FrancophonIA/ELRC3.0 huggingface dataset:
English: On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.
Slovenian: Družba Otsuka Pharmaceutical Europe Ltd. je dne 17. novembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Abilify, namenjenim zdravljenju odpornih večjih epizod depresije.
English: The Committee was also concerned that there was no long-term information from ‘double-blind' studies looking at the maintenance of Abilify's effects and its ability to prevent depression coming back.
Slovenian: Odbor je prav tako izrazil zadržke, da iz „dvojno slepih“ študij ni na voljo nikakršnih dolgoročnih informacij o ohranjanju učinkov zdravila Abilify ter o njegovi sposobnosti preprečevanja ponovne depresije.
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Abilify, aripiprazol, je antipsihotično zdravilo.
English: Since dopamine and 5-hydroxytryptamine are involved in major depression, Abilify is expected to help to normalise the activity of the brain when it is added to antidepressants, reducing the symptoms of major depressive episodes.
Slovenian: Ker dopamin in 5hidroksitriptamin sodelujeta pri hudi depresiji, naj bi zdravilo Abilify, ko je dodano antidepresivom, pomagalo normalizirati delovanje možganov ter s tem zmanjšati simptome večjih epizod depresije.
English: Each patient received an antidepressant that they had not previously taken for the current depressive episode.
Slovenian: Vsak bolnik je prejel antidepresiv, ki ga za trenutno epizodo depresije še ni jemal.
English: The short-term studies involved patients with major depressive episodes that had not responded to up to three previous antidepressant treatments.
Slovenian: Kratkotrajne študije so vključevale bolnike z večjimi epizodami depresije, ki se niso odzvali na do tri predhodna antidepresivna zdravljenja.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Slovenian: To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot živčni prenašalci.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Abilify?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Abilify?
English: It is already used to treat schizophrenia, and to treat and prevent manic episodes (periods of extremely high mood) in patients with bipolar I disorder.
Slovenian: Uporablja se že za zdravljenje shizofrenije ter za zdravljenje in preprečevanje maničnih epizod (obdobij nenormalno privzdignjenega razpoloženja) pri bolnikih z bipolarno motnjo I.
English: The company informed the CHMP that there are no consequences for patients currently in clinical trials or compassionate use programmes using Abilify.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Abilify.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Abilify could not have been approved for the treatment of resistant major depressive episodes.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Abilify ni mogoče odobriti za zdravljenje odpornih večjih epizod depresije.
English: Abilify was also expected to be used, in addition to antidepressants, to treat major depressive episodes in patients who had not responded adequately to previous antidepressant treatment.
Slovenian: Zdravilo Abilify naj bi se poleg antidepresivov uporabljalo tudi za zdravljenje večjih epizod depresije pri bolnikih, ki se na predhodno zdravljenje z antidepresivi niso zadostno odzvali.
English: What is happening with Abilify for the treatment of schizophrenia and the treatment and prevention of manic episodes in bipolar I disorder?
Slovenian: Kakšne so posledice za zdravilo Abilify, indicirano za zdravljenje shizofrenije ter za zdravljenje in preprečevanje maničnih epizod pri bipolarni motnji I?
English: The long-term study looked at the maintenance of Abilify's effects when added to an antidepressant.
Slovenian: V dolgotrajni študiji so raziskovali ohranjanje učinkov zdravila Abilify, po tem ko je bil dodan antidepresivu.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Abilify in the treatment of major depressive episodes did not outweigh its risks.
Slovenian: CHMP je v času umika menil, da koristi zdravila Abilify pri zdravljenju večjih epizod depresije ne odtehtajo z njim povezanih tveganj.
English: How is Abilify expected to work?
Slovenian: Kako naj bi zdravilo Abilify delovalo?
English: The final agreed wording was:
Slovenian: Dogovorjeno je bilo naslednje končno besedilo:
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Slovenian: • odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
English: EMLA was first approved in Sweden in 1984 and is currently nationally approved in 22 countries of the European Economic Area (EEA): Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Slovenian: Zdravilo EMLA je bilo prvič odobreno na Švedskem leta 1984, trenutno pa je na nacionalni ravni odobreno v 22 državah Evropskega gospodarskega prostora (EGP): v Avstriji, Belgiji, na Cipru, v Češki republiki, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Irskem, v Italiji, Latviji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu ter tudi na Islandiji in Norveškem.
English: Overall summary of the scientific evaluation of EMLA cream and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja kreme EMLA in povezanih imen (glejte Prilogo I)
English: • Adults
Slovenian: • Odrasli
English: Interactions are likely to be similar to the adult population” is preferred.
Slovenian: Medsebojno delovanje je verjetno podobno kot pri odrasli populaciji.“
English: In the majority of the countries the following age ranges are approved: neonates 0-2 months, infants 3-11 months and children 1-11 years.
Slovenian: V večini držav so odobrene naslednje starostne skupine: novorojenčki, stari od 0-2 meseca, dojenčki, stari od 3-11 mesecev, in otroci, stari od 1-11 let.
English: This information explains the time-course of the dynamic effects and how health care professionals can adapt to facilitate the procedures.
Slovenian: Te informacije pojasnjujejo, kakšen je časovni potek dinamičnih učinkov in kaj lahko zdravstveni delavci storijo za to, da poenostavijo postopke.
English: Available paediatric data do not demonstrate adequate efficacy for circumcision.”
Slovenian: Razpoložljivi pediatrični podatki ne dokazujejo zadostne učinkovitosti pri obrezovanju.“
English: The indication “topical anaesthesia of the skin” is approved in all countries where EMLA has a marketing authorisation.
Slovenian: Indikacija „topična anestezija kože“ je odobrena v vseh državah, v katerih ima zdravilo EMLA dovoljenje za promet.
English: • Skin of male & female genital organs - prior to injection of local anaesthetics
Slovenian: • Koža na moških in ženskih spolovilih - pred injiciranjem lokalnih anestetikov
English: The Committee also noted that data on efficacy in adults in this indication can be extrapolated to adolescents.
Slovenian: Odbor je prav tako upošteval, da je podatke o učinkovitosti pri tej indikaciji pri odraslih mogoče ekstrapolirati na mladostnike.
English: The wording was improved for clarity to include “self-application by patient”.
Slovenian: Besedilo je bilo zaradi večje jasnosti dopolnjeno z navedbo „samouporaba s strani bolnika“.
English: This dosage was previously approved and supported by the clinical study program.
Slovenian: Navedeni odmerek je bil predhodno odobren in potrjen v programu kliničnih študij.
English: In view of this, Germany (BfArM) notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Products Information (PIs) and thus to harmonise its divergent PIs across the EU.
Slovenian: Nemčija (BfArM) je zato obvestila Sekretariat odbora CHMP/agencije EMA o uradni napotitvi po členu 30 Direktive 2001/83/ES, z namenom odprave razhajanj med nacionalno odobrenimi informacijami o zdravilu in uskladitve razhajajočih se informacij po vsej EU.
English: For children aged 3 months and above, a maximum of 2 doses, separated by at least 12 hours can be given within any 24 hour period, see sections 4.4 and 4.8.”
Slovenian: Otrokom, starim 3 mesece ali več, se lahko dasta največ 2 odmerka, med katerima mora preteči najmanj 12 ur, v 24-urnem obdobju; glejte poglavji 4.4 in 4.8.“
English: The CHMP requested the inclusion of a warning for the paediatric population as regards the maximum number of doses in 24 hours.
Slovenian: Odbor CHMP je zahteval, da se vključi opozorilo za pediatrično populacijo v zvezi z največjim številom odmerkov v 24 urah.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Slovenian: Pri uskladitvi povzetka glavnih značilnosti zdravila so bile upoštevane vse ustrezne terapevtske in regulativne smernice v EU.
English: In addition, since no adequate data are available on the use of EMLA in pregnant women, a more careful wording is suggested and animal data - although not relating to dermal application- should nevertheless be cited.
Slovenian: Poleg tega je glede na to, da ni na voljo nobenih ustreznih podatkov o uporabi zdravila EMLA pri nosečnicah, priporočljivo previdnejše besedilo, navesti pa je treba tudi podatke, pridobljene pri živalih, kljub temu da se ne nanašajo na dermalno uporabo.
English: In general, the CHMP was in agreement with the proposed wording with some minor amendments.
Slovenian: Odbor CHMP se je na splošno strinjal s predlaganim besedilom z nekaj manjšimi spremembami.
English: The CHMP agreed to introduce this information in tabular format as this would be more clearly represented and easier to read.
Slovenian: Odbor CHMP se je strinjal, da se te informacije vključijo v obliki razpredelnice, saj bodo tako predstavljene na jasnejši način in jih bo mogoče lažje brati.
English: This was endorsed by the CHMP.
Slovenian: Odbor CHMP je to odobril.
English: The wording in section 5.2 is based on the MAH's CDS with some amendments.
Slovenian: Besedilo v poglavju 5.2 temelji na dokumentu CDS z nekaj spremembami.
English: 1.5-2 g/10 cm2 for 2-5 hours” was previously approved and is in line with the CSP agreed in 2012.
Slovenian: Odmerek „približno 1,5-2 g/10 cm2 za 2-5 ur“ je bil že odobren in je v skladu z dokumentom CSP, ki je bil potrjen leta 2012.
English: In addition it was recommended that this section should include a list of the most commonly concomitantly used medicines relevant to the population in which they are prescribed making also clear that this list is not exhaustive.
Slovenian: Poleg tega je odbor priporočil, da se v to poglavje vključi seznam najpogosteje sočasno uporabljanih zdravil glede na populacijo, za katero se predpisujejo, pri čemer je treba jasno navesti, da seznam ni izčrpen.
English: A statement like “Specific interaction studies in children have not been performed.
Slovenian: Zato je primernejša navedba, kot je na primer: „Specifične študije medsebojnega delovanja pri otrocih niso bile izvedene.
English: This text was endorsed by the CHMP with the addition of the below paragraph.
Slovenian: Odbor CHMP je to besedilo odobril, vendar pa je dodal spodaj navedeni odstavek.
English: A similar restriction (with caveats) for children 3 months and above was also considered necessary.
Slovenian: Prav tako je ocenil, da je podobna omejitev (z opozorilnimi oznakami) potrebna tudi za otroke, stare 3 mesece ali več.
English: The agreed dosage and application time was “2g (approx. half a 5g tube) or approx. 1.5g/10 cm2 for 1 to 5 hours”.
Slovenian: Dogovorjeni odmerek in čas nanosa sta bila „2 g (približno polovica 5-gramske tube) ali približno 1,5 g/10 cm2 za 1 do 5 ur“.
English: The proposed dose and application time were previously approved and well-established.
Slovenian: Predlagani odmerek in čas nanosa sta bila že odobrena in sta dobro uveljavljena.
English: The proposed dosage and application time for each of the above procedures was also endorsed and was in line with the approved wording in most of the countries.
Slovenian: Predlagani odmerek in čas nanosa za vsakega od zgornjih posegov sta bila prav tako odobrena in sta bila skladna z odobrenim besedilom v večini držav.
English: No maximum dose or maximum area to be treated was specified in the harmonised proposed text.
Slovenian: Največji odmerek in največja površina, na katero se lahko nanese zdravilo, v predlaganem usklajenem besedilu nista bila opredeljena.
English: For female genital skin a footnote was added stating that EMLA alone applied for 60 or 90 min does not provide sufficient anaesthesia for thermocautery or diathermy of genital warts.
Slovenian: Za kožo na ženskih spolovilih je bila dodana opomba, da nanos samega zdravila EMLA za 60 ali 90 minut ne povzroči zadostne anestezije za termokavterizacijo ali diatermijo genitalnih bradavic.
English: As a result the CHMP endorsed the MAH's proposal for this indication with the addition of the related population (i.e. adults only).
Slovenian: Odbor CHMP je zato podprl predlog imetnika dovoljenja za promet z zdravilom za to indikacijo, pri čemer je dodal zadevno populacijo (tj. samo odrasli).
English: Lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anaesthesia.
Slovenian: Lidokain in prilokain stabilizirata nevronske membrane, tako da zavirata prehajanje ionov, ki je potrebno za nastajanje in prevajanje impulzov, s čimer povzročita lokalno anestezijo.
English: In general the proposed paediatric posology was considered acceptable by the CHMP except for the frequency of dosing in the population between 0-3 months.
Slovenian: Na splošno je odbor CHMP menil, da je predlagano odmerjanje pri pediatrični populaciji sprejemljivo, z izjemo pogostnosti odmerjanja pri populaciji, stari od 0 do 3 mesece.
English: The proposed text for fertility and breast-feeding was endorsed by the CHMP.
Slovenian: Predlagano besedilo za plodnost in dojenje je odbor CHMP odobril.
English: The active substances are both local anaesthetics of the amide type with long-standing clinical experience.
Slovenian: Obe zdravilni učinkovini sta amidna lokalna anestetika, s katerima beležimo dolgoletne klinične izkušnje.
English: The CHMP also recommended shortening the detailed study descriptions for the paediatric population to provide a more comprehensive overview about the relevant paediatric study program and the relevant paediatric features.
Slovenian: Prav tako je odbor priporočil, da se za pediatrično populacijo skrajšajo podrobni opisi študij, da se zagotovi celovitejši pregled ustreznega programa pediatričnih študij in pomembnih lastnosti za pediatrično populacijo.
English: The MAH agreed that “anaphylactic reaction” should not be used for allergic reactions; however as there is no Preferred Term (PT) for “allergic reactions” in the current MedDRA coding (version 17) the PT term “hypersensitivity” will be used instead.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal, da se „anafilaktična reakcija“ ne sme uporabiti za alergijske reakcije; ker pa ne obstaja prednostni izraz za „alergijske reakcije“ v trenutni klasifikaciji MedDRA (različica 17), bo namesto tega uporabljen prednostni izraz „preobčutljivost“.
English: As a result, the final agreed wording was: “In term newborn infants and infants below 3 months, only one single dose should be applied in any 24 hour period.
Slovenian: Posledično je bilo dogovorjeno naslednje končno besedilo: „Donošenim novorojenčkom in dojenčkom, mlajšim od 3 mesecev, se lahko da samo en enkratni odmerek v 24-urnem obdobju.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
English: If the recommended dose is exceeded the patient should be monitored for system adverse reactions secondary to methaemoglobinaemia (see sections 4.2, 4.8 and 4.9).”
Slovenian: Če se priporočeni odmerek preseže, je treba bolnika spremljati glede sistemskih neželenih učinkov, ki so posledica methemoglobinemije (glejte poglavja 4.2, 4.8 in 4.9).“
English: • The committee reviewed the data submitted by the MAH on clinical studies, post-marketing data and published literature justifying the proposed harmonisation of the product information
Slovenian: • odbor je pregledal podatke iz kliničnih študij, obdobja trženja in objavljene literature, ki jih je predložil imetnik dovoljenja za promet z zdravilom in ki utemeljujejo predlagano uskladitev informacij o zdravilu;
English: However, the Committee flagged that as per the SmPC Guideline, this section should be presented in the simplest possible way to highlight the interactions resulting in a practical recommendation regarding the use of the medicinal product.
Slovenian: Vendar pa je odbor opozoril, da mora biti to poglavje v skladu s smernicami za povzetek glavnih značilnosti zdravila predstavljeno na kar najbolj preprost način, da se izpostavijo interakcije, na podlagi katerih bodo podana praktična priporočila glede uporabe zdravila.
English: The MAH's proposal included results of a single study for the paediatric population but the CHMP stated that the information for the paediatric population should not consist of a single study data.
Slovenian: Besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je vključevalo rezultate ene same študije pri pediatrični populaciji, vendar je odbor CHMP navedel, da informacije za pediatrično populacijo ne smejo temeljiti na podatkih iz ene same študije.
English: The agreed wording was: “Safety and efficacy for the use of EMLA on genital skin and genital mucosa have not been established in children younger than 12 years.
Slovenian: Dogovorjeno je bilo naslednje besedilo: „Varnost in učinkovitost uporabe zdravila EMLA na koži spolovil in genitalni sluznici pri otrocih, mlajših od 12 let, nista bili dokazani.
English: • Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (selfapplication by patient)
Slovenian: • Dermalni posegi na sveže obriti koži na večjih predelih telesa, npr. laserska odstranitev dlak (samouporaba s strani bolnika)
English: The CHMP agreed with the wording proposed by the MAH, as follows: “EMLA has no or negligible influence on the ability to drive and use machines when used at the recommended doses”.
Slovenian: Odbor CHMP se je strinjal z besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom: „Zdravilo EMLA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, kadar se uporablja v priporočenih odmerkih.“
English: The proposed wording for use on newly shaven skin on large body areas as well as the proposed dosage are previously approved and are in line with the CSP agreed in 2012.
Slovenian: Predlagano besedilo za uporabo na sveže obriti koži na večjih predelih telesa in predlagani odmerek sta bila že odobrena in sta v skladu z dokumentom CSP, ki je bil potrjen leta 2012.
English: Data on vascular response and ease of venepuncture including skin thickness was included in this section mainly to address frequent questions on the effect of EMLA on the technical performance of vascular punctures.
Slovenian: V to poglavje so bili vključeni podatki o odzivu ožilja in lažji venski punkciji, vključno z debelino kože, zlasti da bi odgovorili na pogosta vprašanja o vplivu zdravila EMLA na tehnično izvedbo punkcij žil.
English: There were some divergences in the wording used in some countries (e.g. injuries or lesions and superficial surgical procedures, minor abnormalities) but the CHMP agreed on the above wording as it was consistent with the one approved in the majority of the countries.
Slovenian: Besedila, uporabljena v nekaterih državah članicah, so se nekoliko razhajala (npr. poškodbe ali lezije in površinski kirurški posegi, manjše nepravilnosti), vendar je odbor CHMP potrdil zgoraj navedeno besedilo, ki je skladno s tistim, ki je bilo odobreno v večini držav.
English: As a result of the implementation of the outcome of the paediatric work sharing procedure SE/W/008/pdWS/001 (Article 45 of Regulation (EC) No1901/2006) several divergences between the summaries of product characteristics (SmPCs) of this product, namely in sections 4.1 and 4.2 and respective sections of the package leaflet (PL) have been identified.
Slovenian: Kot rezultat izvajanja dogovorov, sprejetih v okviru pediatričnega postopka delitve dela SE/W/008/pdWS/001 (člen 45 Uredbe (ES) št. 1901/2006), je bilo odkritih več razhajanj med povzetki glavnih značilnosti zdravila za to zdravilo, zlasti v poglavjih 4.1 in 4.2 ter zadevnih poglavjih navodila za uporabo.
English: The dosage was previously approved and is in line with the CSP agreed in 2012.
Slovenian: Odmerek je bil že odobren in je v skladu z dokumentom CSP, ki je bil potrjen leta 2012.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holder the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for EMLA and associated names (see Annex I).
Slovenian: • odbor se je strinjal z uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jo je predlagal imetnik dovoljenja za promet z zdravilom; je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Prilogi III za zdravilo EMLA in povezana imena (glejte Prilogo I).
English: The CHMP agreed to harmonise the indication in the genital mucosa to include the use in adolescents.
Slovenian: Odbor CHMP se je strinjal, da je treba uskladiti indikacijo, povezano z genitalno sluznico, tako da se bo vključila uporaba pri mladostnikih.
English: There are some linguistic differences between the countries, such as “local anaesthesia”, “topical analgesia” and “topical anaesthesia”.
Slovenian: Pri tem med državami obstajajo določene jezikovne razlike, kot na primer „lokalna anestezija“, „topična analgezija“ in „topična anestezija“.
English: For the paediatric population the CHMP agreed to the inclusion of the paragraph describing the interaction of EMLA with vaccines.
Slovenian: Odbor CHMP se je strinjal, da se za pediatrično populacijo vključi odstavek, v katerem bo opisano medsebojno delovanje zdravila EMLA s cepivi.