FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: 1 place Renault 92844 Rueil-Malmaison Cedex
Slovenian: 92844 Rueil-Malmaison Cedex
English: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Finland
Slovenian: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Finska
English: Only 14 subjects on anastrozole completed 36 months.
Slovenian: Samo 14 preiskovancev, ki so dobivali anastrozol, je dokončalo 36 mesecev študije.
English: AstraZeneca AS Hoffsveien 70B, Box 200 Vinderen 0319 Oslo, Norway
Slovenian: AstraZeneca AS Hoffsveien 70B, Box 200 Vinderen 0319 Oslo, Norveška
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: DODATEK III POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Arimidex is not indicated for use in children.
Slovenian: Zdravilo Arimidex ni indicirano za uporabo pri otrocih.
English: There was no significant difference in growth rate after 12 months of treatment, relative to the growth rate during the 6 months prior to entering the study.
Slovenian: Po 12 mesecih zdravljenja ni bilo nobene statistično značilne razlike v hitrosti rasti glede na hitrost rasti v 6 mesecih pred vstopom v študijo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Slovenian: Evropska agencija za zdravila je odstopila od obveznosti po predložitvi rezultatov študij zdravila Arimidex pri eni ali več podskupinah pediatrične populacije z nizko rastjo zaradi pomanjkanja rastnega hormona, testotoksikozo, ginekomastijo in McCune-Albrightovim sindromom.
English: AstraZeneca Produtos Farmacêuticos, Lda.
Slovenian: Portugalska AstraZeneca Produtos Farmacêuticos, Lda.
English: Efficacy has not been established in the paediatric populations studied (see below).
Slovenian: V proučevanih pediatričnih populacijah njegova učinkovitost ni bila ugotovljena (glejte spodaj).
English: Arimidex is not recommended for use in children as safety and efficacy have not been established in this group of patients (see section 5.1).
Slovenian: Zdravila Arimidex ni priporočljivo uporabljati pri otrocih, ker njegova varnost in učinkovitost v tej skupini bolnikov nista ugotovljeni (glejte poglavje 5.1).
English: Testotoxicosis
Slovenian: Testotoksikoza
English: LU1 3LU, UK
Slovenian: LU1 3LU, Velika Britanija
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem B-1180 Bruxelles
Slovenian: Luksemburg NV AstraZeneca SA Rue Egide Van Ophem B-1180 Bruxelles
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
English: After 3 years anastrozole was found to statistically significantly slow bone maturation in pubertal boys on growth hormone therapy.
Slovenian: Po 3 letih se je izkazalo, da anastrozol statistično značilno upočasni dozorevanje kosti pri dečkih v puberteti, zdravljenih z rastnim hormonom.
English: AstraZeneca Pharmaceuticals AB S-15185 Södertälje Sweden
Slovenian: AstraZeneca Pharmaceuticals AB S-15185 Södertälje Švedska
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2-9) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Slovenian: V odprti, neprimerjalni, multicentrični študiji so ocenili 14 bolnikov moškega spola (starih od 2 do 9 let) z družinsko, na moške omejeno prezgodnjo puberteto (znano tudi kot testotoksikoza), zdravljenih s kombinacijo zdravila Arimidex in bikalutamida.
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9-week treatment-free recovery period.
Slovenian: Zmanjšanje je bilo prehodno, ker so bile po 9 tednih brez uporabe zdravila, vrednosti vseh parametrov parjenja in plodnosti podobne kot v kontrolni skupini.
English: Short stature due to growth hormone deficiency A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11-16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Slovenian: Nizka rast zaradi pomanjkanja rastnega hormona V randomizirani, dvojno slepi multicentrični študiji so ocenili 52 pubertetnih dečkov (starih od vključno 11 do vključno 16 let,) s pomanjkanjem rastnega hormona, ki so od 12 do 36 mesecev prejemali zdravilo Arimidex 1 mg/dan ali placebo v kombinaciji z rastnim hormonom.
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Slovenian: Število zdravljenih otrok je bilo sicer premajhno za zanesljive sklepe o varnosti, vendar so v kraku z anastrozolom v primerjavi s placebom opazili večji delež zlomov in trend k manjši mineralni kostni gostoti.
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Slovenian: V študiji plodnosti so nedavno odstavljenim podganjim samcem 10 tednov peroralno, preko njihove vode za pitje, dajali 50 ali 400 mg/l anastrozola.
English: No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity.
Slovenian: V primerjavi s placebom niso ugotovili nobene statistično značilne razlike v rastnih parametrih predvidene odrasle višine, višine, standardnih odklonov višine (Z-vrednosti) in hitrosti rasti.
English: Children
Slovenian: Otroci
English: SK 10 2 NA, UK
Slovenian: SK 10 2 NA, Velika Britanija
English: Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Slovenian: Zdravila Arimidex ni priporočljivo uporabljati pri dečkih s pomanjkanjem rastnega hormona v kombiniranem zdravljenju z rastnim hormonom.
English: Paediatrics
Slovenian: Pediatrični bolniki
English: Magyarország
Slovenian: Madžarska
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Slovenian: Velika Britanija AstraZeneca UK Limited 600 Capability Green
English: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer
Slovenian: Nizozemska AstraZeneca BV Louis Pasteurlaan 5
English: Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Slovenian: Zdravila Arimidex ni priporočljivo uporabljati pri otrocih, ker ni zadostnih podatkov o varnosti in učinkovitosti.
English: 2045 Törökbálint Park u 3.
Slovenian: Park u 3.
English: Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe zdravila
English: Czech Republic AstraZeneca UK Ltd Silk Road Business Park Macclesfield
Slovenian: Češka republika AstraZeneca UK Ltd Silk Road Business Park Macclesfield
English: Since anastrozole reduces oestradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Slovenian: V glavnem kliničnem preskušanju učinkovitost ni bila dokazana in varnost ni bila ugotovljena (glejte poglavje 5.1).Zdravila Arimidex se ne sme uporabljati pri deklicah s pomanjkanjem rastnega hormona v kombiniranem zdravljenju z rastnim hormonom, ker anastrozol zmanjša nivo estradiola.
English: AstraZeneca UK Limited, Silk Road Business Park Macclesfield, Cheshire,
Slovenian: AstraZeneca UK Limited, Silk Road Business Park Macclesfield,
English: Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical FormRoute of Administration
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom
English: These include:
Slovenian: Mednje spadajo:
English: Basis for the recommendations
Slovenian: Osnova za priporočila
English: Information for patients and healthcare professionals
Slovenian: Informacije za bolnike in zdravstvene delavce
English: Member State representatives agree new restrictions and pregnancy prevention programme
Slovenian: Predstavniki držav članic so se dogovorili o novih omejitvah in programu preprečevanja nosečnosti
English: The review of valproate medicines was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo valproat, se je začel 9. marca 2017 na zahtevo francoskega organa za zdravila (ANSM) v skladu s členom 31 Direktive 2001/83/ES.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Slovenian: Odgovorna je za zagotovitev usklajenih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek.
Slovenian: Tržijo se pod različnimi trgovskimi imeni, in sicer: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro in Valprolek.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Slovenian: V nekaterih državah članicah so odobrena tudi za preprečevanje migrenskih glavobolov.
English: It is known that if taken in pregnancy they can cause malformations in the baby and developmental disorders after birth.
Slovenian: Znano je, da lahko ob jemanju v nosečnosti pri otroku povzročijo malformacije in razvojne motnje po rojstvu.
English: − a review of ongoing treatment by a specialist at least annually,
Slovenian: specialistični pregled zdravljenja vsaj enkrat na leto,
English: The medicines authorities in the individual countries will approve appropriate details of the visual warning for their national situation.
Slovenian: Organi za zdravila v posameznih državah se bodo dogovorili o ustreznih podrobnostih vizualnega opozorila glede na nacionalne razmere.
English: • Healthcare professionals will receive further information at national level in due course as the recommendations are implemented.
Slovenian: • Zdravstveni delavci bodo prejeli dodatne informacije na nacionalni ravni, in sicer pravočasno, ko se bodo priporočila začela izvajati.
English: • It is important that patients discuss any concerns about their medication with an appropriate healthcare professional.
Slovenian: • Pomembno je, da se bolniki o vseh pomislekih glede zdravila posvetujejo z ustreznim zdravstvenim delavcem.
English: − counselling about the risks of valproate treatment and the need for effective contraception throughout treatment,
Slovenian: svetovanje o tveganjih zdravljenja z valproatom in potrebi po učinkoviti kontracepciji ves čas zdravljenja,
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position.
Slovenian: Priporočila odbora PRAC so bila poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela stališče.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/145600/2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United
English: The measures are based on a review of available scientific evidence, including drug utilisation studies and clinical and laboratory evidence of the effects of the medicine.
Slovenian: Ukrepi temeljijo na pregledu razpoložljivih znanstvenih dokazov, vključno s študijami uporabe zdravil ter kliničnih in laboratorijskih podatkov o učinkih zdravila.
English: During the review, the PRAC also consulted very widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including healthcare professionals, patients organisations, patients and their families), and via a public hearing.
Slovenian: Med pregledom se je odbor PRAC zelo obsežno posvetoval tudi z zdravstvenimi delavci in bolniki, vključno z ženskami in njihovimi otroki, ki jih je prizadela uporaba valproata med nosečnostjo, s pisnimi predlogi, strokovnimi srečanji, sestanki z deležniki (vključno z zdravstvenimi delavci, organizacijami bolnikov, bolniki in njihovimi družinami) ter z javnim zaslišanjem.
English: In addition, all companies marketing such medicines will need to have in place a risk management plan which details the measures taken to ensure that a medicine is used as safely as possible.
Slovenian: Vse družbe, ki tržijo tovrstna zdravila, bodo morale imeti tudi vzpostavljen načrt za obvladovanje tveganja, v katerem bodo določeni ukrepi za zagotavljanje, da se zdravilo uporablja čim bolj varno.
English: The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant.
Slovenian: Program je zasnovan za zagotavljanje celovite seznanjenosti bolnic s tveganji in potrebo po izogibanju nosečnosti.
English: • Although steps had been taken previously to better inform women about these risks and discourage use of valproate in girls and women unless there was no alternative, the evidence shows that this information is still not getting to patients.
Slovenian: • Čeprav so bili pred tem sprejeti koraki za boljše obveščanje žensk o teh tveganjih in odvračanje od uporabe valproata pri dekletih in ženskah, razen če ni bilo druge možnosti, podatki kažejo, da te informacije bolnic ne dosežejo.
English: Women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Slovenian: Ženske in dekleta, ki so jim predpisali valproat, zdravila ne smejo prenehati jemati brez posvetovanja z zdravnikom, saj bi lahko s tem škodovale sebi ali svojemu nerojenemu otroku.
English: The new measures endorsed by CMDh therefore strengthen previous restrictions on valproate use and requirements to inform women of the risk.
Slovenian: Novi ukrepi, ki jih je sprejela skupina CMDh, torej zaostrujejo prejšnje omejitve glede uporabe valproata in zahteve za obveščanje žensk o tveganju.
English: − pregnancy tests before starting and during treatment as needed,
Slovenian: nosečnostni testi pred začetkom zdravljenja, med njim in po zdravljenju,
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Slovenian: Zdravila, ki vsebujejo valproat, so bila odobrena po nacionalnih postopkih v vseh državah članicah EU ter na Norveškem in na Islandiji.
English: The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy, and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available.
Slovenian: Novi ukrepi vključujejo prepoved uporabe tovrstnih zdravil za preprečevanje migrene ali bipolarne motnje v nosečnosti ter prepoved zdravljenja epilepsije v nosečnosti, razen če ni na voljo nobeno drugo učinkovito zdravilo.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
English: Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met.
Slovenian: Poleg tega se ta zdravila ne smejo uporabljati pri nobeni ženski ali dekletu, ki ima lahko otroke, razen če so izpolnjeni pogoji novega programa za preprečevanje nosečnosti.
English: The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.
Slovenian: Učinkovina v teh zdravilih je lahko valprojska kislina, magnezijev valproat, natrijev valproat, valproat seminatrij ali valpromid.
English: As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision.
Slovenian: Ker je bilo stališče skupine CMDh izglasovano z večino, je bilo predloženo Evropski komisiji, ki je izdala pravno zavezujoči sklep, veljaven po vsej EU.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Slovenian: Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn ter Norveško.
English: − an assessment of each patient's potential for becoming pregnant,
Slovenian: ocena možnosti vsake ženske za zanositev,
English: • Educational materials in the form of guides for patients and doctors will also be updated to reflect the current situation and provide age-appropriate advice.
Slovenian: • Posodobljeno bo tudi izobraževalno gradivo v obliki priročnikov za bolnike in zdravnike, in sicer tako, da bodo v njem upoštevane trenutne okoliščine in bo vsebovalo starosti primerne nasvete.
English: The CMDh agreed with EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures, that despite previous recommendations aimed at better informing patients of the risks with these medicines, women were still not always receiving the right information in a timely manner.
Slovenian: Skupina CMDh se je strinjala z Odborom za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA, ki je izvedel pregled in priporočil nove ukrepe, da ženske kljub prejšnjim priporočilom za boljšo seznanjanje bolnic o tveganjih pri jemanju teh zdravil pravih informacij še vedno ne prejmejo pravočasno.
English: • In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation, for women planning pregnancy; however, there may be a small number of women with epilepsy for whom there is no suitable alternative treatment to valproate and who should be appropriately supported and counselled.
Slovenian: • V nosečnosti je valproat kontraindiciran, zato se je treba pri ženskah, ki načrtujejo nosečnost, ob ustreznem specialističnem svetovanju odločiti za nadomestno zdravljenje; vendar pa pri manjšem številu žensk z epilepsijo ni drugega ustreznega zdravljenja razen valproata, zato jim je treba ustrezno pomagati in jim svetovati.
English: • As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty.
Slovenian: • Tako kot prej se zdravljenje z valproatom ne sme nikoli začeti, razen če ni na voljo drugega zdravljenja, kar velja tudi za deklice pred puberteto.
English: A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
Slovenian: Na ovojnino zdravil je treba namestiti tudi vizualno opozorilo o tveganjih, povezanih z nosečnostjo (v obliki besedila v pravokotniku z drugimi možnimi elementi, npr. znakom za opozorilo), opozorila pa je treba vključiti tudi na kartice bolnikov, ki so pritrjene na škatlo in dobavljene z zdravilom pri vsaki izdaji zdravila.
English: This will include surveys of healthcare professionals and patients to assess the reach and effectiveness of the new measures, and use of data from existing registries to further characterise the malformations known as foetal anticonvulsant syndrome in children whose mothers took valproate in pregnancy and how this compares to other anti-epileptic medicines.
Slovenian: Med drugim bodo izvedle ankete med zdravstvenimi delavci in bolniki za oceno dosega in učinkovitosti novih ukrepov, uporabo podatkov iz obstoječih registrov za nadaljnjo opredelitev malformacij, znanih kot fetalni antikonvulzivni sindrom, pri otrocih, katerih matere so v nosečnosti jemale valproat, in primerjavo z drugimi zdravili za preprečevanje epileptičnih napadov.
English: It also includes a retrospective observational study to look at any association between exposure to valproate in men and the risk of malformations and developmental disorders including autism in offspring, and an observational study to evaluate and identify the best practice for stopping and switching of valproate treatment.
Slovenian: Poleg tega bodo izvedle retrospektivno opazovalno študijo za proučitev povezave med izpostavljenostjo valproatu pri moških ter tveganjem za malformacije in razvojne anomalije, vključno z avtizmom, pri potomcih, ter opazovalno študijo za oceno in prepoznavo dobre prakse za prekinitev in zamenjavo zdravljenja z valproatom.
English: • Valproate medicines are now therefore contraindicated, i.e. must not be used, in girls and women able to have children unless the terms of a special pregnancy prevention programme are followed.
Slovenian: • Zdravila, ki vsebujejo valproat, so zdaj torej kontraindicirana, tj. pri deklicah in ženskah, ki imajo lahko otroke, se ne smejo uporabljati, razen ob upoštevanju pogojev posebnega programa za preprečevanje nosečnosti.
English: In addition, there will be a patient alert card attached to the packaging so that pharmacists can go through it with the patient when the medicine is dispensed.
Slovenian: Poleg tega bo na ovojnino pritrjena opozorilna kartica, tako da jo bodo lahko farmacevti pri izdaji zdravila pregledali skupaj z bolnico.
English: • Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine.
Slovenian: • Zdravila, ki vsebujejo valproat, so v Evropski uniji že vrsto let na voljo za zdravljenje epilepsije, bipolarne motnje in v nekaterih državah migrene.
English: • There will be changes to the product information (package leaflet for patients and SmPC for healthcare professionals) to reflect these new conditions and also to the packaging of the medicine, including a visual warning in the form of boxed text which may be accompanied by other elements such as a symbol.
Slovenian: • Spremenjene bodo informacije o zdravilu (navodilo za uporabo za bolnike in povzetek glavnih značilnosti zdravila za zdravstvene delavce), da bodo vsebovale te nove pogoje, ter tudi ovojnina zdravila, vključno z vizualnim opozorilom v obliki uokvirjenega besedila, ki ga lahko spremljajo drugi elementi, npr. simbol.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Slovenian: Skupina CMDh je organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Slovenian: Zdravila, ki vsebujejo valproat, se uporabljajo za zdravljenje epilepsije in bipolarne motnje.