FrancophonIA/ELRC3.0 huggingface dataset:
English: After the 2nd or 3rd administration of 3 times the recommended dose, clinical signs were observed such as apathy, dyspnoea, elevated rectal temperatures, reddening of the skin, ataxia, and/or adverse events of the legs or joints (such as polyarthritis).
Slovenian: Po drugi ali tretji uporabi trikratnega priporočenega terapevtskega odmerka so bili opaženi klinični znaki kot je apatija, dispneja, zvišana rektalna temperatura, pordelost kože in/ali ataksijo in /ali neželeni učinki na nogah ali sklepih (kot je poliartritis).
English: Toltrazuril-sulfone shows plasma peak concentrations of 6.23 to 8.08 mg/l at 11 to 15 days after injection of the parent drug.
Slovenian: Toltrazurilsulfon kaže koncentracije v plazmi največ 6,23 do 8,08 mg/l 11 do 15 dni po injiciranju zdravila.
English: Should clinical signs be observed in the two weeks following administration of the product, the responsible veterinarian should be informed.
Slovenian: Če opazite klinične znake v dveh tednih po zdravljenju z zdravilom, obvestite odgovornega veterinarja.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer Animal Health GmbH
English: Persistent discolouration of muscle tissue at the injection site may occur.
Slovenian: Lahko se pojavi obstojno razbarvanje mišičnega tkiva na mestu injiciranja.
English: Care should be taken to avoid accidental selfinjection.
Slovenian: Bodite previdni, da se izognete nenamernemu samo-injiciranju.
English: When administering the product to a group of animals, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper.
Slovenian: Pri zdravljenju skupine živali z zdravilom je priporočena uporaba odvzemne igle, ki je vstavljena v zamašek viale, da se tako izognete prekomernemu prebadanju zamaška.
English: Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
Slovenian: KONTRAINDIKACIJE Ne uporabite pri pujskih, pri katerih obstaja sum, da imajo pomanjkanje vitamina E in/ali selena.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
English: After a single intramuscular injection of the recommended dose rate of 20 mg toltrazuril per kg body weight to piglets, toltrazuril plasma pharmacokinetics are characterised by biological variability.
Slovenian: Po enkratnem intramuskularnem injiciranju pri terapevtskem odmerku 20 mg toltrazurila na kg telesne mase pujska je za farmakokinetiko v plazmi značilna biološka variabilnost.
English: Bayer s.r.o., Animal Health Siemensova 2717/4 CZ-155 00 Praha 5
Slovenian: Slovenská republika Bayer s.r.o., Animal Health Siemensova 2717/4 CZ-155 00 Praha 5
English: EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Slovenian: EXP {mesec/leto} Po odprtju uporabite v 28 dneh.
English: After an overdose, iatrogenic poisoning may occur which may cause the following clinical signs: pale mucous membranes, haemorrhagic gastroenteritis, vomiting, tachycardia, hypotension, dyspnoea, oedema of the limbs, lameness, shock, liver damage, and death.
Slovenian: V primeru prevelikega odmerjanja se pojavi iatrogena zastrupitev, ki se pojavi v obliki sledečih kliničnih znakov: bleda sluznica, hemoragični gastroenteritis, bruhanje, tahikardija, hipotenzija, dispneja, edem okončin, šepanje, šok, poškodba jeter, pogin.
English: Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Slovenian: Toltrazuril je derivat triazinona in učinkovina za zdravljenje protozojskih bolezni.
English: Pull the skin to the side before inserting the needle.
Slovenian: Pred vbadanjem igle potegnite kožo na stran.
English: Pharmacologically active substances
Slovenian: Farmakološko aktivna snov
English: Bayer Limited The Atrium Blackthorn Road IE-Dublin 18
Slovenian: Blackthorn Road IE-Dublin 18
English: Pharmacotherapeutic groups: Toltrazuril, combinations ATCvet code: QP51AJ51
Slovenian: Oznaka ATC vet: QP51AJ51
English: Shake the vial well before use.
Slovenian: Pred uporabo vialo dobro pretresite.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE
English: A single intramuscular administration of 5 times the recommended dose, or 3 administrations of the recommended dose, did not cause systemic adverse effects or abnormalities in local injection site observations.
Slovenian: Enkratno intramuskularno dajanje 5-kratnega terapevtskega odmerka ali 3 odmerkov terapevtskega odmerka ni povzročilo sistemskih neželenih učinkov ali sprememb na mestu injiciranja, ki bi odstopale od normalnega stanja.
English: STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 36 mg toltrazuril and 182 mg iron (III) (as gleptoferron)
Slovenian: 1 ml vsebuje 36 mg toltrazurila in 182 mg železa (III) (kot gleptoferon).
English: 5 mg Slightly viscous dark brown suspension.
Slovenian: 5 mg rahlo viskozna temno rjava suspenzija INDIKACIJA(E)
English: The iron (III)-ions are stored as ferritin in the main storage organs (e.g. liver, spleen and the reticuloendothelial system), and iron elimination does not play a quantitatively important role.
Slovenian: Železovi III-ioni so shranjeni kot feritin v glavnih organih za shranjevanje (npr. jetra, vranica in retikuloendotelni sistem)
English: Neonatal piglets may experience clinical signs similar to those due to coccidiosis (such as diarrhoea) for numerous reasons (e.g. other pathogens, stress).
Slovenian: Novo skoteni pujski lahko iz številnih razlogov ( kot so drugi patogeni, stres) izražajo klinične znake, podobne tistim, ki so posledica kokcidioze (kot je driska).
English: The veterinary medicinal product should be administered to piglets between 48 to 72 hours after birth with a single intramuscular injection of 20 mg toltrazuril/kg body weight and 100 mg iron (as gleptoferron complex)/kg body weight, which is a dose volume of 0.55 ml/kg body weight.
Slovenian: Veterinarski produkt je potrebno dati pujskom od 48 do 72 ur po skotitvi z enim intramuskularnim injiciranjem 20 mg toltrazurila/kg telesne mase in 100 mg železa (kot kompleks gleptoferona)/kg telesne mase.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
English: The preferred injection site is the neck area (see illustration below).
Slovenian: Vsakemu pujsku je treba zdravilo injicirati z iglo premera 21 G. Najboljše mesto injiciranja je območje vratu (glej sliko spodaj).
English: Transient discolouration of the tissue and/or slight swelling may be observed commonly at the site of injection.
Slovenian: Pogosto je na mestu injiciranja mogoče opaziti prehodno razbarvanje tkiva in/ali rahlo otekanje.
English: Shelf life after first opening the immediate packaging: 28 days.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
English: TARGET SPECIES Pigs (piglets 48 to 72 hours after birth)
Slovenian: CILJNE ŽIVALSKE VRSTE prašiči (pujski 48 do 72 ur po skotitvi)
English: It is recommended to administer the product to all the piglets in a litter.
Slovenian: Priporočljivo je, da se zdravi vse pujske v leglu.
English: Deaths have been reported rarely in piglets following the administration of parenteral iron injections.
Slovenian: O poginih pujskov po dajanju parenteralnih injekcij železa je bilo poročano redko.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali za oznako EXP.Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.
English: Pregnancy and lactation: Not applicable.
Slovenian: Uporaba v obdobju brejosti, laktacije ali nesnosti: Ni smiselno.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
English: Special precautions for use in animals The product must not be administered more than once.
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Zdravila se ne sme dati več kot enkrat.
English: Slightly viscous dark brown suspension.
Slovenian: FARMACEVTSKA OBLIKA suspenzija za injiciranje rahlo viskozna temno rjava suspenzija
English: 36.4 mg
Slovenian: 36,4 mg železo (III)
English: TARGET SPECIES Pigs (piglets 48 to 72 hours after birth).
Slovenian: 4.1 Ciljne živalske vrste prašiči (pujski 48 do 72 ur po skotitvi).
English: The “No MRL required” classification for iron dextran and iron glucoheptonate is considered to apply to gleptoferron as gleptoferron is expected to release iron dextran and iron glucoheptonate.
Slovenian: Za razvrščanje železovega dekstrana in železovega glukoheptonata ni potreben MRL,
English: MRLs (µg/kg)
Slovenian: (MRL)
English: Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany
Slovenian: Imetnik dovoljenja za promet z zdravilom: Bayer Animal Health GmbH 51368 Leverkusen Nemčija
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml + 182 mg/ml suspension for injection for piglets
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Baycox Iron 36 mg/ml + 182 mg/ml suspenzija za injiciranje za pujske
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox Iron 36 mg/ml +182 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Baycox Iron 36 mg/ml + 182 mg/ml suspenzija za injiciranje za pujske toltrazuril / železo III (kot gleptoferon)
English: This product contains iron (as gleptoferron complex), which has been associated with anaphylactic reactions after injection.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo To zdravilo vsebuje železo (kot kompleks gleptoferona), ki je bilo po injiciranju povezano z anafilaktičnimi reakcijami.
English: Muscle Skin and fat
Slovenian: Maščobno tkivo Jetra Ledvica
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: Uporaba v obdobju brejosti, laktacije ali nesnosti Ni smiselno.
English: MARKETING AUTHORISATION HOLDER Bayer Animal Health GmbH D-51368 Leverkusen
Slovenian: Bayer Animal Health GmbH D-51368 Leverkusen
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
English: This product may be harmful for the unborn child.
Slovenian: To zdravilo lahko škodljivo vpliva na plod.
English: Poultry
Slovenian: Perutnina 100
English: Liver Kidney
Slovenian: OVOJNINAH VIALA
English: Sodium chloride Water for injections
Slovenian: Seznam pomožnih snovi fenol polisorbat 80 polisorbat 20 natrijev klorid voda za injekcije
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: WITHDRAWAL PERIOD(S) Withdrawal period:
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: A new logo has been adopted.
Slovenian: Sprejet je bil nov logotip.
English: • Supplement to Agenda point 12b.
Slovenian: • Dodatek k točki dnevnega reda 12b.
English: More information has been provided in the written report.
Slovenian: Več informacij je na voljo v pisnem poročilu.
English: The proposed amendments were presented at the October meeting and no comments were received.
Slovenian: Predlagane spremembe so bile predstavljene na oktobrski seji, nanje pa ni bilo nobenih pripomb.
English: The first day will be dedicated to discussion on decision-making.
Slovenian: Prvi dan bo namenjen razpravi o odločanju.
English: However, members decided to reject the proposal.
Slovenian: Vendar so člani odbora zavrnili predlog.
English: The main goal for the Agency is to ensure safety of vaccines.
Slovenian: Glavni cilj agencije je zagotavljati varnost cepiv.
English: The Board welcomed the work programme.
Slovenian: Upravni odbor je pozdravil delovni program.
English: However, this is only a fraction of the total number of generic products coming to the EU markets.
Slovenian: Vendar je to le delček skupnega števila generičnih proizvodov, ki prihajajo na trge EU.
English: New visual identity
Slovenian: Nova vizualna podoba
English: The issue of using and reimbursing external experts was also raised.
Slovenian: Odprto je bilo tudi vprašanje uporabe in plačevanja zunanjih strokovnjakov.
English: The budget is €13.6 million lower than the preliminary draft budget adopted in March 2009.
Slovenian: Proračun je za 13,6 milijona EUR manjši od predhodnega predloga proračuna iz marca 2009.
English: The presented priorities, objectives and projects follow proposals made to the Board in March 2009, and include:
Slovenian: Predstavljene prednostne naloge, cilji in projekti upoštevajo predloge, predložene upravnemu odboru marca 2009, in vključujejo:
English: Work will be undertaken in 2010 to address this challenge.
Slovenian: V letu 2010 se bo začelo delo za obvladovanje tega izziva.
English: The members noted the update report from the European Commission on a range of topics, including:
Slovenian: Člani odbora so se seznanili s posodobljenim poročilom Evropske komisije v zvezi z več temami, vključno s:
English: The document has now been submitted for translation.
Slovenian: Dokument je bil posredovan v prevajanje.
English: Both documents will then be presented to the Board.
Slovenian: Oba dokumenta bosta nato predložena upravnemu odboru.
English: It was clarified by the representative of the European Commission that at this point the revision of the decision is no longer possible.
Slovenian: Predstavnik Evropske komisije je pojasnil, da sprememba odločitve na tej točki ni več mogoča.
English: European Commission also referred to the need to reduce the surplus, and noting that the surplus of 2008 needs to be used in 2010.
Slovenian: Predstavnik Evropske komisije se je skliceval tudi na potrebo po zmanjšanju presežka in ugotovil, da je treba presežek iz leta 2008 uporabiti v letu 2010.
English: Topic coordinators will meet to further elaborate their proposal.
Slovenian: Tematski koordinatorji se bodo sestali in nadalje oblikovali svoj predlog.
English: The next Management Board meeting will last two days.
Slovenian: Naslednja seja upravnega odbora bo trajala dva dni.
English: The Management Board was informed that a confidentiality arrangement is under preparation with Switzerland.
Slovenian: Upravni odbor je bil obveščen, da je v pripravi dogovor o zaupnosti s Švico.
English: H1N1 pandemic update
Slovenian: Najnovejše informacije o pandemiji H1N1
English: The budget is in line with the work programme and totals €198.2 million (1.95% increase over the 2009 budget), which includes a general EU contribution of €32.6 million and the €4.5 million orphan medicinal products fund.
Slovenian: Proračun je skladen z delovnim programom in znaša 198,2 milijona EUR (1,95-odstotno povečanje v primerjavi s proračunom za leto 2009), kar vključuje splošni prispevek EU v višini 32,6 milijona EUR in 4,5 milijona EUR iz sklada za zdravila sirote.
English: The funding gap has reappeared and multi-annual funding solutions need to be found.
Slovenian: Znova je nastala vrzel pri financiranju, zato je treba poiskati večletne rešitve v zvezi s financiranjem.
English: The EVVet status report is updated continuously and is also available on the EVVeT website.
Slovenian: Poročilo o stanju EVVet se stalno posodablja in je na voljo tudi na spletni strani EVVeT.
English: The European Commission reserved their position with regard to the expected total amount of the general EU contribution, pending the decision of the European Parliament.
Slovenian: Evropska komisija je pridržala svoje stališče v zvezi s pričakovanim skupnim zneskom splošnega prispevka EU v pričakovanju odločitve Evropskega parlamenta.
English: • transparency and interaction with stakeholders;
Slovenian: • preglednost in sodelovanje z zainteresiranimi stranmi;
English: United Kingdom Kent Woods European Parliament
Slovenian: Združeno kraljestvo Kent Woods Evropski parlament
English: The number of people vaccinated with the three vaccines is growing.
Slovenian: Število oseb, cepljenih z zadevnimi tremi cepivi, narašča.
English: Declaration of conflicts of interests
Slovenian: Izjava o navzkrižju interesov
English: The work in the Committee for Medicinal Products for Human Use and various groups is ongoing.
Slovenian: Delo v Odboru za zdravila za uporabo v humani medicini in različnih skupinah stalno poteka.
English: The first report on pharmacovigilance of the three pandemic vaccines was published and was very well received by stakeholders.
Slovenian: Objavljeno je bilo prvo poročilo o farmakovigilanci zadevnih treh pandemskih cepiv, ki so ga zainteresirane strani zelo dobro sprejele.
English: • Letter from EURODIS (dated 7 December 2009).
Slovenian: • Dopis zveze EURODIS (z dne 7. decembra 2009).
English: A merger of the two committees should be considered.
Slovenian: Treba je razmisliti o združitvi obeh odborov.
English: Financial compensation for Members States' participation in linguistic checks
Slovenian: Finančno nadomestilo za udeležbo držav članic v jezikovnih pregledih
English: Payment system to Member States
Slovenian: Sistem plačil državam članicam
English: The Board will receive the updated document one week before the start of the consultation, to allow for any final comments to be made.
Slovenian: Upravni odbor bo prejel posodobljen dokument teden dni pred začetkom posvetovanja, da se omogoči predložitev kakršnih koli končnih pripomb.
English: The Agency also undertook to review in two years' time whether the doubling of the daily allowance meets financial requirements of patients/consumers' representatives.
Slovenian: Poleg tega se je zavezala tudi, da bo v dveh letih preverila, ali podvojitev dnevnice izpolnjuje finančne zahteve predstavnikov bolnikov/potrošnikov.
English: The strategy supersedes the road map to 2010, the implementation of which finishes next year, and outlines the Agency's strategic direction for the coming five years.
Slovenian: Ta strategija nadomešča časovni načrt do leta 2010, katerega izvajanje se bo končalo naslednje leto, v njej pa je orisana strateška usmeritev agencije za naslednjih pet let.
English: The Executive Director thanked the European experts and the Committee for continuous work in the field of pandemic vaccines.
Slovenian: Izvršni direktor se je zahvalil evropskim strokovnjakom in odboru za neprekinjeno delo na področju pandemskih cepiv.
English: • international cooperation (particularly important in light of the number of clinical trials and amount of manufacturing being done in countries outside the EU);
Slovenian: • mednarodno sodelovanje (posebno pomembno zaradi števila kliničnih preskušanj in obsega proizvodnje v državah zunaj EU);
English: As part of the new identity, the Agency will discontinue the use of the current acronym ‘EMEA' and will use either the full name ‘European Medicines Agency' or simply ‘the Agency'.
Slovenian: V okviru nove podobe bo prenehala uporabljati sedanjo kratico „EMEA“ in bo uporabljala bodisi polno ime „Evropska agencija za zdravila“ bodisi preprosto „agencija“.
English: Once adopted, the Agency will proceed with the implementation.
Slovenian: Agencija bo po njegovem sprejetju predlog začela izvajati.
English: London, 10 December 2009
Slovenian: London, 10. decembra 2009
English: • support to research;
Slovenian: • podporo raziskavam;
English: No conflicts of interests were declared.
Slovenian: Nihče ni navedel, da obstaja navzkrižje interesov.
English: The development takes into account specific needs of the user groups: healthcare professionals, patients and industry.
Slovenian: Pri razvoju se upoštevajo posebne potrebe skupin uporabnikov: zdravstvenih delavcev, bolnikov in industrije.
English: • discussion on the Cross-border Healthcare Directive;
Slovenian: • razpravo o Direktivi o čezmejnem zdravstvenem varstvu;
English: The Agency launched its new visual identity on 8 December 2009.
Slovenian: Agencija je novo vizualno podobo predstavila dne 8. decembra 2009.
English: The Agency will continue weekly publication of pharmacovigilance reports on the vaccines.
Slovenian: Agencija bo še naprej tedensko objavljala poročila o farmakovigilanci teh cepiv.
English: Public consultation on the road map will last three months, during which time meetings with stakeholders will be organised.
Slovenian: Javno posvetovanje o časovnem načrtu bo trajalo tri mesece, med tem pa bodo organizirani sestanki z zainteresiranimi stranmi.
English: The Member States need to find ways to increase the availability of resources to work in the area of herbal medicinal products.
Slovenian: Države članice morajo poiskati načine za izboljšanje razpoložljivosti virov za delo na področju zdravil rastlinskega izvora.
English: ICT planning and priorities 2010
Slovenian: Načrtovanje in prednostne naloge v zvezi z IKT za leto 2010
English: The acronym ‘EMEA' is not well known amongst the Agency's stakeholders such as healthcare professionals and patients in the EU.
Slovenian: Kratica „EMEA“ ni dobro poznana med zainteresiranimi stranmi agencije, kot so zdravstveni delavci in bolniki v EU.
English: Implementation rules regarding training for staff
Slovenian: Izvedbena pravila glede usposabljanja za osebje
English: Budget and establishment plan 2010 and staff policy plan
Slovenian: Proračun in kadrovski načrt za leto 2010 in načrt kadrovske politike
English: In addition to information provided in the previous version, the plan also looks at how to integrate EU telematics systems with those of the national competent authorities.
Slovenian: V načrtu se poleg informacij, predloženih v prejšnji različici, proučuje tudi način, kako telematske sisteme EU integrirati s sistemi nacionalnih pristojnih organov.
English: At the request of the Board, the Agency will provide an estimated amount of resources that are needed to implement the future revised framework of interaction.
Slovenian: Agencija bo na zahtevo upravnega odbora zagotovila ocenjeni znesek virov, potrebnih za izvajanje prihodnjega spremenjenega okvira sodelovanja.
English: • availability of medicines.
Slovenian: • razpoložljivost zdravil.
English: The new organisational structure has also been put in place as of 8 December 2009 and has had a positive impact on the activities of the Agency.
Slovenian: Dne 8. decembra 2009 je bila vzpostavljena tudi nova organizacijska struktura, ki pozitivno vpliva na dejavnosti agencije.
English: Professor Larry Phillips of the London School of Economics will lead the discussions.
Slovenian: Razpravo bo vodil profesor Larry Phillips z „London School of Economics“.
English: The establishment plan increases staffing numbers by 37 posts, brining the maximum permissible number of temporary agents to 567.
Slovenian: V kadrovskem načrtu je opredeljeno povečanje števila osebja za 37 delovnih mest, kar pomeni, da je največje dovoljeno število začasnih uslužbencev 567.
English: The decision is taken following a very positive pilot phase, during which patients/consumers' representatives participated in three meetings of the PhVWP.
Slovenian: Odločitev se sprejme po zelo pozitivni poskusni fazi, v kateri so na treh sestankih skupine PhVWP sodelovali predstavniki bolnikov/potrošnikov.
English: The plan also takes into account the expected impact of upcoming legislative proposals on pharmacovigilance and falsified medicines.
Slovenian: V načrtu se upošteva pričakovani vpliv prihodnjih zakonodajnih predlogov na farmakovigilanco in ponarejena zdravila.