FrancophonIA/ELRC3.0 huggingface dataset:
English: Testosterone-containing medicines work by replacing the missing testosterone, helping to restore normal testosterone levels to ensure normal sexual development and function in men.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: References.
Slovenian: Referenčna literatura
English: Medicines containing testosterone are licensed in the EU to treat men with abnormally low levels of the hormone (hypogonadism).
Slovenian: Zdravila, ki vsebujejo testosteron, so v EU odobrena za zdravljenje moških z nenormalno nizkimi ravnmi hormona (hipogonadizmom).
English: 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.
Slovenian: Raven testosterona s starostjo naravno nekoliko upada, vendar ponovna vzpostavitev teh ravni pri zdravih starejših moških ni odobrena uporaba zdravila v EU.
English: 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
Slovenian: Pojavili so se zlasti pomisleki glede morebitnega povečanega tveganja kardiovaskularnih dogodkov, predvsem miokardnega infarkta, pri moških s srčno boleznijo, zdravljenih s testosteronom.1-3
English: • There is not much information on the use of testosterone medicines in men over 65 years of age.
Slovenian: • Informacije o uporabi zdravil, ki vsebujejo testosteron, pri moških, starejših od 65 let, so skope.
English: Testosterone-containing medicines are used to replace testosterone in men with hypogonadism.
Slovenian: Zdravila, ki vsebujejo testosteron, se uporabljajo za nadomeščanje testosterona pri moških s hipogonadizmom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Raven testosterona z leti naravno upada in zdravila, ki vsebujejo testosteron, v EU niso odobrena za zviševanje ravni testosterona pri zdravih starejših moških.
English: The use of testosterone in healthy older men is not an authorised use in the EU.
Slovenian: Uporaba testosterona pri starejših zdravih moških v EU ni odobrena.
English: Information to healthcare professionals Testosterone-containing medicines are licensed in the EU for the treatment of male hypogonadism.
Slovenian: Informacije za zdravstvene delavce Zdravila, ki vsebujejo testosteron, so v EU odobrena za zdravljenje hipogonadizma pri moških.
English: 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.
Slovenian: 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.
English: Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
Slovenian: Hildreth KL, Barry DW, Moreau KL, et al. Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels.
English: Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.
Slovenian: Finkle WD, Greenland S, Ridgeway GK, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.
English: Ecansya tablets should be swallowed with water within the 30 minutes after a meal.
Slovenian: Tablete zdravila Ecansya je treba pogoltniti z vodo v 30 minutah po obroku.
English: The name of the medicine was changed to Ecansya on 16 November 2012.
Slovenian: Ime zdravila je bilo 16. novembra 2012 spremenjeno v Ecansya.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Krka on 20 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Capecitabine Krka, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
English: The full EPAR for Ecansya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: What are the benefits and risks of Ecansya?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ecansya?
English: This is a summary of the European public assessment report (EPAR) for Ecansya.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ecansya.
English: Ecansya capecitabine
Slovenian: Ecansya kapecitabin
English: 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.
Slovenian: 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.
English: For more information about treatment with Ecansya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: Ecansya is a ‘generic' and a ‘hybrid' medicine.
Slovenian: Ecansya je „generično“ in „hibridno“ zdravilo.
English: 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.
Slovenian: 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.
English: Other information about Ecansya
Slovenian: Druge informacije o zdravilu Ecansya
English: 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.
Slovenian: Kapecitabin je „predzdravilo“, ki se v telesu pretvori v 5-fluorouracil (5-FU), in sicer več v tumorskih celicah kot v normalnem tkivu.
English: Because Ecansya is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Ecansya generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Ecansya has been shown to have comparable quality and to be bioequivalent to Xeloda.
Slovenian: 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.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Slovenian: Jemlje se v obliki tablet, medtem ko je treba 5-fluorouracil navadno injicirati.
English: The Committee recommended that Ecansya be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Ecansya odobri dovoljenje za promet.
English: Ecansya should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Slovenian: Zdravilo Ecansya sme predpisati samo zdravnik, ki je usposobljen za uporabo zdravil proti raku.
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Slovenian: 5fluorouracil v telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri tvorjenju nove DNK.
English: 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.
Slovenian: 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.
English: Ecansya is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Slovenian: Zdravilo Ecansya se uporablja z drugimi zdravili proti raku, vključno z zdravilom proti raku, ki vsebuje platino, kot na primer cisplatin;
English: Why has Ecansya been approved?
Slovenian: Zakaj je bilo zdravilo Ecansya odobreno?
English: Ecansya is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Slovenian: Zdravilo Ecansya se uporablja z docetakselom (drugim zdravilom proti raku), potem ko zdravljenje z antraciklini (drugo vrsto zdravila proti raku) ni bilo uspešno.
English: Ecansya is a medicine that contains the active substance capecitabine.
Slovenian: Ecansya je zdravilo, ki vsebuje zdravilno učinkovino kapecitabin.
English: Ecansya is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Slovenian: Zdravilo Ecansya se uporablja z drugimi zdravili proti raku ali samostojno pri bolnikih po operaciji raka kolona stadija III ali stadija Dukes C;
English: 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'.
Slovenian: Zdravilna učinkovina zdravila Ecansya, kapecitabin, je citotoksik (zdravilo, ki uniči celice v fazi delitve, kot na primer rakave celice) iz skupine antimetabolitov.
English: Ecansya is an anticancer medicine.
Slovenian: Zdravilo Ecansya je zdravilo proti raku.
English: Previously known as Capecitabine Krka.
Slovenian: Prej znano kot zdravilo Capecitabine Krka.
English: Ecansya is used with or without other anticancer medicines;
Slovenian: Zdravilo Ecansya se uporablja z drugimi zdravili proti raku ali samostojno;
English: What is Ecansya used for?
Slovenian: Za kaj se zdravilo Ecansya uporablja?
English: How does Ecansya work?
Slovenian: Kako zdravilo Ecansya deluje?
English: What is Ecansya?
Slovenian: Kaj je zdravilo Ecansya?
English: How has Ecansya been studied?
Slovenian: Kako je bilo zdravilo Ecansya raziskano?
English: How is Ecansya used?
Slovenian: Kako se zdravilo Ecansya uporablja?
English: It is used in the following types of cancer:
Slovenian: Uporablja se pri naslednjih vrstah raka:
English: 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.)
Slovenian: Zdravilo Docetaxel Teva se uporablja le, kadar je število nevtrofilcev (vrste belih krvnih celic) normalno (vsaj 1 500 celic/mm3).
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Slovenian: Z ohranjanjem celovitosti njihovega skeleta se celice ne morejo deliti in sčasoma odmrejo.
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Slovenian: Docetaksel zavira fazo delitve celic, v kateri se notranji „skelet“ celice razgradi, da ji omogoči deljenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva on 26 January 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Teva, veljavno po vsej Evropski uniji, odobrila dne 26. januarja 2010.
English: For more information about treatment with Docetaxel Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: This means that Docetaxel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Teva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Teva.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Slovenian: • lokalno napredovalem raku glave in vratu pri bolnikih (rak je zrastel, vendar se ni razširil).
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Slovenian: • raku prostate, kadar se rak ne odziva na hormonsko zdravljenje.
English: Docetaxel Teva is given as a one-hour infusion every three weeks.
Slovenian: Zdravilo Docetaxel Teva se daje v obliki enourne infuzije vsake tri tedne.
English: Because Docetaxel Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.
Slovenian: Ker je zdravilo Docetaxel Teva generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: 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.
Slovenian: 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.
English: In addition, the company presented studies to show that the Docetaxel Teva solution for infusion has comparable quality to that of Taxotere.
Slovenian: Poleg tega je družba predstavila študije, s katerimi je dokazala, da ima raztopina za infundiranje zdravila Docetaxel Teva primerljivo kakovost kot zdravilo Taxotere.
English: 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.
Slovenian: 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.
English: The full EPAR for Docetaxel Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Docetaxel Teva has been shown to have comparable quality to Taxotere.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Teva primerljivo z zdravilom Taxotere.
English: • non-small cell lung cancer.
Slovenian: • nedrobnoceličnem pljučnem raku.
English: Docetaxel Teva docetaxel
Slovenian: Docetaxel Teva docetaksel
English: Other information about Docetaxel Teva
Slovenian: Druge informacije o zdravilu Docetaxel Teva
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil.
Slovenian: Zdravilo Docetaxel Teva se uporablja s cisplatinom in 5-fluoroacilom.
English: What benefit and risk of Docetaxel Teva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Teva?
English: Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva infusion.
Slovenian: Bolniku je treba dati tudi deksametazon (protivnetno zdravilo), in sicer dan pred infuzijo zdravila Docetaxel Teva.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Slovenian: • adenokarcinomu želodca (vrste želodčnega raka) pri bolnikih, ki se zaradi raka še niso zdravili.
English: Because Docetaxel Teva is a generic medicine, the company has provided data from the published literature on docetaxel.
Slovenian: Ker je zdravilo Docetaxel Teva generično zdravilo, je družba predložila podatke iz objavljene literature o učinkovini docetaksel.
English: The Committee recommended that Docetaxel Teva be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Docetaxel Teva izda dovoljenje za promet.
English: • breast cancer.
Slovenian: • raku dojke.
English: Docetaxel Teva is a ‘generic medicine'.
Slovenian: Zdravilo Docetaxel Teva je „generično zdravilo“.
English: Docetaxel Teva can be used on its own after other treatments have failed.
Slovenian: Zdravilo Docetaxel Teva se lahko uporablja kot monoterapija po neuspešnih drugih oblikah zdravljenja.
English: The active substance in Docetaxel Teva, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Slovenian: Zdravilna učinkovina zdravila Docetaxel Teva, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
English: Docetaxel Teva is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Slovenian: Zdravilo Docetaxel Teva se uporablja s cisplatinom in 5-fluoroacilom (drugima zdraviloma proti raku);
English: Why has Docetaxel Teva been approved?
Slovenian: Zakaj je bilo zdravilo Docetaxel Teva odobreno?
English: Docetaxel Teva is a concentrate and solvent to be made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Docetaxel Teva je koncentrat in vehikel za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Docetaxel Teva is used with prednisone or prednisolone (anti-inflammatory medicines);
Slovenian: Zdravilo Docetaxel Teva se uporablja s prednizonom ali prednizolonom (protivnetnima zdraviloma);
English: Docetaxel Teva is an anticancer medicine.
Slovenian: Zdravilo Docetaxel Teva je zdravilo proti raku.
English: What is Docetaxel Teva?
Slovenian: Kaj je zdravilo Docetaxel Teva?
English: No additional studies were needed as Docetaxel Teva is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Slovenian: Zdravilo Docetaxel Teva se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Taxotere, zato niso bile potrebne nobene dodatne študije.
English: How has Docetaxel Teva been studied?
Slovenian: Kako je bilo zdravilo Docetaxel Teva raziskano?
English: What is Docetaxel Teva used for?
Slovenian: Za kaj se zdravilo Docetaxel Teva uporablja?
English: How is Docetaxel Teva used?
Slovenian: Kako se zdravilo Docetaxel Teva uporablja?
English: How does Docetaxel Teva work?
Slovenian: Kako zdravilo Docetaxel Teva deluje?
English: It contains the active substance docetaxel.
Slovenian: Vsebuje zdravilno učinkovino docetaksel.
English: • If you are over 65.
Slovenian: • Če ste starejši od 65 let.
English: Black/African American Asian
Slovenian: Črnci/afriški Američani Azijci
English: Date of first authorisation: 24 May 2013 Date of latest renewal: 19 April 2018
Slovenian: Datum prve odobritve: 24. maj 2013 Datum zadnjega podaljšanja: 19. april 2018
English: 3 These are drugs within class where similar interactions could be predicted.
Slovenian: 3 To so zdravila znotraj razreda, kjer je mogoče predvideti podobne interakcije.
English: No antagonism was observed for any of these combinations.
Slovenian: Antagonizma niso opazili za nobeno od teh kombinacij.
English: • other allergic reactions
Slovenian: • druge alergijske reakcije
English: b Week 144 window is between Day 967 and 1,050 (inclusive).
Slovenian: b Okno v 144. tednu je med 967 in 1.050 dnevom (vključno z njima).
English: ATC code: J05AR09
Slovenian: Oznaka ATC: J05AR09
English: Stribild reduces the amount of HIV in your body.
Slovenian: Zdravilo Stribild zmanjša količino virusa HIV v vašem telesu.
English: 1 When data available from drug interaction studies.
Slovenian: 1 Ko so razpoložljivi podatki iz študij medsebojnega delovanja zdravil.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>.
English: • Tell your doctor immediately if you become pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: • Zdravnika takoj obvestite, če zanosite, menite, da bi lahko bili noseči, ali načrtujete zanositev.
English: Stopping Stribild can seriously affect your response to future treatment.
Slovenian: Prenehanje jemanja zdravila Stribild lahko resno vpliva na vaš odziv na prihodnje zdravljenje.
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Slovenian: Poleg tega reverzibilnosti ledvične toksičnosti ni možno v celoti potrditi.
English: Mean age, years (range)
Slovenian: Povprečna starost, leta (razpon)
English: INR should continue to be monitored during the first weeks following ceasing treatment with Stribild.
Slovenian: INR je treba še naprej spremljati prve tedne po prenehanju zdravljenja z zdravilom Stribild.
English: These are mentioned above under the heading “Do not take Stribild - If you are taking one of these medicines”.
Slovenian: Ta zdravila so navedena v poglavju »Ne jemljite zdravila Stribild - Če jemljete katero od naslednjih zdravil«.