FrancophonIA/ELRC3.0 huggingface dataset:
English: BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX).
Slovenian: BeneFIX 2.000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2.000 i.e. nonakoga alfa (rekombinantni koagulacijski faktor IX).
English: Potentially life-threatening anaphylactic/anaphylactoid reactions have occurred with factor IX products, including BeneFIX.
Slovenian: Pri zdravilih s faktorjem IX, vključno z zdravilom BeneFIX, so se pojavile anafilaktične/anafilaktoidne reakcije, ki so lahko bile življenjsko ogrožajoče.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 100 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 100 i.e. nonakoga alfa.
English: You may notice a difference in the dose you receive if you are changing from a plasma-derived factor IX product to BeneFIX.
Slovenian: Ob prehodu s faktorja IX, pridobljenega iz plazme, na zdravilo BeneFIX boste morda opazili razliko v odmerku.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 600 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 600 i.e. nonakoga alfa.
English: Ensuring that the syringe plunger rod is still fully depressed, invert the vial.
Slovenian: Prepričajte se, da je bat brizge še vedno do konca potisnjen navzdol, in zasukajte vialo s spodnjim koncem navzgor.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 50 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 50 i.e. nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 300 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 300 i.e. nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 400 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 400 i.e. nonakoga alfa.
English: After reconstitution with the accompanying 5 mL (0.234%) sodium chloride solution for injection, each mL of the solution contains approximately 200 IU nonacog alfa.
Slovenian: Po rekonstituciji s priloženimi 5 ml (0,234-odstotne) raztopine natrijevega klorida za injekcije en mililiter raztopine vsebuje približno 200 i.e. nonakoga alfa.
English: In such cases, the Western blot method is negative.
Slovenian: V takšnih primerih je metoda Western blot negativna.
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 19 October 2014
Slovenian: Datum prve odobritve: 19. oktober 2009 Datum zadnjega podaljšanja: 19. oktober 2014
English: However, the relevance for clinical protection is unknown.
Slovenian: Vendar pa pomen za klinično zaščito ni znan.
English: • Format of the simplified PSUR:
Slovenian: • Format za poenostavljeno poročilo PSUR:
English: - First data-lock point is 30 days later.
Slovenian: - Prvo zaključeno obdobje zbiranja podatkov je 30 dni pozneje.
English: These reactions usually disappear within 1-2 days without treatment.
Slovenian: Te reakcije navadno izginejo v 1 do 2 dneh brez zdravljenja.
English: Adults and elderly: 0.5 ml at an elected date.
Slovenian: Odrasli in starejši: 0,5 ml na izbrani datum.
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Slovenian: Uporabljajo se naslednje starostne skupine: < 2 leti, 2-8 let, ≥ 9 let.
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Slovenian: - „Kumulativno“ pomeni od začetka uporabe cepiva; dogodki, o katerih v obdobju interesa niso poročali, se v teh tabelah ne predstavijo.
English: The following principles should be followed when compiling the data:
Slovenian: Pri zbiranju podatkov se upoštevajo naslednja načela:
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Slovenian: Znaki pandemične gripe so podobni kot pri običajni gripi, vendar so lahko resnejši.
English: Those which have not yet been entered should be reported in the following S-PSUR.
Slovenian: Dogodki, ki še niso bili vneseni, bodo vključeni v naslednje poročilo S-PSUR.
English: 1 Based on the assumption that product name will not be provided in a significant proportion of cases.
Slovenian: 1 Na podlagi predpostavke, da v znatnem številu primerov ime zdravila ne bo znano.
English: - Italy Store in a refrigerator.
Slovenian: - Italija Shranjujte v hladilniku.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Slovenian: zoženo SMQ „Demielinacija“ (ker je GBS tudi vključen v to SMQ, se bodo številni primeri za ti dve kategoriji prekrivali).
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Slovenian: Priskrbeti je treba kratek povzetek, ki potrdi signale in v katerem so poudarjena področja, ki povzročajo skrbi, ob upoštevanju informacij, ki izhajajo iz prospektivne kohortne študije, opisane v poglavju 4.5.
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Slovenian: Pandemična gripa je vrsta gripe, ki se pojavlja v presledkih, ki trajajo od manj kot 10 let do več desetletij.
English: • Frequency of submission:
Slovenian: • Pogostnost predložitve:
English: It spreads rapidly around the world.
Slovenian: Pandemična gripa se zelo hitro širi po svetu.
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Slovenian: V primeru več signalov se lahko da prednost obdelavi signalov in določijo ustrezni roki za predložitev poročila o ocenitvi vseh signalov.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Pred uporabo cepiva natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: It is important that procedures are in place to avoid injury from faints.
Slovenian: Pomembno je, da so uvedeni postopki, s katerimi se preprečijo telesne poškodbe zaradi omedlevice.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
Slovenian: Med pandemijo bo predlagatelj opravil prospektivno kohortno študijo, kot je opredeljeno v načrtu farmakovigilance.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Slovenian: Če stanje pandemije dovoljuje, je treba imunizacijo pri bolnikih s hudo febrilno boleznijo ali akutno okužbo preložiti.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Slovenian: Ti prehodni lažno pozitivni rezultati so lahko posledica nastajanja IgM kot odziv na cepivo.
English: Results are shown by SRH.
Slovenian: Rezultati so prikazani s pomočjo SRH.
English: It is best to see how Foclivia affects you before you try these activities.
Slovenian: Najbolje je, da preskusite, kako zdravilo Foclivia vpliva na vas, preden začnete s temi dejavnostmi.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Slovenian: - Vsi nemedicinsko potrjeni dogodki so tisti, ki so bili vneseni v bazo podatkov do konca zaključenega obdobja zbiranja podatkov.
English: See section 6.5 for the number of doses per vial.
Slovenian: Glejte poglavje 6.5 za število odmerkov v viali.
English: Immunogenicity was assessed in a subset (n=197) of the study population.
Slovenian: Imunogenost so ocenili v podskupini (n = 197) populacije študije.
English: The vaccine contains an ‘adjuvant' (a compound containing squalene) to stimulate a better response.
Slovenian: Cepivo vsebuje „adjuvans“ (spojino, ki vsebuje skvalen) za spodbujanje boljšega odziva.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Slovenian: Poročilo mora vsebovati naslednje tabele združenih podatkov (izdelane z dogovorjenimi predlogami, priloženimi v Prilogi 2).
English: Foclivia should be used in accordance with Official Guidance.
Slovenian: Zdravilo Foclivia je treba uporabljati v skladu z uradnimi smernicami.
English: It should be noted that the adverse reactions may be intensified.
Slovenian: Treba je biti pozoren na to, da so lahko neželeni učinki okrepljeni.
English: Very rare (<1/10,000):
Slovenian: Zelo redki (< 1/10.000):
English: In such cases, the side effects may be more intense).
Slovenian: V takšnih primerih so učinki lahko močnejši.
English: Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Slovenian: Na voljo so podatki, ki nakazujejo, da se večodmerne viale lahko uporabljajo največ 72 ur po odvzemu prvega odmerka, čeprav tako dolgo obdobje shranjevanja ni zaželeno.
English: The safety and efficacy of Foclivia in subjects under 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Foclivia pri preiskovancih, starih do 18 let, še nista bili dokazani.
English: - All tables will be based on generic and not product-specific data1.
Slovenian: - Vse tabele bodo zasnovane na generičnih podatkih, ne pa na podatkih za specifična zdravila1.
English: Tell your doctor if you have any known allergies.
Slovenian: Zdravnika obvestite, če imate katero koli dokazano alergijo.
English: Do not throw away any medicines via wastewater or household waste.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali gospodinjske odpadke.
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki pri preiskovancih, starih od 6 mesecev do 18 let, so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Slovenian: - Čas se začne meriti prvi ponedeljek po dostavi prve serije cepiva.
English: Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Slovenian: Zdravilo Foclivia vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
English: Fertility No fertility data are available.
Slovenian: Plodnost Podatki glede plodnosti niso na voljo.
English: - A line listing of fatal cases will be provided in an Annex.
Slovenian: - V prilogi bodo našteti vsi fatalni primeri.
English: NA*** N=69
Slovenian: n/s*** n = 69
English: NA***
Slovenian: n/s***
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Slovenian: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italija.
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Slovenian: Cepiva za pripravljenost na pandemijo vsebujejo antigene gripe, ki so razlikujejo od antigenov trenutno prisotnih virusov gripe.
English: None of the ingredients in the vaccine can cause flu.
Slovenian: Nobena sestavina cepiva ne povzroča gripe.
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Slovenian: V času pandemične situacije je treba vire osredotočiti na pravočasno in učinkovito nadziranje profila varnosti cepiva proti gripi, ki se uporablja v času pandemije.
English: A protective response may not be elicited in all vaccine recipients (see section 5.1).
Slovenian: Zaščitni odziv morda ne bo sprožen pri vseh prejemnikih cepiva (glejte poglavje 5.1).
English: Foclivia has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo Foclivia je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: • Post-marketing surveillance
Slovenian: • Nadzor v obdobju trženja
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy
Slovenian: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italija
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 in upravljanja s stroji.
English: Adjuvant MF59C.1 containing: Squalene
Slovenian: Adjuvans MF59C.1 vsebuje: skvalen
English: NA*** N=36
Slovenian: n/s*** n = 36
English: They are isolated from the surface of influenza virus particles, which are grown in fertilised hen's eggs from healthy chicken flocks and inactivated with formaldehyde.
Slovenian: Izolirani sta iz delcev plašča virusa gripe, ki jih gojijo v oplojenih kokošjih jajcih iz jat zdravih piščancev in ki so inaktivirani s formaldehidom.
English: 7.5 micrograms**
Slovenian: 7,5 mikrogramov**
English: As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.
Slovenian: Kot vsa cepiva tudi zdravilo Foclivia morda popolnoma ne zaščiti vseh cepljenih oseb.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroj
English: Excipients: Thiomersal
Slovenian: Pomožne snovi: tiomersal
English: This is a multidose container.
Slovenian: To je vsebnik z več odmerki.
English: MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Slovenian: Podobno kot rezultati SRH kažejo tudi rezultati MN močan imunski odgovor po končani seriji primarnega cepljenja v populaciji starejših oseb.
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Slovenian: Lahko se zgodi, da bo 6-mesečni cikel predolg za varnostni nadzor cepiva proti pandemični okužbi, pri katerem se pričakuje visoka raven izpostavljenosti v kratkem časovnem obdobju.
English: Product-specific data can be evaluated during signal work-up.
Slovenian: Podatki za specifična zdravila se lahko ocenijo med prvo obdelavo signalov.
English: This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Slovenian: Cepivo je skladno s priporočili SZO in odločbo EU za pandemijo.
English: Some side effects listed in Section 4.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8.
English: Focetria (H1N1v)
Slovenian: Zdravilo Focetria (H1N1v)
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Kot pri vseh cepivih, ki se injicirajo, morata biti ustrezno zdravljenje in zdravstveni nadzor vedno na voljo za primer redkih anafilaktičnih dogodkov po uporabi cepiva.
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Slovenian: Vendar, če je sočasno cepljenje z drugim cepivom indicirano, je treba imunizacijo opraviti na ločenih okončinah.
English: No data are available in children aged less than 6 months.
Slovenian: Podatki pri otrocih, starih do 6 mesecev, niso na voljo.
English: Depending on and after implementation of vaccine when first pandemic will take place.
Slovenian: Odvisno od uporabe cepiva in po uporabi cepiva v primeru prve pandemije.
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Slovenian: Imunski odziv na cepljenje, ocenjen s testom MN, je v skladu z rezultati, pridobljenimi s testom SRH.
English: The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Slovenian: Odstotek oseb, ki so navedle lokalne neželene učinke, je bil večji v starejših skupinah, zlasti zaradi pogostejših navedb o bolečini.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Slovenian: Vendar je v primeru pandemije lahko cepljenje s tem cepivom primerno, če je takoj na voljo oprema za oživljanje za nujne primere.
English: Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines.
Slovenian: Ker je priporočljivo cepljenje z drugim odmerkom, je treba opozoriti, da ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki podpirajo zamenljivost zdravila Foclivia z drugimi monovalentnimi cepivi H5N1.
English: What Foclivia is and what it is used for
Slovenian: Kaj je zdravilo Foclivia in za kaj ga uporabljamo
English: Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Slovenian: Med pandemijo bo predlagatelj zbral podatke o klinični varnosti in učinkovitosti pandemičnega cepiva in te podatke predložil v oceno komisiji CHMP.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Slovenian: Ko se CHMP strinja, da poročila S-PSUR več niso potrebna, se v časovnem obdobju, dogovorjenem s poročevalcem, predloži celotno poročilo PSUR, ki pokriva obdobje od zaključenega obdobja zbiranja podatkov zadnjega običajnega poročila PSUR.
English: These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
Slovenian: Virusne beljakovine so pripravljene iz seva virusa gripe, ki je skladen s priporočili Svetovne zdravstvene organizacije in odločbo EU pri uradno razglašeni pandemiji.
English: The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Slovenian: Adjuvans vsebuje tudi polisorbat 80 in sorbitantrioleat v citratnem pufru (natrijev citrat, citronska kislina).
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Slovenian: To lahko spremlja več nevroloških znakov, kot so prehodna motnja vida, parestezija in tonično-klonični gibi udov med okrevanjem.
English: Only spontaneously reported data should be included in the PSUR.
Slovenian: V poročilo PSUR se vključijo samo podatki, o katerih se poroča spontano.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Slovenian: Zato se 6-mesečna ali letna redna dopolnjena poročila o varnosti zdravila znotraj obdobja pandemije nadomestijo z mesečnimi poenostavljenimi rednimi dopolnjenimi poročili o varnosti zdravila (S-PSUR), ki se jim predloži povzetek porazdelitve cepiva.
English: injection into the deltoid muscle
Slovenian: injiciranje v deltoidno mišico
English: Warning: Do not inject intravascularly or subcutaneously.
Slovenian: Opozorilo: Ne injicirajte intravaskularno ali subkutano.
English: Instructions for administration of the vaccine:
Slovenian: Navodila za dajanje cepiva:
English: It has to be used in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
Slovenian: Uporablja se pri odraslih (starih od 18 do 60 let) in starejših bolnikih (starejših od 60 let) za preprečevanje gripe, ki jo povzroča virus tipa H5N1.
English: - if you feel feverish, - if you have any illness or infection, - if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).
Slovenian: - če imate zvišano telesno temperaturo, - če imate katero koli bolezen ali okužbo, - če prejemate imunosupresivno zdravljenje, npr. kortikosteroide ali kemoterapijo proti raku, ali če imate kakršno koli bolezen, zaradi katere ste dovzetni za okužbe (pomanjkanje imunosti).
English: Other medicines and Foclivia
Slovenian: Druga zdravila in zdravilo FOCLIVIA
English: Children and adolescents aged 6 months to 17 years:
Slovenian: Otroci in mladostniki, stari od 6 mesecev do 17 let:
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Slovenian: * namnoženi v oplojenih kokošjih jajcih iz jat zdravih piščancev ** izraženo v mikrogramih hemaglutinina.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Slovenian: Zunaj obdobja pandemije se ohrani običajno časovno obdobje in format predložitve PSUR, in sicer s posebnim pregledom neželenih učinkov posebnega interesa in možnih neželenih učinkov, povezanih z adjuvansi.
English: narrow SMQ “Non-infectious encephalitis”
Slovenian: zoženo SMQ „Ne-infekcijski encefalitis“
English: The majority of febrile convulsions occurred in paediatric subjects.
Slovenian: Večina febrilnih konvulzij se je pojavila pri otrocih.
English: Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Slovenian: Farmakoterapevtska skupina: cepiva proti gripi, oznaka ATC: J07BB02
English: Your doctor or nurse administers the vaccine in accordance with official recommendations.
Slovenian: Cepivo vam bosta dala zdravnik ali medicinska sestra v skladu z uradnimi priporočili.
English: One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
Slovenian: En odmerek (0,5 ml) cepiva vsebuje vsaj 7,5 mikrogramov hemaglutinina iz naslednjih priporočenih sevov virusa gripe:
English: This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Slovenian: Vključeni morajo biti podatki potekajočih študij ali, če je ustrezno, dejanske uporabe sevov za pripravljenost na pandemijo in podatkov o varnosti, pomembnih za adjuvantni sistem.