FrancophonIA/ELRC3.0 huggingface dataset:
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of PecFent nasal spray they have to keep it in a safe place to avoid misuse and diversion
Slovenian: • farmacevt mora obvestiti bolnike, da morajo zaradi preprečevanja kraje in zlorabe pršila nos PecFent to zdravilo hraniti na varnem mestu, da preprečijo zlorabo in krajo;
English: • Do not use PecFent nasal spray to treat any other short-term pain or pain status
Slovenian: • ne uporabljajte pršila za nos PecFent za zdravljenje kakšne druge kratkoročne bolečine ali bolečinskega stanja;
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da bodo izpolnjeni vsi pogoji ali uveljavljene vse omejitve v zvezi z varno in učinkovito uporabo zdravila, opisane v nadaljevanju:
English: • The prescribers of PecFent nasal spray must critically select the patients and closely follow o Instructions for use of the nasal spray device o Instructions for opening and closing of the child-resistant box o Information on the correct indication
Slovenian: • Zdravniki, ki predpisujejo pršilo za nos PecFent, morajo izbirati bolnike po strogih merilih in se natančno ravnati po o navodilih za uporabo pripomočka za razprševanje v nos; o navodilih za odpiranje in zapiranje škatle, varne za otroke; o informacijah o pravilni indikaciji.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI NAJ JIH IZPOLNIJO ALI UVELJAVIJO DRŽAVE ČLANICE
English: • PecFent nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain
Slovenian: • pršilo za nos PecFent je indicirano le za zdravljenje prebojne bolečine pri odraslih, ki že prejemajo vzdrževalno opioidno zdravljenje za kronično bolečino zaradi raka;
English: • Do not use PecFent nasal spray for treatment of more than four breakthrough cancer pain episodes a day
Slovenian: • ne uporabljajte pršila za nos PecFent za zdravljenje več kot štirih epizod prebijajoče bolečine zaradi raka na dan;
English: • Only use PecFent nasal spray if you have been experiencing breakthrough cancer pain episodes
Slovenian: • pršilo za nos PecFent uporabljajte le, če doživljate epizode prebojne bolečine zaradi raka;
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga viala (steklo)
English: It was therefore suggested to change the content of the paragraph accordingly.
Slovenian: Zato je bilo predlagano, da se vsebina odstavka ustrezno spremeni.
English: Therefore, a statement should be added on the use in adolescents and adults.
Slovenian: Zato je treba dodati navedbo o uporabi pri mladostnikih in odraslih.
English: The pharmaceutical form and strength is identical in all countries.
Slovenian: Farmacevtska oblika in jakost sta v vseh državah enaki.
English: Subjects with immune deficiencies
Slovenian: Bolniki z imunskimi pomanjkljivostmi
English: The intramuscular route of administration is approved in all Member States except The Netherlands.
Slovenian: Intramuskularni način dajanja je odobren v vseh državah članicah, razen na Nizozemskem.
English: This might need to be reviewed for all concerned products.
Slovenian: Morda bo potrebna revizija za vsa zadevna zdravila.
English: In the past decade, several mumps outbreaks have been reported in highly vaccinated populations (two doses).
Slovenian: V preteklem desetletju so poročali o številnih izbruhih mumpsa pri dobro cepljeni populaciji (dva odmerka).
English: Vaccine efficacy data should differentiate between one or two doses.
Slovenian: Podatki o učinkovitosti cepiva pri enem ali dveh odmerkih naj bodo ločeni.
English: Overall summary of the scientific evaluation of Priorix and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Priorix in povezanih imen (glejte Prilogo I)
English: Although there are only limited data, it was noted that intramuscular administration is standard practice in many Member States.
Slovenian: Čeprav podatkov ni veliko, je bilo ugotovljeno, da je v številnih državah članicah intramuskularno dajanje standardna praksa.
English: During the CHMP discussion it was questioned whether “pregnancy” should continue to be stated under contraindications.
Slovenian: Med razpravo v okviru CHMP se je pojavilo vprašanje, ali naj bo „nosečnost“ še naprej navedena med kontraindikacijami.
English: Some vaccines that can be co-administered with Priorix are listed in the SmPC of Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Luxemburg, Malta, The Netherlands, Poland, Romania and United Kingdom.
Slovenian: Nekatera cepiva, ki jih je mogoče uporabiti sočasno, so navedena v povzetku glavnih značilnosti zdravila za Belgijo, Bolgarijo, Ciper, Dansko, Estonijo, Francijo, Luksemburg, Malto, Nizozemsko, Poljsko, Romunijo in Združeno kraljestvo.
English: In addition, the product information (PI) was presented using the latest version of the QRD template, version 2, published on 12 October 2011.
Slovenian: Predložene so bile tudi informacije o zdravilu v obliki zadnje različice predloge QRD, različice 2, objavljene 12. oktobra 2011.
English: Section 4.6 - Fertility, pregnancy and lactation Fertility
Slovenian: Poglavje 4.6 - Plodnost, nosečnost in dojenje Plodnost
English: In addition it was stated that the advice on breastfeeding should be clearer with respect to the different recommendations for vaccinating mothers with children with or without immunodeficiency.
Slovenian: Poleg tega je bilo navedeno, da mora biti nasvet o dojenju bolj jasen glede različnih priporočil za cepljeno mater pri otroku z imunsko pomanjkljivostjo ali brez nje.
English: As regards HIV, there is no common European guidance on the CD4+ classification for % CD4+ or the cell count number.
Slovenian: Za HIV ni skupnih evropskih smernic o razvrstitvi CD4+ po odstotkih CD4+ ali po številu celic.
English: As Priorix is contraindicated in pregnant women neither interventional nor active surveillance activities have been set up.
Slovenian: Ker je cepivo Priorix pri nosečnicah kontraindicirano, niso bile vzpostavljene ne intervencijske ne aktivne dejavnosti spremljanja.
English: A seropositive response by ELISA may not necessarily represent protection, especially for mumps.
Slovenian: Seropozitivni odziv, dosežen s testom ELISA, ne pomeni nujno zaščite, zlasti ne za mumps.
English: Even if vaccine virus is transmitted, the infection is mild and self-limiting (ACIP 2011).
Slovenian: Tudi če se virus cepiva prenese, je okužba blaga in samoomejujoča (ACIP 2011).
English: The approved lower age limit indicated for the use of Priorix varied from 9 months to 15 months across the individual EU member states reflecting in some cases the national recommendations for routine MMR vaccination.
Slovenian: Odobrena spodnja starostna meja, indicirana za uporabo cepiva Priorix, se razlikuje po posameznih državah članicah EU, in sicer znaša od 9 do 15 mesecev, , kar v nekaterih primerih odraža nacionalna priporočila za rutinska cepljenja proti MMR.
English: The incidence rates among the cases in both these age categories were above 50 and 45 cases per 100,000 respectively.
Slovenian: Stopnji obolevnosti v obeh starostnih kategorijah sta bili v prvem primeru več kot 50 in v drugem več kot 45 primerov na 100 000 oseb.
English: This justification was accepted by the CHMP.
Slovenian: Odbor CHMP je utemeljitev sprejel.
English: The immunogenicity of Priorix was evaluated in several clinical trials in children aged from 12 to 24 months, 11 to 23 months and 9 to 12 months.
Slovenian: Imunogenost cepiva Priorix je bila ocenjena v več kliničnih preskušanjih pri otrocih, starih od 12 do 24 mesecev, od 11 do 23 mesecev in od 9 do 12 mesecev.
English: reduce a long paragraph about the use of epinephrine by a general statement about the availability of appropriate medical treatment and supervision following the administration of the vaccine.
Slovenian: skrajšanje dolgega odstavka o uporabi epinefrina in vključitev splošne navedbe o razpoložljivosti ustreznega medicinskega zdravljenja in nadzoru po cepljenju,
English: However, it was noted by the MAH that the data are very limited considering the contraindication currently in the label.
Slovenian: Vendar pa so opazili, da so podatki imetnika dovoljenja za promet z zdravilom zelo omejeni glede na kontraindikacije, ki so trenutno na oznaki.
English: However, it was considered necessary to include age specific %CD4+ as per WHO guidance since vaccination of children from the age of 9 months onwards is indicated.
Slovenian: Vendar pa meni, da je treba vključiti starostno specifični odstotek CD4+ v skladu s smernico SZO, saj je indicirano cepljenje otrok od starosti 9 mesecev naprej.
English: The CHMP agreed that the dosing recommendations are acceptable, however in order to provide clear instructions to health care professionals a more structured wording was proposed (i.e. to split the recommendations per age group).
Slovenian: CHMP se strinja, da so priporočila za odmerjanje sprejemljiva, vendar je bilo zaradi večje jasnosti navodil za zdravstveno osebje predlagano bolj strukturirano besedilo (tj. ločena priporočila za vsako starostno skupino).
English: Moreover the antibody response to measles vaccine decreases as the level of immunosuppression increases.
Slovenian: Tudi odziv protiteles na cepivo proti ošpicam se manjša z naraščanjem ravni imunosupresije.
English: For this reason and to reflect the most recent information, the immunogenicity data were differentiated between two groups: “Immune response in children 12 months and older” and “Immune response in children aged 9 to 10 months”.
Slovenian: Zaradi tega razloga in za prikaz najnovejših informacij so bili podatki o imunogenosti razdeljeni na dve skupini: „Imunski odziv pri otrocih, starih 12 mesecev in več“ in „Imunski odziv pri otrocih, starih 9 do 10 mesecev“.
English: Priorix is nationally approved in 20 countries and is approved through the mutual recognition procedure (MRP) in 9 countries.
Slovenian: Cepivo Priorix je v 20 državah odobreno po nacionalnem postopku, v 9 državah pa je odobreno v okviru postopka z medsebojnim priznavanjem.
English: The theoretical teratogenic risk following rubella vaccination has been estimated to be 0.5% during the first trimester and is up to 1.6%, if the vaccine is given between 1-2 weeks before and 4-6 weeks after conception.
Slovenian: Teoretično teratogeno tveganje po cepljenju proti rdečkam je bilo ocenjeno na 0,5 % v prvem trimesečju in znaša največ 1,6 %, če se cepivo injicira 1-2 tedna pred spočetjem in 4-6 po njem.
English: The available data do not suggest that co-administration of these vaccines has an impact on the immunogenicity and safety of the antigens tested.
Slovenian: Razpoložljivi podatki ne kažejo, da ima sočasna uporaba teh cepiv vpliv na imunogenost in varnost preskušenih antigenov.
English: This was endorsed by the CHMP following review and assessment of the clinical study report that was submitted to support the coadministration of Priorix with this vaccine.
Slovenian: CHMP je to odobril, ko je pregledal in ocenil poročilo klinične študije, predloženo v podporo sočasnemu dajanju cepiva Priorix s temi cepivi.
English: Because of the much higher likelihood of thrombocytopenia after natural infection, the benefits of vaccination most often exceed the risks of severe symptomatic thrombocytopenia caused by immunization.
Slovenian: Zaradi veliko večje verjetnosti trombocitopenije po naravni okužbi so koristi cepljenja največkrat večje od tveganj hude simptomatske trombocitopenije, ki jih povzroči imunizacija.
English: The final agreed wording is: “Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination.
Slovenian: Dogovorjeno je bilo naslednje končno besedilo: „Ženskam, ki nameravajo zanositi, je treba svetovati, naj zanositev prestavijo na obdobje 1 mesec po cepljenju s cepivom PRIORIX.
English: The MAH was asked to add some information on this issue.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da v zvezi s tem doda nekaj informacij.
English: Natural rubella infection can have a devastating impact on pregnancy, leading to foetal death, premature delivery and an array of congenital defects.
Slovenian: Naravna okužba z virusom rdečk ima lahko na nosečnost poguben vpliv in povzroči smrt plodu, prezgodnji porod in vrsto prirojenih okvar.
English: There is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines however the theoretical concern remains.
Slovenian: Trenutno ni informacij, po katerih bi lahko sklepali na obstoj teratogenega tveganja po cepljenju, vendar teoretični pomislek ostaja.
English: The MAH accepted the new text and also added a sentence on the monitoring of those patients which was endorsed by the CHMP.
Slovenian: Imetnik dovoljenja za promet je novo besedilo sprejel in dodal stavek o spremljanju teh bolnikov, ki ga je CHMP vključil.
English: The CHMP noted that the current clinical experience with Priorix is limited to children and no trials were performed in adolescents and adults.
Slovenian: CHMP je opazil, da so trenutne klinične izkušnje s cepivom Priorix omejene na otroke in da preskušanj pri mladostnikih in odraslih niso opravili.
English: As there is still a theoretical teratogenic risk connected to rubella containing vaccines it was agreed that this very vulnerable group should not be put at risk.
Slovenian: Ker je s cepivi, ki vsebujejo virus rdečk, še vedno povezano teoretično teratogeno tveganje, je bilo dogovorjeno, da se te zelo ranljive skupine ne izpostavi tveganjem.
English: More specifically: “For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.” The MAH had also included in this section the sentence “The use of PRIORIX should be based on official recommendations.” but the CHMP agreed to move it at the beginning of section 4.2 Posology and method of administration because as per the guideline on SmPC dated September 2009 the reference to official recommendations should be made under section 4.2.
Slovenian: Natančneje: „Za uporabo pri otrocih, starih od 9 do 12 mesecev, glejte poglavja 4.2, 4.4 in 5.1.“ Imetnik dovoljenja za promet z zdravilom je v to poglavje vključil tudi stavek „Uporaba cepiva PRIORIX mora temeljiti na uradnih priporočilih.“, vendar je bil v soglasju z odborom CHMP ta stavek premeščen na začetek poglavja 4.2 Odmerjanje in način uporabe, saj je treba v skladu s smernicami za povzetek glavnih značilnosti zdravila, izdanimi septembra 2009, sklicevanje na uradna priporočila vključiti v poglavje 4.2.
English: Although women should be asked about the possibility of early pregnancy prior to vaccination, screening tests to exclude pregnancy are not required.
Slovenian: Čeprav je treba ženske pred cepljenjem vprašati, ali so morda v zgodnji fazi nosečnosti, presejalnih testov za izključitev nosečnosti ni treba izvajati.
English: The vaccine is a lyophilised vaccine preparation, which is reconstituted with separately supplied sterile diluent (water for injection) prior to use.
Slovenian: Cepivo je liofilizirano in se pred uporabo rekonstituira s posebej dobavljenim sterilnim vehiklom (vodo za injekcije).
English: Approximately 85% of pregnancies will be negatively affected when rubella infection occurs during the first trimester.
Slovenian: Okužba z virusom rdečk negativno vpliva na približno 85 % nosečnosti, če se pojavi v prvem trimesečju.
English: Priorix is contraindicated in pregnant women.
Slovenian: Cepivo Priorix je kontraindicirano pri nosečnicah.
English: Compared with 2009, the number of cases in 2010 more than tripled in infants below one year of age, and increased fivefold in adults 20-29 years old.
Slovenian: V primerjavi z letom 2009 se je število primerov v letu 2010 pri otrocih, starih manj kot eno leto, več kot potrojilo, pri odraslih, starih od 20 do 29 let, pa se je povečalo za petkrat.
English: The MAH amended this paragraph as per the CHMP's recommendation and also added in the list one more vaccine (10-valent pneumococcal conjugate vaccine).
Slovenian: Imetnik dovoljenja za promet z zdravilom je ta odstavek spremenil po priporočilih CHMP in na seznam dodal še eno cepivo (10-valentno konjugirano cepivo proti pnevmokokom).
English: In conclusion, based on the clinical data the lower age limit of the indication is endorsed, however since the immune response following a single dose of Priorix is lower in children under 12 months of age a reference to sections 4.2, 4.4 and 5.1 has been included.
Slovenian: Klinični podatki torej kažejo, da je treba podpreti nižjo starostno mejo za omenjeno indikacijo, vendar pa je zaradi manjšega imunskega odziva po enem odmerku cepiva Priorix pri otrocih, starih manj kot 12 mesecev, treba vključiti sklic na poglavja 4.2, 4.4 in 5.1.
English: In addition experiences with other MMR or MMRV (measles, mumps, rubella, varicella) vaccines do not indicate any negative impact on the immune response or safety profile following intramuscular injection.
Slovenian: Tudi izkušnje z drugimi cepivi MMR ali MMRV (ošpice, mumps, rdečke, norice) ne kažejo na negativen vpliv na imunski odziv ali varnostni profil po intramuskularnem injiciranju.
English: The immunogenicity data however clearly demonstrate that lower antibody responses against measles and mumps are observed in children aged 9 to 11 months at the time of primary immunization than in older children which is most likely due to circulating maternal antibodies or the immaturity of the immune system.
Slovenian: Vendar pa podatki o imunogenosti nedvoumno dokazujejo manjši odziv protiteles proti ošpicam in mumpsu pri otrocih, starih od 9 do 11 mesecev, v času primarne imunizacije kot pri starejših otrocih, kar je najverjetneje posledica materinih protiteles v obtoku ali nezrelosti imunskega sistema.
English: The CHMP therefore suggested adding the information from a recent systematic review that “MMR-associated thrombocytopenia is rare and generally self-limited”.
Slovenian: Zato je CHMP predlagal, da se doda informacija iz novejše sistematske revizije, da je „trombocitopenija, povezana s cepivi MMR, redka in običajno samoomejujoča“.
English: A number of studies documented increased risk of developing mumps with increasing time after vaccination (Vandermeulen et al., 2004; Cortese et al., 2008; Castilla et al., 2009), and data from the United Kingdom indicate vaccine effectiveness may decrease with age, which probably also reflects increasing time from vaccination (Cohen et al., 2007).
Slovenian: Številne študije so dokumentirale, da se tveganje za razvoj mumpsa veča s potekom časa po cepljenju (Vandermeulen et al., 2004; Cortese et al., 2008; Castilla et al., 2009), podatki iz Združenega kraljestva pa kažejo, da se lahko učinkovitost cepiva s starostjo slabša, kar verjetno kaže tudi na pretek časa od cepljenja (Cohen et al., 2007).
English: Finally, the CHMP asked the seroconversion rates given to be replaced by more recent data reported for the Human Serum Albumin-free (HSA-free) formulation of Priorix and also asked the MAH if there are any immunogenicity data available from the Human Serum Albumin-free (HSAfree) formulation in children below 12 months of age.
Slovenian: Končno je odbor CHMP zaprosil, da se navedene stopnje serokonverzije nadomestijo z novejšimi podatki, ki so bili poročani za formulacijo cepiva Priorix brez albumina iz človeškega seruma (brez HSA), in imetnika dovoljenja za promet z zdravilom vprašal, ali so na voljo podatki o imunogenosti za formulacijo brez albumina iz človeškega seruma (brez HSA) pri otrocih, starih manj kot 12 mesecev.
English: The CHMP noted that recent data from an outbreak in France indicate that the highest incidence of measles infections was observed in infants below 1 year of age, followed by children between one and two years old.
Slovenian: Odbor CHMP je ugotovil, da novejši podatki o izbruhu bolezni v Franciji kažejo na večjo pojavnost okužb z ošpicami pri dojenčkih, starih manj kot 1 leto, sledijo pa otroci, stari med enim in dvema letoma.
English: The MAH was asked to consider adding an overview of vaccine immunogenicity assessment (clinical trials), and to add vaccine efficacy figures as well, if available, or to mention their inexistence.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil naprošen, da razmisli o vključitvi pregleda ocene imunogenosti cepiva (klinična preskušanja), in da doda tudi številke o učinkovitosti cepiva, če so na voljo, ali da omeni, da ne obstajajo.
English: Priorix is contraindicated in pregnancy but since there is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines the following wording was agreed: “PRIORIX is contraindicated during pregnancy (see section 4.3).
Slovenian: Cepivo Priorix je kontraindicirano pri nosečnicah, vendar je bilo zaradi neobstoja informacij, iz katerih bi lahko sklepali na teratogeno tveganje po cepljenju s cepivi MMR, dogovorjeno naslednje besedilo: „Cepivo PRIORIX je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: As regards the intramuscular route of administration no information was provided in the updated clinical dossier, but was provided in the initial application for marketing authorisation.
Slovenian: Glede intramuskularne poti dajanja v posodobljeni klinični dokumentaciji ni bilo podatkov, so pa bili ti vključeni v začetni vlogi za dovoljenje za promet z zdravilom.
English: The main divergences between the proposed harmonized SmPC and national product information relates to the description of post marketing reports.
Slovenian: Glavna razlika med predlaganim usklajenim povzetkom glavnih značilnosti zdravila in nacionalnimi informacijami o zdravilu se nanaša na opis poročil iz obdobja trženja.
English: Inadvertent vaccination of unknowingly pregnant women with PRIORIX should not be a reason for termination of pregnancy”.
Slovenian: Nenamerno cepljenje žensk, ki so noseče, pa tega ne vedo, s cepivom PRIORIX, ni vzrok za prekinitev nosečnosti“.
English: The geometric mean titers (GMTs) for seroconverters were 2431.9 mIU/ml, 1010.0 U/ml and 67.1 IU/ml for the anti-measles, anti-mumps and anti-rubella antibodies, respectively which were slightly lower than the values reported following subcutaneous administration (2958 mIU/ml, 1400 U/ml and 73 IU/ml, respectively).
Slovenian: Geometrična povprečja titrov (GMT) za serokonverterje so bila 2 431,9 mil. i.e./ml za protitelesa proti ošpicam, 1 010,0 e./ml za protitelesa proti mumpsu in 67,1 i.e./ml za protitelesa proti rdečkam, kar je nekoliko nižje kot vrednosti, o katerih so poročali po subkutanem dajanju (2 958 mil. i.e./ml, 1 400 e./ml in 73 i.e./ml).
English: Section 4.4 - Special warnings and precautions for use To be in line with the SmPC guideline the company proposed to:
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Za zagotovitev skladnosti s smernicami za povzetek glavnih značilnosti zdravila družba predlaga:
English: The sentence was modified as per the QRD recommendation to read “PRIORIX has not been evaluated in fertility studies”.
Slovenian: Stavek je bil spremenjen po priporočilu za pregledovanje kakovosti dokumentov (QRD) in se sedaj glasi „Cepiva PRIORIX v študijah plodnosti niso proučili.“
English: The data available do not suggest any clinically relevant interference in the antibody response to each of the individual antigens (Carmona et al., 2010; Pace et al., 2008).
Slovenian: Razpoložljivi podatki ne kažejo klinično pomembnega medsebojnega delovanja pri nastajanju protiteles proti vsakemu posameznemu antigenu (Carmona et al., 2010; Pace et al., 2008).