natgillin/translations-raw huggingface dataset:
AstraZeneca Pharmaceuticals AB S-15185 Södertälje Sweden 
AstraZeneca Pharmaceuticals AB S-15185 Södertälje Švedska
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. 
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.
The reduction was transient as all mating and fertility parameters were similar to control group values following a 9-week treatment-free recovery period. 
Zmanjšanje je bilo prehodno, ker so bile po 9 tednih brez uporabe zdravila, vrednosti vseh parametrov parjenja in plodnosti podobne kot v kontrolni skupini.
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. 
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.
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. 
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.
In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks. 
V študiji plodnosti so nedavno odstavljenim podganjim samcem 10 tednov peroralno, preko njihove vode za pitje, dajali 50 ali 400 mg/l anastrozola.
No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity. 
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.
Children 
Otroci
SK 10 2 NA, UK 
SK 10 2 NA, Velika Britanija
Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. 
Zdravila Arimidex ni priporočljivo uporabljati pri dečkih s pomanjkanjem rastnega hormona v kombiniranem zdravljenju z rastnim hormonom.
Paediatrics 
Pediatrični bolniki
Magyarország 
Madžarska
United Kingdom AstraZeneca UK Limited 600 Capability Green Luton 
Velika Britanija AstraZeneca UK Limited 600 Capability Green
AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer 
Nizozemska AstraZeneca BV Louis Pasteurlaan 5
Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1). 
Zdravila Arimidex ni priporočljivo uporabljati pri otrocih, ker ni zadostnih podatkov o varnosti in učinkovitosti.
2045 Törökbálint Park u 3. 
Park u 3.
Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of Administration 
Farmacevtska oblika Pot uporabe zdravila
Czech Republic AstraZeneca UK Ltd Silk Road Business Park Macclesfield 
Češka republika AstraZeneca UK Ltd Silk Road Business Park Macclesfield
Since anastrozole reduces oestradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment. 
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.
Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical FormRoute of Administration 
Država članica Imetnik dovoljenja za promet z zdravilom
These include: 
Mednje spadajo:
Basis for the recommendations 
Osnova za priporočila
Information for patients and healthcare professionals 
Informacije za bolnike in zdravstvene delavce
Member State representatives agree new restrictions and pregnancy prevention programme 
Predstavniki držav članic so se dogovorili o novih omejitvah in programu preprečevanja nosečnosti
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. 
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.
It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. 
Odgovorna je za zagotovitev usklajenih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
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. 
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.
In some EU Member States they are also authorised to prevent migraine headaches. 
V nekaterih državah članicah so odobrena tudi za preprečevanje migrenskih glavobolov.
It is known that if taken in pregnancy they can cause malformations in the baby and developmental disorders after birth. 
Znano je, da lahko ob jemanju v nosečnosti pri otroku povzročijo malformacije in razvojne motnje po rojstvu.
− a review of ongoing treatment by a specialist at least annually, 
specialistični pregled zdravljenja vsaj enkrat na leto,
The medicines authorities in the individual countries will approve appropriate details of the visual warning for their national situation. 
Organi za zdravila v posameznih državah se bodo dogovorili o ustreznih podrobnostih vizualnega opozorila glede na nacionalne razmere.
• Healthcare professionals will receive further information at national level in due course as the recommendations are implemented. 
• Zdravstveni delavci bodo prejeli dodatne informacije na nacionalni ravni, in sicer pravočasno, ko se bodo priporočila začela izvajati.
• It is important that patients discuss any concerns about their medication with an appropriate healthcare professional. 
• Pomembno je, da se bolniki o vseh pomislekih glede zdravila posvetujejo z ustreznim zdravstvenim delavcem.
− counselling about the risks of valproate treatment and the need for effective contraception throughout treatment, 
svetovanje o tveganjih zdravljenja z valproatom in potrebi po učinkoviti kontracepciji ves čas zdravljenja,
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position. 
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.
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. 
Ukrepi temeljijo na pregledu razpoložljivih znanstvenih dokazov, vključno s študijami uporabe zdravil ter kliničnih in laboratorijskih podatkov o učinkih zdravila.
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. 
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.
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. 
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.
The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant. 
Program je zasnovan za zagotavljanje celovite seznanjenosti bolnic s tveganji in potrebo po izogibanju nosečnosti.
• 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. 
• 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.
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. 
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.
The new measures endorsed by CMDh therefore strengthen previous restrictions on valproate use and requirements to inform women of the risk. 
Novi ukrepi, ki jih je sprejela skupina CMDh, torej zaostrujejo prejšnje omejitve glede uporabe valproata in zahteve za obveščanje žensk o tveganju.
− pregnancy tests before starting and during treatment as needed, 
nosečnostni testi pred začetkom zdravljenja, med njim in po zdravljenju,
Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland. 
Zdravila, ki vsebujejo valproat, so bila odobrena po nacionalnih postopkih v vseh državah članicah EU ter na Norveškem in na Islandiji.
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. 
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.
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. 
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.
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. 
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.
The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide. 
Učinkovina v teh zdravilih je lahko valprojska kislina, magnezijev valproat, natrijev valproat, valproat seminatrij ali valpromid.
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. 
Ker je bilo stališče skupine CMDh izglasovano z večino, je bilo predloženo Evropski komisiji, ki je izdala pravno zavezujoči sklep, veljaven po vsej EU.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway. 
Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn ter Norveško.
− an assessment of each patient's potential for becoming pregnant, 
ocena možnosti vsake ženske za zanositev,
• 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. 
• 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.
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. 
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.
• 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. 
• 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.
• As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty. 
• 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.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
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. 
Poleg tega bo na ovojnino pritrjena opozorilna kartica, tako da jo bodo lahko farmacevti pri izdaji zdravila pregledali skupaj z bolnico.
• Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine. 
• Zdravila, ki vsebujejo valproat, so v Evropski uniji že vrsto let na voljo za zdravljenje epilepsije, bipolarne motnje in v nekaterih državah migrene.
• 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. 
• 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.
The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. 
Skupina CMDh je organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in
Valproate medicines are used to treat epilepsy and bipolar disorder. 
Zdravila, ki vsebujejo valproat, se uporabljajo za zdravljenje epilepsije in bipolarne motnje.
The CMDh1 has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems. 
Odbor CMDh1 je 21. marca 2018 sprejel nove ukrepe za preprečevanje izpostavljenosti ploda valproatu v maternici, ker izpostavljene otroke ogrožata veliko tveganje za malformacije in razvojne težave.
Companies marketing these medicines are also required to carry out additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies. 
Družbe, ki tržijo ta zdravila, morajo izvesti tudi dodatne študije o naravi in obsegu tveganj ter spremljati uporabo valproata in dolgotrajne učinke na zadevne nosečnosti.
The companies that market valproate must carry out further studies to characterise the nature and extent of the risks posed by valproate and monitor ongoing valproate use and the long-term effects from affected pregnancies. 
Družbe, ki tržijo valproat, morajo izvesti nadaljnje študije za opredelitev narave in obsega tveganja, ki ga predstavlja valproat, ter spremljanje njegove trenutne uporabe in dolgoročnih učinkov pri zadevnih nosečnostih.
Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine. 
Zdravila, ki vsebujejo valproat, so bila v EU odobrena po nacionalnih postopkih za zdravljenje epilepsije in bipolarne motnje, v nekaterih državah pa tudi za preprečevanje migrene.
Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU. 
Ker je skupina svoje stališče sprejela z večino glasov, so ga poslali Evropski komisiji, ki je 31. maja 2018 izdala končni pravno zavezujoči sklep, ki velja po vsej EU.
− introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood. 
uvedba novega obrazca za potrditev seznanjenosti s tveganji za bolnice in zdravnike, ki zdravila predpisujejo, da ga preberejo in potrdijo, da so prejeli/dali potrebne nasvete in da so jih bolnice razumele.
Watch for at least 10 seconds. 
Opazujte jo vsaj 10 sekund.
The experience in children is limited. 
Izkušnje pri otrocih so omejene.
These symptoms generally develop in a rapid fashion. 
Ti simptomi se na splošno pojavijo hitro.
The relevance of these findings for humans is not known. 
Pomen teh ugotovitev za ljudi ni znan.
There is no evidence that such an interaction would be harmful. 
Ni dokazov, da bi bilo takšno medsebojno delovanje škodljivo.
• alcohol wipes or similar. 
• alkoholne krpice ali podobno.
Date of first authorisation: 22 August 2002 Date of latest renewal: 16 July 2007 
Datum prve odobritve: 22. avgust 2002 Datum zadnjega podaljšanja: 16. julij 2007
It is important to tell your doctor if you: 
Pomembno je, da poveste zdravniku, če:
Equipment that you need 
Oprema, ki jo boste potrebovali
This is ok. 
To je v redu.
If the dose is complete, go to the next step. 
Če je dajanje odmerka dokončano, pojdite na naslednji korak.
For safety reasons: 
Zaradi varnosti:
Pull straight as shown in pictures 1 and 2. 
Potegnite ga naravnost dol, kot prikazujeta sliki 1 in 2.
If there are particles in it, you must not use it. 
Če so v njej delci, je ne smete uporabiti.
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
The patient alert card shall contain the following key messages: 
Opozorilna kartica za bolnika bo vsebovala naslednja ključna sporočila:
• think you may be pregnant; or 
• mislite, da bi lahko bili noseči; ali
• You may hear a series of clicks. 
• Morda boste slišali zaporedje klikov.
Consider wearing loose clothing and take care when changing clothes. 
Nosite ohlapna oblačila in pazite, ko se preoblačite.
• Any part appears cracked or broken. 
• se kateri koli del zdi počen ali zlomljen.
As with all therapeutic proteins, there is a potential for immunogenicity. 
Kot pri vseh terapevtskih beljakovinah obstaja možnost imunogenosti.
45 minutes 
45 minut
Not working correctly 
Ne deluje pravilno
• are pregnant; 
• ste noseči;
27 hours 
27 ur
0% (empty) 
0 % (prazno)
See also section 4.8. 
Glejte tudi poglavje 4.8.
You should talk to your doctor about your risks of developing cancers of the blood. 
S svojim zdravnikom se posvetujte o tveganjih za nastanek krvnega raka.
Your doctor will tell you what you can take to ease the bone pain. 
Zdravnik vam bo povedal, kaj lahko vzamete za lajšanje bolečin v kosteh.
Puerto Rico 00777-4060 USA 
Puerto Rico 00777-4060 ZDA
Wash your hands thoroughly. 
Temeljito si umijte roke.
• some changes may occur in your blood, but these will be detected by routine blood tests. 
• pojavijo se lahko nekatere spremembe v krvi, vendar jih zaznamo z rutinskimi krvnimi preiskavami.