FrancophonIA/ELRC3.0 huggingface dataset:
English: A potential serious risk to public health was raised by the Netherlands.
Slovenian: Nizozemska je izpostavila morebitno resno tveganje za javno zdravje.
English: The relevant authorities of the concerned marketing authorisations are: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
Slovenian: Ustrezni organi za zadevna dovoljenja za promet z zdravilom so: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 13 Uredbe (ES) št. 1234/2008;
English: The worksharing procedure SE/H/xxxx/WS/190 started on 20 January 2018.
Slovenian: Postopek za delitev dela SE/H/xxxx/WS/190 se je začel 20. januarja 2018.
English: The CHMP noted that according to the ICH Quality Guidelines, none of the Member States of the EU is considered a Zone IV region.
Slovenian: Odbor CHMP je ugotovil, da v skladu s smernicami o kakovosti ICH nobena od držav članic EU ni država območja IV.
English: The clinical relevance of the test results therefore could not be determined;
Slovenian: Kliničnega pomena rezultatov preskusa torej ni bilo mogoče določiti;
English: As per the Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents (EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
Slovenian: V skladu z Navodili o kliničnih zahtevah za lokalno uporabljana in lokalno delujoča zdravila, ki vsebujejo znane sestavine (EMA CPMP/EWP/239/95), so za ugotavljanje terapevtske enakovrednosti dveh zdravil načeloma potrebni klinični podatki.
English: Day 60 of the CMDh procedure was on 25 October 2018 and as no agreement amongst member states could be reached, Sweden notified the European Medicines Agency on 26 October 2018 of a referral under Article 13 of Regulation EC No 1234/2008.
Slovenian: 60. dan postopka skupine CMDh je bil 25. oktobra 2018, in ker ni bilo mogoče doseči dogovora, je Švedska 26. oktobra 2018 obvestila Evropsko agencijo za zdravila o napotitvi v skladu s členom 13 Uredbe ES št. 1234/2008.
English: The clinical significance of the observed differences cannot be determined, since the criteria for the selected non-inferiority margins have not been adequately justified, and therefore these results cannot support the efficacy and safety of the new formulation.
Slovenian: Kliničnega pomena opaženih razlik ni mogoče določiti, ker merila za izbor meje neinferiornosti niso ustrezno utemeljena, zato ti rezultati ne morejo podpirati učinkovitosti in varnosti nove formulacije.
English: Moreover the Committee noted that the in-vitro tests used were not validated for the therapeutic situation and that they had several methodological limitations.
Slovenian: Poleg tega je odbor ugotovil, da uporabljeni preskusi in vitro niso bili validirani za terapevtske pogoje in da so imeli več metodoloških omejitev.
English: Furthermore, the CHMP considered that the submitted in-vitro studies had several methodological limitations including the absence of a positive control, the duration, and the high heterogeneity among the donors.
Slovenian: Odbor CHMP je ocenil tudi, da imata predloženi študiji in vitro več metodoloških omejitev, vključno z odsotnostjo pozitivne kontrole, trajanjem in veliko raznolikostjo darovalcev.
English: The Committee, as a consequence, recommends the refusal of the variation to the terms of the marketing authorisation application for the medicinal products referred to in Annex I of the CHMP opinion.
Slovenian: je zato odbor priporočil zavrnitev spremembe pogojev dovoljenja za promet z zdravilom za zdravila,navedena v Prilogi I k mnenju odbora CHMP.
English: However, since the tests have not been validated for the therapeutic situation, the clinical relevance of the test results is unclear.
Slovenian: Ker pa preskusi niso bili validirani za terapevtske pogoje, je klinični pomen rezultatov preskusa nejasen.
English: In absence of clinical data, non-clinical validated models can be accepted.
Slovenian: V odsotnosti kliničnih podatkov so lahko sprejemljivi neklinični validirani modeli.
English: The MAH conducted two in-vitro studies which showed that there were differences in the absorbed dose (35% lower absorbed dose) and less significant differences in the penetrated doses.
Slovenian: Imetnik dovoljenja za promet z zdravilom je opravil dve študiji in vitro, ki sta dokazali, da obstajajo razlike v absorbiranem odmerku (za 35 % manjši absorbirani odmerek) in manj pomembne razlike v odmerkih, ki so prodrli v telo.
English: The reformulation was focused on the gelling agent to improve physical stability in order to extend the shelf-life of the products in Zone IV countries where viscosity value tends to decrease due to higher temperature.
Slovenian: Pri reformulaciji so se osredotočili na želirno sredstvo, da bi izboljšali fizikalno stabilnost in tako podaljšali rok uporabnosti v državah območja IV, v katerih se vrednost viskoznosti zaradi višjih temperatur povečuje.
English: As documented in the scientific literature1 changes in the qualitative composition of semi-solid topical formulation can have an impact on drug release and efficacy of the topical products.
Slovenian: Kot je dokumentirano v znanstveni literaturi1, lahko spremembe v kakovostni sestavi poltrdne topične formulacije vplivajo na sproščanje učinkovine in učinkovitost topičnih zdravil.
English: However, in support of this application neither clinical data nor validated non-clinical data have been submitted.
Slovenian: Vendar pa v podporo tej vlogi niso bili predloženi niti klinični podatki niti validirani neklinični podatki.
English: The rationale for the change in the formulation was to extend the shelf-life of the products in Zone IV countries.
Slovenian: Namen spremembe formulacije je bil podaljšanje roka uporabnosti zdravila v državah območja IV.
English: Safety data of the new gelling agent Simulgel 600 PHA has been evaluated in 2008 for Epiduo 0.1%, which contains adapalene 0.1% and benzoyl peroxide 2.5%, in a vehicle containing Simulgel 600 PHA.
Slovenian: Podatke o varnosti novega želirnega sredstva Simulgel 600 PHA so ovrednotili leta 2008 za zdravilo Epiduo 0,1 %, ki vsebuje 0,1 % adapalena in 2,5 % benzoil peroksida v vehiklu, ki vsebuje Simulgel 600 PHA.
English: Therefore the benefit/risk balance of the reformulated medicinal product isconsidered unfavourable.
Slovenian: Razmerje med tveganji in koristmi reformuliranega zdravila torej velja za neugodno,
English: In the clinical studies performed in support of the Epiduo gel, approximately 2500 subjects above 9 years of age were exposed to Simulgel 600 PHA.
Slovenian: V kliničnih študijah, opravljenih v podporo zdravilu Epiduo gel, je bilo sredstvu Simulgel 600 PHA izpostavljenih približno 2 500 preiskovancev, starejših od devet let.
English: This variation relates to a change of formulation for Basiron in order to replace the gelling agent Carbomer 940 with Simulgel 600 PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Slovenian: Ta sprememba se nanaša na spremembo formulacije zdravila Basiron, pri čemer bi se želirno sredstvo Carbomer 940 nadomestilo z želirnim sredstvom Simulgel 600 PHA (kopolimer akrilamida - natrijevega akrilodimetiltavrata, izoheksadekan, polisorbat 80, sorbitan oleat in voda).
English: • Having assessed the totality of the data, the Committee was of the view that the available data were not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Slovenian: • po oceni vseh podatkov je odbor menil, da razpoložljivi podatki ne zadoščajo za dokaz terapevtske enakovrednosti nove formulacije in formulacije, ki je trenutno na trgu.
English: The CHMP concluded that the submitted data are not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Slovenian: Odbor CHMP je zaključil, da predloženi podatki ne zadostujejo za dokazovanje terapevtske enakovrednosti nove formulacije in formulacije, ki je trenutno na trgu.
English: Therefore, the safety and the efficacy of the reformulated product cannot be considered established.
Slovenian: Zato ni mogoče sklepati, da sta varnost in učinkovitost reformuliranega zdravila dokazani.
English: The change in composition due to the replacement of the gelling agent cannot be considered minor per se, and the available data from in-vitro tests are not considered suitable to fully elucidate the clinical impact of this reformulation.
Slovenian: Sprememba v sestavi zaradi zamenjave želirnega sredstva sama po sebi ne more veljati za majhno, razpoložljivi podatki iz preskusov in vitro pa niso primerni za popolno razjasnitev kliničnega vpliva te formulacije.
English: On 1 December 2017, a Quality type II variation application was submitted by Galderma Nordic AB in line with Article 10(1) of Commission Regulation (EC) No 1234/2008 under the worksharing procedure in accordance with Article 20 of Commission Regulation (EC) No 1234/2008 (SE/H/xxxx/WS/190) for the marketing authorisations for Basiron AC 5% w/w gel and 10% w/w gel to change the formulation by replacing the gelling agent excipient Carbomer 940 with Simulgel 600 PHA (acrylamide sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Slovenian: Družba Galderma Nordic AB je v skladu s členom 10(1) Uredbe Komisije (ES) št. 1234/2008 v postopku za delitev dela v skladu s členom 20 Uredbe Komisije (ES) št. 1234/2008 (SE/H/xxxx/WS/190) za dovoljenja za promet z zdravilom za zdravilo Basiron AC 5 % m/m gel in 10 % m/m gel 1. decembra 2017 predložila spremembo tipa II v zvezi s kakovostjo, in sicer za spremembo formulacije z zamenjavo pomožne snovi - želirnega sredstva Carbomer 940 z želirnim sredstvom Simulgel 600 PHA (kopolimer akrilamida - natrijevega akrilodimetiltavrata, izoheksadekan, polisorbat 80, sorbitan oleat in voda).
English: • The Committee considered the supportive clinical data of another medicinal product containing benzoyl peroxide 2.5% in combination with adapalene 0.1%, in a vehicle containing Simulgel 600 PHA, and concluded that data of the reformulated Basiron AC gels 5% w/w and 10% w/w could not be extrapolated from the dossier of another product in view of qualitative and quantitative differences between Basiron AC gels 5% w/w and 10% w/w and the other medicinal product;
Slovenian: • odbor je ocenil podporne klinične podatke za drugo zdravilo, ki vsebuje 2,5 % benzoil peroksida v kombinaciji z 0,1 % adapalena v vehiklu, ki vsebuje Simulgel 600 PHA, in zaključil, da ob upoštevanju kakovostnih in količinskih razlik med zdravilom Basiron AC gel 5 % m/m in 10 % m/m ter drugim zdravilom podatkov za reformulirano zdravilo Basiron AC gel 5 % m/m in 10 % m/m ni mogoče ekstrapolirati iz dokumentacije drugega zdravila;
English: Taking into consideration the qualitative and quantitative differences between Epiduo gel and the re-formulated Basiron, it cannot be concluded based on the data provided that the data from Epiduo gel can be extrapolated to the new formulation of Basiron AC
Slovenian: Z upoštevanjem kakovostnih in količinskih razlik med zdravilom Epiduo gel in reformuliranim zdravilom Basiron na podlagi predloženih podatkov ni mogoče sklepati, da bi podatke o zdravilu Epiduo gel lahko ekstrapolirali na novo formulacijo zdravila Basiron AC.
English: • The Committee noted that the in-vitro tests indicated differences between the marketed formulation and the new proposed formulation containing the new gelling agent Simulgel 600 PHA.
Slovenian: • odbor je ugotovil, da preskusi in vitro kažejo na razlike med formulacijo, ki je na trgu, in novo predlagano formulacijo, ki vsebuje novo želirno sredstvo Simulgel 600 PHA.
English: • The Committee considered the totality of the data submitted by the MAH in support of the type II quality variation for Basiron AC gels 5% w/w and 10% w/w;
Slovenian: • odbor je proučil vse podatke, ki jih je imetnik dovoljenja za promet z zdravilom predložil v podporo spremembi tipa II v zvezi s kakovostjo za zdravili Basiron AC gel 5 % m/m in 10 % m/m;
English: There may be differences in absorption and stability of the active substance between the Epiduo and the new Basiron formulation, which cannot be determined in the absence of relevant data for Basiron.
Slovenian: Med zdravilom Epiduo in novo formulacijo zdravila Basiron lahko obstajajo razlike v absorpciji in stabilnosti učinkovine, ki jih v odsotnosti ustreznih podatkov za zdravilo Basiron ni mogoče določiti.
English: • The Committee noted the absence of clinical data generated with the reformulated product containing the gelling agent excipient Simulgel 600 PHA for Basiron and associated names;
Slovenian: • odbor je poudaril odsotnost kliničnih podatkov, pridobljenih z reformuliranim zdravilom, ki vsebuje pomožno snov - želirno sredstvo Simulgel 600 PHA, za zdravilo Basiron in povezana imena;
English: • The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
Slovenian: • odbor je pregledal razpoložljive podatke, predložene v podporo novi formulaciji zdravila Basiron, ki vsebuje novo pomožno snov - želirno sredstvo Simulgel 600 PHA;
English: The procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by Sweden on 21 August 2018.
Slovenian: Švedska je 21. avgusta 2018 v skladu s prvim odstavkom člena 13(1) Uredbe (ES) št. 1234/2008 postopek napotila na Skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh).
English: Cashel Road, Dublin 12, Ireland.
Slovenian: Cashel Road, Dublin 12, Irska.
English: Very rare Not known (cannot be estimated from the available data)
Slovenian: Zelo redki Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: Date opened: ____________________
Slovenian: Datum odpiranja: ____________________
English: It may harm them, even if their symptoms are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni podobne vašim.
English: It was therefore not possible to add additional wording to the statement in section 4.4.
Slovenian: Zato ni bilo mogoče dodati dopolnjenega besedila izjavi v poglavju 4.4.
English: Effects on endocrine system
Slovenian: Vpliv na endokrini sistem
English: Vodopivceva 9 SI-4000 Kranj Slovenia
Slovenian: Vodopivceva 9 SI-4000 Kranj Slovenija
English: The potential risk for humans is uncertain.
Slovenian: Morebitna tveganja pri ljudeh so nejasna.
English: However, in a number of member states alternative text has been included following the outcome of National Procedures.
Slovenian: Vendar pa je bilo v več državah članicah v skladu z izidi nacionalnih postopkov vključeno tudi alternativno besedilo.
English: The statement “children and adolescents below the age of 18 years” has been simplified to “children below the age of 18 years”.
Slovenian: Izjava „otroci in mladostniki, mlajši od 18 let“ je bila poenostavljena v „otroci, mlajši od 18 let“.
English: % of patients with controlled disease
Slovenian: % bolnikov z nadzorovano boleznijo
English: The CHMP endorsed these changes as they improve the definition of the target population and reflect the data offered in support of the indications.
Slovenian: CHMP je potrdil te spremembe, saj izboljšujejo definicijo ciljne populacije in odražajo podatke, ki so jih predložili za potrditev indikacij.
English: Mean percentage reduction in PASI (SD)
Slovenian: Povprečno zmanjšanje deleža PASI (SD)
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: Ker študije kompatibilnosti niso na voljo, se zdravila ne sme mešati z drugimi zdravili.
English: Plasma elimination half-life after intravenous application is 5-6 hours.
Slovenian: Razpolovni čas plazme po intravenski aplikaciji je 5-6 ur.
English: Protein binding is approx. 64 %.
Slovenian: 64 % se veže s proteini.
English: You may have to stop your treatment.
Slovenian: Morda bo potrebno prekiniti zdravljenje.
English: ATC Code: D05AX52
Slovenian: Oznaka ATC: D05AX52
English: Finally, the possibility of more frequent systemic effects “under occlusion” was not mentioned.
Slovenian: Poleg tega ni bila omenjena možnost pogostejšega pojavljanja sistemskih učinkov „pod okluzijo“.
English: Unevaluated uses
Slovenian: Neocenjene uporabe
English: Overall summary of the scientific evaluation of Daivobet and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Daivobet in z njim povezanih imen (glejte Dodatek I)
English: The CHMP endorsed the mention of such warnings.
Slovenian: CHMP je potrdil omembo takšnih opozoril.
English: This is the proposed basis for its effect in psoriasis.
Slovenian: To je predlagana osnova za njihovo učinkovitost pri psoriazi.
English: Quality Module
Slovenian: Modul kakovosti
English: The bottles are placed in cartons.
Slovenian: Plastenke so pakirane v škatle iz kartona.
English: The recommended treatment period is 4 weeks.
Slovenian: Priporočljivo trajanje zdravljenja je 4 tedne.
English: In such cases symptomatic treatment is indicated.
Slovenian: V takšnih primerih je indicirano simptomatsko zdravljenje.
English: 2 x 60 g (valid for the packaging containing two 60 g bottles)
Slovenian: 2 x 60 g (velja za pakiranje, ki vsebuje dve plastenki po 60 g)
English: The relevance for humans is unknown.
Slovenian: Pomen teh rezultatov za ljudi ni poznan.
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Slovenian: Po izdaji sklepa Evropske komisije bodo pristojni organi držav članic v sodelovanju z referenčno državo članico podatke o zdravilu ustrezno posodobile.
English: Swelling of the mouth/throat and trouble breathing may occur.
Slovenian: Lahko se pojavi otekanje v ustih/grlu in težave pri dihanju.
English: If you forget to use Daivobet Do not take a double dose to make up for forgotten individual doses.
Slovenian: Če ste pozabili uporabiti zdravilo Daivobet Ne uporabite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: The CHMP found the changes proposed appropriate and acceptable.
Slovenian: CHMP je menil, da so predlagane spremembe ustrezne in sprejemljive.
English: The harmonisation of the quality module was requested by the MAH at the beginning of this Referral procedure.
Slovenian: Usklajevanje modula kakovosti je zahteval imetnik dovoljenja za promet z zdravilom na začetku tega napotitvenega postopka.
English: Daivobet gel should not be applied directly to the face or eyes.
Slovenian: Daivobet gela ne smete nanesti neposredno na obraz ali oči.
English: This medicine is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
English: Long-term use
Slovenian: Dolgotrajna uporaba
English: The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes.
Slovenian: Bolnika je treba podučiti o pravilni uporabi zdravila, da se izogne nanosu ali naključnemu prenosu zdravila na obraz, usta in oči.
English: For external use only.
Slovenian: za uporabo na koži samo za zunanjo uporabo
English: The medicinal product should not be used in these areas”.
Slovenian: Na teh predelih se zdravilo ne sme uporabljati.“
English: Rebound effect after end of treatment has been reported but the frequency of this is not known.
Slovenian: Poročali so tudi o povratnem učinku (rebound effect) po končanem zdravljenju, vendar njegova pogostnost ni znana.
English: Both treatments were applied once daily, intermittently as required, for up to 52 weeks.
Slovenian: Obe zdravili so uporabljali v odmerku enkrat dnevno, v presledkih po potrebi, čas trajanja študije pa je bil do 52 tednov.
English: The quality module for Daivobet ointment has also been assessed and its harmonisation has been agreed by the CHMP.
Slovenian: Ocenjen je bil tudi modul kakovosti za zdravilo Daivobet mazilo, njegovo uskladitev pa je potrdil tudi CHMP.
English: The reference to patients with severe renal insufficiency or severe hepatic disorders was removed from this section and included under section 4.2
Slovenian: Besedilo v zvezi z bolniki s hudo ledvično insuficienco ali hudimi jetrnimi motnjami je bilo izbrisano iz tega poglavja in vključeno v poglavje 4.2.
English: The pharmaco-therapeutic group “Like other topical corticosteroids” has also been added.
Slovenian: Dodana je bila tudi farmako-terapevtska skupina „Podobno kot drugi kortikosteroidi“.
English: Rebound effect - included in section 4.4
Slovenian: Povratni učinek (rebound effect) - glejte poglavje 4.4
English: Not known frequency - Rebound effect: A worsening of symptoms/psoriasis after ended treatment.
Slovenian: Neznana pogostnost - Povratni učinek (rebound effect): Poslabšanje znakov bolezni/psoriaze po zaključenem zdravljenju.
English: In three MS the SPC was more general and did not include any study results.
Slovenian: V treh državah članicah pa je bil povzetek glavnih značilnosti zdravila bolj splošen in ni vključeval rezultatov nobene študije.
English: The CHMP considered the addition of the information on misuse of Daivobet helpful and appropriate and other changes were considered acceptable.
Slovenian: CHMP je menil, da je vključitev informacije o zlorabi zdravila Daivobet koristna in ustrezna ter da so sprejemljive tudi druge spremembe.
English: This describes accurately the subjects included in the clinical studies submitted in support of the efficacy and safety of Daivobet ointment.
Slovenian: To natančno opisuje preiskovance, vključene v klinični študiji, ki sta bili predloženi v potrditev učinkovitost in varnosti zdravila Daivobet mazilo.
English: This recommendation is based on non-clinical photo(co)carcinogenicity data.
Slovenian: To priporočilo je utemeljeno na podatkih o ne-klinični foto(ko)kancerogenosti.
English: Do not apply directly to the face or eyes.
Slovenian: Ne uporabljajte zdravila na obrazu in na očeh.
English: Hands must be washed after each application to avoid accidental transfer to these areas.
Slovenian: Po vsaki uporabi si je potrebno umiti roke, da preprečimo nehoteni prenos zdravila na omenjene predele.
English: Detailed information on this medicine is available on the web site of {name of MS/Agency}
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani {Ime države članice/Agencije}
English: With regard to the risk of rebound effects mentioned in section 4.4, the CHMP questioned if there was any evidence that tapering the dose will reduce the chance of this happening.
Slovenian: Ob upoštevanju tveganja, da se lahko pojavijo odtegnitveni učinki, navedeni v poglavju 4.4, je CHMP vprašal, ali obstajajo kakšni dokazi, da zmanjševanje odmerka zmanjšuje možnost pojavljanja odtegnitvenih učinkov.
English: The CHMP noted that the contraindications in erythrodermic, exfoliative and pustular psoriasis are based on medical risk of use in these conditions and are therefore considered to be absolute contraindications.
Slovenian: CHMP je menil, da so kontraindikacije pri eritrodermični, eksfoliativni in pustularni psoriazi utemeljene na medicinskem tveganju uporabe zdravila pri teh stanjih in se zato obravnavajo kot absolutne kontraindikacije.
English: The CHMP noted that, according to the Guideline on Summary of Product Characteristics, the findings of the non-clinical testing, the carcinogenicity study and the photo(co)carcinogenicity study, should be described in brief and qualitative statements.
Slovenian: CHMP je menil, da je v skladu s smernicami o povzetku glavnih značilnosti zdravila treba ugotovitve nekliničnih preskušanj, študije kancerogenosti in študije foto(ko)kancerogenosti opisati na kratko in s kvalitativnimi izjavami.