FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period for meat from pigs treated with Suvaxyn PRRS MLV is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za meso prašičev, ki so prejeli cepivo Suvaxyn PRRS MLV, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: In pregnant gilts and sows with no prior exposure to PRRS virus, Suvaxyn PRRS MLV must not be used in the second half of pregnancy because the virus in the vaccine may cross the placenta and affect the birth rate.
Slovenian: Pri brejih mladicah in plemenskih svinjah, ki nikoli niso bile izpostavljene virusu PRRS, se zdravilo Suvaxyn PRRS MLV ne sme uporabljati v drugi polovici brejosti, ker virus v cepivu lahko prehaja skozi placento in vpliva na zmožnost reprodukcije.
English: Other information about Suvaxyn PRRS MLV
Slovenian: Druge informacije o zdravilu Suvaxyn PRRS MLV
English: Two studies were conducted in female pigs, one which showed that single vaccination of female pigs 10 to 11 weeks before mating protected them against disease when exposed to the virus 26 weeks after vaccination.
Slovenian: Izmed dveh študij, ki so ju izvedli pri svinjah samicah, je ena pokazala, da enkratna injekcija, ki se daje od 10 do 11 tednov pred parjenjem, svinje zaščiti pred boleznimi, če so virusu izpostavljene 26 tednov po cepljenju.
English: Protection starts to be effective 21 days after vaccination and lasts for 26 weeks after vaccination.
Slovenian: Učinkovati začne 21 dni po cepljenju, zaščita pa traja 26 tednov po cepljenju.
English: Why is Suvaxyn PRRS MLV authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Suvaxyn PRRS MLV odobreno v EU?
English: Suvaxyn PRRS MLV is a vaccine.
Slovenian: Zdravilo Suvaxyn PRRS MLV je cepivo.
English: Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS).
Slovenian: Zdravilo Suvaxyn PRRS MLV je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito prašičev pred prašičjim reprodukcijskim in respiratornim sindromom (PRRS).
English: An overview of Suvaxyn PRRS MLV and why it is authorised in the EU
Slovenian: Pregled zdravila Suvaxyn PRRS MLV in zakaj je odobreno v EU
English: A study in piglets showed the vaccine starts to be effective 21 days after vaccination and four studies in piglets showed protection lasts up to 26 weeks.
Slovenian: Ena študija pri prašičkih je pokazala, da zdravilo začne učinkovati 21 dni po cepljenju, v štirih študijah pri prašičkih pa je bilo dokazano, da zaščita traja do 26 tednov.
English: The second study in sows showed that a booster vaccination 6 months after the initial vaccination, with mating performed 4 months after the second vaccination, gave protection for 7 months.
Slovenian: Druga študija pri svinjah je pokazala, da obnovitveni odmerek šest mesecev po začetnem cepljenju in po parjenju, ki se izvede štiri mesece po drugem cepljenju, zaščiti svinje za sedem mesecev.
English: What is Suvaxyn PRRS MLV and what is it used for?
Slovenian: Kaj je zdravilo Suvaxyn PRRS MLV in za kaj se uporablja?
English: For the full list of all side effects and restrictions with Suvaxyn PRRS MLV, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Suvaxyn PRRS MLV, glejte navodilo za uporabo.
English: Suvaxyn PRRS MLV contains a weakened strain of PRRS virus.
Slovenian: Zdravilo Suvaxyn PRRS MLV vsebuje oslabljen sev virusa PRRS.
English: What benefits of Suvaxyn PRRS MLV have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Suvaxyn PRRS MLV izkazalo v študijah?
English: Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription.
Slovenian: Zdravilo Suvaxyn PRRS MLV je na voljo v obliki liofilizata (pelet, sušenih z zamrzovanjem) in vehikla za suspenzijo za injiciranje.
English: What are the risks associated with Suvaxyn PRRS MLV?
Slovenian: Kakšna tveganja so povezana z zdravilom Suvaxyn PRRS MLV?
English: Suvaxyn PRRS MLV is given as a single injection from 1 day of age to pigs for fattening.
Slovenian: Zdravilo Suvaxyn PRRS MLV se daje pitancem od enega dneva starosti kot enkratna injekcija.
English: Suvaxyn PRRS MLV must also not be used in boars producing semen, as PRRS virus can be shed in semen.
Slovenian: Cepivo se ravno tako ne sme uporabljati pri plemenskih merjascih, ki so namenjeni za proizvodnjo semena, saj se virus PRRS lahko širi prek semena.
English: How is Suvaxyn PRRS MLV used?
Slovenian: Kako se zdravilo Suvaxyn PRRS MLV uporablja?
English: The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies.
Slovenian: Laboratorijske študije podpirajo učinkovitost zdravila Suvaxyn PRRS MLV.
English: How does Suvaxyn PRRS MLV work?
Slovenian: Kako zdravilo Suvaxyn PRRS MLV deluje?
English: The main studies supporting intravaginal application are Studies SCO 5109 and SCO 5174.
Slovenian: Glavni študiji, ki podpirata intravaginalno uporabo, sta SCO 5109 in SCO 5174.
English: Whereas
Slovenian: Vendar na podlagi
English: 1 Clinical Gynaecologic Endocrinology and Infertility, 8e, Marc A Fritzand, Leon Speroff (Chapter 17: menopause and the peri-menopausal transition)
Slovenian: 1 Clinical Gynaecologic Endocrinology and Infertility, 8e, Marc A Fritzand, Leon Speroff (Poglavje 17: menopause and the peri-menopausal transition)
English: In terms of pharmacovigilance data, a total of 11 cases were reported including spontaneous reports and literature cases.
Slovenian: V farmkovigilančnih podatkih so poročali o skupno 11 primerih, vključno s spontanimi poročili in primeri iz literature.
English: Linoladiol N and Linoladiol HN are approved via national procedures in different member states.
Slovenian: Zdravili Linoladiol N in Linoladiol HN sta v različnih državah članicah odobreni z nacionalnimi postopki.
English: The peak concentration of estradiol was reached 6 hours after application (median).
Slovenian: Največja koncentracija estradiola se je dosegla 6 ur po uporabi (mediana).
English: Thus, they disagreed with some of the amendments proposed by the CHMP to be implemented in the product information.
Slovenian: Zato se ni strinjal z nekaterimi spremembami, ki jih je odbor CHMP predlagal za vključitev v informacije o zdravilu.
English: In addition, the clear reference to the patient population (postmenopausal women) intended to treat should be added.
Slovenian: Poleg tega je treba jasno navesti populacijo bolnic, kateri je namenjeno zdravljenje (postmenopavzalne ženske).
English: Systemic levels of estradiol in these two studies raised concerns.
Slovenian: Zaradi sistemskih ravni estradiola v teh študijah so se pojavili pomisleki.
English: The CHMP carried out a new assessment of the available efficacy data in the concerned indication.
Slovenian: Odbor CHMP je opravil ponovno oceno razpoložljivih podatkov o učinkovitosti pri zadevni indikaciji.
English: High dose estradiol products such as Linoladiol N are not specifically considered in these recommendations.
Slovenian: Zdravila z visokimi odmerki estradiola, kot je Linoladiol N, v teh priporočilih niso posebej obravnavana.
English: The CHMP therefore recommended the deletion of this indication from the product information.
Slovenian: Odbor CHMP je zato priporočil izbris te indikacije iz informacij o zdravilu.
English: The adjusted mean Cδmax (92.2 pg/ml) amounted to 89% of the total Cmax.
Slovenian: Prilagojena povprečna vrednost Cδmax (92,2 pg/ml) je bila 89 % skupne vrednosti Cmax.
English: Decreases in FSH and LH were also observed, further reflecting the existence of relevant systemic exposure.
Slovenian: Opaženo je bilo tudi zmanjšanje ravni FSH in LH, kar še nadalje odraža obstoj klinično pomembne sistemske izpostavljenosti.
English: An increase in oestrogen-related risk with recurrent use of this product cannot be ruled out.
Slovenian: Povečanega tveganja, povezanega z estrogeni, pri ponavljajoči se uporabi zdravila ni mogoče izključiti.
English: An historical analysis of pharmacokinetic data of estradiol after vaginal application across several published studies has been performed.
Slovenian: Opravljena je bila zgodovinska analiza farmakokinetičnih podatkov o estradiolu po vaginalni uporabi iz več objavljenih študij.
English: Germany was concerned that these products containing estradiol, which are indicated only for local use, exhibit high blood concentration upon application, which is seen only with products authorised for systemic use.
Slovenian: Nemčija je imela zadržke, da ta zdravila, ki vsebujejo estradiol in so indicirana samo za lokalno uporabo, ob uporabi povzročajo veliko koncentracijo v krvi, kar so opazili samo pri zdravilih, odobrenih za sistemsko uporabo.
English: • The Committee reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety these medicinal products for topical use.
Slovenian: • odbor je pregledal vse razpoložljive podatke iz kliničnih študij, farmakoepidemioloških študij, objavljene literature in izkušenj v obdobju trženja, vključno z odgovori, ki so jih v obliki pisnih in ustnih obrazložitev podali imetniki dovoljenj za promet, v zvezi z učinkovitostjo in varnostjo teh zdravil za topično uporabo;
English: The primary objective of the study was to estimate the extent of estradiol exposure after application of the test formulation Linoladiol N.
Slovenian: Primarni cilj študije je bila ocena obsega izpostavljenosti estradiolu po uporabi preiskovane formulacije zdravila Linoladiol N.
English: The mean value of AUC0-36 (1285.2 pg/ml·h) and Cmax (103.5 pg/ml) indicate systemic exposure to estradiol from the intravaginal cream.
Slovenian: Povprečni vrednosti AUC0-36 (1285,2 pg/ml·h) in Cmax (103,5 pg/ml) kažeta na sistemsko izpostavljenost estradiolu, ki jo povzroča intravaginalna krema.
English: However due to no specific safety reports to-date and the known lack of sensitivity of spontaneous reporting, only the well-known risks of systemic HRT are to be expected.
Slovenian: Ker pa ni specifičnih poročil o varnosti in zaradi znane pomanjkljivosti občutljivosti pri spontanem poročanju, se pričakujejo samo dobro znana tveganja sistemskega hormonskega nadomestnega zdravljenja.
English: Clear information should be reflected in the posology section.
Slovenian: V poglavje o odmerjanju je prav tako treba vključiti jasne informacije.
English: Furthermore, due to the content of the corticosteroid prednisolone, use of Linoladiol HN is recommended only for short-term therapy (up to four weeks).
Slovenian: Zaradi vsebnosti kortikosteroida prednizolona, je uporaba zdravila Linoladiol HN priporočena samo za kratkotrajno zdravljenje (do štiri tedne).
English: Following the adoption of the CHMP opinion and recommendations during the December 2013 CHMP meeting, a re-examination request on Linoladiol N medicinal product only was received from one MAH.
Slovenian: Po sprejetju mnenja in priporočil odbora CHMP na sestanku odbora CHMP v decembru 2013 je en imetnik dovoljenja za promet z zdravilom predložil zahtevo samo za ponoven pregled zdravila Linoladiol N.
English: The CHMP noted that the available data on the safety of Linoladiol is limited and no prospective evaluation of safety, in particular endometrial safety was available.
Slovenian: Odbor CHMP je ugotovil, da so razpoložljivi podatki o varnosti zdravila Linoladiol omejeni in da prospektivna ocena varnosti, predvsem za endometrij, ni na voljo.
English: In order to enforce this short duration of use, the CHMP requested withdrawal of the pack sizes of 100 g in all EU Members States where the products are authorised, as this large pack size of cream is considered redundant under the new recommendations for the duration of use.
Slovenian: Da bi okrepili kratko trajanje uporabe, je odbor CHMP zahteval umik velikosti pakiranja po 100 g v vseh državah članicah EU, kjer so ta zdravila odobrena, saj je tako veliko pakiranje kreme nepotrebno v skladu z novimi priporočili za trajanje uporabe.
English: In May 2012, Germany (BfArM) requested the evaluation of the overall benefit risk balance of high concentration estradiol (E2) containing medicinal products indicated for topical use for the treatment of vaginal atrophy (intravaginally and on the skin of vulva and vagina).
Slovenian: Maja 2012 je Nemčija (BfArM) zaprosila za oceno splošnega razmerja med tveganji in koristmi za zdravila z veliko koncentracijo estradiola (E2), indicirana za topično uporabo pri zdravljenju nožnične atrofije (znotraj nožnice in na koži vulve ter nožnice).
English: Overall summary of the scientific evaluation of high concentration estradiol containing medicinal products for topical use
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil z veliko koncentracijo estradiola za topično uporabo
English: In particular, the CHMP re-assessed the pharmacokinetic data available, as well as the comparison to existing treatments in consultation to the international guidelines.
Slovenian: Odbor CHMP je še posebej pozorno ponovno ocenil razpoložljive farmakokinetične podatke in primerjavo z obstoječimi oblikami zdravljenja v skladu z mednarodnimi smernicami.
English: Prolonged use is not recommended and skin irritation, hypersensitivity and spotting were reflected in the undesirable effects.
Slovenian: Podaljšana uporaba ni priporočljiva, draženje kože, preobčutljivost in mazanje pa so bili vključeni v poglavje o neželenih učinkih.
English: The weekly exposure is higher for Linoladiol N than with other products, and this raises safety concerns, in particular considering the potential for long-term systemic exposure in daily clinical practice.
Slovenian: Tedenska izpostavljenost pri zdravilu Linoladiol N je večja kot pri drugih zdravilih, zaradi česar so se pojavili pomisleki, predvsem glede potenciala za dolgotrajno sistemsko izpostavitev v vsakdanji klinični praksi.
English: Vigilance is required for possible systemic side effects and skin atrophy.
Slovenian: Pozornost je potrebna zaradi možnih sistemskih neželenih učinkov in kožne atrofije.
English: The systemic levels seen for this product with twice weekly administration are comparable to those seen for products in the medium range of estradiol dosing.
Slovenian: Sistemske ravni, opažene pri tem zdravilu ob uporabi dvakrat na teden, so primerljive z ravnmi, opaženimi pri zdravilih v srednjem razponu odmerjanja estradiola.
English: The CHMP took also into account the available data for Linoladiol HN, which was limited mainly to postmarketing data.
Slovenian: Odbor je prav tako obravnaval razpoložljive podatke za Linoladiol HN, ki so bili večinoma omejeni na podatke iz obdobja trženja.
English: The Committee accepted the MAH's argument that although current clinical guidelines differentiate between systemic and topical oestrogen treatments and clearly topical treatments are recommended for this condition, they do not make a recommendation for a ranking of the different topical treatments.
Slovenian: Odbor CHMP je sprejel trditev imetnika dovoljenja za promet z zdravilom, da četudi trenutne klinične smernice razlikujejo med sistemskimi ter topičnimi oblikami zdravljenja z estrogenom in so za to stanje jasno priporočene topične oblike zdravljenja, pa ne priporočajo prednostne razvrstitve različnih topičnih oblik zdravljenja.
English: • The Committee, in order to ensure that the 0.01% w/w estradiol containing medicinal products for topical use are not used for periods longer than 4 weeks, imposed the withdrawal of pack size of 100 g in all EU Members States where the products are authorised.
Slovenian: • za zagotovitev, da se zdravila za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, ne uporabljajo dlje kot 4 tedne, je odbor zahteval umik velikosti pakiranja po 100 g v vseh državah članicah EU, kjer so ta zdravila odobrena.
English: With regards to the use of Linoladiol HN for the treatment of lichen sclerosus genitalis, the CHMP noted that according to the current clinical knowledge on the treatment of this condition, estradiol is not a treatment option.
Slovenian: Za uporabo zdravila Linoladiol HN za zdravljenje lichen sclerosus genitalis je odbor CHMP navedel, da glede na trenutno klinično znanje o zdravljenju tega stanja estradiol ni ustrezna možnost.
English: The mean baseline estradiol serum concentration was 11.3 pg/ml.
Slovenian: Povprečna izhodiščna koncentracija estradiola v serumu je bila 11,3 pg/ml.
English: In this comparison, three other intravaginally applied medicinal products were included: 10 mcg and 25 mcg vaginal tablets, and 2 mg vaginal ring.
Slovenian: V to primerjavo so bila vključena tri druga intravaginalna zdravila: 10 µg ter 25 µg vaginalne tablete in 2 mg vaginalni obroček.
English: Primary variables were AUCδ0-36 and Cδmax of estradiol, i.e. the extent of exposure was estimated as area under the baseline adjusted estradiol concentration curve and the baseline-adjusted maximal plasma concentration of estradiol.
Slovenian: Primarni spremenljivki sta bili vrednosti AUCδ0-36 in Cδmax estradiola, tj. obseg izpostavljenosti se je izračunal kot površina pod krivuljo koncentracije estradiola, prilagojene glede na izhodišče, in največje koncentracije estradiola v plazmi, prilagojene glede na izhodišče.
English: Based on study SCO 5109, it is concluded that twice weekly estradiol serum levels similar to those reached with systemic hormonal replacement therapy (HRT) are observed.
Slovenian: Na podlagi študije SCO 5109 je odbor zaključil, da so se opazile ravni estradiola v serumu ob uporabi dvakrat na teden, podobne ravnem, doseženim pri sistemskem hormonskem nadomestnem zdravljenju (HNZ).
English: The CHMP noted that the pharmacokinetic data demonstrate that estradiol is absorbed after vaginal application of the Linoladiol N. Systemic effects can be expected as the estradiol levels are increased above postmenopausal levels which range from 10-20 pg/ml.1
Slovenian: Odbor CHMP je ugotovil, da farmakokinetični podatki kažejo na absorpcijo estradiola po vaginalni uporabi zdravila Linoladiol N. Sistemski učinki so pričakovani, saj se ravni estradiola povišajo nad postmenopavzalne ravni, katerih razpon je od 10 do 20 pg/ml.1
English: The mean estradiol serum concentration at 36 h which is the last time point blood samples were drawn was 10.7 pg/ml.
Slovenian: Povprečna koncentracija estradiola v serumu po 36 urah, zadnji časovni točki odvzema krvnih vzorcev, je bila 10,7 pg/ml.
English: They argued that the pharmacokinetic profile, the systemic exposure and the potential risks should not be evaluated in relation to systemic HRT, and that the topical use of Linoladiol N cannot be compared to systemic HRT treatment.
Slovenian: Menil je, da se farmakokinetični profil, sistemska izpostavljenost in morebitna tveganja ne bi smela ocenjevati v primerjavi s sistemskim hormonskim nadomestnim zdravljenjem ter da se topična uporaba zdravila Linoladiol N ne bi smela primerjati s sistemskim hormonskim nadomestnim zdravljenjem.
English: Linoladiol HN contains both estradiol and prednisolone and an anti-inflammatory effect of the prednisolone on inflamed skin can be expected.
Slovenian: Zdravilo Linoladiol HN vsebuje estradiol in prednizolon, zato se lahko pričakuje protivnetni učinek prednizolona na vneto kožo.
English: In addition, although Linoladiol HN contains a lower (half) concentration of oestrogen than Linoladiol N, the CHMP considered that the product information should still reflect adequate warnings with regards to risks of hormone replacement therapy.
Slovenian: Čeprav zdravilo Linoladiol HN vsebuje manjšo (polovično) koncentracijo estrogena v primerjavi z zdravilom Linoladiol N, je odbor CHMP menil, da morajo informacije o zdravilu kljub temu vključiti ustrezna opozorila glede tveganj hormonskega nadomestnega zdravljenja.
English: Restriction of the indication to only intravaginal use (and not on the skin of vulva) after a lower oestrogen treatment has failed, as well limiting the duration of the treatment, will better reflect the available scientific and clinical data and the current clinical knowledge on the use of topical administered estradiol containing products and Linoladiol N.
Slovenian: Omejitev indikacije samo na intravaginalno uporabo (in izključitev kože zunanjih spolovil) po neuspešnem zdravljenju z zdravili z manjšo vsebnostjo estrogenov in omejitev trajanja zdravljenja bosta bolje odražali razpoložljive znanstvene ter klinične podatke in trenutno strokovno znanje o uporabi topičnih zdravil, ki vsebujejo estradiol, ter zdravila Linoladiol N.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili
English: The CHMP conclusions on these points raised in the MAH's grounds are given below.
Slovenian: Zaključki odbora CHMP glede točk, ki jih je izpostavil imetnik dovoljenja za promet z zdravilom, so navedeni spodaj.
English: Study SCO 5109, an explorative, single-centre, one period study on estradiol was performed to determine the bioavailability of estradiol from Linoladiol N in 16 healthy postmenopausal women aged between 45 and 70.
Slovenian: Študija SCO 5109, eksplorativna, enocentrična študija estradiola v enem obdobju, se je izvedla za ugotavljanje biološke uporabnosti estradiola v zdravilu Linoladiol N pri 16 zdravih postmenopavzalnih ženskah, starih med 45 in 70 let.
English: Thirty six hours after application, the estradiol concentrations had returned to the pre-dose baseline concentration in the majority of subjects.
Slovenian: Šestintrideset (36) ur po uporabi so se koncentracije estradiola pri večini preizkušank povrnile na izhodiščno koncentracijo pred odmerjanjem.
English: Whether twice weekly administration (with high oestrogen systemic exposure occurring twice a week) translates into lower risk than daily administration is currently unknown and represents an important matter of concern.
Slovenian: Trenutno ni znano, ali uporaba dvakrat na teden (pri čemer se velika sistemska izpostavljenost estrogenom pojavi dvakrat na teden) pomeni manjše tveganje kot vsakodnevna uporaba, kar predstavlja pomembno težavo.
English: Restrictions, warnings and other changes to the product information were proposed to reflect current clinical knowledge on the safety of HRT especially regarding thromboembolism, and breast and endometrial cancer.
Slovenian: Predlagane so bile omejitve, opozorila in druge spremembe informacij o zdravilu, ki bodo odražale trenutno klinično znanje glede varnosti hormonskega nadomestnega zdravljenja, predvsem glede trombembolije in raka dojke ter endometrija;
English: In particular, the treatment applies to vaginal atrophy in postmenopausal women, duration of treatment should be limited to four weeks and the product is intended for intravaginal administration only.
Slovenian: Predvsem, da je zdravljenje namenjeno nožnični atrofiji pri postmenopavzalnih ženskah, da je trajanje zdravljenja treba omejiti na štiri tedne in da je zdravilo namenjeno samo intravaginalni uporabi.
English: Comparison of pharmacokinetic data with other locally applied medicinal products was made.
Slovenian: Opravljena je bila primerjava farmakokinetičnih podatkov z drugimi lokalnimi zdravili.
English: Clarification as to the nature of the active substance, estradiol, as the most potent oestrogen and the potential effect on the skin and genetic information were also reflected in the product information, in line with current scientific knowledge.
Slovenian: Pojasnitev glede značaja zdravilne učinkovine, estradiola, kot najmočnejšega estrogena, in informacije o morebitnem učinku na kožo ter spolovila so se prav tako vključile v informacije o zdravilu, kar je bilo skladno s trenutnim strokovnim znanjem.
English: In addition, in study SCO 5174 was observed that estradiol serum concentrations had not returned to baseline levels about 36 h after administration of Linoladiol N.
Slovenian: Poleg tega so v študiji SCO 5174 opazili, da se koncentracije estradiola v serumu približno 36 ur po uporabi zdravila Linoladiol N niso povrnile na izhodiščne ravni.