FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding side effects, although a large proportion of subjects develop injection site reactions, these are only slightly more than for Gardasil.
Slovenian: Kar zadeva neželene učinke, se pri velikem deležu oseb pojavijo reakcije na mestu injiciranja, vendar je njihova pojavnost le nekoliko višja kot pri zdravilu Gardasil.
English: In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache.
Slovenian: V študijah so bili najpogostejši neželeni učinki zdravila Gardasil 9 (opaženi pri več kot 1 osebi od 10) reakcije na mestu injiciranja (rdečina, bolečina in oteklina) in glavobol.
English: Other information about Gardasil 9
Slovenian: Druge informacije o zdravilu Gardasil 9
English: A risk management plan has been developed to ensure that Gardasil 9 is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Gardasil 9 je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Gardasil 9, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Gardasil 9 preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose.
Slovenian: Glavno merilo učinkovitosti je bil razvoj protiteles proti humanim papilomavirusom tipov 6, 11, 16, 18, 31, 33, 45, 52 in 58 mesec dni po tretjem odmerku.
English: Gardasil 9 is a suspension for injection available in vials or prefilled syringes.
Slovenian: Zdravilo Gardasil 9 je suspenzija za injiciranje, ki je na voljo v vialah ali napolnjenih injekcijskih brizgah.
English: The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule.
Slovenian: V okviru pete glavne študije, v katero je bilo vključenih 1 518 oseb, so primerjali učinke sheme z dvema odmerkoma zdravila Gardasil 9 s shemo s tremi odmerki.
English: What are the risks associated with Gardasil 9?
Slovenian: Kakšna tveganja so povezana z zdravilom Gardasil 9?
English: What is Gardasil 9 and what is it used for?
Slovenian: Kaj je zdravilo Gardasil 9 in za kaj se uporablja?
English: • precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus;
Slovenian: • predrakavimi lezijami (nenormalno rastjo celic) in rakom materničnega vratu, vulve, nožnice in zadnjika,
English: For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Gardasil 9 naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It contains purified proteins from the nine types of HPV listed above.
Slovenian: Vsebuje prečiščene beljakovine devetih tipov humanih papilomavirusov, navedenih zgoraj.
English: Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV.
Slovenian: Za zdravilo Gardasil 9 se pričakuje, da bo preprečilo večino rakavih obolenj materničnega vratu, nožnice in vulve ter predrakavih lezij ter tudi bradavic na spolovilih, ki so povezane s humanim papilomavirusom.
English: Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as ‘recombinant DNA technology'.
Slovenian: Zdravilo Gardasil 9 vsebuje prečiščene beljakovine L1 za devet zgoraj navedenih tipov humanega papilomavirusa, ki so pridobljene z metodo, imenovano tehnologija rekombinantne DNK.
English: For a three-dose schedule, the second dose should be given two months after the first and the third given four months after the second.
Slovenian: Pri shemi s tremi odmerki je treba dati drugi odmerek dva meseca po prvem, tretjega pa štiri mesece po drugem.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil 9, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What benefits of Gardasil 9 have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Gardasil 9 izkazalo v študijah?
English: Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all.
Slovenian: Osebe, ki po odmerku zdravila Gardasil 9 (ali cepiv Gardasil oziroma Silgard, ki sta njegova predhodnika) kažejo znake alergijske reakcije, morajo cepljenje prekiniti oziroma zdravila Gardasil 9 sploh ne smejo prejeti.
English: Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.
Slovenian: Zdravilo Gardasil 9 ščiti pred okužbo z vsemi devetimi tipi humanega papilomavirusa, kot je bilo dokazano v petih glavnih študijah.
English: The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years.
Slovenian: V okviru prve študije so raziskovali učinkovitost zdravila Gardasil 9 pri več kot 14 000 ženskah, starih od 16 do 26 let.
English: Nearly 100% of cervical cancers are caused by HPV infection.
Slovenian: Skoraj 100 % rakavih obolenj materničnega vratu povzroči okužba s humanim papilomavirusom.
English: Why is Gardasil 9 approved?
Slovenian: Zakaj je bilo zdravilo Gardasil 9 odobreno?
English: For a twodose schedule, the second dose should be given between five and thirteen months after the first dose.
Slovenian: Pri shemi z dvema odmerkoma je treba dati drugi odmerek v petih do trinajstih mesecih po prvem.
English: Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58):
Slovenian: Zdravilo Gardasil 9 je cepivo, ki se uporablja pri moških in ženskah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzroča devet tipov humanih papilomavirusov (tipi HPV 6, 11, 16, 18, 31, 33, 45, 52 in 58):
English: For the full list of all side effects reported with Gardasil 9, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gardasil 9, glejte navodilo za uporabo.
English: The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26.
Slovenian: V okviru četrte glavne študije so mesec dni po tretjem odmerku primerjali ravni protiteles proti vsem devetim tipom humanega papilomavirusa pri 1 419 moških, starih od 16 do 26 let, in pri 1 101 ženski, stari od 16 do 26 let.
English: HPV types 16 and 18 cause a large majority of cervical and anal cancers, while HPV types 6 and 11 cause most of genital warts.
Slovenian: Tipa 16 in 18 humanega papilomavirusa povzročata večino rakavih obolenj nožnice in zadnjika, tipa 6 in 11 pa večino bradavic na spolovilih.
English: It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine.
Slovenian: Priporočljivo je, da osebe, ki so prejele prvi odmerek zdravila Gardasil 9, celotno shemo cepljenja opravijo z istim cepivom.
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Slovenian: Med prvim in drugim odmerkom mora vedno preteči vsaj en mesec, med drugim in tretjim pa vsaj trije meseci.
English: human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Slovenian: devetvalentno cepivo (rekombinantno, adsorbirano) proti humanim papilomavirusom
English: Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over.
Slovenian: Običajno se daje po shemi cepljenja z dvema odmerkoma ali tremi odmerki za moške in ženske, stare od 9 do 14 let ter shemi cepljenja s tremi odmerki za moške in ženske, starejše od 15 let.
English: The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years.
Slovenian: V drugi študiji, v katero je bilo vključenih 3 066 oseb, so učinek zdravila Gardasil 9 pri dekletih in fantih, starih od 9 do 15 let, primerjali z učinkom zdravila Gardasil 9 pri mladih ženskah, starih od 16 od 26 let.
English: This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.
Slovenian: Ta študija, v kateri so proučevali razvoj protiteles mesec dni po zadnjem odmerku, je pokazala, da so imeli dečki in deklice, ki so prejeli dva odmerka zdravila Gardasil 9 podobne ravni zaščite proti vsem devetim tipom virusa kot dekleta in ženske, ki so prejele tri odmerke zdravila Gardasil 9.
English: The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types.
Slovenian: Menil je, da zdravilo Gardasil 9 zagotavlja širšo zaščito pred rakavimi obolenji kot zdravilo Gardasil, ki je njegov predhodnik, saj ščiti pred dodatnimi petimi tipi HPV (31, 33, 45, 52 in 58), ki so sicer manj razširjeni kot tipa 16 in 18, vendar prav tako spadajo med tipe humanega papilomavirusa z visokim tveganjem.
English: This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil.
Slovenian: Študija je pokazala, da je od 6 016 žensk, cepljenih s tremi odmerki zdravila Gardasil 9, za boleznijo, povezano s humanim papilomavirusom tipov 31, 33, 45, 52 ali 58, zbolela ena, od 6 017 žensk, cepljenih s tremi odmerki zdravila Gardasil, pa jih je zbolelo 30.
English: It is not intended to provide practical advice on how to use Gardasil 9.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women.
Slovenian: Študija je pokazala, da pri mladih moških in ženskah zdravilo Gardasil 9 spodbudi podobne ravni zaščite proti vsem devetim tipom virusa.
English: The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18).
Slovenian: V študiji so proučevali, pri koliko ženskah, ki so prejele zdravilo Gardasil 9, se je pojavila bolezen (nenormalna rast celic ali rakavo obolenje) zaradi okužbe s humanim papilomavirusom tipov 31, 33, 45, 52 in 58 v primerjavi s cepivom Gardasil (že odobrenim cepivom, ki ščiti pred okužbami s to boleznijo tipov 6, 11, 16 in 18).
English: The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.
Slovenian: Študija, v kateri so proučevali razvoj protiteles mesec dni po tretjem odmerku, je pokazala, da je raven zaščite proti tipom 6, 11, 16 in 18 pri deklicah, cepljenih z zdravilom Gardasil 9, podobna kot pri deklicah, cepljenih z zdravilom Gardasil.
English: How is Gardasil 9 used?
Slovenian: Kako se zdravilo Gardasil 9 uporablja?
English: How does Gardasil 9 work?
Slovenian: Kako zdravilo Gardasil 9 deluje?
English: The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study.
Slovenian: Študija je pokazala, da v primerjavi z ženskami, starimi od 16 do 26 let, pri katerih je bila učinkovitost zaščite pred boleznimi dokazana v prvi študiji, cepivo pri dekletih in fantih, starih od 9 do 15 let, spodbuja razvoj zadostnih ravni protiteles proti vsem devetim tipom HPV.
English: The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years.
Slovenian: V okviru tretje študije so pri 600 deklicah, starih od 9 do 15 let, učinkovitost zdravila Gardasil 9 primerjali z učinkovitostjo zdravila Gardasil.
English: The study should be conducted in more than one Member State.
Slovenian: Študija mora biti izvedena v več kot eni državi članici.
English: The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC:
Slovenian: Protokol je treba predložiti v skladu s členom 107n (1) Direktive 2001/83/ES:
English: Within 6 months of the Coordination group agreement.
Slovenian: v 6 mesecih od sporazuma usklajevalne skupine
English: Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years.
Slovenian: Preostala vmesna poročila je treba nato odboru PRAC predložiti vsakih 6 mesecev prvi 2 leti.
English: The final study report shall be submitted to the PRAC:
Slovenian: Končno poročilo o študiji je treba odboru PRAC predložiti:
English: These should be submitted to the National Competent Authorities: By 12 January 2015
Slovenian: do 12. januarja 2015
English: National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je to ustrezno, bodo zagotovili, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
English: The first interim report shall be submitted to the PRAC :
Slovenian: Prvo vmesno poročilo je treba odboru PRAC predložiti:
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in utero exposure.
Slovenian: Ta gradiva morajo zagotoviti, da bodo zdravniki obveščeni in da bodo bolniki poznali ter razumeli tveganja, povezana z izpostavljenostjo valproatu in utero.
English: The study design should aim to evaluate and quantify the effectiveness of the risk minimisation measures, and should include a pre- and postimplementation analysis and assessment.
Slovenian: Zasnova študije mora omogočati ovrednotenje in kvantifikacijo učinkovitosti ukrepov za zmanjšanje tveganja ter vključevati analizo ter oceno pred in po njihovem izvajanju.
English: The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements.
Slovenian: Imetniki dovoljenj za promet z zdravilom za valproat in sorodne učinkovine morajo pripraviti in predložiti izobraževalna gradiva ob upoštevanju dogovorjenih bistvenih delov.
English: The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Slovenian: Imetniki dovoljenj za promet z zdravilom za valproat in sorodne učinkovine bodo izvedli študijo o uporabi zdravila, namenjeno oceni učinkovitosti ukrepov za zmanjšanje tveganja in podrobnejši opredelitvi vzorcev predpisovanja valproata.
English: 10 (1 x 10) vial (multipack)
Slovenian: 10 (1 x 10) vial (pakiranje z več vialami)
English: 10 mg/ml / 3 mg/ml
Slovenian: 10 mg/ml/ 3 mg/ml koncentrat za raztopino za intraokularno izpiranje intraokularna uporaba viala (steklena)
English: 28 March 2014
Slovenian: 28. marec 2014
English: The re-examination procedure started on 11 June 2013.
Slovenian: Postopek ponovnega pregleda se je začel 11. junija 2013.
English: International non-proprietary name (INN): barium selenate
Slovenian: Mednarodno nelastniško ime (INN): barijev selenat
English: On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment.
Slovenian: Evropska komisija je 23. avgusta 2013 zaprosila odbor CVMP, da ponovno pregleda mnenje, zlasti da bi razjasnili nekatere vidike, povezane z oceno tveganja za potrošnike.
English: The referral started on 15 September 2011.
Slovenian: Napotitveni postopek se je začel 15. septembra 2011.
English: Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
Slovenian: Predlagatelji in imetniki dovoljenja za promet z zdravilom so 14. novembra 2011 in 30. novembra 2012 predložili pisna pojasnila.
English: EMA/197955/2014 Veterinary Medicines
Slovenian: EMA/197955/2014
English: During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.
Slovenian: Na zasedanju odbora CVMP, ki je potekalo od 14. do 16. maja 2013, sta bila za poročevalko in soporočevalca v postopku ponovnega pregleda mnenja imenovana K. Törneke in K. Baptiste.
English: An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.
Slovenian: Predlagatelj oziroma imetniki dovoljenja za promet z zdravilom so 6. marca 2013 podali še ustna pojasnila.
English: On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013.
Slovenian: Družbi Cross Vetpharm Group Limited in Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) sta 26. aprila 2013 obvestili agencijo, da nameravata zahtevati ponovno presojo mnenja odbora CVMP z dne 10. aprila 2013.
English: The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products.
Slovenian: Odbor je zato dne 10. aprila 2013 z večino glasov sprejel negativno mnenje in priporočil začasen umik dovoljenj za promet za vsa zadevna zdravila.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.
Slovenian: Seznam zadevnih imen zdravila je na voljo v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s pogojem za preklic začasnega umika dovoljenj za promet z zdravili v Prilogi III. Revidirano mnenje je bilo spremenjeno v sklep Evropske komisije 28. marca 2014.
English: Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health.
Slovenian: Na podlagi ocene razpoložljivih podatkov je odbor CVMP menil, da je razmerje med tveganji in koristmi za zadevna zdravila za uporabo v veterinarski medicini negativno, saj barijev selenat po zdravljenju s priporočenimi odmerki še dolgo časa ostane na mestih injiciranja, zaradi česar bi zaužitje ostankov z mesta injiciranja lahko predstavljalo veliko nevarnost za zdravje ljudi.
English: Opinion following an Article 350F referral for long-acting formulations for injection containing barium selenate for all food producing species EMA/197955/2014
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 350F za dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil EMA/197955/2014
English: Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Slovenian: Barijev selenat se uporablja v zdravilih za injiciranje s počasnim sproščanjem, ki se uporabljajo v veterinarski medicini in so namenjena terapevtski in profilaktični uporabi proti pomanjkanju selena pri govedu ter ovcah.
English: On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.
Slovenian: Odbor CVMP je 6. novembra 2013 z večino glasov sprejel revidirano mnenje, s katerim je potrdil priporočilo, vključeno v mnenje odbora z dne 17. julija 2013, da je razmerje med tveganji in koristmi za zadevna zdravila za uporabo v veterinarski medicini negativno, in zato priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom ter začasen umik obstoječih dovoljenj za zadevna zdravila.
English: The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013.
Slovenian: Družbi Cross Vetpharm Group Limited in Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) sta 10. junija 2013 predložili usklajene podrobne razloge za ponovni pregled.
English: Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenatecontaining injectable veterinary medicinal products.
Slovenian: Nemčija je zadevo napotila na odbor CVMP zaradi resnih tveganj za zdravje ljudi, povezanih z izpostavljenostjo ostankom na mestu injiciranja pri uporabi dolgodelujočih zdravil za injiciranje, ki vsebujejo barijev selenat in se uporabljajo v veterinarski medicini.
English: On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.
Slovenian: Odbor CVMP je 17. julija 2013 z večino glasov sprejel mnenje, s katerim je potrdil priporočilo o začasnem umiku dovoljenj za promet za zadevna zdravila za uporabo v veterinarski medicini.
English: Opinion following an Article 351 referral for long-acting formulations for injection containing barium selenate for all food producing species
Slovenian: za dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil
English: On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species.
Slovenian: Direktive 2011/82/ES za vse dolgodelujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil.
English: 29 January 2016
Slovenian: 04. april 2016