FrancophonIA/ELRC3.0 huggingface dataset:
English: [EMA/MB/82882/2012] The Management Board noted the document outlining the preliminary budget for ICT project development and systems maintenance in 2013.
Slovenian: (EMA/MB/82882/2012) Upravni odbor se je seznanil z dokumentom, ki vključuje predhodni predlog proračuna za razvoj projektov IKT in vzdrževanje sistemov leta 2013.
English: • [EMA/MB/137391/2012] Overview of implementing rules to Staff Regulations signed by the MB Chair during the period from 7 October 2011 to 29 February 2012.
Slovenian: • (EMA/MB/137391/2012) Pregled izvedbenih pravil za kadrovske predpise, ki ga je podpisal predsednik upravnega odbora, v obdobju od 7. oktobra 2011 do 29. februarja 2012.
English: Patient representatives requested a possibility for both a member and an alternate to attend all PRAC meetings.
Slovenian: Zaprosili so za možnost, da se vseh sej odbora PRAC lahko udeležita član in namestnik.
English: a.) Preliminary draft work programme 2013
Slovenian: a) Predhodni osnutek delovnega programa za leto 2013
English: Another proposal offered, which would allow knowledge about a product that had been gathered at the pre-authorisation stage to be retained, was to appoint the PRAC rapporteur from among the experts who had acted as peer-reviewers in the pre-authorisation phase.
Slovenian: Skladno z drugim podanim predlogom, ki bi omogočil ohranitev znanja o zdravilu, pridobljenega v fazi pred izdajo dovoljenja za promet, naj se poročevalca odbora PRAC imenuje izmed strokovnjakov, ki so delovali kot strokovni ocenjevalci v fazi pred izdajo dovoljenja za promet.
English: It was suggested that for already authorised products and ongoing procedures, the system of the rapporteur in the pre-authorisation stage being appointed as the PRAC rapporteur could be applied.
Slovenian: Predlagano je bilo, naj se za zdravila, ki že imajo dovoljenje za promet, in postopke, ki potekajo, uporabi sistem, po katerem se za poročevalca PRAC imenuje poročevalca iz faze pred izdajo dovoljenja za promet.
English: [EMA/MB/955795/2012] The Management Board noted the document outlining the high-level budgetary requirements for 'Project 2014' (the move of the Agency to its new premises).
Slovenian: (EMA/MB/955795/2012) Upravni odbor se je seznanil z dokumentom o velikih proračunskih zahtevah za projekt za leto 2014 (selitev agencije v nove prostore).
English: • A discussion on the concept of public hearing and transparency.
Slovenian: • razpravo o konceptu javne obravnave in preglednosti,
English: • The implementing measures for the falsified medicines legislation (public consultations on unique identifier finishes 27 April 2012, on GMP for active substances from non-EU countries finishes 23
Slovenian: • ukrepi za izvajanje zakonodaje o ponarejenih zdravilih (javno posvetovanje o posebnem identifikatorju bo končano 27. aprila 2012, o dobri proizvodni praksi za zdravilne učinkovine iz držav, ki niso članice EU bo končano 23. marca 2012, o načelih in smernicah dobre proizvodne prakse za zdravilne učinkovine pa bo končano 20. aprila 2012);
English: This would increase the overall headcount by 14 FTEs.
Slovenian: To bi povečalo število zaposlenih za 14 ekvivalentov polne zaposlitve.
English: The discussion of the Board focused on the possible divergence of opinions between the PRAC and the CHMP/CMD(h).
Slovenian: Razprava upravnega odbora se je osredotočila na morebitna razhajanja mnenj odbora PRAC in odbora CHMP/skupine CMD(h).
English: The Board was informed that, to date, the Agency has introduced a revised policy on managing conflicts of interests of experts, adopted rules on managing conflicts of interests of staff, discussed the Management Board policy and presented it for adoption at this meeting, drafted the breach of trust procedure, is introducing ex post controls, has published risk ratings for committee members, and has
Slovenian: strokovnjakov, sprejela pravila o obvladovanju navzkrižij interesov osebja, razpravljala o politiki upravnega odbora in jo predložila v sprejetje na tej seji, pripravila osnutek postopka pri zlorabi zaupanja, uvaja naknadne kontrole ter je objavila ocene tveganj za člane odborov in strokovne profile direktorjev agencije ter članov odborov in upravnega odbora.
English: The Agency will draft a reflection paper based on the guidance provided today, and will seek written comments from the Board.
Slovenian: Agencija bo na podlagi tokrat sprejetih smernic pripravila osnutek študije in upravni odbor zaprosila za pisne pripombe.
English: It was also argued that the knowledge obtained about a product in the pre-authorisation stage is important for PRAC rapporteurship.
Slovenian: Nekateri so še trdili, da je znanje, pridobljeno o zdravilu v fazi pred izdajo dovoljenja za promet, pomembno tudi za poročanje odbora PRAC.
English: [EMA/MB/121516/2012] The Board adopted the Agency's preliminary draft budget and the draft establishment plan for 2013.
Slovenian: (EMA/MB/121516/2012) Upravni odbor je sprejel predhodni predlog proračuna in osnutek kadrovskega načrta agencije za leto 2013.
English: [EMA/MB/945561/2011] The Management Board adopted the Agency's preliminary draft work programme 2013.
Slovenian: (EMA/MB/945561/2011) Upravni odbor je sprejel predhodni osnutek delovnega programa agencije za leto 2013.
English: There are a number of precursors to adaptive licensing - such as conditional marketing authorisation, new pharmacovigilance legislation, risk-management plans, periodic safety update reports, etc.
Slovenian: Udeleženci so med razpravo ugotovili, da koncept kot tak na regulativnem področju ni popolnoma nov. Prilagodljivo izdajanje dovoljenj ima več predhodnih korakov, kot so pogojno izdajanje dovoljenj, nova zakonodaja o farmakovigilanci, načrti za obvladovanje tveganj, redno posodobljena poročila o varnosti zdravila itd.
English: • Consultation no. 15/2011 on the appointment of Esther Werner as CVMP alternate, proposed by Germany, ended, with observations from Members raised in respect of the candidate's expertise, on 3 January 2012.
Slovenian: • Posvetovanje št. 15/2011 o imenovanju Esther Werner za namestnico v odboru CVMP na predlog Nemčije, končano, člani so 3. januarja 2012 podali pripombe v zvezi s strokovnim znanjem kandidatke.
English: • Consultation no. 03/2012 on the appointment of Martti Nevalainen as CVMP member, proposed by Finland ended on 2 February 2012 with Members' observations, raised in respect of the candidate's level of conflict of interests and supported by the CVMP Chair, sent to the nominating authority on 13 February 2012.
Slovenian: • Posvetovanje št. 03/2012 o imenovanju Marttija Nevalainena za člana v odboru CVMP na predlog Finske, končano 2. februarja 2012 s pripombami članov v zvezi s kandidatovim navzkrižjem interesov, te je podprl tudi predsednik odbora CVMP in so bile 13. februarja 2012 poslane organu za imenovanja.
English: • [EMA/177625/2012 Rev.1] Minutes from the Management Board Telematics Committee meeting held on 14 February 2012.
Slovenian: • (EMA/177625/2012 Rev. 1) Zapisnik seje odbora za telematiko pri upravnem odboru z dne 14. februarja 2012.
English: A discussion on the concept of public hearing and transparency
Slovenian: 1. zasedanje: razprava o konceptu javne obravnave in preglednosti
English: [EMA/154320/2012] The Management Board endorsed the breach of trust procedure on conflicts of interests for scientific-committee members and experts.
Slovenian: (EMA/154320/2012) Upravni odbor je potrdil postopek pri zlorabi zaupanja v zvezi z navzkrižjem interesov za člane znanstvenih odborov in strokovnjake.
English: The nominating authority confirmed the withdrawal of the nomination in a letter addressed to the MB Chair, received on 24 February 2012.
Slovenian: Ta je v dopisu predsedniku upravnega odbora, prejetem 24. februarja 2012, potrdil umik imenovanja.
English: • Consultation no. 02/2012 on the appointment of Outi Maki-Ikola as CHMP member, proposed by Finland, ended on 26 January 2012.
Slovenian: • Posvetovanje št. 02/2012 o imenovanju Outi Maki-Ikola za članico v odboru CHMP na predlog Finske, končano 26. januarja 2012.
English: The mandate of the nominee commenced on 9 December 2011.
Slovenian: Kandidatka je mandat nastopila 9. decembra 2011.
English: • Update on the implementation of the pharmacovigilance legislation.
Slovenian: • najnovejše podatke o izvajanju zakonodaje o farmakovigilanci,
English: The mandate of the nominee commenced on 4 January 2012.
Slovenian: Kandidatka je mandat nastopila 4. januarja 2012.
English: The mandate of the nominee commenced on 27 January 2012.
Slovenian: Kandidatka je mandat nastopila 27. januarja 2012.
English: • Publication of agendas and minutes.
Slovenian: • objavo dnevnih redov in zapisnikov,
English: • The implementing measures of the pharmacovigilance legislation (planned adoption in Q2 2012).
Slovenian: • ukrepi za izvajanje zakonodaje o farmakovigilanci (načrtovano sprejetje v drugem četrtletju leta
English: b.) Preliminary draft budget and establishment plan 2013
Slovenian: b.) Predhodni predlog proračuna in kadrovski načrt za leto 2013
English: [EMA/513078/2010] The Management Board endorsed the amendments to the revised conflicts of interests policy for Committee members and experts.
Slovenian: (EMA/513078/2010) Upravni odbor je potrdil spremembe spremenjene politike o navzkrižju interesov za člane odborov in strokovnjake.
English: Some outstanding work will be finalised by mid
Slovenian: Nekaj nedokončanih nalog bo izvedenih do sredine maja 2012.
English: [EMA/154547/2012] The Board noted the analysis on the implementation of the revised conflicts of interests policy for Committee members and experts.
Slovenian: (EMA/154547/2012) Upravni odbor se je seznanil z analizo izvajanja spremenjene politike o navzkrižju interesov za člane odborov in strokovnjake.
English: A gap of one week between PRAC and CHMP/CMD(h) meetings was proposed.
Slovenian: Predlagan je bil enotedenski premor med sejami odbora PRAC in odbora CHMP/skupine CMD(h).
English: The meeting also noted the proposal about the timing between PRAC and CHMP/CMD(h) meetings.
Slovenian: Udeleženci seje so se seznanili še s predlogom časovne uskladitve sej odbora PRAC in odbora CHMP/skupine CMD(h).
English: • Consultation no. 01/2012 on the appointment of Ingunn Hagen Westgaard as CHMP alternate, proposed by Norway, ended on 26 January 2012.
Slovenian: • Posvetovanje št. 01/2012 o imenovanju Ingunn Hagen Westgaard za namestnico v odboru CHMP na predlog Norveške, končano 26. januarja 2012.
English: • Consultation no. 13/2011 on the appointment of Merete Blixenkrone-Moller as CVMP alternate, proposed by Denmark, ended on 8 December 2011.
Slovenian: • Posvetovanje št. 13/2011 o imenovanju Merete Blixenkrone-Moller za namestnico v odboru CVMP na predlog Danske, končano 8. decembra 2011.
English: • Consultation no. 14/2011 on the appointment of Ugne Zymantaite as CVMP alternate, proposed by Lithuania, ended on 19 December 2011.
Slovenian: • Posvetovanje št. 14/2011 o imenovanju Ugne Zymantaite za namestnico v odboru CVMP na predlog Litve, končano 19. decembra 2011.
English: Representative of veterinarians' organisations Observers
Slovenian: Predstavnik veterinarskih organizacij
English: Wednesday meeting, held on 21 March 2012
Slovenian: Seja, ki je potekala v sredo, 21. marca 2012
English: EMA/MB/221361/2012 Adopted Management Board
Slovenian: EMA/518119/2012 sprejet upravni odbor
English: Thursday meeting, held on 22 March 2012
Slovenian: Seja, ki je potekala v četrtek, 22. marca 2012
English: Minutes from the 74th meeting, held on 15 December
Slovenian: Zapisnik 74. seje, ki je potekala 15. decembra 2011
English: The mandate of the nominee commenced on 20 December
Slovenian: Kandidatka je mandat nastopila 20. decembra 2011.
English: EU/1/14/967/001 Rezolsta
Slovenian: EU/1/14/967/001
English: 800 mg/150 mg Film-coated tablet Oral use
Slovenian: 800 mg/150 mg filmsko obložena tableta peroralna uporaba plastenka (HDPE)
English: MA (EU) number (Invented) name
Slovenian: Številka postopka EMA (Izmišljeno) ime Jakost
English: Strength
Slovenian: Rezolsta
English: Bottle (HDPE) 30 tablets
Slovenian: 30 tablet
English: This applies to the following conditions:
Slovenian: To velja za naslednje bolezni:
English: Duration of Use
Slovenian: Trajanje uporabe
English: • if you are using another hormonal contraceptive
Slovenian: • če uporabljate drug hormonski kontraceptiv
English: Venous thromboembolism can be fatal in 1-2% of cases.
Slovenian: Venska trombembolija je lahko v 1 - 2 % primerov smrtna.
English: The risk is not as high as the risk of developing a blood clot during pregnancy.
Slovenian: Tveganje ni tako veliko kot tveganje za nastanek krvnega strdka med nosečnostjo.
English: - obesity (body mass index over 30 kg/m2).
Slovenian: - debelostjo (indeks telesne mase več kot 30 kg/m²)
English: In these situations it is advisable to discontinue use (in the case of elective surgery at least four weeks in advance) and not to resume until two weeks after complete remobilisation.
Slovenian: V teh primerih je priporočljivo jemanje zdravila prekiniti (vsaj štiri tedne pred načrtovanim kirurškim posegom) in ga ponovno začeti jemati šele dva tedna po popolnem okrevanju.
English: You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives
Slovenian: Vi in vaš zdravnik morata upoštevati tudi vse drugo, kar običajno velja za varno uporabo peroralnih hormonskih kontraceptivov.
English: The symptoms are described in section 2 ‘Blood clots (Thrombosis)'.
Slovenian: Simptomi so opisani v poglavju 2 "Krvni strdki (tromboza)".
English: Following a blood clot, recovery is not always complete.
Slovenian: Okrevanje po krvnem strdku ni vedno popolno.
English: A full recovery is not always made and in 1-2% of cases, can be fatal.
Slovenian: Vedno ne pride do popolnega okrevanja, v 1- 2 % primerov pa je nastanek krvnih strdkov lahko smrten.
English: Possible side effects [This wording should be added under ‘Rare side effects'] Venous blood clot.
Slovenian: Možni neželeni učinki [To besedilo je treba dodati v “Redki neželeni učinki”] krvni strdki v venah
English: What < invented name > is and what it is used for
Slovenian: Kaj je zdravilo <ime zdravila> in za kaj ga uporabljamo
English: Your doctor may then advise you to use a different treatment:
Slovenian: Vaš zdravnik vam bo morda svetoval uporabo drugih oblik zdravljenja:
English: • Concomitant use with another hormonal contraceptive (see section 4.1)
Slovenian: • sočasna uporaba z drugimi hormonskimi kontraceptivi (glejte poglavje 4.1)
English: For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.
Slovenian: Na primer, krvni strdek v arteriji srca lahko povzroči srčni infarkt, v možganih pa možgansko kap.
English: with increasing age; if you smoke.
Slovenian: • če kadite.
English: Since <invented name> is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3).
Slovenian: Ker je zdravilo <ime zdravila> tudi hormonski kontraceptiv, se ga ne sme uporabljati sočasno z drugimi hormonskimi kontraceptivi (glejte poglavje 4.3).
English: Time to relief of symptoms is at least three months.
Slovenian: Da simptomi izzvenijo mora zdravljenje trajati vsaj tri mesece.
English: • if you have problems with blood clotting (e.g. protein C deficiency)
Slovenian: • če imate motnjo strjevanja krvi (npr. pomanjkanje proteina C)
English: Do not take <invented name>
Slovenian: Ne jemljite zdravila <ime zdravila>
English: A blood clot in an artery can cause serious problems.
Slovenian: Krvni strdek v arteriji lahko povzroči resne težave.
English: If this applies to you, it is important to tell your doctor that you are using <invented name>, as the treatment may have to be stopped.
Slovenian: Če karkoli od navedenega velja za vas, je pomembno, da zdravnika opozorite, da uporabljate zdravilo <ime zdravila>, saj bo morda treba zdravljenje prekiniti.
English: • Epidemiological studies have shown that the incidence of VTE is 1.5 to 2 times higher in users of <invented name> than in users of levonorgestrel-containing combined oral contraceptives (COCs) and may be similar to the risk for desogestrel / gestodene / drospirenone-containing COCs.
Slovenian: • Epidemiološke študije so pokazale, da je incidenca VTE 1,5-krat do 2-krat večja pri uporabnicah zdravila <ime zdravila>, kot pri uporabnicah kombiniranih peroralnih kontraceptivov, ki vsebujejo levonorgestrel, in je lahko podobna tveganju pri kombiniranih peroralnih kontraceptivih, ki vsebujejo dezogestrel/gestoden/drosperinon.
English: Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate.
Slovenian: Zaradi kontraceptivnih lastnosti vam zdravnik lahko to zdravilo predpiše le, če meni, da je za vas primerno, da se zdravite s hormonskim kontraceptivom.
English: • if you have a condition that may increase the risk of a blood clot in your arteries.
Slovenian: • če imate kakšno bolezen, ki lahko poveča tveganje za nastanek krvnega strdka v arterijah.
English: Section 4.8 - Undesirable effects [The wording below should be inserted in this section]
Slovenian: Poglavje 4.8 - Neželeni učinki [Spodnje besedilo je treba vstaviti v to poglavje]
English: The risk of blood clots in a vein in users of a combined pill increases further:
Slovenian: Tveganje za nastanek krvnih strdkov v venah pri uporabnicah kombiniranih kontraceptivov se dodatno poveča:
English: • Epidemiological studies have also associated the use of hormonal contraceptive with an increased risk for arterial (myocardial infarction, transient ischaemic attack) thromboembolism.
Slovenian: • V epidemioloških študijah so povezovali uporabo hormonskih kontraceptivov tudi z večjim tveganjem za arterijsko trombembolijo (miokardni infarkt, prehodni ishemični napad).
English: The need to continue treatment should be evaluated periodically by the treating physician (see section 4.2).
Slovenian: Lečeči zdravnik mora redno ocenjevati potrebo po nadaljevanju zdravljenja (glejte poglavje 4.2).
English: The increased risk of thromboembolism in the puerperium must be considered (for information on ‘Pregnancy and lactation' see section 4.6).
Slovenian: V poporodni dobi je treba upoštevati povečano tveganje za trombembolijo (za informacije o uporabi med nosečnostjo in dojenjem glejte poglavje 4.6).
English: The physician should then decide on whether the use of <invented name> should be discontinued.
Slovenian: Zdravnik se bo nato odločil, ali je treba uporabo zdravila <ime zdravila> prekiniti.
English: <invented name> also works as an oral contraceptive.
Slovenian: Zdravilo <ime zdravila> deluje tudi kot peroralni kontraceptiv.
English: Rarely serious permanent disabilities may occur or the blood clot may even be fatal.
Slovenian: Krvni strdek je lahko redko vzrok za hudo trajno invalidnost ali pa je lahko celo smrten.
English: If any of the conditions/risk factors mentioned below is present, the benefits of the use of <invented name> should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using <invented name>.
Slovenian: Če je prisotno katerokoli od spodaj omenjenih stanj/dejavnikov tveganja, je treba pri vsaki ženski pretehtati koristi in morebitna tveganja uporabe zdravila <ime zdravila> in se o tem z njo pogovoriti, še preden se odloči, da bo zdravilo <ime zdravila> začela uporabljati.
English: Symptoms of blood clots
Slovenian: Simptomi krvnih strdkov
English: A blood clot in a vein (known as a ‘venous thrombosis') can block the vein.
Slovenian: Krvni strdek v veni (znan tudi kot "venska tromboza") lahko zamaši veno.
English: Duration of use Your doctor will tell you how long you need to keep taking <invented name>.
Slovenian: Trajanje uporabe Vaš zdravnik vam bo svetoval, kako dolgo morate jemati zdravilo <ime zdravila>.
English: <Invented name> is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age.
Slovenian: Zdravilo <ime zdravila> se uporablja za zdravljenje bolezni kože, kot so akne, čezmerno mastna koža in pretirana poraščenost pri ženskah v rodni dobi.
English: o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides)
Slovenian: o sladkorna bolezen s prizadetostjo krvnih žil o zelo visok krvni tlak o zelo visoke vrednosti maščob v krvi (holesterola ali trigliceridov)
English: • Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
Slovenian: • podedovana ali pridobljena nagnjenost k venski ali arterijski trombozi, npr. odpornost na aktivirani protein C (APC), pomanjkanje antitrombina III, pomanjkanje proteina C, pomanjkanje proteina S, hiperhomocisteinemija in antifosfolipidna protitelesa (antikardiolipinska protitelesa, lupusni antikoagulant)
English: This can happen in veins of the leg, the lung (a lung embolus), or any other organ.
Slovenian: To se lahko zgodi v venah nog, pljuč (krvni strdek v pljučih) ali drugih organov.
English: Blood clots (thrombosis)
Slovenian: Krvni strdki (tromboza)
English: In case of suspected or confirmed thrombosis, <invented name> use should be discontinued.
Slovenian: V primeru suma na trombozo ali potrjene tromboze je treba z jemanjem zdravila <ime zdravila> prekiniti.
English: Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking < invented name >.
Slovenian: Neposredno po porodu je pri ženskah tveganje za nastanek krvnih strdkov povečano, zato se posvetujte z zdravnikom, kdaj po porodu lahko začnete jemati zdravilo <ime zdravila>.
English: Taking <invented name> may slightly increase your risk of having a blood clot (called a thrombosis).
Slovenian: Jemanje zdravila <ime zdravila> lahko nekoliko poveča tveganje za nastanek krvnih strdkov (imenovano tromboza).
English: The need to continue treatment should be evaluated periodically by the treating physician.
Slovenian: Lečeči zdravnik mora redno ocenjevati potrebo po nadaljevanju zdravljenja.
English: Your chances of having a blood clot are only increased slightly by taking <invented name> compared with women who do not take <invented name> or any contraceptive pill.
Slovenian: Možnost, da pri vas nastane krvni strdek, se z jemanjem zdravila <ime zdravila> v primerjavi z ženskami, ki ne jemljejo zdravila <ime zdravila> ali katerega koli drugega kontraceptiva, le malo poveča.
English: • The user group of <invented name> is likely to include patients that may have an inherently increased cardiovascular risk such as that associated with polycystic ovarian syndrome.
Slovenian: • V skupini uporabnic zdravila <ime zdravila> bodo verjetno bolnice, ki že imajo povečano tveganje za srčnožilne bolezni, kot na primer tiste povezane s policističnim ovarijskim sindromom.
English: You should only take <invented name> if your skin condition has not improved after use of other antiacne treatments, including topical treatments and antibiotics.
Slovenian: Zdravilo <ime zdravila> jemljite za zdravljenje bolezni kože le, če se stanje po uporabi drugih zdravil proti aknam, vključno zdravili za lokalno zdravljenje in antibiotiki, ni izboljšalo.
English: An increase in frequency or severity of migraine during use of <invented name > (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of <invented name>.
Slovenian: Če se pri ženskah, ki uporabljajo zdravilo <ime zdravila>, pogosteje pojavijo migrene ali so te hujše (kar je lahko prodrom cerebrovaskularnega dogodka), je to lahko razlog za takojšnjo prekinitev jemanja zdravila <ime zdravila>.