natgillin/translations-raw huggingface dataset:
What is Pregabalin Pfizer and what is it used for? 
Kaj je zdravilo Pregabalin Pfizer in za kaj se uporablja?
What are the risks associated with Pregabalin Pfizer? 
Kakšna tveganja so povezana z zdravilom Pregabalin Pfizer?
Pregabalin Pfizer has been compared with placebo (a dummy treatment) in 22 studies. 
Zdravilo Pregabalin Pfizer so v 22 študijah primerjali s placebom (zdravilom brez zdravilne učinkovine).
Stopping treatment with Pregabalin Pfizer should also be done gradually, over at least a week. 
Največji odmerek je 600 mg na dan. Tudi prenehanje zdravljenja z zdravilom Pregabalin Pfizer mora potekati postopno, in sicer najmanj en teden.
In epilepsy, the benefits of Pregabalin Pfizer were evaluated in 3 studies involving 1,000 patients that looked at how much it reduced the number of seizures patients had after 11 to 12 weeks. 
Pri epilepsiji so koristi zdravila Pregabalin Pfizer ocenjevali v treh študijah, v katerih je sodelovalo 1 000 bolnikov in v katerih so preučevali, v kolikšni meri se je ob jemanju zdravila zmanjšalo število napadov.
The recommended starting dose of Pregabalin Pfizer is 150 mg per day, 
Priporočeni začetni odmerek zdravila Pregabalin Pfizer je 150 mg na dan, ki se porazdeli na dva ali tri odmerke.
What benefits of Pregabalin Pfizer have been shown in studies? 
Kakšne koristi je zdravilo Pregabalin Pfizer izkazalo v študijah?
Other information about Pregabalin Pfizer 
Druge informacije o zdravilu Pregabalin Pfizer
Pregabalin Pfizer was more effective than placebo in generalised anxiety disorder: in 8 studies involving over 3,000 patients, 52% of the patients taking Pregabalin Pfizer had an improvement of 50% or more in their anxiety measured with a standard anxiety questionnaire, compared with 38% of the patients taking placebo. 
Zdravilo Pregabalin Pfizer je bilo pri generaliziranih anksioznih motnjah učinkovitejše od placeba: v osmih študijah, v katerih je sodelovalo več kot 3 000 bolnikov, je bilo pri 52 % bolnikov, ki so jemali zdravilo Pregabalin Pfizer, izboljšanje 50 % ali več v primerjavi z 38 % bolnikov, ki so jemali placebo.
In a smaller study involving 137 patients with central neuropathic pain due to a spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo. 
V manjši študiji, v katerih je sodelovalo 137 bolnikov s centralno nevropatsko bolečino, ki je bila posledica poškodbe hrbtenjače, je bilo pri 22 % bolnikov, zdravljenih z zdravilom Pregabalin Pfizer, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 8 % bolnikov, ki so se zdravili s placebom.
In 10 studies involving over 3,000 patients with peripheral neuropathic pain (either diabetic pain or shingles), 35% of the patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo. 
V desetih študijah, v katerih je sodelovalo 3 000 bolnikov s periferno nevropatsko bolečino (bolečo diabetično nevropatijo ali pasovcem), je bilo pri 35 % bolnikov, zdravljenih z zdravilom Pregabalin Pfizer, doseženo izboljšanje točkovanja bolečine za 50 % ali več v primerjavi z 18 % bolnikov, ki so se zdravili s placebom.
Why is Pregabalin Pfizer approved? 
Zakaj je bilo zdravilo Pregabalin Pfizer odobreno?
It is not intended to provide practical advice on how to use Pregabalin Pfizer. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How is Pregabalin Pfizer used? 
Kako se zdravilo Pregabalin Pfizer uporablja?
How does Pregabalin Pfizer work? 
Kako zdravilo Pregabalin Pfizer deluje?
Contact our press officers Monika Benstetter or Martin Harvey 
Stopite v stik z našima predstavnikoma za tisk Monika Benstetter ali Martin Harvey
Information for women 
Informacije za ženske
• Women who have any questions or concerns should speak to their doctor or pharmacist. 
• Ženske, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z zdravnikom ali farmacevtom.
Information to healthcare professionals 
Informacije za zdravstveno osebje
• a meta-analysis of three WHO studies3,4,5, which primarily included African and Asian women. 
• metaanalizo treh študij SZO3,4,5, ki so v glavnem zajele Afričanke in Azijke.
For more information on these studies, see the CHMP assessment report for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf 
Za več informacij o teh študijah glejte poročilo o oceni CHMP za zdravilo ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
Studies HRA2914-507, HRA2914-508, HRA2914-509 and HRA2914-513. 
Študije HRA2914-507, HRA2914-508, HRA2914-509 in HRA2914-513.
The review was conducted by the Committee for Medicinal Products for Human Use (CHMP), the Committee responsible for questions concerning medicines for human use, which adopted the Agency's final opinion. 
Pregled je izvedel Odbor za zdravila za uporabo v humani medicini (CHMP), pristojni odbor za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
The review of emergency contraceptives containing levonorgestrel and ulipristal acetate was initiated in January 2014 at the request of Sweden, under Article 31 of Directive 2001/83/EC. 
Pregled urgentnih kontraceptivov, ki vsebujejo levonorgestrel in ulipristalacetat, se je pričel januarja 2014 na zahtevo Švedske v skladu s členom 31 Direktive 2001/83/ES.
The CHMP opinion was then forwarded to the European Commission, which issued a final legally binding decision on 30 September 2014. 
Mnenje CHMP je bilo nato poslano Evropski komisiji, ki je 30. septembra 2014 izdala končno pravno zavezujočo odločitev.
Emergency contraceptives work by stopping or delaying ovulation. 
Urgentni kontraceptivi delujejo tako, da zaustavijo ali odložijo ovulacijo.
The CHMP recommendation was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 30 September 2014. 
Priporočilo CHMP je bilo poslano Evropski komisiji, ki je 30. septembra 2014 izdala pravno zavezujoč sklep, veljaven po celotni EU.
The emergency contraceptives included in this review are medicines containing levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna, which have been authorised in the EU through national procedures. 
Urgentni kontraceptivi, vključeni v ta pregled, so zdravila, ki vključujejo levonorgestrel, kot so Norlevo, Levonelle/Postinor in Levodonna, ki so pridobila dovoljenje za promet v EU na podlagi nacionalnih postopkov.
Both meta-analyses did not include off-label use (i.e. intake later than 72 hours after unprotected sexual intercourse). 
Iz obeh metaanaliz je bila izključena nenamenska uporaba (tj. uporaba več kot 72 ur po nezaščitenem spolnem odnosu).
However, in order to maximise the likelihood that they will work, it is important that they are taken as soon as possible after unprotected intercourse. 
Vendar pa jih je, da bi kar najbolj povečali verjetnost, da bodo delovali, treba vzeti čim prej po nezaščitenem spolnem odnosu.
Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions. 
Podobno so pri ulipristalacetatu, čeprav omejeni podatki iz kliničnih preskušanj kažejo na možen trend zmanjševanja kontracepcijskega učinka, podatki preveč omejeni in premalo natančni, da bi omogočali dokončne zaključke.
For ulipristal acetate, the Agency considered the following data: 
Pri ulipristalacetatu je agencija upoštevala naslednje podatke:
The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009. 
Pregled je prav tako vključeval zdravilo ellaOne, odobreno po centraliziranem postopku, ki vsebuje ulipristalacetat in je pridobilo dovoljenje za promet v EU leta 2009.
EllaOne can only be obtained with a prescription. 
Izdaja zdravila EllaOne je le na recept.
For emergency contraceptives containing levonorgestrel, the Agency considered the following data: 
Pri urgentnih kontraceptivih, ki vsebujejo levonorgestrel, je agencija upoštevala naslednje podatke:
• An EU-wide review was carried out to assess whether emergency contraceptives are less effective in overweight or obese women. 
• Izveden je bil pregled po celotni EU, da bi ocenili, ali so urgentni kontraceptivi manj učinkoviti pri ženskah s čezmerno telesno maso ali debelih ženskah.
Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse. 
Ženske bi morale biti opozorjene, da morajo urgentni kontraceptiv vzeti čim prej po nezaščitenem spolnem odnosu.
On 24 July 2014, the European Medicines Agency concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure. 
24. julija 2014 je Evropska agencija za zdravila zaključila svoj pregled urgentnih kontraceptivov, ki vsebujejo levonorgestrel ali ulipristalacetat, v okviru katerega je ugotavljala, ali višja telesna masa vpliva na učinkovitost teh zdravil pri preprečevanju neželene nosečnosti po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
• Healthcare professionals should continue to remind women that emergency contraception is an occasional ‘rescue' method and should not replace a regular contraceptive method. 
• Zdravstveni delavci bi morali še naprej opozarjati ženske, da so urgentni kontraceptivi občasna metoda „v sili“ in da ne smejo nadomestiti redne kontracepcijske metode.
Those containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure, while ulipristal acetate can be used up to 120 hours. 
Kontraceptivi, ki vsebujejo levonorgestrel, se lahko uporabijo do 72 ur po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji, medtem ko se lahko ulipristalacetat uporabi do 120 ur kasneje.
The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that these emergency contraceptives could continue to be used in women of all weights as the benefits were considered to outweigh the risks. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je priporočil, naj se ta urgentna kontraceptiva še naprej uporabljata pri ženskah ne glede na telesno maso, saj je ocenil, da so njune koristi večje od tveganj.
The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the statements on the impact of bodyweight in the product information for Norlevo should be deleted. 
CHMP je priporočil, naj se rezultati iz teh študij vključijo v informacije o zdravilu za urgentne kontraceptive, trditve o učinku telesne mase v informacijah o zdravilu Norlevo pa naj se črtajo.
For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed. 
Pri zdravilih, ki vsebujejo levonorgestrel, so nekatere klinične študije nakazale zmanjšano učinkovitost pri ženskah z visoko telesno maso, vendar pa pri drugih ni bilo zaznati trenda zmanjševanja učinka pri višji telesni masi.
Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo. 
Na podlagi ocene vseh razpoložljivih dokazov o učinkovitosti urgentnih kontraceptivov je CHMP zaključil, da so razpoložljivi podatki preveč omejeni in premalo trdni, da bi lahko z gotovostjo trdili, da se kontracepcijski učinek pri višji telesni masi zmanjša, kot je navedeno v informacijah o zdravilu Norlevo.
It concluded that the limited data available do not support with certainty the previous conclusion that their contraceptive effect is reduced in women with high bodyweight. 
Ugotovljeno je bilo, da omejeni podatki, ki so na voljo, ne podpirajo z gotovostjo predhodnega sklepa, da je njihov kontracepcijski učinek manjši pri ženskah z visoko telesno maso.
Levonorgestrel-containing emergency contraceptives are available 'over the counter' in several European countries. 
Urgentni kontraceptivi, ki vsebujejo levonorgestrel, so na voljo brez recepta v številnih evropskih državah.
The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI. 
Razpoložljivi podatki so omejeni in premalo trdni, da bi z gotovostjo podpirali predhodni zaključek, da se kontracepcijski učinek pri višji telesni masi/ITM zmanjša.
The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman's bodyweight. 
CHMP je menil, da je varnostni profil urgentnih kontraceptivov glede na običajno mile neželene učinke ugoden in da se lahko ti še naprej jemljejo ne glede na telesno maso ženske.
• Women are reminded that emergency contraception is an occasional ‘rescue' method, which does not work as well as regular methods of contraception, such as the pill. 
• Ženske se morajo zavedati, da so urgentni kontraceptivi občasna metoda „v sili“, ki ne deluje tako dobro kot redne metode kontracepcije, kot so kontracepcijske tablete.
They should only be used as an occasional ‘rescue' method as they do not work as well as regular contraceptive methods. 
Urgentne kontraceptive bi morali uporabljati le kot občasno metodo „v sili“, saj ne delujejo tako dobro kot redne kontracepcijske metode.
The results of this analysis conflict with the results above and show no trend for a reduced efficacy with increasing bodyweight/BMI (pregnancy rate was 0.99% [CI: 0.70-1.35] in women with BMI 18.525; 0.57% [CI: 0.21-1.24] in women with BMI 25-30; and 1.17% [CI: 0.24-3.39] in women with BMI ≥30). 
Rezultati analize se ne skladajo z zgornjimi rezultati in ne kažejo trenda zmanjševanja učinkovitosti pri višji telesni masi/ITM (odstotek nosečnosti je bil 0,99 % [IZ: 0,70-1,35] pri ženskah z ITM 18,5-25; 0,57 % [IZ: 0,21-1,24] pri ženskah z ITM 25-30; in 1,17 % [IZ: 0,24-3,39] pri ženskah z ITM ≥ 30).
In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate. 
Vključena je bila trditev, da je zdravilo Norlevo manj učinkovito pri ženskah, ki tehtajo 75 kg ali več, in neučinkovito pri ženskah, ki tehtajo več kot 80 kg. Nato je sledil pregled po celotni EU, da bi ocenili, ali bi morali podobne informacije vključiti v informacije o zdravilu za druge urgentne kontraceptive, ki vsebujejo levonorgestrel, in za zdravilo ellaOne, urgentni kontraceptiv, ki vsebuje ulipristalacetat.
Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure. 
Urgentni kontraceptivi so kontracepcijska sredstva, ki se uporabljajo za preprečevanje neželene nosečnosti po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
• Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI). 
• Urgentni kontraceptivi se lahko še naprej uporabljajo za preprečevanje neželene nosečnosti pri ženskah ne glede na njihovo telesno maso ali indeks telesne mase (ITM).
• a meta-analysis of two published studies1,2, which primarily included Caucasian women, where a reduced contraceptive efficacy was observed with increased bodyweight or BMI (pregnancy rate was 0.96% [CI: 0.44-1.82] in women with BMI 18.5-25; 2.36% [CI: 1.02-4.60] in women with BMI 25-30; and 5.19% [CI: 2.62-9.09] in women with BMI ≥30). 
• metaanalizo dveh objavljenih študij1,2, ki sta v glavnem zajeli belke in v katerih so opazili zmanjšano kontracepcijsko učinkovitost pri višji telesni masi ali ITM (odstotek nosečnosti je bil 0,96 % [IZ: 0,44-1,82] pri ženskah z ITM 18,5-25; 2,36 % [IZ: 1,02-4,60] pri ženskah z ITM 25-30; in 5,19 % [IZ: 2,62-9,09] pri ženskah z ITM ≥ 30).
• Emergency contraceptives can continue to be taken after unprotected intercourse or contraceptive failure, regardless of the woman's bodyweight. 
• Urgentni kontraceptivi se lahko še naprej jemljejo po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji ne glede na telesno maso ženske.
• Emergency contraceptives are used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure. 
• Urgentni kontraceptivi se uporabljajo za preprečevanje neželene nosečnosti po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
4. von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. 
Lancet 1998; 352: 428-33. 4. von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
• a meta-analysis of four clinical studies that were submitted as part of the application for marketing authorisation of ellaOne6, which suggests a possible trend for a reduced contraceptive efficacy with high bodyweight or BMI, although confidence limits overlap (pregnancy rate was 1.23% [CI: 0.78 
• metaanalizo štirih kliničnih študij, ki so bile predložene kot del vloge za izdajo dovoljenja za promet z zdravilom ellaOne6, ki kaže na možen trend zmanjševanja kontracepcijske učinkovitosti pri visoki telesni masi ali ITM, čeprav se intervali zaupanja prekrivajo (odstotek nosečnosti je bil 1,23 % [IZ: 0,78-1,84] pri ženskah z ITM 18,5-25; 1,29 % [IZ: 0,59-2,43] pri ženskah z ITM 25-30; in 2,57 % [IZ: 1,34-4,45] pri ženskah z ITM ≥ 30).
References. 
Viri
90 (3 x 30 x 1) capsules (unit dose) (multipack) 
90 (3 x 30 x 1) kapsul (za enkratni odmerek) (skupno pakiranje)
30 x 1 capsules (unit dose) 
30 x 1 kapsula (za enkratni odmerek)
The final opinion was converted into a Decision by the European Commission on 19 November 2012. 
Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 19. novembra 2012.
The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Urbain as co-rapporteur. 
Za poročevalca je bil imenovan G. J. Schefferlie, za soporočevalca pa dr. B. Urbain.
The re-examination procedure started on 3 May 2012. 
Postopek ponovne presoje se je začel 3. maja 2012.
The referral started on 9 March 2011. 
Postopek se je začel 9. marca 2011.
On 23 March 2012, MERIAL notified the Agency of their intention to request a re-examination of the CVMP opinion of 8 March 2012. 
23. marca 2012 je družba MERIAL obvestila agencijo, da namerava zaprositi za ponovno presojo mnenja odbora CVMP z dne 8. marca 2012.
International non-proprietary names (inn): clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole 
Mednarodna nelastniška imena (INN): klorsulon, klozantel, nitroksinil, rafoksanid in triklabendazol
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics and package leaflets in Annex III. 
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila in navodil za uporabo v Prilogi III.
Supplementary information was provided by some of the applicants/marketing authorisation holders by 26 August 2011. 
Nekateri predlagatelji oziroma imetniki dovoljenj za promet z zdravili so do 26. avgusta 2011 predložili dodatne informacije.
During its meeting of 11-13 April 2012 the CVMP appointed Dr C. Muñoz as the rapporteur and Dr E. Persson as the co-rapporteur for the re-examination procedure. 
Na zasedanju odbora CVMP, ki je potekalo od 11. do 13. aprila 2012, je bil za poročevalca v postopku ponovne presoje mnenja imenovan dr. C. Muñoz, za soporočevalca pa dr. E. Persson.
The detailed grounds for the re-examination request were submitted by MERIAL on 2 May 2012. 
Podrobne razloge za zahtevo za ponovno presojo mnenja je družba MERIAL predložila 2. maja 2012.
The flukicidal substances for which a maximum residue limit has not been established in milk and that are included as active substances in authorised veterinary medicinal products in the Member States (EU/EEA) are clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole. 
Snovi proti metljajem, za katere ni bila določena mejna vrednost ostankov v mleku in ki so vključene kot zdravilne učinkovine v zdravila za uporabo v veterinarski medicini, odobrena v državah članicah (EU/EGP), so klorsulon, klozantel, nitroksinil, rafoksanid in triklabendazol.
Oral explanations were given by MERIAL on 16 May 2012. 
Dne 16. maja 2012 je družba MERIAL podala ustna pojasnila.
The CVMP was therefore requested to give its opinion as to whether measures are necessary to ensure that the use, during the non-lactating period, of veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole, would not lead to residues in milk that, combined with residues of these flukicidal substances from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je bil naprošen za mnenje o potrebnosti ukrepov, s katerimi bi zagotovili, da uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo klorsulon, klozantel, nitroksinil, rafoksanid in triklabendazol, zunaj obdobja laktacije ne bi povzročila ostankov v mleku, ki bi v kombinaciji z ostanki teh snovi proti metljajem iz drugih živil privedli do izpostavljenosti potrošnikov, ki presega sprejemljiv dnevni vnos.
Written explanations were provided by a group of marketing authorisation holders on 11 January 2012. 
Skupina imetnikov dovoljenj za promet z zdravili je 11. januarja 2012 predložila pisna pojasnila.
Oral explanations were given by a group of marketing authorisation holders on 8 February 2012. 
Skupina imetnikov dovoljenj za promet z zdravili je 8. februarja 2012 podala ustna pojasnila.
On 14 February 2011, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk intended for use in all ruminants producing milk for human consumption. 
Evropska komisija je 14. februarja 2011 začela napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilne učinkovine proti metljajem, za katere ni bila določena mejna vrednost ostankov v mleku, in ki se uporabljajo pri vseh prežvekovalcih, katerih mleko je namenjeno prehrani ljudi.
The issues considered during the reexamination related to the recommended amendments of section 4.11 Withdrawal period(s) of the summaries of product characteristics for the veterinary medicinal products containing nitroxinil that are administered to cattle. 
V postopku so bila obravnavana vprašanja, povezana s predlaganimi spremembami poglavja 4.11 Karenca v povzetkih glavnih značilnosti zdravil za uporabo v veterinarski medicini, ki vsebujejo nitroksinil in se dajejo govedu.