FrancophonIA/ELRC3.0 huggingface dataset:
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Slovenian: Te spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo so izid napotitvenega postopka.
English: If pregnancy occurs in a woman treated with [INN], treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Slovenian: Če pride do zanositve pri bolnici, ki je zdravljena z [mednarodno nelastniško ime], je zdravljenje potrebno prekiniti in bolnico napotiti na pregled in posvet k zdravniku specialistu ali zdravniku z izkušnjami s področja teratologije.
English: The warning on psychiatric disorders should be revised as follows:
Slovenian: Opozorilo glede psihiatričnih motenj je treba posodobiti kot sledi:
English: Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Slovenian: Kjer je indiciran, je treba test nosečnosti izvesti na dan obiska, pri katerem se predpiše zdravilo, ali v roku 3 dni pred obiskom.
English: As these products will now be subject to additional monitoring the black symbol and relevant statement should be included preceding section 1.
Slovenian: Za ta zdravila se bo sedaj izvajalo dodatno spremljanje varnosti, zato je treba pred poglavje 1 dodati črni simbol in spremljajoče besedilo.
English: The warning regarding teratogenic effects and information on the pregnancy prevention programme should be aligned with the following text; furthermore a boxed warning as presented below should be added:
Slovenian: Opozorila glede teratogenih učinkov in informacije o programu za preprečevanje nosečnosti morajo biti usklajene s spodnjim besedilom; dodati je treba tudi opozorilo v okvirju kot je prikazano spodaj: Opozorilo v okvirju
English: • The patient understands that she must consistently and correctly use one highly effective method of contraception (i.e. a user-independent form) or two complementary user-dependent forms of contraception, for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month [3 years for acitretin] after cessation of treatment.
Slovenian: • Bolnica razume, da mora redno in pravilno uporabljati eno visoko učinkovito metodo kontracepcije (obliko neodvisno od uporabnice) ali dve dopolnjujoči metodi kontracepcije, ki sta odvisni od uporabnice, najmanj 1 mesec pred začetkom zdravljenja, uporablja učinkovito zaščito med celotnim zdravljenjem in še najmanj 1 mesec [3 leta za acitretin] po zaključku zdravljenja.
English: • She has acknowledged that she has understood the hazards and necessary precautions associated with the use of [INN].
Slovenian: • Bolnica potrdi, da je razumela tveganje in potrebno previdnost pri uporabi [mednarodno nezaščiteno ime].
English: If you get pregnant while taking <TRADENAME>, stop taking the medicine straight away, and contact your doctor.
Slovenian: Če med jemanjem zdravila <ZAŠČITENO IME> zanosite, takoj prenehajte z jemanjem zdravila in se posvetujte z zdravnikom.
English: The test must show that you are not pregnant when starting treatment with <TRADENAME>
Slovenian: Test mora pokazati, da niste noseči, ko pričnete zdravljenje z zdravilom <ZAŠČITENO IME>.
English: Women must use effective contraception before, during and after taking <TRADENAME>
Slovenian: Ženske morajo uporabljati zanesljivo kontracepcijo pred, med in po jemanju zdravila
English: Contraception should be used for at least 1 month prior to starting treatment, throughout treatment and continue for at least 1 month [3 years for acitretin] after stopping treatment with [INN], even in patients with amenorrhea.
Slovenian: Kontracepcijo je treba uporabljati najmanj 1 mesec pred začetkom zdravljenja, med zdravljenjem in najmanj 1 mesec [3 leta za acitretin] po zaključku zdravljenja z [mednarodno nezaščiteno ime], tudi pri bolnicah z amenorejo.
English: For more information on pregnancy and contraception, see section 2 ”Pregnancy and prevention programme”.
Slovenian: Nosečnost, dojenje in plodnost Za več informacij o nosečnosti in kontracepciji, gleje poglavje 2 ”Nosečnost in program zaščite pred zanositvijo”.
English: Section 2 Warnings and precautions
Slovenian: Poglavje 2 Opozorila in previdnostni ukrepi
English: Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Slovenian: Pri izbiri kontracepcijske metode je posamezne okoliščine treba oceniti za vsak primer posebej, se pogovoriti z bolnico, da zagotovimo njeno zavzetost in sodelovanje pri izvajanju izbranih ukrepv.
English: Depression, depression aggravated, aggressive tendencies, anxiety, mood alterations.
Slovenian: Depresija, poslabšanje depresije, težnja k nasilnemu vedenju, anksioznost, spremembe razpoloženja.
English: Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
Slovenian: Bolnice morajo dobiti izčrpne informacije o zaščiti pred zanositvijo, svetovati jim je potrebno učinkovito kontracepcijo, če le te ne uporabljajo.
English: Section 4.6 Fertility, pregnancy and breastfeeding:
Slovenian: − ženske, ki načrtujejo nosečnost Poglavje 4.6 Plodnost, nosečnost in dojenje:
English: [for acitretin: ‘every 1 to 3 months for 3 years after stopping <TRADENAME>']
Slovenian: [za acitretin: ‘v presledkih od 1 do 3 mesecev v obdobju 3 let po koncu zdravljenja z <ZAŠČITENO IME>']
English: For women of childbearing potential, the prescription duration of [TRADENAME] should ideally be limited to 30 days in order to support regular follow up, including pregnancy testing and monitoring.
Slovenian: Ženskam v rodni dobi naj se zdravilo [ZAŠČITENO IME] ne bi predpisalo za več kot 30 dni, da lahko zagotovimo redne obiske, vključno s testiranjem nosečnosti in spremljanjem bolnice.
English: You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour.
Slovenian: da poveste svojim prijateljem in družini, da to zdravilo lahko vpliva na vaše razpoloženje in vedenje.
English: This risk persists until the product has been completely eliminated, which is within one month following the end of treatment [3 years for acitretin].
Slovenian: Tveganje obstaja, dokler se zdravilo popolnoma ne izloči, kar je en mesecu po koncu zdravljenja [3
English: This is because taking <TRADENAME> may affect your mood.
Slovenian: Zdravilo <ZAŠČITENO IME>, ki ga jemljete, lahko namreč vpliva na vaše razpoloženje.
English: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with <INN> (see section 4.8).
Slovenian: Psihiatrične motnje Pri bolnikih, zdravljenih z <mednarodno nelastniško ime>, so poročali o pojavu depresije, poslabšanju depresije, o pojavu anksioznosti, težnjah k agresivnemu vedenju, spremembah razpoloženja, simptomih psihoze in zelo redko o razmišljanju o samomoru, poskusih samomora ter samomoru (glejte poglavje 4.8).
English: Suicide, suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour Package leaflet
Slovenian: Samomor, poskus samomora, razmišljanje o samomoru, psihoze, vedenjske motnje.
English: Women must agree to pregnancy testing before, during and after taking <TRADENAME>
Slovenian: Ženske se morajo strinjati s testom nosečnosti pred jemanjem, med in po jemanju zdravila
English: You must agree to regular follow-up visits, ideally every month.
Slovenian: • Strinjati se morate z rednimi kontrolnimi obiski zdravnika (najbolje vsak mesec).
English: You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that you are taking this medicine.
Slovenian: Določenih sprememb v razpoloženju in vedenju morda ne boste sami opazili, zato je zelo pomembno,
English: As a minimum requirement, female patients of childbearing potential must use at least one highly effective method of contraception (i.e. a user-independent form), or two complementary user-dependent forms of contraception.
Slovenian: Najmanjša zahteva za bolnice v rodni dobi je, da uporabljajo najmanj eno visoko učinkovito metodo kontracepcije (neodvisno od uporabnice), ali dve dopolnjujoči metodi kontracepcije, ki sta odvisni od uporabnice.
English: o [for acitretin this last bullet point should be]
Slovenian: o [za acitretin se mora zadnja točka glasiti]
English: You must have talked about contraception (birth control) with your doctor.
Slovenian: • Z zdravnikom se morate pogovoriti o kontracepciji (preprečevanju nosečnosti).
English: Follow-up visits
Slovenian: Kontrolni obiski
English: 4.4 Special warnings and precautions for use Teratogenic effects [TRADENAME] is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects.
Slovenian: Teratogeni učinki Zdravilo [ZAŠČITENO IME] je zelo teratogeno pri ljudeh in zelo pogosto povzroča hude in življenjsko ogrožajoče malformacije ploda.
English: for acitretin this last bullet point should be:
Slovenian: • za acitretin se mora zadnja točka glasiti:
English: • Even if she has amenorrhea she must follow all the advice on effective contraception.
Slovenian: • Bolnica mora upoštevati vsa navodila o učinkoviti kontracepciji, tudi če ima amenorejo.
English: It also makes a miscarriage more likely.
Slovenian: Poveča tudi tveganje za splav.
English: Full patient information about the teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme should be given by the physician to all patients, both male and female.
Slovenian: Zdravnik mora vsem bolnikom, tako ženskam kot moškim, dati podrobne informacije o tveganju za teratogenost in strogih ukrepih za preprečevanje nosečnosti, kot so opisani v programu za preprečevanje nosečnosti.
English: What you need to know before you take <TRADENAME>
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo <ZAŠČITENO IME> Ne jemljite zdravila <ZAŠČITENO IME>
English: Women who are pregnant must not take <TRADENAME>
Slovenian: Program za preprečevanje nosečnosti Bolnice, ki so noseče, ne smejo jemati zdravila <ZAŠČITENO IME>
English: Mental problems
Slovenian: Duševne motnje
English: The following boxed warning should be included in the PL for the oral retinoids acitretin, alitretinoin and isotretinoin, under the invented name:
Slovenian: V navodilo za uporabo je treba vključiti sledeče opozorilo v okvirju za retinoide acitretin, alitretinoin in izotretinoin, ki se jemljejo peroralno, pod zaščitenim imenom:
English: Very rare effects (may affect up to 1 in every 10,000 people)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov)
English: • Negative pregnancy test results have been obtained before, during and 1 month after the end of treatment.
Slovenian: • Ima negativen test nosečnosti pred, med in 1 mesec po zaključku zdravljenja.
English: Section 4.4 Special warnings and precautions for use Psychiatric disorders
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi
English: You must not take <TRADENAME> if you are pregnant or if you think you might be pregnant.
Slovenian: Ne uporabljajte, če ste noseči ali če mislite, da ste noseči.
English: Ideally, pregnancy testing, issuing a prescription and dispensing of [TRADENAME] should occur on the same day.
Slovenian: Najbolje je, da se test nosečnosti izvede na isti dan, kot se predpiše recept in izda zdravilo [ZAŠČITENO IME].
English: Your doctor may tell you to stop taking <TRADENAME>.
Slovenian: Zdravnik bo morda prekinil vaše zdravljenje z zdravilom <ZAŠČITENO IME>.
English: Patients should not donate blood during therapy and for 1 month [3 years for acitretin] following discontinuation of [INN] because of the potential risk to the foetus of a pregnant transfusion recipient.
Slovenian: Med zdravljenjem in en mesec [3 leta za acitretin] po končanem zdravljenju z [mednarodno nelastniško ime] bolniki ne smejo darovati krvi zaradi možnega škodljivega vpliva na plod nosečnice, ki prejme transfuzijo krvi.
English: The doctor may send you to a specialist for contraception advice.
Slovenian: Zdravnik vam bo dal informacije o preprečevanju nosečnosti in vas morda napotil k specialistu po nasvet glede kontracepcije.
English: [TRADENAME] is strictly contraindicated in: - Pregnant women - Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met Pregnancy Prevention Programme This medicinal product is TERATOGENIC [INN] is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Programme are met:
Slovenian: - nosečnicah - ženskah v rodni dobi, razen če so izpolnjeni vsi pogoji programa za preprečevanje nosečnosti.
English: Women should undergo pregnancy test periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Slovenian: Ženske morajo po prenehanju zdravljenja nosečnostne teste izvajati v presledkih od 1 do 3 mesecev v obdobju 3 let po uporabi zadnjega odmerka.
English: The following adverse reaction(s) should be included:
Slovenian: Dodati je potrebno sledeče neželene učinke:
English: Particulars to appear on the outer packaging
Slovenian: Podatki na zunanji ovojnini Škatla
English: • She understands the need and accepts to undergo regular pregnancy testing before, ideally monthly during treatment and 1 month after stopping treatment.
Slovenian: • Bolnica razume potrebo in sprejme redna testiranja nosečnosti pred, mesečno med zdravljenjem in 1 mesec po zaključku zdravljenja.
English: • She understands the need and accepts to undergo regular pregnancy testing before, ideally monthly during treatment and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Slovenian: • Bolnica razume potrebo in sprejme redna testiranja nosečnosti pred, mesečno med zdravljenjem in periodično v 1 do 3 mesečnih intervalih še 3 leta po zaključku zdravljenja.
English: Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort
Slovenian: Znaki vključujejo slabo voljo ali spremembe razpoloženja, tesnobo, siljenje na jok.
English: Male patients
Slovenian: Navodilo za bolnika
English: • She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the entire duration of treatment and for 1 month [3 years for acitretin] after the end of treatment.
Slovenian: • Bolnica razume in sprejema pogoje za uporabo zanesljive neprekinjene kontracepcijske zaščite 1 mesec pred začetkom zdravljenja, med zdravljenjem in še 1 mesec [3 leta za acitretin] po zaključku zdravljenja.
English: You should never give this medicinal product to another person.
Slovenian: Tega zdravila ne smete deliti z nikomer.
English: You must use contraception for a month before taking <TRADENAME>, during treatment and for a month afterwards [for acitretin should be during 3 years]
Slovenian: IME>, med zdravljenjem in še en mesec po njem [za acitretin mora biti navedeno 3 leta].
English: Also, if you become pregnant within one month [3 years for acitretin] after you stop taking <TRADENAME>, you should contact your doctor.
Slovenian: Tudi če zanosite v enem mesecu [v 3 letih za acitretin] po prenehanju jemanja zdravila <ZAŠČITENO
English: {Active substance(s)}
Slovenian: leta za acitretin].
English: DO NOT use <TRADENAME> if you are pregnant or thinking of becoming pregnant.
Slovenian: Ne uporabljajte zdravila <ZAŠČITENO IME>, če ste noseči ali načrtujete nosečnost.
English: [for acitretin this last paragraph should be]
Slovenian: [za acitretin se mora zadnji odstavek glasiti]
English: CAN SERIOUSLY HARM AN UNBORN BABY Women must use effective contraception Do not use if you are pregnant or think you may be pregnant
Slovenian: LAHKO RESNO ŠKODUJE NEROJENEMU OTROKU Ženske morajo uporabljati zanesljivo kontracepcijo.
English: A contraindication should be added as follows: Section 4.3 Contraindications:
Slovenian: Opozorilo glede psihiatričnih motenj je potrebno spremeniti kot sledi: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi
English: • Individual circumstances should be evaluated in each case, when choosing the contraception method, involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures.
Slovenian: • Pri izbiri kontracepcijske metode je posamezne okoliščine treba oceniti za vsak primer posebej,
English: Annex III Amendments to relevant sections of the product information
Slovenian: Spremembe relevantnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
English: You must not take <TRADENAME> if you could get pregnant during treatment.
Slovenian: • Zdravila < ZAŠČITENO IME > ne smete jemati, če obstaja možnost, da med zdravljenjem zanosite.
English: The available data suggest that the level of maternal exposure from the semen of the patients receiving [TRADENAME], is not of a sufficient magnitude to be associated with the teratogenic effects of [TRADENAME].
Slovenian: Moški bolniki Podatki, ki so na razpolago, kažejo, da maternalna izpostavljenost semenčicam bolnikov, ki prejemajo
English: This is because your mood may be affected while taking <TRADENAME>.
Slovenian: Med jemanjem zdravila <ZAŠČITENO IME> se namreč lahko vaše razpoloženje spremeni.
English: • Negative pregnancy test results have been obtained before, during and periodically with 1-3 monthly intervals for a period of 3 years after stopping treatment.
Slovenian: • Ima negativen test nosečnosti pred, med zdravljenjem in v presledkih od 1 do 3 mesecev v obdobju 3 let po uporabi zadnjega odmerka.
English: The levels of oral retinoid in the semen of men taking <TRADENAME> are too low to harm their partners' unborn baby.
Slovenian: je prenizka, da bi škodovala nerojenemu otroku vaše partnerke.
English: − If you are pregnant
Slovenian: • Če ste noseči ali dojite.
English: You must not take <TRADENAME> if you are breastfeeding.
Slovenian: • Zdravila <ZAŠČITENO IME> ne smete jemati, če dojite.
English: At least one highly effective method of contraception (i.e. a user-independent form) or two complementary user-dependent forms of contraception should be used.
Slovenian: (obliko, neodvisno od uporabnice) ali dve dopolnjujoči obliki kontracepcije, ki sta odvisni od uporabnice.
English: A boxed warning should be added to the outer packaging for the oral retinoids acitretin, alitretinoin and isotretinoin as follows:
Slovenian: Na zunanjo ovojnino za retinoide acitretin, alitretinoin in izotretinoin, ki se jemljejo peroralno, je potrebno dodati opozorilo v okvirju, kot sledi:
English: [for acitretin this last bullet point should be]
Slovenian: • [za acitretin se mora zadnja točka glasiti]
English: You should not donate blood during treatment with this medicine and for 1 month [3 years for acitretin] after stopping <TRADENAME> because an unborn baby could be harmed if a pregnant patient receives your blood.
Slovenian: Med zdravljenjem s tem zdravilom in mesec dni [3 leta za acitretin] po koncu zdravljenja z zdravilom <ZAŠČITENO IME> ne smete darovati krvi kot krvodajalec.
English: You must not get pregnant for one month after stopping this treatment because some medicine may still be left in your body.
Slovenian: • Po zaključku zdravljenja še en mesec ne smete zanositi, ker je lahko zdravilo še vedno prisotno v vašem telesu.
English: You must not get pregnant for 3 years after stopping this treatment because some medicine may still be left in your body.
Slovenian: • Po zaključku zdravljenja še 3 leta ne smete zanositi, ker je lahko zdravilo še vedno prisotno v vašem telesu.
English: Prior to starting therapy
Slovenian: Pred pričetkom zdravljenja
English: • The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding.
Slovenian: • bolnica razume in izpolnjuje zgoraj navedene pogoje za preprečevanje nosečnosti.
English: For all topical retinoids containing adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Slovenian: Za vse retinoide za lokalno uporabo, ki vsebujejo adapalen, alitretinoin, izotretinoin, tretinoin in tazaroten, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including <INN>.
Slovenian: Psihiatrične motnje Pri bolnikih, zdravljenih s sistemskimi retinoidi, vključno z <mednarodno nelastniško ime>, so poročali o depresiji, poslabšanju depresije, anksioznosti in spremembah razpoloženja.
English: You must not get pregnant during treatment or for a month afterwards because some medicine may still be left in your body.
Slovenian: • Med zdravljenjem in še en mesec po koncu zdravljenja ne smete zanositi, ker je zdravilo še vedno lahko prisotno v vašem telesu.
English: - Pregnancy (see section 4.6) - Women planning a pregnancy
Slovenian: Poglavje 4.3 Kontraindikacije: − nosečnost (glejte poglavje 4.6)
English: For all oral retinoids containing acitretin, tretinoin and bexarotene, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Slovenian: Za vse retinoide, ki se uporabljajo peroralno in vsebujejo acitretin, tretinoin in beksaroten, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
English: You must not get pregnant during treatment or for 3 years afterwards because some medicine may still be left in your body.
Slovenian: • Med zdravljenjm in še 3 leta po zaključku zdravljenja ne smete zanositi, ker je lahko zdravilo še vedno prisotno v vašem telesu.
English: For all oral retinoids products containing alitretinoin and isotretinoin, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
Slovenian: Za vse retinoide, ki se uporabljajo peroralno in vsebujejo alitretinoin in izotretinoin, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
English: For all oral retinoids containing acitretin, alitretinoin and isotretinoin, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below
Slovenian: Za retinoidna zdravila, ki se jemljejo peroralno in vsebujejo acitretin, alitretinoin in izotretinoin, je treba obstoječe informacije o zdravilu (z vstavljanjem, nadomeščanjem ali črtanjem besedila, kot je ustrezno) spremeniti tako, da bodo odražale dogovorjeno besedilo, navedeno spodaj.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levemir on 1 June 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Levemir, veljavno po vsej Evropski uniji, izdala 1. junija 2004.
English: What measures are being taken to ensure the safe and effective use of Levemir?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Levemir?