FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you have any known allergies.
Slovenian: Obvestite svojega zdravnika, če imate kakršnokoli alergijo.
English: Interpandemic trivalent vaccines
Slovenian: Interpandemska trivalentna cepiva
English: • The correct way to prepare the vaccine prior to administration.
Slovenian: • Pravilno pripravo cepiva pred uporabo.
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Slovenian: Zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5.1).
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Slovenian: • Alergijske reakcije z nevarnim znižanjem krvnega tlaka, ki lahko brez zdravljenja povzročijo šok.
English: • Severe stabbing or throbbing pain along one or more nerves
Slovenian: • Hujša zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev.
English: Prompt analysis of cumulative safety information, in light of the extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Slovenian: V luči obsega izpostavljenosti bo takojšnja analiza kumulativnih informacij o varnosti ključnega pomena za regulativno odločanje in zaščito prebivalstva, ki bo cepljeno.
English: Prior to administration, the two components should be mixed.
Slovenian: Pred uporabo je treba obe komponenti zmešati skupaj.
English: None of the ingredients in the vaccine can cause flu.
Slovenian: Sestavine cepiva ne morejo povzročiti gripe.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: Uradno sproščanje serije: V skladu s 114. členom Direktive 2001/83/EC z vsemi spremembami opravi sproščanje serije državni laboratorij ali laboratorij, imenovan v ta namen.
English: The Applicant/MAH commits not to release lots prepared using the extended formulation/fill process until the relevant validation data have been submitted and approved (RR#7Q5)
Slovenian: Predlagatelj/imetnik dovoljenja za promet se obvezuje, da ne bo sproščal serij, pripravljenih z uporabo podaljšane oblike/postopka polnjenja, dokler ne bodo vloženi in odobreni relevantni validacijski podatki (RR#7Q5).
English: The characteristics and the validity of these sources is to be agreed with EMEA within 1 month of the Commission Decision granting the Marketing Authorisation in order to conduct additional studies for emerging benefitrisk evaluation.
Slovenian: O značilnostih in veljavnosti teh virov se je treba dogovoriti z EMEA v 1 mesecu po odločbi Komisije o izdaji dovoljenja za promet, da bi izvedli dodatne študije za prihajajoče ovrednotenje koristi in tveganj.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/624/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/624/001
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Slovenian: • Minimalne podatkovne elemente, ki jih je treba sporočiti v vsakem poročilu, da se olajša vrednotenje in identifikacija uporabljenega cepiva pri posamezni osebi, vključno z imenom cepiva, izdelovalcem in številko serije.
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Slovenian: Suspenzije in emulzije ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: This means that there is more evidence to come about this medicine.
Slovenian: To pomeni, da so potrebni o tem zdravilu še dodatni dokazi.
English: Read all of this leaflet carefully before you receive this vaccine.
Slovenian: Natančno preberite navodilo, preden dobite to cepivo!
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Slovenian: DRUGI PODATKI Shranjevanje (2°C-8°C), ne zamrzujte, zaščitite pred svetlobo.
English: Instructions for mixing and administration of the vaccine:
Slovenian: Navodila za mešanje in injiciranje cepiva:
English: Pharmacovigilance The Applicant/MAH will support one prospective and one retrospective cohort safety study with Arepanrix, in at least 9,000 patients, in accordance with the protocols submitted with the Risk Management Plan.
Slovenian: Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet bo podprl eno prospektivno in eno retrospektivno kohortno študijo varnosti cepiva Arepanrix pri vsaj 9.000 pacientih, v skladu s protokoli, vloženimi z načrtom za obvladovanje tveganja.
English: >80 years
Slovenian: >80 let
English: PSUR submission during the influenza pandemic:
Slovenian: Vlaganje PSUR med pandemijo gripe:
English: Quality
Slovenian: Kakovost
English: • Unusual weakness
Slovenian: • neobičajna oslabelost
English: • The Applicant/MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Arepanrix.
Slovenian: • Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravnikom omogočali stalen dostop do posodobljenih informacij o cepivu Arepanrix.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Slovenian: Prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM kot odziv na cepivo.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature.
Slovenian: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) pustiti, da dosežeta sobno temperaturo.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Slovenian: Zelo pogosti (≥ 1/10) Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Slovenian: V kateremkoli od navedenih primerov OBVESTITE SVOJEGA ZDRAVNIKA ALI MEDICINSKO SESTRO, saj cepljenje ni priporočljivo ali ga je potrebno opraviti kasneje.
English: • If a specific notification system has been put in place, how to report adverse reactions.
Slovenian: • Način poročanja, če je bil uveljavljen specifičen sistem poročanja o neželenih učinkih,
English: The side-effects are generally similar to those related to seasonal flu vaccines.
Slovenian: Neželeni učinki so na splošno podobni tistim, ki se pojavijo pri cepivih proti sezonski gripi.
English: Retrospective cohort: to be initiated in Feb 2010; Preliminary analysis in April
Slovenian: Retrospektivna kohorta: predvideni začetek februarja 2010, preliminarna analiza aprila.
English: • Active substance:
Slovenian: • Pomožne snovi:
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Slovenian: Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali akutno okužbo.
English: In such cases, you should be aware that the side effects may be more intense.
Slovenian: V takih primerih se morate zavedati, da so neželeni učinki lahko izrazitejši.
English: The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Slovenian: Neželeni učinki, ki so navedeni spodaj, so se pojavili v dnevih ali tednih po cepljenju s cepivi, s katerimi se vsako leto cepi proti gripi.
English: Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were reported very commonly.
Slovenian: Poleg tega, so pri otrocih, starih od 3 do 5 let zelo pogosto poročali o zaspanosti, razdražljivosti in izgubi apetita.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zato mora zdravnik oceniti koristi in možna tveganja uporabe cepiva pri osebah s trombocitopenijo ali kakršnokoli motnjo strjevanja krvi, ki bi bila kontraindikacija za intramuskularno injiciranje, razen če možna korist odtehta tveganje krvavitve.
English: • Sweating
Slovenian: • znojenje
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Slovenian: Po cepljenju se lahko pojavijo alergijske reakcije, ki v redkih primerih povzročijo šok.
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Slovenian: • Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
English: • The Applicant/MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Slovenian: • Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost pandemskega cepiva A/H1N1, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Slovenian: Cepivo vam bodo injicirali v mišico (po navadi na nadlahti).
English: • Clinical trials
Slovenian: • Klinična preskušanja
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Slovenian: V tem primeru bo zdravnik cepljenje običajno odložil, dokler ne boste ozdraveli.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Slovenian: Znaki alergijske reakcije so lahko srbeč izpuščaj na koži, težko dihanje in otekanje obraza ali jezika.
English: Area
Slovenian: Področje
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Slovenian: Pripravljeno cepivo lahko shranjujete v hladilniku (2°C - 8°C) ali na sobni temperaturi, ki ne presega 25 °C.
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Slovenian: Vendar bo v primeru pandemije cepljenje za vas morda priporočljivo, če bo takoj na voljo ustrezna medicinska oprema za primer alergijske reakcije.
English: >60 years
Slovenian: > 60 let
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Slovenian: Zdravniki se tega zavedajo in imajo pripravljeno nujno zdravljenje za takšne primere.
English: Nervous system disorders Febrile convulsions
Slovenian: Bolezni živčevja febrilne konvulzije
English: • if you have a poor immune response (as for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer),
Slovenian: • če je vaš imunski sistem oslabljen (kot na primer pri imunosupresivni terapiji, npr. kortikosteroidno zdravljenje ali kemoterapija pri raku),
English: Arepanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Arepanrix takes due account of the officially declared pandemic strain.
Slovenian: Cepivo Arepanrix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Arepanrix upošteva uradno razglašen pandemski sev.
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Slovenian: Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov na osnovi ELISA metode za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in še posebej proti HTLV-1.
English: In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Slovenian: Če opazite eno ali drugo (vključno z gumijastimi delci iz zamaška), morate cepivo zavreči.
English: This medicinal product has been authorised under a so-called “conditional approval” scheme.
Slovenian: Zdravilo je pridobilo tako imenovano »pogojno dovoljenje za promet«.
English: The Applicant/MAH commits to set a maximum decrease of 20% of HA content for the Drug Substance and to review when data for H1N1 become available.
Slovenian: Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo postavil največ 20 % zmanjšanje vsebnosti HA za zdravilno učinkovino in bo opravil pregled, ko bodo na voljo podatki za H1N1.
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Slovenian: Če vaš otrok dobi cepivo, morate vedeti, da so lahko neželeni učinki po drugem odmerku izrazitejši; to še zlasti velja za zvišanje telesne temperature nad 38 °C.
English: If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
Slovenian: Če pripravljeno cepivo shranjujete v hladilniku, morate poskrbeti, da doseže sobno temperaturo preden izvlečete posamezni odmerek.
English: Immune response to Arepanrix (H1N1) in adults aged 18-60 years:
Slovenian: Imunski odziv na cepivo Arepanrix (H1N1) pri odraslih, starih od 18 do 60 let:
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije Preprečevanje gripe v uradno razglašenih pandemskih razmerah (glejte poglavji 4.2 in 5.1).
English: The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03 adjuvantation.
Slovenian: Rezultati te heterologne provokacijske študije kažejo od 80,7-odstotno do 100-odstotno zaščito pri vseh kandidatnih cepivih z adjuvansom, v primerjavi s 43-odstotno zaščito pri cepivih brez adjuvansa, kar kaže na korist adjuvansa AS03.
English: See section 6.5 for the number of doses per vial.
Slovenian: Za število odmerkov v viali glejte poglavje 6.5.
English: 24-35 months4
Slovenian: 24-35 mesecev4
English: The emulsion is a whitish homogeneous liquid.
Slovenian: Emulzija je belkasta homogena tekočina.
English: Such situation requires rapid notification of safety information that may have the greatest implications for benefit-risk balance in a pandemic.
Slovenian: Takšne okoliščine zahtevajo hitro prijavljanje varnostnih informacij, ki so lahko pri pandemiji izjemno pomembne za razmerje med koristjo in tveganjem.
English: For a full list of excipients see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: The anti-HA antibody responses 21 days after a first dose were as follows:
Slovenian: Odzivi anti-HA protiteles so bili 21 dni po prvem odmerku naslednji:
English: After the addition of the adjuvant to the antigen, the mixture should be well shaken.
Slovenian: Potem, ko adjuvans dodate antigenu, morate mešanico dobro pretresti.
English: The MAH shall submit on a monthly basis a simplified periodic safety update report with the timelines, format and content as defined in the CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009) and any subsequent update.
Slovenian: Imetnik dovoljenja za promet bo mesečno vlagal poenostavljeno redno posodobljeno poročilo o varnosti s časovnim razporedom, obliko in vsebino, opredeljenimi v Priporočilih za farmakovigilančni načrt CHMP kot del načrta za obvladovanje tveganja, ki mora biti vložen z vlogo za pridobitev dovoljenja za promet s cepivom proti pandemski gripi (EMEA/359381/2009) in morebitnimi poznejšimi posodobitvami.
English: There are currently no data available on the use of Arepanrix in pregnancy.
Slovenian: Trenutno ni podatkov o uporabi cepiva Arepanrix med nosečnostjo.
English: If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Slovenian: Če menite, da je cepljenje nujno, mora biti takoj na voljo oprema za oživljanje za nujne primere.
English: • Adjuvant:
Slovenian: • Adjuvans:
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Slovenian: Če ste noseči, mislite, da ste noseči, nameravate zanositi, to povejte svojemu zdravniku.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Slovenian: Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) proti bolezni.
English: As with all vaccines, Arepanrix may not fully protect all persons who are vaccinated.
Slovenian: Kot druga cepiva tudi cepivo Arepanrix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: anti-HA antibody
Slovenian: anti-HA protitelesa
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Slovenian: Podatki, pridobljeni pri nosečnicah, ki so bile cepljene z drugačnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne nakazujejo na malformacije ali toksične učinke na plod ali novorojenca.
English: Before the vaccine is mixed:
Slovenian: Pred premešanjem cepiva:
English: Pharmacovigilance The Applicant/MAH commits to support a Postauthorisation study in immunocompromised subjects (adults with HIV) being conducted by PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) and provide the final result
Slovenian: Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl postavtorizacijsko študijo pri imunsko oslabelih osebah (odrasli s HIV), ki jo izvaja PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network), in da bo posredoval končne rezultate.
English: Excipients: the vaccine contains 5 micrograms thiomersal
Slovenian: Pomožne snovi: Cepivo vsebuje 5 mikrogramov tiomersala.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Slovenian: Dokazano je bilo, da je cepivo, pripravljeno za uporabo, pri temperaturi 25°C kemijsko in fizikalno stabilno 24 ur.
English: Important information about some of the ingredients of Arepanrix This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva Arepanrix To cepivo vsebuje kot konzervans tiomersal, ki lahko povzroči alergijsko reakcijo.
English: Prospective cohort: initiated 23 Oct 2009; First endpoints available in Feb
Slovenian: Prospektivna kohorta: začetek 23. oktobra 2009, prve končne točke bodo na voljo februarja
English: The MAH should check regarding the possible confounding layouts with other pandemic vaccine supplied in EU.
Slovenian: Imetnik dovoljenja za promet mora preveriti morebitne možnosti zamenjave načrtov z drugimi pandemskimi cepivi, ki so na trgu v EU.
English: Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Arepanrix after an interval of at least three weeks.
Slovenian: Osebe, ki so dobile cepivo proti sezonski gripi brez adjuvansa, lahko dobijo cepivo Arepanrix po presledku vsaj treh tednov.
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Slovenian: Če pa se sočasni uporabi ni mogoče izogniti, je treba cepiva injicirati v različne okončine.
English: You should discuss with your doctor whether you should receive Arepanrix.
Slovenian: Posvetujte se z zdravnikom, ali morate dobiti cepivo Arepanrix.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have also been reported:
Slovenian: Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
English: 4all subjects seronegative prior to vaccination
Slovenian: 4Vsi preiskovanci so bili pred cepljenjem seronegativni.
English: 6-9 years
Slovenian: 6-9 let
English: If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Slovenian: Če je uporabljen drugi odmerek, mora biti med prvim in drugim odmerkom presledek vsaj treh tednov.
English: Adults including the elderly and children from the age of 10 years onwards: A dose (0.5 ml) of the vaccine will be given
Slovenian: Odrasli, vključno s starejšimi osebami in otroki od 10. leta naprej Dobili boste en odmerek (0,5 ml) cepiva.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Slovenian: Cepljenje je treba opraviti z intramuskularnim injiciranjem, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
English: B-1330 Rixensart Belgium
Slovenian: B-1330 Rixensart Belgija
English: 21 days after 2nd dose
Slovenian: 21. dni po 2. odmerku
English: If any of these side effects occur, please tell your doctor or nurse immediately.
Slovenian: Če se pojavi kateri od teh neželenih učinkov, morate to nemudoma povedati zdravniku ali medicinski sestri.
English: Pharmacovigilance The Applicant/MAH commits to support an effectiveness study with Arepanrix ongoing and submit the results one week after being available.
Slovenian: Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl študijo učinkovitosti cepiva Arepanrix, ki že poteka, in bo predložil rezultate en teden potem, ko bodo na voljo.
English: 2.5 ml per vial.
Slovenian: 2,5 ml na vialo
English: Antigen suspension for injection 50 vials: suspension
Slovenian: suspenzija antigena za injiciranje 50 vial: suspenzija
English: It is recommended that subjects who receive a first dose of Arepanrix should complete the vaccination course with Arepanrix (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva Arepanrix, cepljenje tudi zaključijo s cepivom Arepanrix (glejte poglavje 4.4).
English: Immune response to A/Vietnam/1194/2004
Slovenian: Imunski odziv na A/Vietnam/1194/2004
English: * propagated in eggs ** haemagglutinin
Slovenian: * namnožen v jajcih ** hemaglutinin
English: Animal studies with Arepanrix do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih, opravljene s cepivom Arepanrix, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).