolezni, ki jo povzroča bakterija S. pneumoniae.
English: A third study, which involved 900 adults aged 18 to 49, compared the immune response to Prevenar 13 with the response in adults aged 60 to 64.
Slovenian: V tretji študiji, v katero je bilo vključenih 900 odraslih, starih od 18 do 49 let, so imunski odziv na cepivo Prevenar 13 primerjali z imunskim odzivom v skupini odraslih, starih od 60 do 64 let.
English: A fourth study involved approximately 85,000 adults over 65 year of age who had not previously been vaccinated with the 23-valent polysaccharide vaccine, and compared Prevenar 13 with placebo (a dummy treatment).
Slovenian: V četrto študijo je bilo vključenih 85 000 odraslih, starejših od 65 let, ki predhodno niso bili cepljeni s 23-valentnim polisaharidnim cepivom, v njej pa so zdravilo Prevenar 13 primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The fourth study in adults over 65 years of age showed that Prevenar 13 reduced the incidence of pneumonia by almost half: 49 out of 42,240 (around 0.1%) subjects fell ill with pneumonia caused by
Slovenian: Četrta študija pri odraslih, starejših od 65 let, je pokazala, da je zdravilo Prevenar 13 zmanjšalo pogostnost pljučnice skoraj za polovico: v skupini, ki je prejela cepivo, je za pljučnico, ki jo je povzročila bakterija S. pneumoniae, zbolelo 49 oseb od 42 240 (približno 0,1 %) v primerjavi z 90 osebami od 42 256 (približno 0,2 %) v skupini, ki je prejela placebo.
English: The CHMP noted that in children the immune system's response to Prevenar 13 was comparable to that of Prevenar, which is already authorised for the protection of children against S. pneumoniae in the EU.
Slovenian: CHMP je ugotovil, da je bil pri otrocih imunski odziv na cepivo Prevenar 13 primerljiv z imunskim odzivom na cepivo Prevenar, ki je že odobreno v Evropski uniji (EU) za zaščito otrok pred okužbo z bakterijo S. pneumoniae.
English: Adults aged 18 to 49 had an immune response with Prevenar 13 which was as good as the response in adults aged 60 to 64.
Slovenian: Pri odraslih, starih od 18 do 49 let, je bil imunski odziv s cepivom Prevenar 13 ravno tako dober kot v skupini odraslih, starih od 60 do 64 let.
English: The additional studies showed that Prevenar 13 led to an increase in antibody production following booster vaccinations and supported a switch to Prevenar 13 in children who had started vaccination with Prevenar.
Slovenian: Dodatne študije so pokazale, da je zdravilo Prevenar 13 po poživitvenih odmerkih povečalo tvorjenje protiteles, kar je bilo v podporo prehodu na zdravilo Prevenar 13 pri otrocih, ki so bili sprva cepljeni s cepivom Prevenar.
English: • children between 12 and 23 months of age should receive two doses with an interval of at least two months;
Slovenian: • otroci, stari od 12 do 23 mesecev, morajo prejeti dva odmerka, med katerima mora biti vsaj dvomesečni presledek;
English: In the first two studies they were compared directly, and in the third study the results for Prevenar 13 were compared to those obtained for Prevenar in a previous study.
Slovenian: V prvih dveh študijah so ju primerjali neposredno, v tretji študiji pa so rezultate zdravila
English: All six of the additional polysaccharides in Prevenar 13 produced a response that was similar to the response seen with Prevenar against the seven polysaccharides.
Slovenian: Vseh šest dodatnih polisaharidov v zdravilu Prevenar 13 je sprožilo odziv, ki je bil podoben opaženemu odzivu na sedem polisaharidov pri zdravilu Prevenar.
English: In children aged between five and 17 years old, Prevenar 13 produced a response that was at least as good as Prevenar for all seven S. pneumoniae polysaccharides they share in common.
Slovenian: Pri otrocih, starih od pet do 17 let, je zdravilo Prevenar 13 sprožilo vsaj tako dober odziv kot pri zdravilu Prevenar za vseh sedem polisaharidov bakterije S. pneumoniae, ki so cepivoma skupni.
English: What is Prevenar 13 used for?
Slovenian: Za kaj se zdravilo Prevenar 13 uporablja?
English: The immune response to the additional six polysaccharides in Prevenar 13 was compared with the lowest immune response to any of the polysaccharides in Prevenar.
Slovenian: Imunski odziv na dodatnih šest polisaharidov v zdravilu Prevenar 13 so primerjali z imunskim odzivom na polisaharide v zdravilu Prevenar, pri katerem je prišlo do najslabšega imunskega odziva.
English: The studies compared the immune response for Prevenar 13 with that for Prevenar against the seven polysaccharides that they share in common.
Slovenian: V študijah so primerjali imunski odziv na zdravilo Prevenar 13 z odzivom na cepivo Prevenar z vidika sedmih polisaharidov, ki jih vsebujeta obe cepivi.
English: How has Prevenar 13 been studied?
Slovenian: Kako je bilo zdravilo Prevenar 13 raziskano?
English: How is Prevenar 13 used?
Slovenian: Kako se zdravilo Prevenar 13 uporablja?
English: In adults aged 50 and older, in the first two main studies Prevenar 13 produced an immune response that was at least as good as the 23-valent polysaccharide vaccine for all 12 of the S. pneumoniae polysaccharides they share in common, and for several of these serotypes the immune response was better with Prevenar 13.
Slovenian: Pri odraslih, starejših od 50 let, je zdravilo Prevenar 13 v prvih dveh glavnih študijah sprožilo imunski odziv, ki je bil vsaj tako dober kot pri 23-valentnem polisaharidnem cepivu pri vseh 12 polisaharidih bakterije S. pneumoniae, ki so cepivoma skupni.
English: What is Prevenar 13?
Slovenian: Kaj je zdravilo Prevenar 13?
English: In children under five years of age, Prevenar 13 produced a response that was at least as good as Prevenar for six of the seven S. pneumoniae polysaccharides they share in common in the first main study, and for five of the seven in the second.
Slovenian: V prvi glavni študiji z otroki, mlajšimi od pet let, je zdravilo Prevenar 13 sprožilo odziv, ki je bil za šest od sedmih polisaharidov bakterije S. pneumoniae , ki so cepivoma skupni, vsaj tako dober kot pri zdravilu Prevenar.
English: • head and neck cancer in patients whose cancer is advanced (has started to spread).
Slovenian: • raka glave in vratu pri bolnikih z napredovalim rakom (ki se je začel širiti).
English: With the skeleton still in place, the cells cannot divide and they eventually die.
Slovenian: Če se skelet ohrani, se celice ne morejo deliti in sčasoma odmrejo.
English: Docetaxel Mylan is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Slovenian: Zdravilo Docetaxel Mylan se uporablja le, kadar je število nevtrofilcev (raven vrste belih krvnih celic v krvi) normalno (vsaj 1 500 celic/mm3).
English: It is available as a concentrate to make up into a solution for infusion (drip into a vein).
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Mylan on 31 January 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Mylan, veljavno po vsej Evropski uniji, odobrila dne 31. januarja 2012.
English: The company provided data from the published literature on docetaxel.
Slovenian: Družba je predstavila podatke o docetakselu iz objavljene literature.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Slovenian: Docetaksel učinkuje tudi na nerakave celice, kot so krvne celice, kar lahko povzroča neželene učinke.
English: For more information about treatment with Docetaxel Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Docetaxel Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Mylan.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Mylan.
English: This means that Docetaxel Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
English: Because Docetaxel Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Docetaxel Mylan generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: EPAR summary for the public docetaxel
Slovenian: Povzetek EPAR za javnost docetaksel
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Slovenian: Prav tako se lahko uporablja sočasno z drugimi zdravili proti raku (doksorubicinom, ciklofosfamidom, transtuzumabom ali kapecitabinom) pri bolnicah, ki proti raku še niso prejele nobenih zdravil ali pri katerih so bile druge oblike zdravljenja neuspešne, odvisno od vrste in stadija raka dojke, ki se zdravi;
English: Docetaxel Mylan is given as a one-hour infusion every three weeks.
Slovenian: Zdravilo Docetaxel Mylan se daje v obliki enourne infuzije vsake tri tedne.
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Taxotere, odtehtajo znana tveganja.
English: Docetaxel Mylan is used to treat the following types of cancer:
Slovenian: Zdravilo Docetaxel Mylan se uporablja za zdravljenje naslednjih vrst raka:
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 Docetaxel Mylan.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Docetaxel Mylan, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The full EPAR for Docetaxel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the benefits and risks of Docetaxel Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Mylan?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Mylan infusion.
Slovenian: Bolniku je treba dati tudi deksametazon (protivnetno zdravilo), in sicer dan pred infuzijo zdravila Docetaxel Mylan.
English: Other information about Docetaxel Mylan
Slovenian: Druge informacije o zdravilu Docetaxel Mylan
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Mylan has been shown to be comparable to Taxotere.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Mylan primerljivo z zdravilom Taxotere.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Slovenian: • adenokarcinoma želodca (vrste želodčnega raka) pri bolnikih, ki se zaradi raka še niso zdravili.
English: The Committee recommended that Docetaxel Mylan be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Docetaxel Mylan odobri dovoljenje za promet.