natgillin/translations-raw huggingface dataset:
The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them. 
Odbor PRAC je te študije obravnaval skupaj z razpoložljivimi podatki iz drugih študij in analiz ter informacijami o varnosti, zbranimi v obdobju trženja zdravil, in ugotovil, da so dokazi glede tveganja težav s srcem neskladni: nekatere študije so nakazovale povečano tveganje, nekatere ne, v nekaterih študijah pa so težave z zasnovo omejile veljavnost sklepov, ki bi jih lahko izpeljali iz njih.
The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review (to which these medicines, like all medicines in the EU, are subject). 
Odbor PRAC je nadalje menil, da bi morali še naprej spremljati tveganja učinkov na srce in krvni obtok in vsakršne morebitne mehanizme za nastanek takšnih učinkov ter da bi morali v okviru naslednjega rednega pregleda varnosti (ki se tako kot za vsa zdravila v EU izvaja za zadevna zdravila) zagotoviti informacije iz študij, ki še potekajo.
• Caution is also advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure. 
• Previdnost je potrebna tudi pri bolnikih z obstoječo hipertenzijo, ker lahko testosteron povzroči povišanje krvnega tlaka.
Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive. 
Ob upoštevanju vseh podatkov so dokazi glede povečanega kardiovaskularnega tveganja, povezanega z uporabo testosterona, še vedno šibki in neprepričljivi.
Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men. 
Testosteron je hormon, znan kot androgeni hormon, odgovoren za razvoj in vzdrževanje reproduktivne funkcije in spolnih značilnosti pri moških.
As the CMDh position was adopted by consensus, it will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised. 
Ker je bilo stališče skupine CMDh sprejeto soglasno, bo zdaj uveljavljeno neposredno v skladu s sprejetim časovnim razporedom v državah članicah, v katerih so bila zdravila odobrena.
• Some recent studies have suggested that using testosterone may increase a man's risk of heart attacks or other serious effects on the heart and circulation. 
• Rezultati nekaterih nedavnih študij so nakazali, da lahko uporaba testosterona pri bolniku poveča tveganje srčnih napadov ali drugih resnih učinkov na srce in krvni obtok.
Testosterone levels should then be monitored regularly during treatment. 
Med zdravljenjem je nato treba redno spremljati ravni testosterona.
• However, other findings4-7 do not provide evidence of an association between testosterone and cardiovascular events, and data from a multinational observational registry study (RHYME) looking at prostate health outcomes in men treated with testosterone for over 2 years also indicate cardiovascular events within the anticipated range. 
• Vendar pa druge ugotovitve4-7 ne dokazujejo povezave med testosteronom in kardiovaskularnimi dogodki, podatki iz večnacionalne opazovalne registrske študije (RHYME), ki je preučevala izide glede zdravja prostate pri moških, ki so se več kot dve leti zdravili s testosteronom, pa kažejo, da so bili kardiovaskularni dogodki v pričakovanem razponu.
• The product information will also be amended to make it clear that these medicines should only be given to men in whom both signs and symptoms and laboratory tests confirm abnormally low levels of testosterone. 
• Spremenjene bodo tudi informacije o zdravilu, da bi bilo iz njih jasno razvidno, da se ta zdravila lahko dajejo le moškim, pri katerih tako simptomi in znaki kot laboratorijske preiskave potrjujejo nenormalno nizke ravni testosterona.
The changes to the product information for testosterone medicines are based on a PRAC review of data available from clinical trials, observational studies, meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy. 
Spremembe informacij o zdravilu za zdravila, ki vsebujejo testosteron, temeljijo na pregledu razpoložljivih podatkov iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatkov iz obdobja trženja in dodatnih objavljenih podatkov o kardiovaskularnem tveganju, povezanem z zdravljenjem s testosteronom, ki ga je opravil odbor PRAC.
• Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently. 
• Čeprav nekatere študije kažejo povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom, ugotovitve v literaturi tega ne kažejo dosledno.
• The cardiovascular safety of testosterone medicines will continue to be monitored and the findings of ongoing studies will be reflected in the next regular benefit-risk assessments when available. 
• Kardiovaskularna varnost zdravil, ki vsebujejo testosteron, se bo še naprej spremljala, ugotovitve študij, ki še potekajo, pa bodo, ko bodo na voljo, zajete z naslednjo redno oceno razmerja med tveganji in koristmi.
The CMDh1, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism). 
Skupina CMDh1, regulativni organ, ki predstavlja države članice EU, je soglasno sklenila, da dokazi o povečanem tveganju težav s srcem pri moških, ki jim primanjkuje testosterona (bolezen znana kot hipogonadizem), zdravljenih z zdravili, ki vsebujejo testosteron, niso zanesljivi.
The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it. 
Pregled je bil sprožen, ker so nekatere nedavne študije pokazale povečanje težav s srcem pri moških, ki so jemali testosteron, v primerjavi z moškimi, ki ga niso jemali.
However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines. 
Informacije o zdravilu je treba posodobiti v skladu z najnovejšimi dostopnimi dokazi o varnosti, skupaj z opozorilom, da mora biti pomanjkanje testosterona potrjeno z znaki in simptomi ter laboratorijskimi preiskavami, preden se pri moških uvede zdravljenje s temi zdravili.
In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function. 
Pri moških s hipogonadizmom so ravni testosterona nenormalno nizke, kar vpliva na normalen spolni razvoj in funkcijo.
• Some recent studies have shown an increased risk of cardiovascular events in men treated with testosterone. 
• Nekatere nedavne študije so pokazale povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom.
The CMDh position follows a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines. 
Mnenje skupine CMDh je bilo oblikovano na podlagi pregleda, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in ki je obravnaval tveganje resnih težav s srcem in krvnim obtokom, zlasti srčnih napadov, pri moških, zdravljenih s tovrstnimi zdravili.
The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems. 
Odbor PRAC je predlagal posodobitev informacij o zdravilu v skladu z najnovejšimi dokazi in posredovanje opozoril o bolnikih, ki bi lahko bili izpostavljeni povečanemu tveganju težav s srcem.
The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems. 
Odbor PRAC je prav tako izpostavil, da bi tveganje težav s srcem lahko povečalo sámo pomanjkanje testosterona.
• Testosterone is a hormone responsible for normal sexual development and function in men. 
• Testosteron je hormon, odgovoren za normalen spolni razvoj in spolno funkcijo pri moških.
Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men. 
Zdravila, ki vsebujejo testosteron, delujejo tako, da nadomeščajo manjkajoči testosteron in pomagajo ponovno vzpostaviti normalne ravni testosterona, da bi zagotovili normalen spolni razvoj in funkcijo pri moških.
The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests. 
V informacije o zdravilu bi morali jasno zapisati, da se testosteron lahko uporablja le, kadar so bile nenormalno nizke ravni hormona potrjene z znaki in simptomi ter ustreznimi laboratorijskimi preiskavami.
• Patients who are prescribed testosterone should remind their doctors if they are being treated for high blood pressure, as testosterone can also increase blood pressure. 
• Bolniki, ki jim je predpisan testosteron, bi morali, če se zdravijo zaradi visokega krvnega tlaka, na to opozoriti svojega zdravnika, saj lahko testosteron krvni tlak poviša.
The CMDh has endorsed the PRAC recommendations by consensus and they will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised. 
Skupina CMDh je soglasno podprla priporočila odbora PRAC, ki bodo zdaj neposredno uveljavljena v skladu s sprejetim časovnim razporedom v državah članicah, v katerih so bila zdravila odobrena.
References. 
Referenčna literatura
Medicines containing testosterone are licensed in the EU to treat men with abnormally low levels of the hormone (hypogonadism). 
Zdravila, ki vsebujejo testosteron, so v EU odobrena za zdravljenje moških z nenormalno nizkimi ravnmi hormona (hipogonadizmom).
Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorised use of the medicine in the EU. 
Raven testosterona s starostjo naravno nekoliko upada, vendar ponovna vzpostavitev teh ravni pri zdravih starejših moških ni odobrena uporaba zdravila v EU.
In particular, concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease.1-3 
Pojavili so se zlasti pomisleki glede morebitnega povečanega tveganja kardiovaskularnih dogodkov, predvsem miokardnega infarkta, pri moških s srčno boleznijo, zdravljenih s testosteronom.1-3
• There is not much information on the use of testosterone medicines in men over 65 years of age. 
• Informacije o uporabi zdravil, ki vsebujejo testosteron, pri moških, starejših od 65 let, so skope.
Testosterone-containing medicines are used to replace testosterone in men with hypogonadism. 
Zdravila, ki vsebujejo testosteron, se uporabljajo za nadomeščanje testosterona pri moških s hipogonadizmom.
It should be borne in mind that physiological testosterone levels decrease somewhat with age, though there is no current consensus on appropriate age-specific testosterone reference values, and use to boost these levels in healthy older men is not an authorised use in the EU. 
Treba je upoštevati, da fiziološke ravni testosterona v krvi z leti nekoliko upadajo, pri čemer pa ni veljavnega soglasja o referenčnih vrednostih za ustrezne letom primerne ravni testosterona, in da uporaba zdravil, ki vsebujejo testosteron, za zviševanje teh ravni pri zdravih starejših moških v EU ni odobrena.
The level of testosterone falls naturally with age and testosterone-containing medicines are not approved in the EU for use to boost testosterone levels in healthy older men. 
Raven testosterona z leti naravno upada in zdravila, ki vsebujejo testosteron, v EU niso odobrena za zviševanje ravni testosterona pri zdravih starejših moških.
The use of testosterone in healthy older men is not an authorised use in the EU. 
Uporaba testosterona pri starejših zdravih moških v EU ni odobrena.
Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism. 
Informacije za zdravstvene delavce Zdravila, ki vsebujejo testosteron, so v EU odobrena za zdravljenje hipogonadizma pri moških.
The benefit-risk balance of these medicines has been reviewed following recent published evidence pointing to an increased risk of cardiovascular events, particularly myocardial infarction, in men treated with testosterone. 
Po nedavno objavljenih dokazih, ki so kazali povečano tveganje kardiovaskularnih dogodkov, zlasti miokardnega infarkta, pri moških, zdravljenih s testosteronom, je bilo pregledano razmerje med koristmi in tveganji teh zdravil.
Ecansya tablets should be swallowed with water within the 30 minutes after a meal. 
Tablete zdravila Ecansya je treba pogoltniti z vodo v 30 minutah po obroku.
The name of the medicine was changed to Ecansya on 16 November 2012. 
Ime zdravila je bilo 16. novembra 2012 spremenjeno v Ecansya.
The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Krka on 20 April 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Capecitabine Krka, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
The full EPAR for Ecansya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ecansya je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Ecansya is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight). 
Jemlje se dvakrat na dan v odmerkih med 625 in 1 250 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove višine in telesne mase).
What are the benefits and risks of Ecansya? 
Kakšne so koristi in tveganja, povezani z zdravilom Ecansya?
This is a summary of the European public assessment report (EPAR) for Ecansya. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ecansya.
This means that it is similar to a ‘reference medicine', but it contains capecitabine at a new strength in addition to existing strengths: while the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Ecansya is also available as 300 mg tablets. 
To pomeni, da je podobno „referenčnemu zdravilu“, vendar je kapecitabin poleg že obstoječih jakosti na voljo tudi v novih jakostih: medtem ko je referenčno zdravilo Xeloda je na voljo v obliki 150- in 500-miligramskih tablet, je zdravilo Ecansya je na voljo tudi v obliki 300-miligramskih tablet.
For more information about treatment with Ecansya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ecansya preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Ecansya is a ‘generic' and a ‘hybrid' medicine. 
Ecansya je „generično“ in „hibridno“ zdravilo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ecansya. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ecansya, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Ecansya 
Druge informacije o zdravilu Ecansya
Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues. 
Kapecitabin je „predzdravilo“, ki se v telesu pretvori v 5-fluorouracil (5-FU), in sicer več v tumorskih celicah kot v normalnem tkivu.
Because Ecansya is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Ecansya generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The CHMP concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ecansya primerljivo raven kakovosti kot zdravilo Xeloda ter da mu je biološko enakovredno.
It is taken as tablets, while 5-FU normally needs to be injected. 
Jemlje se v obliki tablet, medtem ko je treba 5-fluorouracil navadno injicirati.
The Committee recommended that Ecansya be given marketing authorisation. 
Priporočil je, da se za zdravilo Ecansya odobri dovoljenje za promet.
Ecansya should only be prescribed by a doctor who is qualified in the use of anticancer medicines. 
Zdravilo Ecansya sme predpisati samo zdravnik, ki je usposobljen za uporabo zdravil proti raku.
In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA. 
5fluorouracil v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri tvorjenju nove DNK.
The company carried out a ‘bioequivalence' study to show that 500 mg Ecansya produces the same levels of capecitabine in the blood as 500 mg of the reference medicine. 
Izvedla je študije biološke enakovrednosti, s katerimi je dokazala, da 500-miligramski odmerek zdravila Ecansya dosega enake ravni kapecitabina v krvi kot 500-miligramski odmerek referenčnega zdravila.
Ecansya is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin; 
Zdravilo Ecansya se uporablja z drugimi zdravili proti raku, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin;
Why has Ecansya been approved? 
Zakaj je bilo zdravilo Ecansya odobreno?
Ecansya is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed. 
Zdravilo Ecansya se uporablja z docetakselom (drugim zdravilom proti raku), potem ko zdravljenje z antraciklini (drugo vrsto zdravila proti raku) ni bilo uspešno.
Ecansya is a medicine that contains the active substance capecitabine. 
Ecansya je zdravilo, ki vsebuje zdravilno učinkovino kapecitabin.
Ecansya is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer; 
Zdravilo Ecansya se uporablja z drugimi zdravili proti raku ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
The active substance in Ecansya, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'. 
Zdravilna učinkovina zdravila Ecansya, kapecitabin, je citotoksik (zdravilo, ki uniči celice v fazi delitve, kot na primer rakave celice) iz skupine antimetabolitov.
Ecansya is an anticancer medicine. 
Zdravilo Ecansya je zdravilo proti raku.
Previously known as Capecitabine Krka. 
Prej znano kot zdravilo Capecitabine Krka.
Ecansya is used with or without other anticancer medicines; 
Zdravilo Ecansya se uporablja z drugimi zdravili proti raku ali samostojno;
What is Ecansya used for? 
Za kaj se zdravilo Ecansya uporablja?
How does Ecansya work? 
Kako zdravilo Ecansya deluje?
What is Ecansya? 
Kaj je zdravilo Ecansya?
How has Ecansya been studied? 
Kako je bilo zdravilo Ecansya raziskano?
How is Ecansya used? 
Kako se zdravilo Ecansya uporablja?
It is used in the following types of cancer: 
Uporablja se pri naslednjih vrstah raka:
Docetaxel Teva is only used when the neutrophil count (the level of a type of white blood cell) is normal (at least 1,500 cells/mm3.) 
Zdravilo Docetaxel Teva se uporablja le, kadar je število nevtrofilcev (vrste belih krvnih celic) normalno (vsaj 1 500 celic/mm3).
By keeping the skeleton intact the cells cannot divide and they eventually die. 
Z ohranjanjem celovitosti njihovega skeleta se celice ne morejo deliti in sčasoma odmrejo.
Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide. 
Docetaksel zavira fazo delitve celic, v kateri se notranji „skelet“ celice razgradi, da ji omogoči deljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010. 
Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Teva, veljavno po vsej Evropski uniji, odobrila dne 26. januarja 2010.
For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Docetaxel Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
This is a summary of the European public assessment report (EPAR) for Docetaxel Teva. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Teva.
• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). 
• lokalno napredovalem raku glave in vratu pri bolnikih (rak je zrastel, vendar se ni razširil).
• prostate cancer, when the cancer does not respond to hormonal treatment. 
• raku prostate, kadar se rak ne odziva na hormonsko zdravljenje.
Docetaxel Teva is given as a one-hour infusion every three weeks. 
Zdravilo Docetaxel Teva se daje v obliki enourne infuzije vsake tri tedne.
Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine. 
Ker je zdravilo Docetaxel Teva generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Docetaxel Teva should be used in wards specialised in chemotherapy (medicines to treat cancer) and it should only be given under the supervision of a doctor who is qualified in the use of cancer chemotherapy. 
Zdravilo Docetaxel Teva je treba uporabljati na specializiranih oddelkih za kemoterapijo (zdravila za zdravljenje raka) in se sme dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije proti raku.
In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere. 
Poleg tega je družba predstavila študije, s katerimi je dokazala, da ima raztopina za infundiranje zdravila Docetaxel Teva primerljivo kakovost kot zdravilo Taxotere.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Teva. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.