FrancophonIA/ELRC3.0 huggingface dataset:
English: The results were similar to those from three other studies involving 170 adults given pandemic preparedness vaccines containing similar types of bird flu virus, such as H7N9 and H7N7, instead of H5N1.
Slovenian: Rezultati so bili podobni rezultatom treh drugih študij, v katerih je 170 odraslih prejelo cepiva za pripravljenost na pandemijo, ki so namesto virusa H5N1 vsebovala podobne vrste virusov ptičje gripe, kot sta H7N9 in H7N7.
English: It is not possible to prepare a vaccine for a future pandemic because the strain of the pandemic flu virus is not known in advance.
Slovenian: Cepiva za prihodnjo pandemijo ni mogoče pripraviti, saj sev virusa pandemske gripe ni vnaprej znan.
English: Pandemic influenza vaccine H5N1 AstraZeneca must not generally be given to children who have had a severe allergic reaction to any of the substances in the vaccine including gelatin and gentamicin or to children who have had a severe allergic reaction to eggs or egg proteins, such as ovalbumin.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca se v splošnem ne sme dati otrokom, ki so imeli hudo alergijsko reakcijo na katero koli snov v cepivu, vključno z želatino in gentamicinom, ter otrokom, ki so imeli hudo alergijsko reakcijo na jajca ali jajčne beljakovine, npr. ovalbumin.
English: Instead, a pandemic preparedness vaccine can be made to contain a bird flu virus strain that could potentially cause a future pandemic.
Slovenian: Namesto tega se lahko izdela cepivo za pripravljenost na pandemijo, ki vsebuje sev virusa ptičje gripe, ki bi morda lahko povzročil prihodnjo pandemijo.
English: A vaccine against a specific disease ‘teaches' the immune system (the body's natural defences) to defend itself against the disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo‟, kako naj se brani pred boleznijo.
English: Because a new pandemic live attenuated vaccine cannot be tested in children, the benefit of this vaccine in children was predicted from studies in adults and from studies of similar live attenuated flu vaccines in children.
Slovenian: Ker novega pandemskega živega oslabljenega cepiva ni mogoče preizkusiti na otrocih, so bile koristi tega cepiva pri njih predvidene na podlagi študij pri odraslih in študij podobnih živih oslabljenih cepiv proti gripi pri otrocih.
English: In those who received the second vaccine 3 weeks to 5 years after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca, antibodies increased 4-fold in 73% (8 out of 11) of the individuals compared with 10% of the individuals who had not been previously vaccinated with Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: Pri tistih, ki so drugo cepivo prejeli v obdobju od treh tednov do petih let po cepljenju s cepivom proti pandemski gripi H5N1 AstraZeneca, so protitelesa štirikratno porasla pri 73 % (8 od 11) oseb, v primerjavi z 10 % oseb, ki predhodno niso bile cepljene s cepivom proti pandemski gripi H5N1
English: The full EPAR for Pandemic influenza vaccine H5N1 AstraZeneca 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 cepivo proti pandemski gripi H5N1 AstraZeneca je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic influenza vaccine H5N1 MedImmune on 20 May 2016.
Slovenian: Evropska komisija je dovoljenje za promet s cepivom proti pandemski gripi H5N1 MedImmune, veljavno po vsej Evropski uniji, izdala 20. maja 2016.
English: The most common side effects with Pandemic influenza vaccine H5N1 AstraZeneca (which may affect more than 1 in 10 people) are decreased appetite, headache, runny or stuffy nose, and feeling unwell.
Slovenian: Najpogostejši neželeni učinki cepiva proti pandemski gripi H5N1 AstraZeneca (ki lahko prizadenejo več kot 1 osebo od 10) so zmanjšan tek, glavobol, izcedek iz nosu, zamašen nos in slabo počutje.
English: In addition, the company presented extensive supportive data from large studies and from clinical practice on how well other similar pandemic and seasonal live attenuated influenza A vaccines work in children.
Slovenian: Poleg tega je družba predložila obsežne podporne podatke iz obsežnih študij in klinične prakse o učinkovitosti drugih podobnih pandemskih in sezonskih živih oslabljenih cepiv proti gripi A pri otrocih.
English: Pandemic influenza vaccine H5N1 AstraZeneca contains live, attenuated (weakened) influenza A virus A/Vietnam/1203/2004 (H5N1) strain.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca vsebuje živ, oslabljen sev virusa gripe A, in sicer sev A/Vietnam/1203/2004 (H5N1).
English: Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine developed to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je cepivo, ki so ga razvili za zaščito otrok, starih od 12 mesecev do 18 let, pred gripo med njeno pandemijo.
English: This is a summary of the European public assessment report (EPAR) for Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo proti pandemski gripi H5N1 AstraZeneca.
English: Thus, the CHMP decided that the benefits of the medicine in children aged 1 to 18 years are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zato zaključil, da so koristi cepiva proti pandemski gripi H5N1 AstraZeneca pri otrocih, starih od 1 do 18 let, večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: For more information about prevention of influenza with Pandemic influenza vaccine H5N1 AstraZeneca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o preprečevanju gripe s cepivom proti pandemski gripi H5N1 AstraZeneca preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Three main studies involving 107 adults found that Pandemic influenza vaccine H5N1 AstraZeneca was able to prepare the immune system to defend itself against the H5N1 virus strain in individuals who had never come into contact with it. Antibodies against this type of vaccine are not easy to measure.
Slovenian: Tri glavne študije, v katere je bilo vključenih 107 odraslih, so pokazale, da lahko cepivo proti pandemski gripi H5N1 AstraZeneca pripravi imunski sistem oseb, ki niso bile nikoli izpostavljene sevu virusa H5N1, da se brani pred njim.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pandemic influenza vaccine H5N1 AstraZeneca have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo cepiva proti pandemski gripi H5N1 AstraZeneca upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For practical information about using Pandemic influenza vaccine H5N1 AstraZeneca, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi cepiva proti pandemski gripi H5N1 AstraZeneca naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The immune system will then be able to produce antibodies more quickly and in large numbers when it comes into contact with the virus again.
Slovenian: Ob ponovni izpostavitvi virusu jih bo imunski sistem tako lahko tvoril hitreje in več.
English: Since Pandemic influenza vaccine H5N1 AstraZeneca has been granted a conditional approval, the company that markets Pandemic influenza vaccine H5N1 AstraZeneca will conduct studies to gather more information on its effectiveness and side effects during its use in a pandemic as well as its shelf life.
Slovenian: Ker je cepivo proti pandemski gripi H5N1 AstraZeneca pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, izvedla študije, v katerih bo zbrala več informacij o njegovi učinkovitosti in neželenih učinkih pri uporabi med pandemijo ter roku uporabnosti.
English: This showed that antibodies against Pandemic influenza vaccine H5N1 AstraZeneca increased substantially when vaccinated adults came into contact with the virus again.
Slovenian: To je dokaz, da je pri uporabi cepiva proti pandemski gripi H5N1 AstraZeneca nastalo bistveno več protiteles, kadar so bili cepljeni odrasli ponovno izpostavljeni virusu.
English: The name of the medicine was changed to Pandemic influenza vaccine H5N1 AstraZeneca on 24 May 2017.
Slovenian: Ime zdravila je bilo 24. maja 2017 spremenjeno v cepivo proti pandemski gripi H5N1 AstraZeneca.
English: Although Pandemic influenza vaccine H5N1 AstraZeneca might increase wheezing in children aged 1 to 2 years, the risk is considered acceptable in a pandemic situation.
Slovenian: Zaradi cepiva proti pandemski gripi H5N1 AstraZeneca je lahko pri otrocih, starih od enega do dveh let, pogostejše piskajoče dihanje, vendar je tveganje v primeru pandemije ocenjeno kot sprejemljivo.
English: Previously known as Pandemic influenza vaccine H5N1 MedImmune
Slovenian: Prej znano kot cepivo proti pandemski gripi H5N1 MedImmune.
English: What measures are being taken to ensure the safe and effective use of Pandemic influenza vaccine H5N1 AstraZeneca?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe cepiva proti pandemski gripi H5N1 AstraZeneca?
English: Pandemic influenza vaccine H5N1 AstraZeneca is a pandemic preparedness vaccine.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je cepivo za pripravljenost na pandemijo.
English: However, a second vaccine that acts in a different way is able to make antibodies that can be measured easily.
Slovenian: Preprosto pa je mogoče meriti nastanek protiteles, ki jih sproži drugo cepivo z drugačnim delovanjem.
English: For the full list of all side effects reported with Pandemic influenza vaccine H5N1 AstraZeneca, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva proti pandemski gripi H5N1 AstraZeneca, glejte navodilo za uporabo.
English: Pandemic influenza vaccine H5N1 AstraZeneca has been given ‘conditional approval'.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je pridobilo „pogojno dovoljenje za promet“.
English: pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno)
English: Other information about Pandemic influenza vaccine H5N1 AstraZeneca
Slovenian: Druge informacije o cepivu proti pandemski gripi H5N1 AstraZeneca
English: What is Pandemic influenza vaccine H5N1 AstraZeneca and what is it used for?
Slovenian: Kaj je cepivo proti pandemski gripi H5N1 AstraZeneca in za kaj se uporablja?
English: This is further supported by data in children given similar seasonal and pandemic live attenuated flu vaccines in large studies and in clinical practice.
Slovenian: To pričakovanje podpirajo tudi podatki iz obsežnejših študij in klinične prakse o delovanju podobnih sezonskih in pandemskih živih, oslabljenih cepiv proti gripi pri otrocih.
English: What benefits of Pandemic influenza vaccine H5N1 AstraZeneca have been shown in studies?
Slovenian: Kakšne koristi je cepivo proti pandemski gripi H5N1 AstraZeneca izkazalo v študijah?
English: The vaccine is expected to protect children against pandemic flu, on the basis of data obtained with this vaccine in adults.
Slovenian: Na podlagi podatkov, ki so bili pridobljeni pri odraslih, se pričakuje, da bo cepivo otroke zaščitilo pred pandemsko gripo.
English: Further studies on the effects on the vaccine in children will need to be provided once the the flu strain causing the pandemic is included in the vaccine.
Slovenian: Ko bo v cepivo vključen sev gripe, ki bo vzrok pandemije, bo treba predložiti dodatne študije učinkov cepiva pri otrocih.
English: What are the risks associated with Pandemic influenza vaccine H5N1 AstraZeneca?
Slovenian: Kakšna tveganja so povezana s cepivom proti pandemski gripi H5N1 AstraZeneca?
English: Why is Pandemic influenza vaccine H5N1 AstraZeneca approved?
Slovenian: Zakaj je bilo cepivo proti pandemski gripi H5N1 AstraZeneca odobreno?
English: The dose is one spray (0.1 ml) into each nostril.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je na voljo v obliki pršila za nos. Odmerek je en vpih (0,1 ml) v vsako nosnico.
English: What information is still awaited for Pandemic influenza vaccine H5N1 AstraZeneca?
Slovenian: Katere informacije o cepivu proti pandemski gripi H5N1 AstraZeneca še pričakujemo?
English: How does Pandemic influenza vaccine H5N1 AstraZeneca work?
Slovenian: Kako cepivo proti pandemski gripi H5N1 AstraZeneca deluje?
English: How is Pandemic influenza vaccine H5N1 AstraZeneca used?
Slovenian: Kako se cepivo proti pandemski gripi H5N1 AstraZeneca uporablja?
English: • hypertension;
Slovenian: • hipertenzijo;
English: Plendil has been approved through national procedures in the following countries in the European Economic Area (EEA): Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Slovenian: Zdravilo Plendil je bilo z nacionalnimi postopki odobreno v naslednjih državah v Evropskem gospodarskem prostoru (EGP): Avstriji, Belgiji, Bolgariji, Hrvaški, Cipru, Češki republiki, Danski, Estoniji, Finski, Franciji, Nemčiji, Grčiji, Madžarski, Islandiji, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Norveški, Poljski, Portugalski, Romuniji, Slovaški, Španiji, Švedski in Združenem Kraljestvu.
English: These changes were agreed accordingly.
Slovenian: Te spremembe so bile soglasno odobrene.
English: The following wording was agreed:
Slovenian: Dogovorjeno je bilo naslednje besedilo:
English: This formulation was available until 1994, though only launched in Australia.
Slovenian: Ta formulacija je bila na voljo do leta 1994, vendar se je tržila samo v Avstraliji.
English: Therefore such combinations should be avoided (see section 4.5).'
Slovenian: Posledično se je treba tem kombinacijam izogibati (glejte poglavje 4.5).
English: Overall summary of the scientific evaluation of Plendil and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Plendil in povezanih imen (glejte Prilogo I)
English: The prolonged release tablet is available in three tablet strengths 2.5mg, 5mg and 10mg.
Slovenian: Tableta s podaljšanim sproščanjem je na voljo v treh jakostih: 2,5 mg, 5 mg in 10 mg.
English: • stable angina pectoris.
Slovenian: • stabilno angino pektoris.
English: The CHMP requested some additional wordings.
Slovenian: Odbor CHMP je predlagal nekaj dodatnega besedila.
English: The CHMP therefore considers it necessary to include the following text in Section 4.4, including a reference to Section 4.5:
Slovenian: Odbor CHMP zato meni, da je treba v poglavje 4.4, vključno z referenco na poglavje 4.5, vključiti naslednje besedilo:
English: − UK/W/002/pdWS/001 Article 45 Paediatric Workshare, finalised 15 October 2009.
Slovenian: − UK/W/002/pdWS/001, člen 45, Paediatric Workshare, zaključeno 15. oktobra 2009;
English: This method generates the Empirical Bayesian Geometric Mean (EBGM) with a 90% confidence interval (EB05 to EB95).
Slovenian: Bayesovo geometrično povprečje (EBGM) z 90-odstotnim intervalom zaupanja (EB05 do EB95).
English: In Europe, the prolonged release tablet was first approved in December 1987 and was first launched in Denmark in 1988.
Slovenian: V Evropi je bila tableta s podaljšanim sproščanjem prvič odobrena decembra 1987, prvič pa so je dali v promet na Danskem leta 1988.
English: The divergences were due to differences in the indication, recommendation in maximum daily dose and down titration.
Slovenian: Razhajanja so bila posledica razlik v indikaciji, priporočilu za največji dnevni odmerek in postopnem zmanjševanju odmerka.
English: For the indication “stable angina pectoris” there were several divergences.
Slovenian: Pri indikaciji „stabilna angina pektoris“ je bilo več razhajanj.
English: Today, Plendil is available worldwide for oral administration as a prolonged release tablet (except in Japan where another immediate release tablet is marketed).
Slovenian: Danes je zdravilo Plendil na voljo po celem svetu za peroralno uporabo v obliki tablete s podaljšanim sproščanjem (razen na Japonskem, kjer je v prometu druga tableta s takojšnjim sproščanjem).
English: If patients taking felodipine suffer from headache, nausea, dizziness or fatigue the ability to react may be impaired.
Slovenian: Če se pri bolniku, ki jemlje felodipin, pojavijo glavobol, navzea, omotica ali utrujenost, je lahko sposobnost reagiranja poslabšana.
English: Section 4.1 - Therapeutic Indications Plendil is indicated for:
Slovenian: Poglavje 4.1 - Terapevtske indikacije Zdravilo Plendil je indicirano za:
English: The European Commission notified the European Medicines Agency/ Committee for Medicinal Products for Human Use (EMA/CHMP) secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product information (PI) for the above-mentioned products and thus to harmonise them across the EU.
Slovenian: Evropska komisija je Evropsko agencijo za zdravila/Odbor za zdravila za uporabo v humani medicini (EMA/CHMP) obvestila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave razlik med nacionalno odobrenimi informacijami o zdravilu za zgoraj navedena zdravila in uskladitve teh informacij po vsej EU.
English: The MAH considered an EB05 >1.8 a possible signal i.e. the event is reported disproportional often in association with that drug.
Slovenian: Imetnik dovoljenja za promet je vrednost EB05 > 1,8 obravnaval kot morebitni signal, tj. o dogodku poročajo nesorazmerno pogosto v povezavi z zdravilom.
English: However, outside the referenced trials, no significant publication have been found, limiting the total reported material on felodipine use in vasospastic angina to around 30 patients.
Slovenian: Vendar razen navedenih preskušanj ni bilo mogoče najti nobene pomembne publikacije, kar je omejilo skupno gradivo, s katerim so poročali o uporabi felodipina pri vazospastični angini, na približno 30 bolnikov.
English: The final agreed wording is as follows: ‘Felodipine should not be given during pregnancy.
Slovenian: Dogovorjeno je bilo naslednje končno besedilo: „Felodipin se ne sme uporabljati med nosečnostjo.
English: When taken in therapeutic doses by the nursing mother it is, however, not likely to affect the infant”.
Slovenian: Kadar pa ga mater jemlje v terapevtskih odmerkih, ni verjetno, da bo vplival na dojenčka“.
English: The wording for hypertension was divergent in all EU MSs.
Slovenian: Besedilo za hipertenzijo je bilo različno v vseh državah članicah EU.
English: Plendil can also be used in the treatment of vasospastic (Prinzmetal's) angina”.
Slovenian: Zdravilo Plendil se lahko uporablja tudi za zdravljenje vazospastične (Prinzmetalove) angine“.
English: The proposal for the harmonised EU SmPC is based on the CPS from 2011 and CDS from October 2012.
Slovenian: Predlog za usklajeni povzetek glavnih značilnosti zdravila v EU temelji na ključnem varnostnem profilu iz leta 2011 in CDS iz oktobra 2012.
English: There were also discrepancies regarding recommendations for special population groups namely elderly and paediatric, renal and hepatic impairment, administration with/ without food.
Slovenian: Prisotna so bila tudi odstopanja glede priporočil za posebne skupine bolnikov, tj. starejši in pediatrični bolniki, okvara ledvic ter jeter, dajanje skupaj s hrano/brez nje.
English: There are no data on the effects of felodipine on patient fertility.
Slovenian: Podatkov o učinkih felodipina na bolnikovo plodnost ni.
English: Plendil was originally approved for marketing in Denmark on 16 March 1987, as an immediate release tablet.
Slovenian: Prvo dovoljenje za promet z zdravilom Plendil je bilo odobreno 16. marca 1987 na Danskem v obliki tablete s takojšnjim sproščanjem.
English: Some MSs were missing a text referring to absorption, distribution, metabolism and elimination.
Slovenian: V nekaterih državah članicah je manjkalo besedilo, povezano z absorpcijo, porazdelitvijo, presnovo in izločanjem.
English: The results of the conducted studies on felodipine in vasospastic angina show an effect on the condition, as there are improvements in angina symptoms and reductions or disappearance of transient ST-segment elevations at hyperventilation or systemic ergonovine provocation.
Slovenian: Rezultati opravljenih študij s felodipinom pri vazospastični angini kažejo učinek na to stanje, saj je prišlo do izboljšanja simptomov angine in zmanjšanja ali izginotja prehodnega povečanja segmenta ST pri hiperventilaciji ali sistemski provokaciji z ergonovinom.
English: It is expected that the patient has been informed to seek medical advice in that situation, and that all aspects of therapies are considered, included actions to be taken regarding discontinuation of felodipine treatment.
Slovenian: Pričakovano je, da je bila bolnica obveščena, naj se v takih okoliščinah posvetuje z zdravnikom, in da so bili upoštevani vsi vidiki zdravljenja, vključno z ukrepi, ki jih je treba uvesti glede prekinitve zdravljenja s felodipinom.
English: The wording on section 4.8 was divergent.
Slovenian: Besedila v poglavju 4.8 so se razlikovala.
English: Section 4.6 - Fertility, pregnancy and lactation The wording in section 4.6 was divergent.
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje Besedila v poglavju 4.6 so se razlikovala.
English: Felodipine is a dihydropyridine-type calcium channel blocker (calcium antagonist) and is indicated for the control of hypertension and in many countries also for the treatment of stable angina pectoris.
Slovenian: Felodipin je dihidropiridinski blokator kalcijevih kanalčkov (kalcijev antagonist) in je indiciran za nadzorovanje hipertenzije, v mnogih državah pa tudi za zdravljenje stabilne angine pektoris.
English: Three European procedures have been completed leading to agreed wording in Plendil Summary of Product Characteristics (SmPCs):
Slovenian: Zaključili so se trije evropski postopki, s katerimi se je poenotilo besedilo v povzetkih glavnih značilnosti zdravila Plendil:
English: Modifications relate to deletion of unnecessary and outdated wording, table format and addition of Hypotension as an adverse drug reaction (ADR).
Slovenian: Spremembe so povezane z izbrisom nepotrebnih in zastarelih besedil, obliko preglednice in dodajanjem hipotenzije kot neželenega učinka na zdravilo.
English: ‘Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.
Slovenian: „Sočasna uporaba zdravil, ki močno inducirajo ali zavirajo encime CYP3A4, povzroča zelo znižane oziroma zvišane ravni felodipina v plazmi.
English: The findings in the reproduction studies do not demonstrate evidence of direct fetotoxicity.
Slovenian: Ugotovitve študij razmnoževanja niso pokazale dokazov glede neposredne toksičnosti za plod.
English: Searches were also conducted in the FDA Adverse Event Reporting System (AERS) database and in the WHO Vigibase database.
Slovenian: Opravili so tudi iskanje po naboru podatkov v Sistemu za poročanje neželenih dogodkov (AERS) urada FDA in naboru podatkov Vigibase organizacije SZO.