FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell the doctor if you have any known allergies.
Slovenian: Povejte zdravniku, če imate znane alergije.
English: Information from non-clinical studies
Slovenian: Informacije iz nekliničnih študij
English: - if you have a severe infection with a high temperature (over 38°C).
Slovenian: - Če imate hudo okužbo z visoko telesno temperaturo (več kot 38 °C).
English: After mixing: use within 24 hours.
Slovenian: Po premešanju: uporabite v 24 urah.
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Slovenian: Cepivo ustreza priporočilu Svetovne zdravstvene organizacije in Odločbi EU za pandemijo.
English: - Other ingredients:
Slovenian: - Druge sestavine:
English: The use of a second half-dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Slovenian: Pri uporabi drugega odmerka je treba upoštevati informacije v poglavjih 4.4, 4.8 in 5.1.
English: Before use, the two components should be mixed.
Slovenian: Pred uporabo je treba ti dve sestavini premešati.
English: The safety has been assessed after each administration.
Slovenian: Varnost so ocenili po vsakem odmerku.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Slovenian: Če to velja za vas, vam bodo cepljenje verjetno prestavili na kasneje, ko se boste počutili bolje.
English: A partially used multidose vial must be discarded immediately if: - Sterile dose withdrawal has not been fully observed.
Slovenian: Delno uporabljeno večodmerno vialo takoj zavrzite, če: - Postopek sterilnega odvzema odmerka ni bil povsem upoštevan.
English: This leaflet was last approved in {MM/YYYY}
Slovenian: Navodilo je bilo zadnjič odobreno {MM/LLLL}
English: In the first few weeks after vaccination with HUMENZA the results of these tests may not be correct.
Slovenian: V prvih nekaj tednih po cepljenju s cepivom HUMENZA so lahko rezultati teh preiskav napačni.
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Slovenian: Preprečevanje gripe v uradno razglašenih pandemskih razmerah (glejte poglavji 4.2 in 5.1).
English: This means that further evidence on this medicinal product is awaited.
Slovenian: To pomeni, da se pričakuje pridobitev več podatkov o tem zdravilu.
English: Clinical data suggest that a single dose may be sufficient.
Slovenian: Klinični podatki kažejo, da morda zadošča en sam odmerek.
English: Four weeks after the last vaccine administration, ferrets were challenged with the wild type homologous strain A/H1N1/Netherlands/602/2009.
Slovenian: Štiri tedne po zadnji aplikaciji cepiva so dihurje izzvali z divjo vrsto homolognega seva A/H1N1/Netherlands/602/2009.
English: See section 6.5 for the number of doses per vial.
Slovenian: Glejte poglavje 6.5 za število odmerkov na vialo.
English: For further information, see section 5.1.
Slovenian: Za več informacij glejte poglavje 5.1.
English: The symptoms (signs) of pandemic flu are similar to those of an ordinary flu but may be more severe.
Slovenian: Simptomi pandemske gripe so podobni simptomom običajne gripe, vendar pa so lahko hujši.
English: 69007 Lyon - France
Slovenian: 69007 Lyon - Francija
English: Risk Management Plan
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: • In rare cases leading to shock (a failure of the circulatory system to maintain adequate blood flow to the different organs leading to medical emergency).
Slovenian: • v redkih primerih je prišlo do šoka (odpovedi obtočilnega sistema, ki vzdržuje ustrezni pretok krvi do različnih organov, kar je povzročilo nujen medicinski primer)
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02.
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02.
English: - No data on antibody persistence are currently available.
Slovenian: - Podatki o prisotnosti protiteles trenutno niso na voljo.
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: Spodaj našteti neželeni učinki so se pojavili v dneh ali tednih po cepljenju s cepivom, ki se rutinsko uporablja vsako leto za preprečevanje gripe.
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: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja strojev.
English: - There is any suspicion that the partially used vial has been contaminated.
Slovenian: - Sumite, da je bila delno uporabljena viala kontaminirana.
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant or if you are breastfeeding.
Slovenian: Svojega zdravnika nemudoma obvestite, če ste noseči, mislite, da ste noseči, če načrtujete nosečnost ali dojite.
English: - as with all vaccines, HUMENZA may not fully protect all persons who are vaccinated.
Slovenian: - Kot velja za vsa cepiva, morda tudi cepivo HUMENZA ne zaščiti povsem vseh cepljenih oseb.
English: The content of the multidose vial as well as the content of the syringe after withdrawal should be inspected visually.
Slovenian: Vsebino večodmerne viale in vsebino brizge po izvlečenju morate vizualno pregledati.
English: Official batch release: in accordance with Article 114 of 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: Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: For adjuvant, see section 2.
Slovenian: Za adjuvans glejte poglavje 2.
English: For instructions for preparation, see section 6.6.
Slovenian: Za navodila o pripravi glejte poglavje 6.6.
English: Clinical
Slovenian: Klinično
English: This body weight loss was reduced to ≤ 8% in animals that received 1 or 2 doses of HUMENZA.
Slovenian: Izguba telesne mase je bila za to ≤ 8 % nižja pri živalih, ki so prejele 1 ali 2 odmerka cepiva HUMENZA.
English: From post marketing surveillance with interpandemic trivalent vaccines, the following adverse events have been reported very rarely, even if an exact incidence rate cannot be precisely calculated:
Slovenian: V opazovanem obdobju po začetku trženja interpandemičnih trivalentnih cepiv so zelo redko poročali o naslednjih neželenih učinkih, čeprav natančne stopnje incidence ni možno natančno izračunati:
English: Immunogenicity data obtained at three weeks after administration of Humenza in clinical studies suggest that a single dose may be sufficient.
Slovenian: Podatki o imunogenosti, dobljeni tri tedne po uporabi cepiva Humenza v kliničnih študijah kažejo, da morda lahko zadošča en sam odmerek.
English: HUMENZA 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 HUMENZA takes due account of the officially declared pandemic strain.
Slovenian: Cepivo HUMENZA se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom HUMENZA upošteva uradno razglašen pandemski sev.
English: Before injection the vaccine should be allowed to reach room temperature by gently swirling the vial between hands (not more than 5 minutes).
Slovenian: Pred injiciranjem počakajte, da cepivo doseže sobno temperaturo, ob čemer vialo nežno obračajte med rokami (ne več kot 5 minut).
English: Local and systemic reactions occurred within 7 days following any vaccine administration.
Slovenian: Lokalne in sistemske reakcije so se pojavile v 7 dneh po apliciranju katerega koli odmerka cepiva.
English: Not computed
Slovenian: ni izračunano
English: In all age goups, the side effects listed above usually disappeared without treatment within 1 to 3 days after onset.
Slovenian: V vseh starostnih skupinah so zgoraj navedeni neželeni učinki običajno izginili brez zdravljenja v 1 do 3 dneh po pojavu.
English: To facilitate tracking and timely disposal of partially used vials, it is suggested that the date and hour of mixing be clearly written on the label of adjuvant vial.
Slovenian: Za lažje sledenje in pravočasno odstranitev delno uporabljenih vial predlagamo, da na oznako viale z adjuvansom jasno zabeležite datum in uro mešanja.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Slovenian: Zdravniki poznajo to nevarnost, zato imajo za take primere pripravljeno nujno medicinsko pomoč.
English: Four days after challenge, in the control group, 34% of the lungs were affected and presented lung lesions associated with high levels of virus replication in lung tissue (≥ 4.7 TCID50/g tissue).
Slovenian: Štiri dni po izzivu je bilo v kontrolni skupini prizadetih 34 % pljuč, kar se je kazalo s pljučnimi lezijami, povezanimi z visokimi ravnmi repliciranih virusov v pljučnem tkivu (≥ 4,7 TCID 50/g tkiva).
English: There are very limited safety and immunogenicity data available from clinical studies with HUMENZA in adults aged over 60 years of age.
Slovenian: Zelo malo je podatkov o varnosti in imunogenosti iz kliničnih študij s cepivom HUMENZA (H1N1) pri odraslih, starejših od 60 let.
English: Overall, reactions were more frequent in children and adolescents than in adults and elderly.
Slovenian: V splošnem so bile reakcije pogostejše pri otrocih in mladostnikih kakor pri odraslih in starejših.
English: Elderly (>60 years of age):
Slovenian: Starejši (> 60 let):
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, ali če ste bili cepljeni z drugim cepivom.
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding HUMENZA.
Slovenian: • 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 HUMENZA.
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 (EMA/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 pandemični gripi (EMA/359381/2009) in morebitnimi poznejšimi posodobitvami.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Slovenian: Cepil vas bo zdravnik ali medicinska sestra v skladu z uradnimi priporočili.
English: • The 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: • 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: It should be noted that the adverse reactions may be intensified.
Slovenian: Zavedati se je treba, da so lahko neželeni učinki izrazitejši.
English: • Differences in the perception of touch, pain, heat and cold (paraesthesia),
Slovenian: • razlike v zaznavanju dotika, bolečine, vročine in mraza (parestezija)
English: Repeated injections of the vaccine induced moderate local inflammation in rabbits and no exacerbation of pneumonia after exposure to the parental wild-type virus in monkeys.
Slovenian: Ponavljajoče injiciranje cepiva je povzročilo zmerno lokalno vnetje pri kuncih in nobenega poslabšanja pljučnice po izpostavitvi starševski divji vrsti virusa pri opicah.
English: It is recommended that subjects who receive a first dose of HUMENZA, complete the vaccination course with HUMENZA (see section 4.4).
Slovenian: Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva HUMENZA , cepljenje tudi zaključijo s cepivom HUMENZA (glejte poglavje 4.4).
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 vseh zgoraj naštetih primerih OBVESTITE SVOJEGA ZDRAVNIKA ALI MEDICINSKO SESTRO, saj morda cepljenje ni priporočljivo ali ga je treba prestaviti na kasneje.
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 v nujnih primerih takoj na voljo oprema za oživljanje.
English: The European Medicines Agency will review any new information on the medicine and this Summary of Product Characteristics will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo redno ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: See section 4.4. for Special warnings and special precautions for use.
Slovenian: Glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi.
English: Excipients: The vaccine contains 11.3 micrograms thiomersal.
Slovenian: Cepivo vsebuje 11,3 mikrograma tiomersala.
English: The protection against infection in the lungs was associated with vaccine-induced HI titers ≥ 40, a titer described in humans to be associated with protection against seasonal influenza.
Slovenian: Zaščita pred okužbo v pljučih je bila povezana z s cepivom induciranimi HI titri ≥ 40, kar je titer, ki se pri človeku povezuje kot zaščitni titer pred sezonsko gripo.
English: HUMENZA is a vaccine to prevent pandemic influenza (flu).
Slovenian: Cepivo HUMENZA je cepivo za preprečevanje pandemije gripe (influence).
English: Prospective cohort safety study protocol update to be submitted within one week of Commission Decision granting
Slovenian: Posodobitev protokola prospektivne kohortne študije varnosti, ki jo je treba predložiti v roku enega tedna po odločitvi Komisije za izdajo dovoljenja za promet z zdravilom.
English: The antigen is a colourless limpid to opalescent suspension.
Slovenian: Antigen je brezbarvna, bistra do opalescentna suspenzija.
English: All children aged from 3 to 8 years were seronegative prior to vaccination.
Slovenian: Vsi otroci, stari od 3 do 8 let, so bili pred cepljenjem seronegativni.
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 metode ELISA za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in še posebej proti HTLV-1.
English: EXP MM/YYYY
Slovenian: EXP: MM/LLLL
English: Important information about some of the ingredients of HUMENZA This medicine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Pomembne informacije o nekaterih sestavinah cepiva HUMENZA Zdravilo vsebuje tiomersal kot konzervans, zato boste morda imeli alergijske reakcije.
English: The ability of one or two administrations of HUMENZA to protect ferrets against infection in the lungs was evaluated.
Slovenian: Ocenili so zmožnost ene ali dveh aplikacij cepiva HUMENZA, da zaščiti dihurje pred okužbo v pljučih.
English: For all age groups: - Immunogenicity results observed with the seroneutralisation (SN) method reflect those observed
Slovenian: Za vse starostne skupine: - Rezultati imunogenosti določeni po metodi seronevtralizacije (SI) odgovarjajo rezultatom
English: All children aged from 6 to 35 months were seronegative prior to vaccination.
Slovenian: Vsi otroci, stari od 6 do 35 mesecev, so bili pred cepljenjem seronegativni.
English: In adolescents from 9 to 17 years of age, the most frequent reactions were injection site pain and headache.
Slovenian: Pri mladostnikih, starih od 9 do 17 let, sta bili najpogostejši reakciji bolečina na mestu injiciranja in glavobol.
English: Pharmacovigilance The MAH will submit the results of a prospective cohort safety study in at least 9,000 patients in different age groups, including immunocompromised subjects, in accordance with the protocol submitted with the Risk
Slovenian: Farmakovigilanca Imetnik dovoljenja za promet z zdravilom bo rezultate prospektivne kohortne študije varnosti na najmanj 9000 bolnikih iz različnih starostnih skupin, vključno z imunokomprimiranimi osebami, posredoval v skladu s protokolom, predloženim skupaj z načrtom o
English: These reactions were usually resolved spontaneously within 1 to 3 days after onset.
Slovenian: Te reakcije so spontano izzvenele v 1 do 3 dneh od pojava.
English: • Including swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases.
Slovenian: • v zelo redkih primerih so se pojavile otekline, ki so bile najbolj očitne na glavi in vratu, vključno z obrazom, ustnicami, jezikom, grlom ali drugimi deli telesa (angioedem).
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 pojavnost zvišane telesne temperature (aksilarna temperatura ≥ 38°C).
English: However, if co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Slovenian: Toda če se razmišlja o sočasni uporabi z drugim cepivom, je treba imunizacijo opraviti na drugi okončini.
English: The adjuvant, AF03, was not mutagenic or clastogenic and induced transient inflammatory changes in repeat dose toxicity studies (in rats and rabbits).
Slovenian: Adjuvans, AF03, ni mutagen ali klastogen in je povzročil prehodne vnetne spremembe v študijah toksičnosti cepljenja pri ponavljajočih se odmerkih (pri podganah in kuncih).
English: - Side effects related to the central nervous system:
Slovenian: - Z osrednjim živčnim sistemom povezani neželeni učinki:
English: Overall, systemic reactions were more frequently reported in children from 6 to 11 months compared to children from 12 to 23 months.
Slovenian: V splošnem so o sistemskih reakcijah pogosteje poročali pri otrocih, starih od 6 do 11 mesecev, v primerjavi z otroci, starimi od 12 do 23 mesecev.
English: Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain-Barré syndrome
Slovenian: Nevralgija, parestezija, febrilne konvulzije, nevrološke motnje, kot so encefalomielitis, nevritis in Guillain-Barréjev sindrom
English: Elderly 81 years of age and over
Slovenian: Starejše osebe, stare 81 let in več
English: HUMENZA should under no circumstances be administered intravascularly.
Slovenian: Cepiva HUMENZA se ne sme v nobenem primeru aplicirati intravaskularno.
English: • The MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
Slovenian: • Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
English: Moreover, a higher frequency of fever and headache was reported after the second dose than after the first dose.
Slovenian: Pogostnost zvišane telesne temperature in glavobola je bila večja po drugem odmerku kot po prvem.
English: The most frequent reaction was injection site pain.
Slovenian: Najpogostejša reakcija je bila bolečina na mestu injiciranja.
English: Overall, reactions were more frequent in adults than in elderly and less frequent after the second dose in both age groups.
Slovenian: V splošnem so bile reakcije pogostejše pri odraslih kot pri starejših bolnikih in manj pogoste po drugem odmerku v obeh skupinah.
English: - Temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia), temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy).
Slovenian: - Prehodno zmanjšanje števila nekaterih vrst delcev v krvi, ki se imenujejo trombociti; nizko število trombocitov lahko povzroči prekomerno nastajanje modric ali krvavitev (prehodna trombocitopenija), prehodno oteklost bezgavk v vratu, pod pazduho ali v dimljah (prehodna
English: What HUMENZA looks like and contents of the pack
Slovenian: Izgled cepiva HUMENZA in vsebina pakiranja
English: Pharmacovigilance The MAH commits to present a plan for the definition of the sources to collect safety data on immunocompromised patient within the prospective cohort safety study.
Slovenian: Farmakovigilanca Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo predstavil načrt za določanje virov zbiranja podatkov o varnosti pri imunokomprimitiranih bolnikih s prospektivno kohortno študijo varnosti.
English: Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile France
Slovenian: Campus Mérieux 1541, avenue Marcel Mérieux 69280 Marcy l'Etoile Francija
English: When HUMENZA is given for the first dose, it is recommended that HUMENZA (and not another vaccine against H1N1) be given for the complete vaccination course.
Slovenian: Če je za prvi odmerek uporabljeno cepivo HUMENZA, je priporočljivo, da se cepljenje tudi dokonča s cepivom HUMENZA (in ne drugim cepivom proti H1N1).
English: The MAH must ensure that the system of pharmacovigilance, as described in version 10.0 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 10.0, 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 any of these side effects occur, please tell your doctor or nurse immediately.
Slovenian: Če opazite kateregakoli od teh neželenih učinkov, takoj obvestite svojega zdravnika ali medicinsko sestro.
English: Immune system disorders: Allergic reactions, in rare cases leading to shock, angioedema
Slovenian: Bolezni imunskega sistema: Alergijske reakcije, ki so v redkih primerih povzročile šok, angioedem
English: If deviations from this description and/or any foreign particulate matter are observed (including rubber particles from the stopper), the vaccine should be discarded.
Slovenian: Če videz odstopa od tega opisa in/ali opazite tujke (vključno z delci gume od zamaška), morate cepivo zavreči.
English: In this leaflet: What HUMENZA is and what it is used for
Slovenian: KAJ JE CEPIVO HUMENZA IN ZA KAJ GA UPORABLJAMO