FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: PRILOGA III Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
English: If liver function tests show pathological results your doctor will ask you to discontinue intake/use of <Product Name> immediately.
Slovenian: Če testi delovanja jeter kažejo patološke rezultate, bo vaš zdravnik nemudoma prekinil jemanje/uporabo < zdravila {X} >.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z <zdravnikom> <ali> <,> <farmacevtom> <ali> <medicinsko sestro>.
English: Very common: Liver enzymes increased Frequency not known: Hepatitis, liver failure
Slovenian: Zelo pogosti: zvišanje jetrnih encimov Neznana pogostnost: vnetje jeter (hepatitis), odpoved jeter
English: < Product Name > must only be used if treatment with other analgesics (e.g. non-steroidal antiinflammatory drugs, weak opioids) is contraindicated.
Slovenian: < Zdravilo {X} > se sme uporabljati le, če je zdravljenje z drugimi analgetiki (npr. nesteroidnimi protivnetnimi zdravili, šibkimi opioidi) kontraindicirano.
English: If abnormal liver function tests or clinical symptoms consistent with liver disease occur, treatment with <Product Name> must be discontinued.
Slovenian: Če se pojavijo nenormalni izvidi jetrnih testov ali klinični simptomi značilni za bolezen jeter, je treba zdravljenje z < zdravilom {X} > prekiniti.
English: What you need to know before you use < product name > [The wording below should be inserted in the relevant sections]
Slovenian: Kaj morate vedeti, preden boste vzeli < zdravilo {X} > [Spodaj navedeno besedilo je potrebno vključiti v ustrezne odstavke]
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: If you observe any symptoms that may indicate hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal discomfort, fatigue, dark urine, jaundice, pruritus) you have to discontinue intake/use of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Slovenian: Če opazite simptome, ki bi lahko kazali na poškodbo jeter med zdravljenjem z < zdravilom {X} > (npr. izguba apetita, siljenje na bruhanje, bruhanje, bolečine v trebuhu, utrujenost, temen urin, zlatenica, srbenje), morate prekiniti z jemanjem/uporabo < zdravila {X} > in nemudoma poiskati zdravniško pomoč, če se pojavijo takšni simptomi.
English: Section 4.5 Interaction with other medicinal products and other forms of interaction [The wording below should be inserted in this section]
Slovenian: Poglavje 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
English: Patients should be advised to remain vigilant for any symptoms compatible with hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, pruritus) and to discontinue intake of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Slovenian: Bolnikom je treba svetovati, naj bodo med zdravljenjem z < zdravilom {X} > pozorni na morebitne simptome značilne za poškodbo jeter (npr. izguba apetita, navzea, bruhanje, bolečine v trebuhu, utrujenost, temen urin, zlatenica, srbenje) in naj prenehajo z jemanjem < zdravila {X} > ter nemudoma poiščejo zdravniško pomoč, če se pojavijo takšni simptomi.
English: [All pharmaceutical forms]
Slovenian: [Peroralne farmacevtske oblike in svečke]
English: [The wording below should be inserted at the end of this section]
Slovenian: [Naslednje besedilo je treba vnesti na konec tega poglavja]
English: <Product Name> should not be used in patients with pre-existing liver disease or alcohol abuse.
Slovenian: < Zdravila {X} > se ne sme uporabljati pri bolnikih z že obstoječo boleznijo jeter ali bolnikih, ki zlorabljajo alkohol.
English: <Product name > must only be used if treatment with other analgesics is contraindicated.
Slovenian: < Zdravilo {X} > se sme uporabljati le, če je zdravljenje z drugimi analgetiki kontraindicirano.
English: [The wording below should be inserted in this section]
Slovenian: [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
English: Your doctor will test liver function every week during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Slovenian: Vaš zdravnik bo opravil preiskave delovanja jeter vsak teden med zdravljenjem z < zdravilom {X} >, ker so v povezavi s terapijo s flupirtinom poročali o povišani ravni jetrnih encimov, hepatitisu in odpovedi jeter.
English: Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.5).
Slovenian: Sočasni uporabi flupirtina z drugimi zdravili, ki povzročajo z zdravili inducirano poškodbo jeter, se je potrebno izogibati (glejte poglavje 4.5).
English: Section 4.8 Undesirable effects [The wording below should be inserted in this section]
Slovenian: Poglavje 4.8 Neželeni učinki [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
English: Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.3).
Slovenian: Sočasni uporabi flupirtina z drugimi zdravili, ki povzročajo z zdravili inducirano poškodbo jeter, se je potrebno izogibati (glejte poglavje 4.3).
English: Not known: Hepatitis, liver failure.
Slovenian: Neznana pogostnost: hepatitis, odpoved jeter.
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Slovenian: [Peroralne farmacevtske oblike in svečke] Ne <jemljite> <uporabljajte> zdravila X: če imate že obstoječo bolezen jeter če ste alkoholik če sočasno uporabljate druga zdravila, za katere je znano, da povzročajo z zdravili povzročeno poškodbo jeter
English: Do not use <Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Slovenian: Ne <jemljite> <uporabljajte> zdravila X: če imate že obstoječo bolezen jeter če ste alkoholik če sočasno uporabljate druga zdravila, za katere je znano, da povzročajo z zdravili povzročeno poškodbo jeter
English: How to take < product name > [the wording below should be inserted in the relevant sections]
Slovenian: Kako jemati < zdravilo {X} > [Spodaj navedeno besedilo je potrebno vključiti v ustrezne odstavke]
English: Liver function tests must be performed at weekly intervals during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Slovenian: V tedenskih presledkih med zdravljenjem z < zdravilom {X} > je potrebno opraviti jetrne teste, ker so v povezavi s terapijo s flupirtinom poročali o povišani ravni jetrnih encimov, hepatitisu in odpovedi jeter.
English: B. Package Leaflet <This medicine is subject to additional monitoring.
Slovenian: < Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: [100 mg IR pharmaceutical form, suppositories] Flupirtine should be administered at the lowest effective dose for the shortest duration necessary to achieve adequate analgesia.
Slovenian: [100 mg farmacevtska oblika s takojšnjim sproščanjem, svečke] Flupirtin je potrebno uporabljati v najnižjem učinkovitem odmerku najkrajši možni čas, ki je potreben za doseg ustrezne analgezije.
English: [All pharmaceutical forms] Liver disorders:
Slovenian: [Vse farmacevtske oblike] Bolezni jeter, žolčnika in žolčevodov:
English: [100 mg IR pharmaceutical form, suppositories] Flupirtine should be used at the lowest effective dose for the shortest duration necessary to achieve adequate pain relief.
Slovenian: [100 mg farmacevtska oblika s takojšnjim sproščanjem, svečke] Flupirtin je potrebno uporabljati v najnižjem učinkovitem odmerku najkrajši možni čas, ki je potreben za lajšanje bolečine.
English: Section 4.3 Contraindications [The wording below should be inserted in this section]
Slovenian: Poglavje 4.3 Kontraindikacije [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
English: [Oral pharmaceutical forms and suppositories] Patients with pre-existing liver disease or alcohol abuse must not take <Product Name>.
Slovenian: Bolniki z že obstoječo boleznijo jeter ali bolniki, ki zlorabljajo alkohol, ne smejo jemati < zdravila {X} >.
English: What < product name > is and what it is used for [This section should replace any existing one and should read as follows:] [Oral pharmaceutical forms and suppositories] Treatment of acute pain in adults.
Slovenian: Kaj je < zdravilo {X} > in za kaj ga uporabljamo [Ta del mora zamenjati obstoječega in se glasi:]
English: Section 4.4 Special warnings and precautions for use
Slovenian: Poglavje 4.2 Odmerjanje in način uporabe
English: [Oral pharmaceutical forms and suppositories] Treatment of acute pain in adults.
Slovenian: Zdravljenje akutne bolečine pri odraslih.
English: Section 4.2 Posology and method of administration [The wording below should be inserted in this section]
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi [V to poglavje je potrebno vključiti spodaj navedeno besedilo]
English: Flupirtine should be administered for the shortest duration necessary to achieve adequate analgesia.
Slovenian: [400 mg farmacevtska oblika s prirejenim sproščanjem] Flupirtin je potrebno uporabljati najkrajši možni čas, ki je potreben za doseg ustrezne analgezije.
English: Number of cases Number of individuals*
Slovenian: Število primerov Število oseb*
English: Use with hormonal contraceptives
Slovenian: Uporaba s hormonskimi kontraceptivi
English: Date of first authorisation: 20 September 2006
Slovenian: Datum prve odobritve: 20. september 2006 Datum zadnjega podaljšanja: 20. julij 2011
English: 1 dose (0.5 ml) contains approximately:
Slovenian: 1 odmerek (0,5 ml) vsebuje približno:
English: % Efficacy
Slovenian: % učinkovitosti
English: Results of individual studies support the results from the combined analysis.
Slovenian: Rezultati posameznih študij podpirajo rezultate združene analize.
English: All three doses should be given within a 1-year period.
Slovenian: Vse tri odmerke je treba dati v obdobju 1 leta.
English: Silgard should be administered as soon as possible after being removed from the refrigerator.
Slovenian: Cepivo Silgard je treba uporabiti čim prej potem, ko ga vzamete iz hladilnika.
English: HIV infection was an exclusion criterion (see also section 4.4).
Slovenian: Okužba s HIV je bila izključitveni kriterij (glejte tudi poglavje 4.4).
English: Other medicines or vaccines and Silgard
Slovenian: Druga zdravila ali cepiva in cepivo Silgard
English: Efficacy against PIN grades
Slovenian: Učinkovitost proti PIN stopenj
English: At the end of this period Silgard should be used or discarded.
Slovenian: Ob koncu tega obdobja je treba cepivo Silgard ali uporabiti ali zavreči.
English: Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C.
Slovenian: Podatki iz stabilnostnih študij kažejo, da so komponente cepiva stabilne 72 ur pri shranjevanju pri temperaturi od 8 °C do 42 °C.
English: In this study, a durable protection was statistically demonstrated to approximately 10 years.
Slovenian: V tej študiji je bilo trajanje zaščite statistično ocenjeno na približno 10 let.
English: The results are summarised in Table 3.
Slovenian: Ti rezultati so povzeti v preglednici 3.
English: Afterwards, the GMTs declined through Month 24 - 48 and then generally stabilized.
Slovenian: Pozneje so se geometrijski srednji titri od 24. do 48. meseca zniževali in se nato na splošno stabilizirali.
English: The duration of protection is currently unknown.
Slovenian: Trajanje zaščite trenutno ni znano.
English: If you are from 9 to and including 13 years of age
Slovenian: Če ste stari od 9 do vključno 13 let
English: Long-term follow-up studies are currently ongoing to determine the duration of protection (see
Slovenian: Trenutno potekajo študije dolgotrajnega spremljanja, ki bodo pokazale trajanje zaščite (glejte
English: However, these data are insufficient to recommend use of Silgard during pregnancy.
Slovenian: Vendar pa ti podatki ne zadostujejo za priporočilo uporabe cepiva Silgard med nosečnostjo.
English: Headache was also seen.
Slovenian: Poročali so tudi o glavobolu.
English: The median duration of follow-up was 2.9 years.
Slovenian: Mediani čas spremljanja je bil 2,9 leta.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
English: For the 10 individual HPV types, statistical significance was only reached for HPV 31.
Slovenian: Za 10 posameznih tipov HPV je bila statistična značilnost dosežena samo pri HPV 31.
English: Efficacy was measured starting after the Month 7 visit.
Slovenian: Učinkovitost so začeli meriti po obisku v 7. mesecu.
English: A subset of individuals enrolled in the Phase III studies was followed up for a long-term period for safety, immunogenicity and effectiveness.
Slovenian: Podskupino oseb, vključenih v študije III. faze, so dolgotrajno spremljali glede varnosti, imunogenosti in učinkovitosti.
English: Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
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
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
English: Silgard is a vaccine.
Slovenian: Silgard je cepivo.
English: It is important that procedures are in place to avoid injury from faints.
Slovenian: Pomembno je, da so na voljo ukrepi za preprečitev poškodbe zaradi omedlevice.
English: The exact duration of immunity following a 3-dose series has not been established and is currently being studied.
Slovenian: Natančno trajanje imunosti po cepljenju s 3 odmerki ni ugotovljeno in ga trenutno preučujejo.
English: The safety profile was similar to non-HIV infected subjects in other studies.
Slovenian: Varnostni profil je bil podoben kot pri s HIV neokuženih osebah v drugih študijah.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: • has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.
Slovenian: • oslabljen imunski sistem, npr. zaradi genetske okvare, okužbe z virusom HIV ali zdravil, ki vplivajo na imunski sistem.
English: EXP MM/YYYY
Slovenian: EXP MM/LLLL
English: The duration of protection against anal cancer is currently unknown.
Slovenian: Trajanje zaščite proti raku anusa trenutno ni znano.
English: These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Slovenian: Ti podatki so namenjeni kot vodilo zdravstvenim delavcem le v primeru prehodnih nihanj temperature.
English: 20 micrograms 40 micrograms 40 micrograms 20 micrograms.
Slovenian: 20 mikrogramov 40 mikrogramov 40 mikrogramov 20 mikrogramov
English: • First injection: at chosen date
Slovenian: • Prva injekcija: ob izbranem času
English: Evidence of Anamnestic (Immune Memory) Response
Slovenian: Dokaz anamnestičnega odziva (imunskega spomina)
English: What you need to know before you receive Silgard
Slovenian: Kaj morate vedeti, preden boste prejeli cepivo Silgard
English: The median duration of follow-up for this study was 4.0 years.
Slovenian: Mediani čas spremljanja te študije je bil 4,0 leta.
English: Pharmacotherapeutic group: Viral Vaccine, ATC code: J07BM01
Slovenian: Farmakoterapevtska skupina: Virusna cepiva, oznaka ATC: J07BM01
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Slovenian: Še naprej morate upoštevati zdravnikova navodila o brisih materničnega vratu/Pap testih in preventivnih ter zaščitnih
English: • you or your child suffer from an illness with high fever.
Slovenian: • če imate vi ali vaš otrok bolezen z močno zvišano telesno temperaturo.
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity.
Slovenian: Razlike so bile < 10 %, v večini primerov pa so poročali, da je bil neželeni učinek blag do zmeren.
English: The safety and efficacy of Silgard in children below 9 years of age have not been established.
Slovenian: Varnost in učinkovitost cepiva Silgard pri otrocih, mlajših od 9 let, nista bili dokazani.
English: • The vaccine should be used as supplied.
Slovenian: • Cepivo morate uporabiti, kot je pripravljeno.
English: Silgard is intended to prevent these diseases.
Slovenian: Cepivo Silgard je namenjeno preprečitvi teh bolezni.
English: Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Silgard worldwide.
Slovenian: Preglednica 1 vključuje tudi dodatne neželene učinke, o katerih so spontano poročali v obdobju trženja cepiva Silgard po vsem svetu.
English: Side effects that have been reported during marketed use include:
Slovenian: Neželeni učinki, o katerih so poročali v času trženja:
English: * Post-Marketing adverse events (frequency cannot be estimated from the available data).
Slovenian: * Neželeni učinki v obdobju trženja zdravila (pogostnosti ni mogoče oceniti iz razpoložljivih
English: Impact on Biopsy and Definitive Therapy Procedures
Slovenian: Vpliv na postopke biopsije in dokončnega zdravljenja
English: Seroconversion to all four antigens occurred in more than ninety-six percent of the subjects.
Slovenian: Serokonverzija za vse štiri antigene se je pojavila pri več kot 96 odstotkih oseb.
English: Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Slovenian: Opomba: Ocenjene vrednosti in intervali zaupanja so prilagojeni glede na čas spremljanja osebe.
English: What Silgard is and what it is used for What you need to know before you receive Silgard
Slovenian: Kaj je cepivo Silgard in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Silgard
English: n % of seropositive subjects
Slovenian: n % seropozitivnih oseb
English: The use of Silgard should be in accordance with official recommendations.
Slovenian: Cepivo Silgard je treba uporabljati v skladu z uradnimi priporočili.
English: Name and address of the manufacturers of the biological active substances
Slovenian: Ime in naslov izdelovalcev bioloških zdravilnih učinkovin
English: Talk to your doctor, pharmacist or nurse before vaccination if you or your child
Slovenian: Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate vi ali vaš otrok:
English: The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Slovenian: Primarna analiza vseh vnaprej določenih opazovanih dogodkov po 3 letih ni dosegla statistične značilnosti.
English: MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Slovenian: Populacija MSM ima večje tveganje za analno okužbo s HPV kot splošna populacija; za absolutno korist cepljenja za preprečevanje analnega raka v splošni populaciji se pričakuje, da je zelo majhna.
English: Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Slovenian: Kaže, da uporaba hormonskih kontraceptivov ni vplivala na imunski odziv na cepivo Silgard.
English: These adverse reactions usually were mild or moderate in intensity.
Slovenian: Ti neželeni učinki so bili po navadi blagi ali zmerni.
English: Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Slovenian: Ker gre za učinke, poročane prostovoljno in iz populacije, katere velikost je negotova, ni vedno mogoče zanesljivo oceniti njihove pogostnosti ali ugotoviti vzročne povezanosti z izpostavljenostjo cepivu.
English: Silgard may not have an optimal effect if: • used with medicines that suppress the immune system.
Slovenian: Optimalni učinek cepiva Silgard morda ne bo dosežen: • v primeru sočasne uporabe zdravil, ki zavirajo imunski sistem.
English: Efficacy results are presented for the combined analysis of study protocols.
Slovenian: Na voljo so rezultati o učinkovitosti iz združene analize študijskih protokolov.
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccine administration.
Slovenian: Zato je treba cepljene osebe po cepljenju opazovati približno 15 minut.
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
Slovenian: • motnje strjevanja krvi (bolezen, pri kateri neobičajno pogosto krvavite), na primer hemofilijo;
English: Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen.
Slovenian: Zato je pomembno, da se pri celotni shemi odmerjanja uporablja enako cepivo.
English: 40 micrograms
Slovenian: 40 mikrogramov
English: The data on Silgard administered during pregnancy did not indicate any safety signal.
Slovenian: Podatki o uporabi cepiva Silgard med nosečnostjo niso pokazali nobenega signala glede varnosti.
English: Silgard may be given to women who are breast-feeding or intend to breast-feed.
Slovenian: Cepivo Silgard se lahko daje ženskam, ki dojijo ali nameravajo dojiti.
English: These data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity.
Slovenian: Ti podatki o nosečnicah (več kot 1.000 izpostavljenih izidov) ne kažejo malformacijskih učinkov ali toksičnih učinkov na plod/novorojenčka.
English: During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Slovenian: Med programom kliničnega razvoja so pri 3.819 ženskah (cepivo = 1.894, placebo = 1.925) poročali o vsaj eni nosečnosti.