FrancophonIA/ELRC3.0 huggingface dataset:
English: Lumigan's effect when added to beta-blocker treatment has also been compared with that of latanoprost in another study in 437 patients.
Slovenian: V drugi študiji s 437 bolniki so primerjali učinek dodajanja zdravila Lumigan zdravljenju z zaviralcem receptorjev beta tudi z dodajanjem lanoprosta.
English: Lumigan was as effective as latanoprost when added to beta-blocker treatment, with reductions in eye pressure of 8.0 and 7.4 mmHg, respectively, after three months.
Slovenian: Dodajanje zdravila Lumigan zdravljenju z zaviralcem receptorjev beta (znižanje očesnega tlaka za 8,0 mmHg) je bilo po treh mesecih enako učinkovito kot dodatek latanoprosta (znižanje očesnega tlaka za 7,4 mmHg).
English: What is Lumigan?
Slovenian: Kaj je zdravilo Lumigan?
English: The effect of adding Lumigan 0.3 mg/ml to existing treatment with a beta-blocker eye drop has been compared with that of adding placebo (a dummy eye drop) in one study involving 285 patients.
Slovenian: V eni študiji z 285 bolniki so primerjali učinkovitost dodatka zdravila Lumigan 0,3 mg/ml obstoječemu zdravljenju z zaviralcem receptorjev beta v obliki kapljic za oko in dodatka placeba (zdravila brez zdravilne učinkovine).
English: More information is available below.
Slovenian: Več informacij je na voljo v nadaljevanju.
English: The review of retinoid medicines was initiated on 8 July 2016 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled retinoidov se je začel 8. julija 2016 na zahtevo Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
English: − an assessment of each woman's potential for becoming pregnant;
Slovenian: − ocena možnosti vsake ženske za zanositev;
English: Updated measures for pregnancy prevention during retinoid use
Slovenian: Posodobljeni ukrepi za preprečevanje nosečnosti med uporabo retinoidov
English: Particular care should be taken in patients with history of depression.
Slovenian: Posebno pozornost je treba nameniti bolnikom z anamnezo depresije.
English: Evidence from published literature and individual case reports is conflicting, and many published studies have a number of limitations.
Slovenian: Podatki iz objavljene literature in poročila o posameznih primerih si nasprotujejo, številne od objavljenih študij pa imajo vrsto omejitev.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
English: Some retinoids are also used to treat certain forms of cancer.
Slovenian: Nekateri retinoidi se uporabljajo tudi za zdravljenje nekaterih oblik raka.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 June 2018 EMA/261767/2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: − an ‘acknowledgement form' to confirm that appropriate advice has been given to patients;
Slovenian: − „potrditveni obrazec“ za potrditev, da so bolnice prejele ustrezne nasvete;
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/06/2018.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 21. 6. 2018 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: − a ‘patient reminder card' stating that the medicine must not be used during pregnancy, and including information about pregnancy testing and the need to use effective contraception.
Slovenian: − „opozorilno kartico za bolnico“, na kateri bo navedeno, da se zdravila ne sme jemati med nosečnostjo, in ki bo vključevala informacije o testiranju nosečnosti in nujnosti uporabe učinkovite kontracepcije.
English: • Patients taking oral retinoids should be advised that they may experience changes in their mood and/or behaviour and that they and their families should be alert to this, and speak to their doctor if this occurs.
Slovenian: • Bolnicam, ki jemljejo peroralne retinoide, je treba pojasniti, da se lahko spremeni njihovo razpoloženje in/ali vedenje ter da morajo biti one in njihove družine na to pozorni in obvestiti svojega zdravnika, če se to zgodi.
English: Retinoids taken by mouth are used to treat various forms of severe acne, severe hand eczema that does not respond to treatment with corticosteroids, severe forms of psoriasis and other skin conditions, and certain types of cancer.
Slovenian: Retinoidi za zaužitje se uporabljajo za zdravljenje različnih oblik hudih aken, hudega ekcema rok, ki se ne odziva na zdravljenje s kortikosteroidi, hudih oblik luskavice in drugih bolezni kože ter nekaterih vrst raka.
English: The following retinoids have been authorised nationally in a number of Member States of the EU and are covered by this review: acitretin, adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin.
Slovenian: Naslednji retinoidi so bili odobreni nacionalno v številnih državah članicah Evropske unije in so zajeti v tem pregledu: acitretin, adapalen, alitretinoin, izotretinoin, tazaroten in tretinoin.
English: The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy.
Slovenian: Ta pregled je potrdil, da lahko peroralni retinoidi škodujejo nerojenim otrokom, zato se ne smejo uporabljati med nosečnostjo.
English: On 22 March 2018, the European Medicines Agency (EMA) completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed.
Slovenian: Evropska agencija za zdravila (EMA) je zaključila pregled retinoidnih zdravil in potrdila, da je potrebna posodobitev ukrepov za preprečevanje nosečnosti.
English: The review of retinoids was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which assessed the available data including published literature, post-marketing reports of side effects and additional information collected from stakeholder meetings and written submissions.
Slovenian: Pregled retinoidov je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC) Evropske agencije za zdravila (EMA), ki je ocenil razpoložljive podatke, vključno z objavljeno literaturo, poročili o neželenih učinkih v obdobju trženja ter na sestankih deležnikov zbranimi in pisno posredovanimi dodatnimi informacijami.
English: Warnings will be included in the package leaflet of oral retinoids, as well as signs and symptoms that patients and their families should look out for (such as changes in mood or behaviour).
Slovenian: Opozorila bodo vključena v navodilo za uporabo peroralnih retinoidov, v to navodilo pa bodo vključeni tudi znaki in simptomi, na katere morajo biti bolnice in njihove družine pozorni (npr. spremembe vedenja ali razpoloženja).
English: • Patients treated with oral retinoids should be monitored for signs and symptoms of depression and referred for appropriate treatment, if necessary.
Slovenian: • Pri bolnicah, zdravljenih s peroralnimi retinoidi, je treba biti pozoren na morebitne znake in simptome depresije ter jih po potrebi napotiti na ustrezno zdravljenje.
English: Retinoids are vitamin A derivatives that are available as capsules to be taken by mouth or as creams and gels to be applied to the skin.
Slovenian: Retinoidi so derivati vitamina A, ki so na voljo kot kapsule za zaužitje ali kot kreme in geli za nanos na kožo.
English: • The above information will also be included in the package leaflet, and a boxed warning will be added to the outer packaging.
Slovenian: • Navedeni podatki bodo vključeni tudi v navodilo za uporabo, uokvirjeno besedilo pa bo dodano na zunanjo ovojnino.
English: The CHMP opinion was sent to the European Commission, which issued a final legally binding decision valid across the EU.
Slovenian: Priporočilo odbora CHMP bo predloženo Evropski komisiji, ki bo izdala pravno zavezujoč sklep, veljaven v vsej EU.
English: Alitretinoin has also been authorised centrally as Panretin for the treatment of skin lesions in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Slovenian: Alitretinoin je bil po centraliziranem postopku odobren tudi kot zdravilo Panretin za zdravljenje lezij kože pri bolnikih z aidsom in Kaposijevim sarkomom (vrsto raka kože).
English: They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis.
Slovenian: Ti se jemljejo peroralno ali nanašajo kot kreme ali geli za zdravljenje več bolezni, ki prizadenejo predvsem kožo, vključno s hudimi aknami in luskavico.
English: • However, since severe skin disorders themselves increase the risk of psychiatric disorders, a warning about this possible risk is being included in the product information for oral retinoids.
Slovenian: • Ker pa hude bolezni kože same po sebi povečujejo tveganje za duševne motnje, bo opozorilo o tem možnem tveganju vključeno v informacije o zdravilu za peroralne retinoide.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
English: Regarding the risk of neuropsychiatric disorders, the limitations of the available data did not allow to clearly establish whether this risk was due to the use of retinoids.
Slovenian: Kar zadeva tveganje za nevropsihiatrične motnje, omejenost razpoložljivih podatkov ne dopušča nedvomne ugotovitve, ali je to tveganje povezano z uporabo retinoidov.
English: • Oral (taken by mouth) retinoids must not be used during pregnancy.
Slovenian: • Peroralni (ki se jemljejo skozi usta) retinoidi se med nosečnostjo ne smejo jemati.
English: The EMA's Committee for Medicinal Products for Human use (CHMP) then endorsed the PRAC recommendations and adopted the Agency's final opinion.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zdaj sprejel priporočila odbora PRAC in sprejel končno mnenje agencije.
English: Bexarotene has been authorised centrally as Targretin for the treatment of cutaneous T-cell lymphoma (CTCL, a rare cancer of the lymph tissue).
Slovenian: Beksaroten je bil po centraliziranem postopku odobren kot zdravilo Targretin za zdravljenje kožnega T-celičnega limfoma (CTCL, redke vrste raka limfatičnega tkiva).
English: • With oral retinoids, there may be a possible risk of disorders such as depression and anxiety.
Slovenian: • Peroralni retinoidi so lahko povezani s tveganjem za motnje, kot sta depresija in tesnoba.
English: − the need to use at least one effective method of contraception during and after treatment;
Slovenian: − nujnost uporabe vsaj ene učinkovite kontracepcijske metode med zdravljenjem in po njem;
English: However, considering that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, the prescribing information for oral retinoids will be updated to include a warning about this possible risk.
Slovenian: Vendar pa bodo glede na to, da so lahko bolniki z resnimi boleznimi kože zaradi narave bolezni bolj ranljivi za nevropsihiatrične motnje, informacije o predpisovanju vseh peroralnih retinoidov posodobljene tako, da bodo vključevale opozorilo o tem možnem tveganju.
English: Retinoids applied to the skin are used to treat various skin conditions including mild to moderate acne.
Slovenian: Na kožo naneseni retinoidi se uporabljajo za zdravljenje različnih bolezni kože, vključno z zmernimi do zmerno hudimi aknami.
English: • Retinoid medicines, used mainly to treat conditions affecting the skin such as severe acne, are harmful to the unborn baby if taken during pregnancy.
Slovenian: • Retinoidna zdravila, ki se uporabljajo predvsem za zdravljenje bolezni, ki prizadenejo kožo, npr. hudih aken, so ob jemanju med nosečnostjo škodljiva za nerojenega otroka.
English: Available data suggest that topical retinoids do not carry a risk of neuropsychiatric side effects, and therefore no additional warnings need to be added to the prescribing information.
Slovenian: Razpoložljivi podatki kažejo da topični retinoidi niso povezani s tveganji za nevropsihiatrične neželene učinke, zato ni treba informacij o predpisovanju dopolniti z nobenim dodatnim opozorilom.
English: • For bexarotene and oral tretinoin it is considered that, in the light of the target population and an oncological indication subject to specialist care in the hospital setting, the implementation of a PPP is not necessary.
Slovenian: • Pri beksarotenu in peroralnem tretinoinu velja, da zaradi ciljne populacije in onkološke indikacije, ki se obravnava v specialističnem bolnišničnem okolju izvedba programa za preprečevanje nosečnosti ni nujna.
English: • In addition, the oral retinoids acitretin, alitretinoin and isotretinoin must not be taken by women able to have children unless the conditions of a special pregnancy prevention programme are met.
Slovenian: • Poleg tega peroralnih retinoidov acitretina, alitretinoina in izotretinoina ne smejo jemati ženske, ki imajo lahko otroke, razen če so izpolnjeni pogoji posebnega programa za preprečevanje nosečnosti.
English: − pregnancy tests before, during and after stopping treatment;
Slovenian: − nosečnostne teste pred zdravljenjem, med njim in po ustavitvi zdravljenja;
English: However, as a precaution, topical retinoids are contraindicated in pregnant women and in women planning a pregnancy.
Slovenian: Vseeno pa so kot previdnostni ukrep pri nosečnicah in ženskah, ki načrtujejo nosečnost, kontraindicirani.
English: − pregnancy tests before starting treatment, during treatment and after treatment;
Slovenian: − nosečnostni testi pred začetkom zdravljenja, med njim in po zdravljenju;
English: In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children.
Slovenian: Poleg tega je treba peroralne retinoide acitretin, alitretinoin in izotretinoin, ki se uporabljajo za zdravljenje bolezni, ki prizadenejo predvsem kožo, uporabljati skladno s pogoji novega programa za preprečevanje nosečnosti pri ženskah, ki imajo lahko otroke.
English: Information for healthcare professionals A review of available data on teratogenicity and neuropsychiatric disorders with retinoid medicines has concluded that there is the need to strengthen the recommendations for pregnancy prevention and to raise awareness about possible neuropsychiatric risks.
Slovenian: Pregled razpoložljivih podatkov o teratogenosti in nevropsihiatričnih motnjah, povezanih z uporabo retinoidov, je pokazal, da je treba okrepiti priporočila za preprečevanje nosečnosti in povečati seznanjenost z možnimi nevropsihiatričnimi tveganji.
English: Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin.
Slovenian: Retinoidi vključujejo učinkovine acitretin, adapalen, alitretinoin, beksaroten, izotretinoin, tazaroten in tretinoin.
English: Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby.
Slovenian: Prav tako se v nosečnosti ne smejo uporabljati topični retinoidi (tisti, ki se nanašajo na kožo), uporabljati pa jih ne smejo niti ženske, ki načrtujejo otroka.
English: • The pregnancy prevention programme for acitretin, alitretinoin and isotretinoin includes:
Slovenian: • Program za preprečevanje nosečnosti ob uporabi acitretina, alitretinoina in izotretinoina bo vključeval:
English: • Oral retinoids (acitretin, alitretinoin, bexarotene, isotretinoin and tretinoin) are highly teratogenic and must not be used during pregnancy.
Slovenian: • Peroralni retinoidi (acitretin, alitretinoin, beksaroten, izotretinoin in tretinoin) so zelo teratogeni in se med nosečnostjo ne smejo uporabljati.
English: Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids
Slovenian: Za peroralne retinoide bo vključeno tudi opozorilo o možnem tveganju za nevropsihiatrične motnje
English: − a ‘risk acknowledgement form' for patients and prescribers to go through and confirm that appropriate advice has been given and understood.
Slovenian: − „potrditveni obrazec“ za bolnice in osebe, ki zdravila predpisujejo, da ga preberejo in potrdijo, da so prejeli/dali potrebne nasvete glede tveganj in da so jih bolnice razumele.
English: • For topically applied retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin), systemic absorption is negligible, and unlikely to result in psychiatric disorders.
Slovenian: • Retinoidi, ki se uporabljajo topično (adapalen, alitretinoin, izotretinoin, tazaroten in tretinoin), se sistemsko absorbirajo zanemarljivo malo in je le malo verjetno, da bi povzročili psihiatrične motnje.
English: • Cases of depression, depression-aggravated anxiety and mood alterations have been reported rarely in patients taking oral retinoids.
Slovenian: • Pri bolnicah, ki jemljejo peroralne retinoide, so v redkih primerih poročali o depresiji, z depresijo poslabšani tesnobi in spremembah razpoloženja.
English: In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids (those taken by mouth).
Slovenian: Poleg tega bo v informacije o predpisovanju za peroralne retinoide (tj. tiste retinoide, ki se jemljejo peroralno) vključeno tudi opozorilo o možnosti pojava nevropsihiatričnih motenj (npr. depresije, tesnobe in sprememb razpoloženja).
English: • Updated educational material will be provided to guide the discussion about the risks of oral retinoids before prescribing acitretin, alitretinoin and isotretinoin to women of childbearing potential.
Slovenian: • Ženske v rodni dobi bodo prejele posodobljeno izobraževalno gradivo, preden jim bodo predpisani acitretin, alitretinoin ali izotretinoin.
English: • Acitretin, alitretinoin and isotretinoin must be used in accordance with the conditions of a pregnancy prevention programme (PPP) for all women of childbearing potential.
Slovenian: • Acitretin, alitretinoin in izotretinoin je treba pri vseh plodnih ženskah uporabljati skladno s pogoji programa za preprečevanje nosečnosti.
English: On this basis, it has not been possible to identify a clear increase in the risk of neuropsychiatric disorders in people who take oral retinoids compared to those that do not.
Slovenian: Na podlagi tega pri ljudeh, ki jemljejo peroralne retinoide, ni bilo mogoče prepoznati jasnega povečanja tveganja za nevropsihiatrične motnje.
English: • For topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin), the available data show that systemic absorption is negligible following topical application and that these products are unlikely to cause fetal harm.
Slovenian: • Razpoložljivi podatki kažejo, da je sistemska absorpcija topičnih retinoidov (adapalena, alitretinoina, izotretinoina, tazarotena in tretinoina) po nanosu na kožo zanemarljiva in da ta zdravila najverjetneje ne škodujejo plodu.
English: • Topical (applied to the skin) retinoids are less likely to cause harm to the unborn child.
Slovenian: • Topični (nanašanje na kožo) retinoidi manj verjetno škodujejo nerojenemu otroku, vendar se zaradi previdnosti med nosečnostjo ne smejo uporabljati, prav tako pa jih ne smejo uporabljati ženske, ki načrtujejo otroka.
English: List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in predlagateljev v državah članicah
English: Annex I
Slovenian: PRILOGA I
English: Strength Pharmaceutical form Route of administration
Slovenian: Farmacevtska oblika Pot uporabe zdravila
English: - if you are older than 70 years of age.
Slovenian: - Če ste starejši od 70 let.
English: However, no unacceptable risks appear to be present in this patient group.
Slovenian: Vendar pa ne kaže, da bi v tej skupini bolnikov prihajalo do nesprejemljivih tveganj.
English: Lutomierska 50,95-200 Pabianice, Poland
Slovenian: Lutomierska 50,95-200 Pabianice, Poljska
English: Supportive measures should be provided as necessary.
Slovenian: Treba je poskrbeti za ustrezne podporne ukrepe.
English: Errors in how you take this medicine may have serious health consequences.
Slovenian: Napačno jemanje tega zdravila ima namreč lahko resne posledice za zdravje.
English: • raised liver enzymes (your doctor will check this)
Slovenian: • povečana količina jetrnih encimov (to bo preveril vaš zdravnik)
English: For the eligible histology population, the efficacy results were similar.
Slovenian: Pri ustrezni histološki populaciji so bili rezultati učinkovitosti podobni.
English: feeling that one's surroundings are spinning
Slovenian: občutek, da se okolica vrti
English: In this case, your doctor will also prescribe medicine to help you prevent this typeof pneumonia (PCP).
Slovenian: V tem primeru vam bo zdravnik predpisal tudi zdravilo za preprečevanje tega tipa pljučnice (PCP).
English: During treatment patients should be monitored and managed appropriately.
Slovenian: Med zdravljenjem je potrebno ustrezno spremljati in obravnavati bolnike.
English: Avoid inhaling the powder.
Slovenian: Izognite se vdihavanju praška.
English: TMZ can have genotoxic effects.
Slovenian: TMZ ima lahko genotoksične učinke.
English: • dose level -1 (100 mg/m2 ) still results in unacceptable toxicity
Slovenian: • stopnja odmerka -1 (100 mg/m2 ) še vedno povzroči nesprejemljivo toksičnost
English: Once the radiotherapy is completed, you will interrupt treatment for 4 weeks to give your body a chance to recover.
Slovenian: Ko bo radioterapija zaključena, boste zdravljenje prekinili za 4 tedne, da si vaše telo opomore.
English: These blood cells are important for fighting infection and for proper blood clotting.
Slovenian: Te krvne celice so pomembne za boj proti okužbam in za pravilno strjevanje krvi.
English: Capsules should not be opened.
Slovenian: Kapsul se ne sme odpirati.
English: There are no data in pregnant women.
Slovenian: Ni podatkov o uporabi pri nosečih ženskah.
English: Hypersensitivity to dacarbazine (DTIC).
Slovenian: Preobčutljivost za dakarbazin (DTIC).
English: Do not double the next dose to make up for a forgotten dose, unless your doctor tells you to do so.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadoknadili pozabljeni odmrek, razen če vam to naroči zdravnik.
English: - if you have had an allergic reaction to another anti-cancer medicine called dacarbazine.
Slovenian: - če ste imeli alergijsko reakcijo na drugo zdravilo za zdravljenje raka, imenovano dakarbazin.
English: This latency period is very short even for an alkylating agent.
Slovenian: Ta latentna doba je zelo kratka celo za alkilirajočo snov.
English: Temozolomide treatment can cause a reduction in certain kinds of blood cells.
Slovenian: Zdravljenje s temozolomidom lahko povzroči zmanjšanje števila nekaterih vrst krvnih celic.
English: The median PFS was 5.4 months.
Slovenian: Mediana vrednost PFS je bila 5,4 mesecev.
English: Reduction for prior toxicity
Slovenian: Zmanjšanje zaradi predhodne toksičnosti
English: Medical attention may be required.
Slovenian: Morda boste potrebovali zdravniško pomoč.
English: Your blood will be tested regularly to monitor your condition.
Slovenian: Vašo kri bodo redno pregledovali in tako spremljali vaše stanje.
English: Do not give this medicine to children under the age of 3 years because it has not been studied.
Slovenian: Tega zdravila ne dajajte otrokom mlajšim od 3 let, ker pri njih zdravila niso preučevali.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Slovenian: V tem primeru ne smete voziti ali uporabljajti orodij in ne upravljajti strojev, ali se voziti s kolesom, dokler ne ugotovite, kako zdravilo vpliva na vas (glejte poglavje 4).