FrancophonIA/ELRC3.0 huggingface dataset:
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Slovenian: Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance.
Slovenian: Vsako posamezno vialo je potrebno pretresti in pregledati, ali morda vsebuje tuje delce (različne od belih sedimentov opisanih zgoraj) in/ali je nenormalnega videza.
English: • The Applicant/MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
Slovenian: • Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
English: This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Slovenian: To cepivo vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek, kar v bistvu pomeni “brez natrija” in “brez kalija”.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Slovenian: Pri bolnikih z endogeno ali iatrogeno zmanjšanim imunskim odzivom je protitelesni odziv lahko nezadosten.
English: The Applicant/Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the continuous reassessment of the benefit/risk profile.
Slovenian: Predlagatelj/Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za stalno ponovno oceno razmerja med koristjo in tveganjem.
English: Immune system disorders Anaphylaxis, allergic reactions
Slovenian: Bolezni imunskega sistema anafilaksa, alergijske reakcije
English: Pharmacovigilance The Applicant/MAH commits to provide the results of a study in a pregnancy registry conducted with Arepanrix.
Slovenian: Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil rezultate študije registra nosečnosti, izvedene s cepivom Arepanrix.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Slovenian: Klinični pomen titra inhibicije hemaglutinacije (HI) ≥ 1:40 pri otrocih ni znan.
English: Rare: Neuralgia, transient thrombocytopenia.
Slovenian: Redki: Nevralgija, prehodna trombocitopenija.
English: The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly.
Slovenian: Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih študijah s cepivom Arepanrix (H5N1) pri odraslih, vključno s starejšimi osebami.
English: You should not receive Arepanrix:
Slovenian: Cepiva Arepanrix ne smete dobiti:
English: 21 days after 1st dose
Slovenian: 21 dni po 1. odmerku
English: Read the package leaflet before use
Slovenian: Pred uporabo preberite priloženo navodilo.
English: Immune response to A/Indonesia/5/2005 18-60 years
Slovenian: Imunski odziv proti A/Indonesia/5/2005 18-60 let
English: 04 June 2010
Slovenian: 04. junij 2010
English: 05 March 2010
Slovenian: 05. marec 2010
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.05 (dated September 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3,05 (September 2009), predstavljeni v modulu 1.8.1 vloge za pridobitev dovoljenja za promet, vzpostavljen in da deluje preden začne tržiti zdravilo in ves čas uporabe cepiva.
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Slovenian: Če ste negotovi, se pred cepljenjem posvetujte z zdravnikom ali s farmacevtom.
English: If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Slovenian: Če je uporabljen drugi odmerek (0,25 ml), ga bo otrok dobil vsaj tri tedne po prvem odmerku.
English: The frequency of possible side effects listed below is defined using the following convention:
Slovenian: Pogostnost neželenih učinkov, navedenih spodaj, je določena po naslednjem dogovoru:
English: Immune response to A/Indonesia/5/2005
Slovenian: Imunski odziv proti A/Indonesia/5/2005
English: The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMEA) bo redno ponovno pregledala vse nove podatke, o tem zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Biologicals, Rixensart - Belgija
English: Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Slovenian: Bolezni kože in podkožja angioedem, generalizirane kožne reakcije, urtikarija
English: • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Slovenian: • Vaskulitis (vnetje žil, ki lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami).
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Arepanrix with other H1N1 pandemic vaccines.
Slovenian: Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Arepanrix z drugimi pandemskimi cepivi proti H1N1.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (dated January 2010) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4 (januar 2010) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: 3-5 years
Slovenian: 3 do 5 let
English: What Arepanrix is and what it is used for Before you receive Arepanrix How Arepanrix is given Possible side effects
Slovenian: Kaj je cepivo Arepanrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Arepanrix Kako uporabljati cepivo Arepanrix Možni neželeni učinki
English: In the event of other variation being observed, discard the vaccine.
Slovenian: Če opazite kakšno drugo spremembo, morate cepivo zavreči.
English: The MAH should provide an inventory of all valuable database ready to be use to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Slovenian: Imetnik dovoljenja za promet mora posredovati seznam vseh pomembnih podatkovnih baz, pripravljenih za uporabo za takojšnjo proučitev vprašanj, ki zadevajo razmerje koristi in tveganj cepiva.
English: • Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
Slovenian: • bolečina v hrbtu ali vratu, mišična okorelost, mišični krči, bolečina v rokah ali nogah.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a syringe and by adding it to the vial containing the antigen.
Slovenian: Cepivo zmešate tako, da z injekcijsko brizgo izvlečete celotno vsebino viale adjuvansa in jo dodate v vialo z antigenom.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly.
Slovenian: Vsak odmerek cepiva z 0,5 ml (polni odmerek) ali z 0,25 ml (polovični odmerek) izvlecite v injekcijsko brizgo in injicirajte intramuskularno.
English: One pack of Arepanrix consists of:
Slovenian: Eno pakiranje cepiva Arepanrix vsebuje:
English: Arepanrix should under no circumstances be administered intravascularly.
Slovenian: Cepiva Arepanrix se v nobenem primeru ne sme injicirati v žilo.
English: Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age.
Slovenian: Prebavni simptomi in drgetanje so bili pogostejši pri otrocih, starih od 10 do 17 let.
English: Adults aged 18-60 years:
Slovenian: Odrasli, stari od 18 do 60 let:
English: The Applicant/MAH commits to provide abridged report for the following study performed in children
Slovenian: Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri otrocih:
English: Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Slovenian: Nasprotno pa je kombinacija različnih odmerkov antigena H5N1 z adjuvansom AS03 bele dihurje zaščitila pred poginom in zmanjšala virusno breme v pljučih ter izločanje virusa po intratrahealni provokaciji s homolognim divjim tipom virusa H5N1.
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Slovenian: Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično z A/Indonesia/05/05 (H5N1) s provokacijskim modelom pri belem dihurju.
English: Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Slovenian: Pri serološkem testiranju so odkrili neposredno povezavo med s cepivom induciranimi HI in titri nevtralizacijskih protiteles pri zaščitenih živalih, v primerjavi s kontrolnimi živalmi, ki so prejele le antigen ali adjuvans.
English: Suspension and emulsion for emulsion for injection.
Slovenian: suspenzija in emulzija za emulzijo za injiciranje
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Slovenian: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgija
English: Areapanrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Slovenian: Cepivo Arepanrix je mogoče dati hkrati s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
English: See section 4.4 for Special warnings and special precautions for use.
Slovenian: Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
English: When Arepanrix is given for the first dose, it is recommended that Arepanrix (and not another vaccine against H1N1) be given for the complete vaccination course.
Slovenian: Če je za prvi odmerek uporabljeno cepivo Arepanrix, je priporočljivo, da se cepljenje tudi dokonča s cepivom Arepanrix (in ne z drugim cepivom proti H1N1).
English: A dose (0.25 ml) of the vaccine will be given.
Slovenian: Otrok bo dobil en odmerek (0,25 ml) cepiva.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Slovenian: Na voljo ni podatkov o cepljenju s cepivi z adjuvansom AS03, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemsko ali pandemsko uporabo.
English: Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Slovenian: Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo zagotovil mehanizme za takojšnjo proučitev vprašanj v zvezi z razmerjem koristi in tveganj cepiva.
English: Tell the doctor requesting these tests that you have recently been given Arepanrix.
Slovenian: Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Arepanrix.
English: Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to 11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to 35 months old).
Slovenian: Analiza podskupine 36 otrok, starih od 6 do 35 mesecev, je pokazala, da je imelo 21 dni po prvem odmerku 80,6 % otrok 4-kratno povečanje nevtralizirajočih protiteles v serumu (66,7 % od 12 otrok, starih od 6 do 11 mesecev, 91,7 % od 12 otrok, starih od 12 do 23 mesecev, in 83,3 % od 12 otrok, starih od 24 do 35 mesecev).
English: In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Slovenian: Še zlasti se lahko po drugem odmerku občutno poveča delež zvišane telesne temperature (aksilarna temperatura ≥ 38 °C).
English: Day 42 N=1,488
Slovenian: 42. dan n=1.488
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA emulzija adjuvansa za injiciranje 25 vial: emulzija
English: The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Slovenian: Po premešanju suspenzije in emulzije nastane večodmerno cepivo v viali.
English: The European Medicines Agency (EMEA) will review any new information on this medicine and this SPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMEA) bo redno ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila to navodilo za uporabo, če bo potrebno.
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Slovenian: V kontrolnih skupinah so bili beli dihurji, ki so bili cepljeni samo samo z adjuvansom in cepivom brez adjuvansa (7,5 mikrogramov HA).
English: • Tingling or numbness of the hands or feet
Slovenian: • mravljinčenje ali odrevenelost v rokah ali nogah.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Slovenian: Cepivo kot konzervans vsebuje tiomersal (organska živosrebrova spojina), ki lahko povzroči preobčutljivostne reakcije (glejte poglavje 4.4).
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of the AS03-containing vaccine containing HA from H1N1v alone.
Slovenian: Sočasne uporabe ni spremljal večji delež lokalnih ali sistemskih reakcij kot uporaba cepiva z AS03 z vsebnostjo HA iz H1N1v samega.
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Slovenian: • Nevrološke motnje, npr. encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
English: • Pain in the chest
Slovenian: • bolečina v prsnem košu
English: Two clinical studies evaluated the immunogenicity of a half (0.25 ml) dose and a full (0.5 ml) adult dose in healthy children 10 to 17 years of age.
Slovenian: Z dvema kliničnima študijama so ocenili imunogenost polovičnega odmerka (0,25 ml) in polnega odmerka (0,5 ml) za odrasle pri zdravih otrocih, starih od 10 do 17 let.
English: One dose of 0.5 ml at an elected date.
Slovenian: En 0,5 ml odmerek na izbrani datum.
English: Children aged 6-35 months
Slovenian: Otroci, stari od 6 do 35 mesecev
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
Slovenian: PAKIRANJE, KI VSEBUJE 1 PAKIRANJE S 50 VIALAMI SUSPENZIJE IN 2 PAKIRANJI S 25 VIALAMI EMULZIJE
English: Therefore the data indicate that Arepanrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Slovenian: Podatki torej kažejo, da se cepivo Arepanrix lahko uporabi tri tedne po uporabi cepiva proti sezonski gripi brez adjuvansa.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
Slovenian: FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
English: Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Slovenian: Predklinični podatki, pridobljeni z različico cepiva Arepanrix z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 (H5N1) z uporabo seva H5N1, na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio-fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
English: In two clinical studies (D-Pan H1N1-007 and D-Pan H1N1-008) that evaluated immunogenicity in healthy subjects aged 18-60 years the anti-HA antibody responses were as follows:
Slovenian: V dveh kliničnih študijah (D-Pan H1N1-007 in D-Pan H1N1-008), s katerima so pri zdravih preiskovancih, starih od 18 do 60 let, ocenili imunogenost, so bili odzivi protiteles na anti-HA naslednji:
English: Arepanrix consists of two containers:
Slovenian: Cepivo Arepanrix je na voljo v dveh vsebnikih:
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Arepanrix.
Slovenian: Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Arepanrix o tem vseeno posvetujte s svojim zdravnikom.
English: Study D-Pan H1N1-008 evaluated immunogenicity in healthy subjects (N=120) aged >60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age).
Slovenian: S klinično študijo D-Pan H1N1-008 so ocenili imunogenost pri zdravih preiskovancih (n = 120), starih več kot 60 let (razdeljenih v skupine od 61 do 70, 71 do 80 in > 80 let).
English: 31-January-2010
Slovenian: 31. januar 2010
English: For the most up-to-date information please consult the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/.
Slovenian: Za najnovejše informacije glejte spletno stran Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu/.
English: - Challenge with a heterologous pandemic H5N1 strain (A/Hong Kong/156/97)
Slovenian: - Heterologni provokacijski poskus s pandemskim sevom H5N1 (A/Hong Kong/156/97)
English: The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Slovenian: Neželeni učinki, našteti spodaj, so se pojavili med spremljanjem podobnega cepiva H1N1 po prihodu na trg.
English: • Redness and swelling at the injection site
Slovenian: • rdečina in oteklina na mestu injiciranja
English: Blood and lymphatic system disorders Uncommon: lymphadenopathy
Slovenian: Bolezni krvi in limfatičnega sistema Občasni: limfadenopatija
English: - Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
Slovenian: - Homologni provokacijski poskus s pandemičnim sevom H5N1 (A/Indonesia/5/05)
English: Information from non-clinical studies:
Slovenian: Podatki iz predkliničnih študij:
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
English: How to store Arepanrix Further information
Slovenian: Shranjevanje cepiva Arepanrix Dodatne informacije
English: Adverse reactions reported are listed according to the following frequency:
Slovenian: Opisani neželeni učinki so navedeni po naslednjih skupinah pogostnosti:
English: Children and adolescents aged 10-17 years
Slovenian: Otroci in mladostniki, stari od 10 do 17 let
English: Seroprotection rate1
Slovenian: Delež serološke zaščite1
English: The mixed vaccine is a whitish emulsion.
Slovenian: Pripravljeno cepivo je belkasta emulzija.
English: • Reactions at the injection site such as bruising, hard lump, itching, warmth
Slovenian: • reakcije na mestu injiciranja kot so modrica, zatrdlina, srbenje, občutek toplote
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Arepanrix
Slovenian: IME ZDRAVILA Emulzija za emulzijo za injiciranje za Arepanrix
English: There are no data on co-administration of Arepanrix with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Arepanrix z drugimi cepivi ni.
English: In a consistency study, the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Slovenian: V študiji konsistentnosti je bil odziv v obliki antihemaglutininskih (anti-HA) protiteles enaindvajseti dan in šest mesecev po cepljenju z drugim odmerkom naslednji:
English: Adults aged 18-60 years
Slovenian: Odrasli, stari od 18 do 60 let
English: Seroconversion factor3
Slovenian: Faktor serokonverzije3
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Slovenian: • eno pakiranje s 50 vialami po 2,5 ml suspenzije (antigen)
English: AS03-containing vaccine containing HA from H1N1v manufactured using a different process N=164
Slovenian: cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom n=164
English: Suspension vial:
Slovenian: VIALA S SUSPENZIJO
English: These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly).
Slovenian: Te neželene učinke so s podobnimi pogostnostmi opažali tudi v kliničnih študijah s podobnim cepivom (H1N1) pri odraslih, vključno s starejšimi osebami, in pri otrocih, starih od 10 do 17 let; izjemi sta pordelost (občasna pri odraslih in pogosta pri starejših osebah) in zvišana telesna temperatura (občasna pri odraslih in starejših).
English: The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Vialo morate pred vsako aplikacijo cepiva pretresti in pregledati, ali morda vsebuje tuje delce in/ali je nenormalnega videza.
English: Arepanrix has been authorised under “Conditional Approval”.
Slovenian: Cepivo Arepanrix je pridobilo dovoljenje za promet pod «posebnimi pogoji».
English: Day 180 N=353
Slovenian: 180. dan n=353
English: After mixing, use the vaccine within 24 hours.
Slovenian: Po mešanju morate cepivo uporabiti v 24 urah.