FrancophonIA/ELRC3.0 huggingface dataset:
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) Bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih kužnih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Slovenian: Če na infekcijo sumite zaradi pozitivnega IgM odgovora, so potrebni dodatni testi, da se ugotovi ali je bila žival okužena ali cepljena.
English: CONTRAINDICATIONS None.
Slovenian: KONTRAINDIKACIJE Niso znane.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Slovenian: Datum pridobitve dovoljenja za promet: 21/11/2008 Datum podaljšanja dovoljenja za promet: 12/09/2013
English: No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Slovenian: Narejene niso bile nobene študije, ki bi dokazale, da ni interference med maternalnimi protitelesi in odzivom na cepljenje.
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Slovenian: Vendar pa je porast IgM po cepljenju redek, zato je pozitiven ELISA rezultat IgM močan pokazatelj naravne infekcije z virusom West Nile.
English: The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Slovenian: Uporaba Equip WNV zniža število konjev z viremijo po naravni infekciji, je pa ne prepreči.
English: Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Slovenian: Celotno vsebino brizge (1 ml) aplicirajte globoko intramuskularno na področje vratu po naslednjem programu:
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: As with any vaccine rare, occasional hypersensitivity reactions may occur.
Slovenian: Kot pri vsakem cepljenju se lahko pojavijo preobčutljivostne reakcije.
English: SPECIAL WARNING(S) Special precautions for use in animals: Vaccinate healthy animals only.
Slovenian: POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave konje.
English: Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.
Slovenian: Enoodmerna (1 ml) napolnjena steklena brizga iz stekla tipa I zaprta z zamaškom iz bromobutilne gume.
English: DATE OF THE REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/086/004 (2 enoodmerni stekleni brizgi) EU/2/08/086/005 (4 enoodmerne steklene brizge) EU/2/08/086/006 (10 enoodmernih steklenih brizg)
English: Onset of immunity: 3 weeks after primary vaccination course.
Slovenian: Začetek imunosti: 3 tedne po prvem krogu cepljenja.
English: For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Slovenian: Za aktivno imunizacijo konjev, starih 6 mesecev ali več, proti virusu bolezni West Nile (VWN), z zmanjševanjem števila viremičnih konj po infekciji z VWN linije 1 ali 2 ter za zmanjšanje trajanja in resnosti kliničnih znakov okužbe z VNW linije 2.
English: Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin): Zoetis Inc.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za ekvide, inaktivirana virusna cepiva za konje.
English: Shelf life of the veterinary product as packaged for sale: pre-filled glass syringe: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: Napolnjena steklena brizga: 2 leti.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samo-injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Inactivated West Nile virus, strain VM-2
Slovenian: Inaktiviran virus West Nile, sev VM-2
English: Any person intending to manufacture, import, possess, sell, supply and use Equip WNV must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Equip WNV, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: MARKETING AUTHORISATION NUMBERS EU/2/08/086/004-006
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/086/004 - 006
English: Minimum essential medium (MEM) Phosphate buffered saline
Slovenian: Minimum essential medium (MEM)
English: Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains.
Slovenian: Trajanje imunosti: 12 mesecev po prvem krogu cepljenja za VNW linije 1.
English: The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Equip WNV je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: RP* 1.0-2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Slovenian: *Relativna učinkovitost (Relative Potency) pri in vitro metodi v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri konjih.
English: The vaccine can be used during pregnancy and lactation.
Slovenian: Cepivo se lahko uporablja v obdobju brejosti in laktacije.
English: In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
Slovenian: V primeru nenamernega samo-injiciranja, zaužitja ali razlitja po koži se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Slovenian: Pakiranje: škatla z 2, 4 ali 10 enoodmernimi brizgami z iglami.
English: For WNV lineage 2 strains the duration of immunity has not been established.
Slovenian: trajanja imunosti niso določili.
English: PACKAGE SIZE 2 single-dose syringes 4 single-dose syringes 10 single-dose syringes
Slovenian: 2 enooddmerni brizgi 4 enoodmerne brizge
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intramuscular use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: Luxembourg/ Luxemburg Zoetis Belgium SA Tél/Tel.
Slovenian: Tél/Tel.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glejte navodilo za uporabo.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated West Nile virus, strain VM-2.
Slovenian: 1 ml vsebuje: Inaktiviran virus West Nile, sev VM-2
English: 6.2 Incompatibilities
Slovenian: Inkompatibilnosti:
English: Zoetis Belgium SA Teл: +359 2 4775791
Slovenian: Teл: +359 2 4775791
English: Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days and that are sometimes associated with pain and mild depression were reported in very rare cases.
Slovenian: Zelo redko so poročali o prehodnih lokalnih reakcijah v obliki blage lokalne otekline ne mestu injiciranja (maksimalno 1 cm v premeru), ki izginejo sponatno v 1 do 2 dneh.
English: Active substance:
Slovenian: Zdravilo učinkovino:
English: Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov razen tistih, opisanih v poglavju 4.6.
English: Zoetis France Tél: +33 (0)810 734 937
Slovenian: Tél: +33 (0)810 734 937
English: Name and address of the manufacturers responsible for batch release: Zoetis Belgium SA
Slovenian: Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega(odgovornih) za sprostitev serije: Zoetis Belgium SA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2, 4 or 10 single-dose pre-filled syringes
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 2,4, 5, 10, ali 25 enoodmernimi napolnjemi brizgami
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE
English: Agrimed Limited Tel: +356 21 465 797
Slovenian: Tel: +356 21 465 797
English: Zoetis Belgium SA Tel: +353 (0) 1 256 9800
Slovenian: Tel: +353 (0) 1 256 9800
English: However, no specific efficacy studies were conducted in pregnant mares.
Slovenian: Pri brejih kobilah niso bile narejene študije učinkovitosti zdravila.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single dose syringe
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE(ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: PACKAGE LEAFLET FOR: Equip WNV emulsion for injection for horses
Slovenian: NAVODILO ZA UPORABO: Equip WNV emulzija za injiciranje za konje
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: fosfatni pufer s soljo 6.2 Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec odgovoren za sproščanje serij:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses
Slovenian: Equip WNV emulzija za injiciranje za konje
English: Oriola Vilnius UAB Tel: +370 610 05088
Slovenian: Tel: +370 610 05088
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV injection for horses
Slovenian: Equip WNV injekcija za konje
English: Zoetis Finland Oy Sími: +358 (0)9 4300 40
Slovenian: Sími: +358 (0)9 4300 40
English: United Kingdom Zoetis UK Limited Tel: +44 (0) 845 300 8034
Slovenian: Tel: +44 (0) 845 300 8034
English: This will help to protect against the disease caused by the virus.
Slovenian: To pripomore k zaščiti pred boleznijo, ki jo povzroča virus.
English: A second dose may be given after an interval of at least three weeks, particularly in children from six months to nine years of age.
Slovenian: Drugi odmerek se lahko injicira v presledku vsaj treh tednov po prvem odmerku, zlasti pri otrocih, starih od šest mesecev do devet let.
English: This means that there is more evidence to come about the medicine, in particular the results of further clinical studies in children, adolescents and adults.
Slovenian: To pomeni, da pričakujemo še več dokazov o zdravilu, zlasti rezultati nadaljnjih kliničnih študij pri otrocih, mladostnikih in odraslih.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
English: It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Slovenian: Uporablja se lahko samo proti pandemski gripi A (H1N1), ki jo je Svetovna zdravstvena organizacija uradno razglasila 11. junija 2009.
English: In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection.
Slovenian: V skladu z merili, ki jih je določil CHMP, je iz tega razvidno, da je cepivo vzpostavilo ustrezno raven zaščite.
English: This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.
Slovenian: Te bodo obsegale informacije o njegovih neželenih učinkih ter varnosti pri otrocih, starostnikih, nosečnicah, bolnikih s hudimi boleznimi in osebah, ki imajo težave z imunskim sistemom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arepanrix to GlaxoSmithKline Biologicals s.a. on on 23 March 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Arepanrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 23. marca 2010.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Slovenian: Vendar pa bo med pandemijo cepljenje takih oseb morda vseeno upravičeno, če bo na voljo oprema za oživljanje.
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Slovenian: Vsebuje delce virusov influence (gripe), ki so inaktivirani (uničeni).
English: This document is a summary of the European Public Assessment Report (EPAR) for Arepanrix.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Arepanrix.
English: The percentage of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100%.
Slovenian: Odstotek oseb, ki so imele v svoji krvi dovolj visoko raven protiteles za nevtralizacijo virusa H1N1 (delež serološke zaščite), je bil 100 %.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Vehikel vsebuje „adjuvans“ (sestavino, ki vsebuje olje) za okrepitev imunskega odziva.
English: Arepanrix is very similar to another pandemic vaccine called Pandemrix, which has been available in the European Union (EU) since September 2009.
Slovenian: Zdravilo Arepanrix je zelo podobno drugemu cepivu proti pandemski gripi, imenovanemu Pandemrix, ki je v Evropski uniji (EU) na voljo od septembra 2009.
English: The resulting ‘emulsion' is then injected.
Slovenian: Nastala „emulzija“ se nato injicira.
English: The CHMP noted that Arepanrix had already been marketed in Canada and used to vaccinate over 5 million people with no safety concerns.
Slovenian: Odbor CHMP je upošteval, da je bilo zdravilo Arepanrix že na trgu v Kanadi in je bilo uporabljeno kot cepivo pri več kot 5 milijonih ljudi brez pomislekov glede njegove varnosti.
English: Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with a solvent.
Slovenian: Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje virusne delce, in vehikla.
English: The studies of Arepanrix H5N1 showed that the vaccine was able to bring about protective levels of antibodies in at least 70% of people in which it was studied.
Slovenian: Študije zdravila Arepanrix H5N1 so pokazale, da je cepivo uspelo vzpostaviti zaščitne ravni protiteles pri najmanj 70 % oseb, pri katerih je bilo proučevano.
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 Arepanrix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Arepanrix.
English: For more information about treatment with Arepanrix, read the Package Leaflet (also part of the EPAR).
Slovenian: Za več informacij o zdravljenju z zdravilom Arepanrix preberite navodilo za uporabo (ki je prav tako del EPAR).
English: Other information about Arepanrix:
Slovenian: Druge informacije o zdravilu Arepanrix:
English: The most common side effects with Arepanrix (seen with more than 1 in 10 doses of the vaccine) are headache, joint pain, muscle aches, pain at the site of the injection and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Arepanrix (opaženi pri več kot 1 odmerku cepiva od 10) so glavobol, bolečine v sklepih, bolečine v mišicah, bolečina na mestu injiciranja ter utrujenost.
English: Arepanrix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Slovenian: Cepivo Arepanrix se ne sme dajati osebam, ki so kdaj imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva ali katero koli snov, ki je v cepivu v sledeh, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid in natrijev deoksiholat.
English: This study looked at the immunogenicity against influenza A(H1N1)v.
Slovenian: V tej študiji so proučevali imunogenost proti gripi A(H1N1)v.
English: Because Arepanrix is similar to Pandemrix, the company used the data on the use of Pandemrix in children to support the use of Arepanrix in children.
Slovenian: Ker je zdravilo Arepanrix podobno zdravilu Pandemrix, je družba podatke o uporabi zdravila Pandemrix pri otrocih uporabila v podporo uporabe zdravila Arepanrix pri otrocih.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se hitro širi med ljudmi, ker proti njemu ljudje nimajo imunosti (zaščite).
English: Which measures are being taken to ensure the safe use of Arepanrix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Arepanrix?
English: Arepanrix is given as one dose, injected into the shoulder muscle.
Slovenian: Zdravilo Arepanrix se daje v enkratnem odmerku, ki se injicira v ramensko mišico.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Slovenian: Ko osebo cepimo, imunski sistem prepozna virus kot „tujek“, zato proti njemu tvori protitelesa.
English: Arepanrix is given according to official recommendations.
Slovenian: Zdravilo Arepanrix se daje v skladu z uradnimi priporočili.
English: The Committee decided that Arepanrix's benefits are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and recommended that it be given marketing authorisation.
Slovenian: Odbor je odločil, da so koristi zdravila Arepanrix za preprečevanje gripe v primeru uradne razglasitve pandemije H1N1 večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What benefit has Arepanrix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Arepanrix izkazalo med študijami?
English: Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Slovenian: Arepanrix cepivo proti pandemski gripi (H1N1)v (z delci virionov, inaktivirano, z adjuvansom)
English: Arepanrix has been given ‘Conditional Approval'.
Slovenian: Zdravilo Arepanrix je „pogojno odobreno“.
English: Arepanrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).
Slovenian: Zdravilo Arepanrix vsebuje sev virusa gripe A/California/7/2009 (X-179A), ki je podoben sevu A/California/7/2009 (H1N1)v.
English: The company that makes Arepanrix will collect information on the safety of the vaccine while it is being used.
Slovenian: Družba, ki izdeluje zdravilo Arepanrix, bo med uporabo tega cepiva zbirala informacije o njegovi varnosti.
English: Arepanrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic.
Slovenian: Zdravilo Arepanrix vsebuje majhne količine hemaglutininov (beljakovin s površine) virusa, imenovanega A(H1N1)v, ki povzroča trenutno pandemijo.
English: This included one study in 4,561 adults, which looked at the ability of Arepanrix H5N1 to trigger the production of antibodies (‘immunogenicity') against this H5N1 strain, and one study comparing it with Pandemrix H5N1.
Slovenian: V eno študijo je bilo vključenih 4 561 odraslih, v kateri so proučevali sposobnost zdravila Arepanrix H5N1 za sprožitev tvorbe protiteles („imunogenost“) proti temu sevu H5N1, v drugi študiji pa so ga primerjali z zdravilom Pandemrix H5N1.
English: The company presented information from studies carried out with an earlier version of Arepanrix, containing the ‘bird flu' strain H5N1.
Slovenian: Družba je predložila podatke iz študij, izvedenih s starejšo različico zdravila Arepanrix, ki vsebuje sev H5N1 „ptičje gripe“.
English: The company that makes Arepanrix will provide data collected in clinical trials of Arepanrix in adults and children, as well as information collected on the safety and effectiveness of the vaccine, to the CHMP for evaluation.
Slovenian: Družba, ki izdeluje zdravilo Arepanrix, bo odboru CHMP v oceno predložila zbrane podatke iz kliničnih preskušanj zdravila Arepanrix pri odraslih in otrocih ter zbrane informacije o varnosti in učinkovitosti cepiva.