natgillin/translations-raw huggingface dataset:
Furthermore, the PRAC was requested to review any additional risk minimisation measures to ensure that these are optimal in terms of provision of information and delivery of effective risk management that is subject to appropriate monitoring.
Odbor PRAC je bil zaprošen tudi, naj pregleda vse dodatne ukrepe za zmanjšanje tveganja in zagotovi, da so ti ukrepi optimalni v smislu zagotavljanja informacij in učinkovitega obvladovanja tveganja, za katerega se izvaja ustrezno spremljanje.
However, there was a consensus that several other factors may contribute to an increased systemic exposure and therefore the risk cannot be excluded.
Soglašali pa so, da k povečani sistemski izpostavljenost lahko prispevajo drugi dejavniki, zato tveganja ni mogoče izključiti.
The CHMP clarified that the communication plan should be modified to say ‘healthcare professionals who may be involved in the management of patients treated with retinoids'.
Odbor CHMP je pojasnil, da je treba načrt obveščanja spremeniti tako, da bo navajal „zdravstveni delavci, ki utegnejo biti vključeni v obravnavo bolnikov, zdravljenih z retinoidi“.
The PRAC has also recommended that educational materials be distributed via electronic channels such as QR codes, and websites to make better use of the existing technology bearing in mind the young patient population using these products.
Odbor PRAC je priporočil tudi, naj se izobraževalna gradiva distribuirajo po elektronskih kanalih, kot so QR-kode in spletna mesta, s čimer se bolje izkoristi obstoječa tehnologija z mislijo na mlajšo populacijo bolnikov, ki uporabljajo ta zdravila.
Therefore, the PRAC agrees that all oral retinoids should contain a warning about the potential risk of neuropsychiatric disorders in line with some key principles.
Zato se odbor PRAC strinja, da morajo vsi peroralni retinoidi vsebovati opozorilo o možnem tveganju za nevropsihiatrične motnje v skladu z določenimi ključnimi načeli.
The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU.
Odbor PRAC je ugotovil, da kljub uvedbi ukrepov za preprečevanje nosečnosti, vključno s programi preprečevanja nosečnosti, v EU še naprej poročajo o primerih nosečnosti med zdravljenjem s peroralnimi retinoidi.
Although the underlying risk of psychiatric disorders within the patient populations can be significant, it is advisable that patients taking oral retinoids are warned about the potential risk of psychiatric reactions and the signs and symptoms to look out for.
Čeprav je osnovno tveganje za psihiatrične motnje znotraj populacij bolnikov lahko precejšnje, je priporočljivo, da se bolnike, ki jemljejo peroralne retinoide, opozori o možnem tveganju za psihiatrične učinke ter o znakih in simptomih, na katere morajo biti pozorni.
The animal reproductive toxicity data for the oral retinoids demonstrate a typical pattern of retinoid embryopathy.
Podatki o reproduktivni toksičnosti peroralnih retinoidov pri živalih kažejo značilen vzorec retinoidne embriopatije.
The data support that for isotretinoin and alitretinoin the information in section 4.4 and 4.8, of the SmPC, should be in line with the agreed outcome of the 2003 Art 30 referral for isotretinoin.
Podatki so v prid dejstvu, da morajo biti informacije za izotretinoin in alitretinoin v poglavjih 4.4 in 4.8 povzetka glavnih značilnosti zdravila v skladu z dogovorjenim izidom napotitve v skladu s členom 30 iz leta 2003 za izotretinoin.
The review confirms the already known teratogenic risks associated with the use of oral retinoids in pregnant women.
Pregled potrjuje že znana tveganja za teratogenost, povezana z uporabo peroralnih retinoidov pri nosečnicah.
Studies that examine the effects of human pregnancy on systemic absorption of topical retinoids are also lacking.
Prav tako ni študij, ki bi preučevale vpliv nosečnosti pri ljudeh na sistemsko absorpcijo lokalnih retinoidov.
However, given that humans are the most sensitive species to retinoid embryopathy and that several other factors may contribute to an increased systemic exposure, such as excessive use and damaged skin barrier, the PRAC agreed that the teratogenic risk cannot be completely excluded.
Vendar glede na dejstvo, da smo ljudje najobčutljivejša vrsta za retinoidno embriopatijo in da k povečani sistemski izpostavljenosti lahko prispeva še več drugih dejavnikov, kot sta čezmerna uporaba in poškodovana kožna pregrada, se je odbor PRAC strinjal, da tveganja za teratogenost ni mogoče popolnoma izključiti.
These include a patient reminder card, physician checklist/acknowledgement form and pharmacist checklist ensuring the understanding and the awareness of prescribers and patients on the risks.
Ti vključujejo opozorilno kartico za bolnika, zdravnikov kontrolni seznam/potrditveni obrazec in farmacevtov kontrolni seznam, ki zagotavljajo, da predpisovalci in bolniki razumejo tveganja in se jih zavedajo.
Given that humans are the most sensitive species with respect to retinoid toxicity and considering the limitations of the available data with respect to understanding the systemic absorption and also the possible risks, the PRAC, considers that it is appropriate to take a very precautious approach.
Glede na to, da smo ljudje najobčutljivejša vrsta, kar zadeva toksičnost retinoidov, in glede na omejenost razpoložljivih podatkov v zvezi z razumevanjem sistemske absorpcije in morebitnih tveganj odbor PRAC meni, da je primerno uporabiti previden pristop.
On 7 July 2016 the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to review the routine risk minimisation measures in place for the oral and topical retinoids to ensure the available data and the risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed within the product information where appropriate and justified by data.
Združeno kraljestvo je 7. julija 2016 sprožilo napotitev v skladu s členom 31 Direktive 2001/83/ES zaradi farmakovigilančnih podatkov in odbor PRAC zaprosilo, naj pregleda rutinske ukrepe za zmanjšanje tveganja, vzpostavljene za peroralne in lokalne retinoide, da se zagotovi, da so razpoložljivi podatki in tveganja, povezana z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami, natančno in skladno obravnavani v informacijah o zdravilu, kadar je to primerno, in utemeljeni s podatki.
The PRAC acknowledged that the implementation of the following elements of the PPP need to be considered and agreed at national level to account for the different healthcare systems in the EU:
Odbor PRAC je potrdil, da je treba upoštevati uvedbo naslednjih elementov programov preprečevanja nosečnosti in se o njih dogovoriti na nacionalni ravni, saj se zdravstveni sistemi v EU med seboj razlikujejo:
The PRAC recognizes that the available data in relation to oral retinoids and the occurrence of neuropsychiatric disorders have a number of important limitations that preclude the establishment of a clear causal association.
Odbor PRAC priznava, da imajo razpoložljivi podatki v povezavi s peroralnimi retinoidi in pojavom nevropsihiatričnih motenj številne pomembne omejitve, ki preprečujejo določitev jasne vzročne povezave.
• Patient signature of the physician checklist/acknowledgement form;
• bolnikov podpis zdravnikovega kontrolnega seznama/potrditvenega obrazca;
The data suggest that the risk of adverse pregnancy outcomes is more strongly associated with the oral retinoids than the topical retinoids.
Podatki kažejo, da je tveganje za neželene izide nosečnosti močneje povezano s peroralnimi retinoidi kot z lokalnimi retinoidi.
• A direct healthcare professional communication (DHPC) was also considered appropriate for all oral and topical retinoids.
• tudi neposredna obvestila za zdravstvene delavce so bila ocenjena kot primerna za vse peroralne in lokalne retinoide;
After reviewing all the available data to address the concerns discussed, the PRAC adopted a recommendation on 8 February 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
8. februarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES
The PRAC noted the systemic exposure is negligible following topical application of retinoids and that this does not appear to be affected to a clinically significant degree by the severity or extent of skin disease.
Odbor PRAC je ugotovil, da je sistemska izpostavljenost po lokalni uporabi retinoidov zanemarljiva in da resnost ali obsežnost kožne bolezni nanjo ne vplivata v klinično pomembnem obsegu.
Nevertheless, the PRAC considers that the data from patients presented in case series, spontaneous case reports and individual patients' experiences are considered to be very important.
spontanih poročilih o primerih in izkušnjah posameznih bolnikov, veljajo za zelo pomembne.
However, taking into account the target patient population, the PRAC recognised the possible underlying risk of psychiatric disorders, and therefore recommended some changes to the product information such as warnings and precautions and so that the current level of available evidence is appropriately reflected.
upoštevanjem ciljne populacije bolnikov je odbor PRAC priznal, da obstaja možnost osnovnega tveganja za psihiatrične motnje, zato je priporočil spremembe informacij o zdravilu, kot so opozorila in previdnostni ukrepi, tako da bodo odražali trenutno razpoložljive dokaze;
• With regards to the teratogenic risk, the PRAC confirmed that all oral retinoids (acitretin, alitretinoin, bexarotene, isotretinoin and tretinoin) are highly teratogenic and therefore must continue to be contraindicated during pregnancy or in women of child bearing potential unless they are using effective contraception.
• kar zadeva tveganje za teratogenost, je odbor PRAC potrdil, da so vsi peroralni retinoidi (acitretin, alitretinoin, beksaroten, izotretinoin in tretinoin) zelo teratogeni in morajo biti še naprej kontraindicirani med nosečnostjo in pri ženskah v rodni dobi, razen kadar te uporabljajo učinkovito kontracepcijo.
• The option of a pictogram/symbol to accompany the box warning wording and to be included in the visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product.
• vključitev preglednice z urnikom obiskov v opozorilno kartico za bolnika; • možnost uporabe piktograma/simbola, ki spremlja opozorilo na škatli in se vključi v vizualni opomnik na zunanji embalaži, da bolnike opozarja o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila.
Compliance with the PPP is crucial to a positive benefit/risk balance for these products; therefore, the adequacy of the pregnancy prevention measures, including PPPs, for the oral retinoids acitretin, alitretinoin and isotretinoin has been reviewed to ensure that the available materials effectively encourage contraception use, regular pregnancy testing and shared responsibility between patients, doctors and pharmacists in adhering to recommendations, and that this is communicated consistently and effectively for all products.
Skladnost s programi preprečevanja nosečnosti je ključnega pomena za pozitivno razmerje med tveganji in koristmi teh zdravil, zato je bila pregledana ustreznost ukrepov za preprečevanje nosečnosti, vključno s programi preprečevanja nosečnosti, za peroralne retinoide acitretin, alitretinoin in izotretinoin, da se zagotovi, da razpoložljiva gradiva učinkovito spodbujajo uporabo kontracepcije, redno testiranje nosečnosti in skupno odgovornost med bolniki, zdravniki in farmacevti, ter da je obveščanje pri vseh zdravilih skladno in učinkovito.
• With regards to neuropsychiatric disorders, the PRAC noted the limitations of the available data and considered that a clear causal relationship could not be established with the oral retinoids.
• kar zadeva nevropsihiatrične motnje, je odbor PRAC ugotovil, da so razpoložljivi podatki omejeni, in ocenil, da ni mogoče določiti jasne vzročne povezave s peroralnimi retinoidi.
The PRAC reviewed all available data from pre-clinical studies, pharmacovigilance data, published literature and spontaneous reports on the risks associated with the adverse teratogenic effects and neuropsychiatric disorders of oral and topical retinoids.
Odbor PRAC je pregledal vse razpoložljive podatke iz predkliničnih študij, farmakovigilančne podatke, objavljeno literaturo in spontana poročila o tveganjih, povezanih z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami peroralnih in lokalnih retinoidov.
Given this and the negligible systemic exposure following topical use, the PRAC considered that no further risk minimization activities are deemed necessary.
Glede na to in na zanemarljivo sistemsko izpostavljenost po lokalni uporabi je odbor PRAC ocenil, da nadaljnje aktivnosti za zmanjšanje tveganja niso potrebne.
The indications for the topical retinoids are non-life-threatening and there is no absolute clinical need for the treatment during pregnancy and pregnancy should be excluded before prescribing.
ki niso življenjsko nevarna, zato ni absolutne klinične potrebe po zdravljenju med nosečnostjo.
• With regards to the teratogenic risk of topical retinoids (adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene), the PRAC concluded that the data available show that after topical application, systemic exposure is expected to be negligible and unlikely to result in adverse fetal outcomes.
• kar zadeva tveganje lokalnih retinoidov (adapalena, alitretinoina, izotretinoina, tretinoina in tazarotena) za teratogenost, je odbor PRAC zaključil, da razpoložljivi podatki kažejo, da je sistemska izpostavljenost po lokalni uporabi po pričakovanju zanemarljiva in ni verjetno, da bi pri plodu povzročila neželene izide.
• The PRAC considered the totality of the data submitted, including responses from the marketing authorisation holders with regard to the consistency and effectiveness of existing routine and additional risk minimisation measures for oral and topical retinoids-containing medicinal products in relation to teratogenic effects and neuropsychiatric disorders.
• odbor PRAC je ocenil vse predložene podatke, vključno z odgovori imetnikov dovoljenj za promet z zdravilom, glede skladnosti in učinkovitosti obstoječih rutinskih in dodatnih ukrepov za zmanjšanje tveganja pri peroralnih in lokalnih zdravilih, ki vsebujejo retinoide, v zvezi s teratogenimi učinki in nevropsihiatričnimi motnjami.
• The PRAC further considered that for the oral retinoids acitretin, alitretinoin and isotretinoin a drug utilisation study with a complementary survey should be conducted to assess the effectiveness of the proposed updated risk minimisation measures.
• odbor PRAC je nadalje menil, da je za peroralne retinoide acitretin, alitretinoin in izotretinoin treba opraviti študijo o uporabi zdravil z dopolnilno raziskavo, namenjeno oceni učinkovitosti predlaganih posodobljenih ukrepov za zmanjšanje tveganja;
In addition, the views of patients and healthcare professionals regarding communication, awareness and understanding of the risks of retinoids during pregnancy and in women of childbearing potential were taken into account in the recommendation along with their views on options for improving risk communication.
Pri oblikovanju priporočila so upoštevali tudi stališča bolnikov in zdravstvenih delavcev glede obveščanja o tveganjih retinoidov med nosečnostjo in pri ženskah v rodni dobi, glede seznanjenosti s tveganji in njihovega razumevanja, upoštevali pa so tudi njihova stališča o možnostih za izboljšanje obveščanja o tveganju.
Given this and the negligible systemic exposure following topical no further risk minimization activities are deemed necessary.
Glede na to in na zanemarljivo sistemsko izpostavljenost po lokalni uporabi nadaljnje aktivnosti za zmanjšanje tveganja niso potrebne.
For tretinoin and bexarotene, it was considered that in light of the oncological indications, specialist management in a hospital setting and population at risk that existing risk minimisation was appropriate and proportionate.
Za tretinoin in beksaroten je bilo ocenjeno, da so obstoječi ukrepi za zmanjšanje tveganja v luči onkoloških indikacij, specialistične obravnave v bolnišničnem okolju in ogrožene populacije ustrezni in sorazmerni;
The PRAC thereby concludes that the benefit-risk balance of topical retinoids in pregnancy is not favourable, and therefore recommends that use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy.
Odbor PRAC torej zaključuje, da razmerje med tveganji in koristmi lokalnih retinoidov med nosečnostjo ni ugodno, zato priporoča kontraindikacijo za uporabo lokalnih retinoidov med nosečnostjo in pri ženskah, ki načrtujejo nosečnost.
• The PRAC also concluded that there was a need to further harmonise and streamline the measures in the PPP including associated educational materials for the oral retinoids acitretin, alitretinoin and isotretinoin to ensure these are optimal to support discussions between patients and healthcare professionals on the risks and the associated risk minimisation measures.
• odbor PRAC je zaključil tudi, da je treba nadalje uskladiti in racionalizirati ukrepe v okviru programa preprečevanja nosečnosti, vključno s povezanimi izobraževalnimi gradivi za peroralne retinoide acitretin, alitretinoin in izotretinoin, da se zagotovi, da so ti ukrepi optimalni za podporo pogovorom med bolniki in zdravstvenimi delavci o tveganjih in povezanih ukrepih za zmanjšanje tveganja;
The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for retinoid-containing medicinal products.
Odbor PRAC posledično priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo retinoide.
• Dissemination of the patient reminder card;
• razdelitev opozorilnih kartic za bolnika;
In addition, the PRAC considered the views of patients and healthcare professionals in relation to their understanding and the awareness of the teratogenic risk associated with the use of retinoid-containing medicines.
Odbor je upošteval tudi stališča bolnikov in zdravstvenih delavcev v zvezi z njihovim razumevanjem tveganja za teratogenost, povezanega z uporabo zdravil, ki vsebujejo retinoide, in seznanjenostjo s tem tveganjem;
In view of the above, the PRAC considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication.
Glede na zgoraj navedeno odbor PRAC meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo retinoide, še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in načrta za obvladovanje tveganja, pogojev dovoljenj za promet z zdravilom in povezanega obveščanja.
In this respect, the PRAC recommended amendments to the product information, including harmonising the warnings and precautions of use for the oral retinoids acitretin, alitretinoin and isotretinoin to reflect the teratogenic risk associated with their use and communication to healthcare professionals through a direct healthcare professional communication.
V zvezi s tem je odbor PRAC priporočil dopolnitev informacij o zdravilu, vključno z uskladitvijo opozoril in previdnostnih ukrepov za peroralne retinoide acitretin, alitretinoin in izotretinoin, da bodo vključevali tveganje za teratogenost, povezano z njihovo uporabo, in obveščanje zdravstvenih delavcev z neposrednimi obvestili za zdravstvene delavce.
Given the indications and patients populations that use acitretin, alitretinoin and isotretinoin, it was considered that any use of these oral retinoids in female patients at risk of pregnancy must be in accordance with the conditions of a pregnancy prevention programme (PPP).
alitretinoin in izotretinoin, je bilo ocenjeno, da mora biti vsaka uporaba teh peroralnih retinoidov pri bolnicah s tveganjem za nosečnost v skladu s pogoji programa preprečevanja nosečnosti.
The human data on congenital malformations after oral retinoid exposure show a significant risk of retinoid embryopathy (of up to 30% of fetuses exposed); furthermore it is known that approximately one-third of pregnant patients exposed to oral retinoids during pregnancy will have spontaneous abortions.
Podatki o prirojenih malformacijah pri ljudeh po izpostavljenosti peroralnim retinoidom kažejo precejšnje tveganje za retinoidno embriopatijo (do 30 % izpostavljenih plodov).
PRAC considered that given the oncological indications of oral tretinoin and oral bexarotene, further risk minimisation measures (RMMs) for these products regarding teratogenic effects, such as strengthening the product information (PI) and additional risk minimisation measures (aRMMs) would not provide an added value given the specialist management, the population at risk and the nature of the illness.
Odbor PRAC je presodil, da glede na onkološke indikacije peroralnega tretinoina in peroralnega beksarotena in zaradi specialistične obravnave, ogrožene populacije in narave bolezni nadaljnji ukrepi za zmanjšanje tveganja za ti zdravili glede teratogenih učinkov, kot so okrepitev informacij o zdravilu,
Furthermore, specific studies to measure effectiveness of the agreed changes to the PPP have been imposed on the marketing authorisation holders as an outcome of the referral.
Nadalje je bila kot izid napotitve imetnikom dovoljenj za promet z zdravilom naložena izvedba posebnih študij za ugotavljanje učinkovitosti dogovorjenih sprememb programov preprečevanja nosečnosti.
• Furthermore, the PRAC noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids.
• odbor PRAC je nadalje ugotovil, da so podatki o nevropsihiatričnih učinkih po lokalnem dajanju retinoidov zelo omejeni.
Overall, the PRAC concludes that the benefit-risk balance of medicinal products containing retinoids remains favourable, but that marketing authorisation(s) should be varied for both the oral and topical retinoids to ensure risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed, as appropriate.
ostaja ugodno, vendar je treba spremeniti dovoljenja za promet z zdravilom za peroralne in lokalne retinoide, da se zagotovi točna in skladna obravnava tveganj, povezanih z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami, kot ustreza.
The PRAC further noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids.
Odbor PRAC je nadalje ugotovil, da so podatki o nevropsihiatričnih učinkih po lokalnem dajanju retinoidov zelo omejeni.
The PRAC was requested to assess the impact of the above concerns on the benefit-risk balance of retinoid-containing medicinal products and issue a recommendation on whether the products should be maintained, varied, suspended or revoked.
ter izda priporočilo o tem, ali naj se ta zdravila ohranijo, spremenijo, začasno umaknejo ali prekličejo.
The CHMP, as a consequence, considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication.
še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in načrta za obvladovanje tveganja, pogojev dovoljenj za promet z zdravilom in povezanega obveščanja.