FrancophonIA/ELRC3.0 huggingface dataset:
English: The patient's blood sugar should be tested regularly to find the lowest effective dose.
Slovenian: Za določitev najnižjega učinkovitega odmerka je potrebno redno spremljati bolnikovo raven sladkorja v krvi.
English: Ultratard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Slovenian: Z uporabo zdravila Ultratard se je znižala raven HbA1c, kar kaže na to, da je bila raven sladkorja v krvi omejena na podobno raven kot pri uporabi drugih vrst humanega insulina.
English: Ultratard was effective for both Type 1 and Type 2 diabetes.
Slovenian: Zdravilo Ultratard se je izkazalo kot učinkovito tako za sladkorno bolezen tipa 1 kot tudi tipa 2.
English: Ultratard contains the active ingredient insulin human (rDNA).
Slovenian: Zdravilo Ultratard vsebuje zdravilno učinkovino humani insulin (rDNA).
English: The full EPAR for Ultratard is available here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ultratard je na voljo tukaj.
English: How has Ultratard been studied?
Slovenian: Kako je bilo zdravilo Ultratard raziskano?
English: Ultratard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Ultratard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Slovenian: Zdravilno učinkovino zdravila Ultratard, humani insulin (rDNA), izdelujejo z metodo, znano pod imenom “rekombinantna tehnologija”.
English: For the full description of the side effects reported with Ultratard, please see the Package Leaflet.
Slovenian: Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Ultratard, najdete v Navodilih za uporabo.
English: How does Ultratard work?
Slovenian: Kako zdravilo Ultratard deluje?
English: What is Ultratard used for?
Slovenian: Za kaj se zdravilo Ultratard uporablja ?
English: How is Ultratard used?
Slovenian: Kako se zdravilo Ultratard uporablja?
English: What is Ultratard?
Slovenian: Kaj je zdravilo Ultratard?
English: The European Commission issued a Decision on 22 September 2011.
Slovenian: Evropska komisija je odločbo izdala dne 22. septembra 2011.
English: Why was Canazole reviewed?
Slovenian: Zakaj je bilo zdravilo Canazole pregledano?
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.
Slovenian: Vendar se državi članici nista uspeli dogovoriti in irska regulativna agencija za zdravila je dne 25. novembra 2010 zadevo napotila na CHMP v arbitražo.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Slovenian: Deluje s preprečevanjem nastajanja ergosterola, ki je pomemben del celične stene glivic.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da trenutno razpoložljivi podatki ne zadostujejo za dokaz terapevtske enakovrednosti z referenčnim zdravilom in da je treba pridobiti dodatne informacije.
English: The company which recently marketed this product wanted the authorisation to be recognised in the United Kingdom (the ‘concerned Member State').
Slovenian: Družba, ki je tržila to zdravilo, je želela, da se dovoljenje za promet prizna v Združenem kraljestvu („zadevni državi članici“).
English: What is Canazole?
Slovenian: Kaj je zdravilo Canazole?
English: In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.
Slovenian: Poleg tega je Odbor priporočil tudi, da se dovoljenje za promet z zdravilom Canazole na Irskem začasno umakne, dokler se ne izvedejo dodatne študije.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.
Slovenian: Evropska agencija za zdravila je zaključila arbitražni postopek, uveden zaradi nestrinjanja držav članic Evropske unije (EU) glede pridobitve dovoljenja za promet z zdravilom Canazole.
English: Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000.
Slovenian: Družba Pinewood Laboratories Ltd je za zdravilo Canazole začela postopek z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Irskem dne 8. decembra 2000.
English: The marketing authorisation in Ireland should also be suspended.
Slovenian: Dovoljenje za promet z zdravilom na Irskem je prav tako treba začasno umakniti.
English: Canazole is a generic medicine based on a ‘reference medicine', Canesten, which is authorised in the United Kingdom.
Slovenian: Zdravilo Canazole je generično zdravilo na osnovi „referenčnega zdravila“ Canesten, ki je odobreno v Združenem kraljestvu.
English: Questions and answers on Canazole (clotrimazole cream 1%) EMA/837098/2011
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Canazole (klotrimazol krema 1 %) EMA/206825/2011
English: It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.
Slovenian: Uporablja se za zdravljenje kožnih okužb z glivicami, kot so sor, dermatofitoza ali atletsko stopalo.
English: The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.
Slovenian: Podlaga za napotitev je bilo nestrinjanje Združenega kraljestva s trditvijo, da sta zdravilo Canazole krema in zdravilo Canesten krema dovolj podobna, da bi bila terapevtsko enakovredna.
English: Canazole is a cream that contains the active substance clotrimazole (1%).
Slovenian: Zdravilo Canazole je krema, ki vsebuje zdravilno učinkovino klotrimazol (1 %).
English: The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles.
Slovenian: Zdravilna učinkovina v zdravilu Canazole, klotrimazol, je protiglivično zdravilo, ki spada v skupino triazolov.
English: The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State.
Slovenian: CHMP je zato zaključil, da koristi zdravila Canazole ne odtehtajo z njim povezanih tveganj, in priporočil, da se v zadevni državi članici dovoljenje za promet ne odobri.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Canazole ne odtehtajo z njim povezanih tveganj, zato dovoljenje za promet z zdravilom, odobreno na Irskem, ni mogoče priznati v ostalih državah članicah EU.
English: Without ergosterol, the fungus is killed or prevented from spreading.
Slovenian: Glivica brez ergosterola odmre oziroma se ne razmnožuje več.
English: Questions and answers on Canazole (clotrimazole cream
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Canazole (klotrimazol krema 1 %)
English: Ref.: EMEA/528144/2009 EMEA/H/C/535
Slovenian: : EMEA/528144/2009 EMEA/H/C/535
English: The marketing authorisation was renewed on 13 October 2009.
Slovenian: Dovoljenje za promet je bilo podaljšano 13. oktobra 2009.
English: A reduced dose is used in children.
Slovenian: Pri otrocih se uporablja zmanjšan odmerek.
English: It is available as capsules (blue: 25 mg; orange: 50 mg).
Slovenian: Na voljo je v obliki kapsul (modrih: 25 mg; oranžnih: 50 mg).
English: The usual dose for adults is 50 mg three times a day.
Slovenian: Priporočeni odmerek za odrasle je 50 mg trikrat na dan.
English: This causes a variety of effects, including liver disease and damage to the nervous system.
Slovenian: To povzroča številne učinke, vključno z boleznimi jeter in poškodbami živčevja.
English: This results in copper building up in the body, first in the liver, then in other organs such as the eye and the brain.
Slovenian: Posledično se baker kopiči v telesu, najprej v jetrih, zatem pa tudi v drugih organih, kot so oči in možgani.
English: Wilzin zinc EPAR summary for the public
Slovenian: Wilzin cink Povzetek EPAR za javnost
English: Other information about Wilzin:
Slovenian: Druge informacije o zdravilu Wilzin:
English: The main measure of effectiveness was whether patients had adequate control of copper levels.
Slovenian: Glavno merilo učinkovitosti je bilo, ali je pri bolnikih doseženo ustrezno vzdrževanje ravni bakra.
English: Gastric irritation is usually worst with the first morning dose and disappears after the first few days of treatment.
Slovenian: Draženje želodca je navadno najhujše pri prvem jutranjem odmerku, po prvih nekaj dneh zdravljenja pa izgine.
English: Over time, the amount of copper in the body falls, improving the symptoms of the disease.
Slovenian: Sčasoma se količina bakra v telesu zmanjša, kar izboljša simptome bolezni.
English: Wilzin should be taken on an empty stomach, at least one hour before or two to three hours after meals.
Slovenian: Zdravilo Wilzin je treba jemati na prazen želodec, najmanj eno uro pred obrokom ali dve do tri ure njem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL on 13 October 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Wilzin, veljavno po vsej Evropski uniji, odobrila družbi Orphan Europe SARL dne 13. oktobra 2004.
English: The main study involved 148 patients who were treated with Wilzin, but did not compare Wilzin with any other treatments.
Slovenian: V glavno študijo je bilo vključenih 148 bolnikov, ki so bili zdravljeni z zdravilom Wilzin, v njej pa zdravila Wilzin niso primerjali z nobenim drugim zdravljenjem.
English: This protein attaches to copper and prevents it being transferred into the blood.
Slovenian: Ta beljakovina se veže na baker in preprečuje njegov prenos v kri.
English: Because zinc has been used to treat Wilson's disease for many years, the company presented the results of studies from the published literature.
Slovenian: Ker se cink že dolgo časa uporablja za zdravljenje Wilsonove bolezni, je družba predstavila rezultate študij iz objavljene literature.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Wilzin is available here.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Wilzin je na voljo tukaj.
English: What benefit has Wilzin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Wilzin izkazalo med študijami?
English: In the main study, 91% of the patients evaluated (91 out of 100) had adequate control of their copper levels within the first year of treatment with Wilzin.
Slovenian: V okviru glavne študije je 91 % ovrednotenih bolnikov (91 bolnikov od 100) v prvem letu zdravljenja z zdravilom Wilzin doseglo ustrezno vzdrževanje ravni bakra.
English: Delaying the first dose to mid-morning or taking the dose with a small amount of food containing protein, such as meat, may help.
Slovenian: Preložitev prvega odmerka na sredino dopoldneva ali jemanje odmerka z malo beljakovinske hrane, npr. mesa, navadno olajša simptome.
English: Patients who are switching from a ‘chelating agent' (another type of medicine for Wilson's disease) to Wilzin should continue to take the chelating agent for two to three weeks after starting Wilzin, because Wilzin takes some time to start working fully.
Slovenian: Bolniki, ki z jemanja „kelatorjev“ (druge vrste zdravila za Wilsonovo bolezen) prehajajo na zdravilo Wilzin, morajo kelatorje jemati še dva do tri tedne po začetku jemanja zdravila Wilzin, saj je za pričetek popolnega delovanja zdravila Wilzin potreben določen čas.
English: The Committee for Medicinal products for Human Use (CHMP) noted that Wilson's disease is a fatal disease and the other medicines already being used for the disease can have severe side effects.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je Wilsonova bolezen smrtna in da imajo zdravila, ki so že v uporabi, hude neželene učinke.
English: The most common side effects with Wilzin (seen in between 1 and 10 patients in 100) are gastric irritation (irritation of the stomach) and increased blood levels of enzymes (amylase, lipase and alkaline phosphatase).
Slovenian: Najpogostejši neželeni učinki zdravila Wilzin (opaženi pri 1 do 10 bolnikih izmed 100) so draženje želodca in povišane ravni encimov v krvi (amilaze, lipaze in alkalne fosfataze).
English: In total, data to support the use of Wilzin came from 255 patients with Wilson's disease.
Slovenian: Podatki v podporo uporabi zdravila Wilzin prihajajo skupaj od 255 bolnikov z Wilsonovo boleznijo.
English: Wilzin has been shown to be effective in reducing the absorption of copper and reducing the amount of copper in the body.
Slovenian: Zdravilo Wilzin se je izkazalo kot učinkovito pri zmanjševanju absorpcije bakra in zmanjševanju količine bakra v telesu.
English: Wilzin should not be used in people who may be hypersensitive (allergic) to zinc or any of the other ingredients.
Slovenian: Zdravila Wilzin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) cink ali katero koli drugo sestavino zdravila.
English: Zinc has been used to treat Wilson's disease since 1958.
Slovenian: Cink se za zdravljenje Wilsonove bolezni uporablja od leta 1958 naprej.
English: Wilson's disease is a rare inherited disorder where patients lack an enzyme that is needed to eliminate the copper contained in food from the body.
Slovenian: Wilsonova bolezen je redka prirojena napaka, pri kateri bolniki nimajo encima, potrebnega za izločanje bakra, ki se nahaja v hrani, iz telesa.
English: Because the number of patients with Wilson's disease is low, the disease is considered ‘rare', and Wilzin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 July 2001.
Slovenian: Ker je bolnikov z Wilsonovo boleznijo malo, velja ta bolezen za redko, zato je bilo zdravilo Wilzin dne 31. julija 2001 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: It works by stimulating the body to produce a protein called metallothionein in the cells lining the gut.
Slovenian: Zdravilo spodbudi telo, da začne tvoriti beljakovino, imenovano metalotionein, v celicah, ki obkrožajo črevesje.
English: The Committee recommended that Wilzin be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Wilzin odobri dovoljenje za promet.
English: What is the risk associated with Wilzin?
Slovenian: Kakšna tveganja so povezana z zdravilom Wilzin?
English: Wilzin is a medicine that contains the active substance zinc.
Slovenian: Wilzin je zdravilo, ki vsebuje zdravilno učinkovino cink.
English: Wilzin treatment should be started by a doctor who has experience in the treatment of Wilson's disease.
Slovenian: Zdravljenje z zdravilom Wilzin mora uvesti zdravnik z izkušnjami z zdravljenjem Wilsonove bolezni.
English: Why has Wilzin been approved?
Slovenian: Zakaj je bilo zdravilo Wilzin odobreno?
English: For the full list of all side effects reported with Wilzin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Wilzin, glejte navodilo za uporabo.
English: The active substance in Wilzin is the zinc cation (positively charged zinc), which blocks the absorption of copper from the diet.
Slovenian: Zdravilna učinkovina zdravila Wilzin je cinkov kation (pozitivno nabit cink), ki zavira absorpcijo bakra iz hrane.
English: Therefore, the Committee decided that Wilzin's benefits are greater than its risks for the treatment of Wilson's disease.
Slovenian: Zato je Odbor zaključil, da so koristi zdravila Wilzin za zdravljenje Wilsonove bolezni večje od z njim povezanih tveganj.
English: The copper is then passed out of the body in the stools.
Slovenian: Baker se nato izloči iz telesa z blatom.
English: Wilzin is used to treat Wilson's disease.
Slovenian: Zdravilo Wilzin je namenjeno za zdravljenje Wilsonove bolezni.
English: The maximum dose of Wilzin is 50 mg five times a day.
Slovenian: Najvišji odmerek zdravila Wilzin je 50 mg petkrat na dan. Za več informacij glejte navodilo za uporabo.
English: What is Wilzin used for?
Slovenian: Za kaj se zdravilo Wilzin uporablja?
English: How has Wilzin been studied?
Slovenian: Kako je bilo zdravilo Wilzin raziskano?
English: What is Wilzin?
Slovenian: Kaj je zdravilo Wilzin?
English: How does Wilzin work?
Slovenian: Kako zdravilo Wilzin deluje?
English: The full EPAR for Wilzin can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Wilzin je na voljo tukaj.
English: How is Wilzin used?
Slovenian: Kako se zdravilo Wilzin uporablja?
English: Wilzin is a long-term treatment.
Slovenian: Zdravljenje z zdravilom Wilzin traja vse življenje.
English: - Tell your doctor:
Slovenian: - Povejte zdravniku:
English: Date of first authorisation: 9 January 2012 Date of latest renewal: 9 September 2016
Slovenian: Datum prve odobritve: 9. januar 2012 Datum zadnjega podaljšanja: 9. september 2016
English: This combination should be used with caution.
Slovenian: To kombinacijo je treba uporabljati previdno.
English: The combination was generally well tolerated.
Slovenian: Kombinacijo so na splošno dobro prenašali.
English: (see section 4.3).
Slovenian: (Glejte poglavje 4.4.)
English: Risk to the infant cannot be excluded.
Slovenian: Tveganja za novorojenca ne moremo izključiti.
English: 10000 Zagreb, Croatia
Slovenian: 10000 Zagreb Hrvaška
English: Adults and adolescents over 40 kg
Slovenian: Odrasli in mladostniki težji od 40 kg
English: - If any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Slovenian: - če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen z okvaro na srcu.
English: Keep the medicine container with you so that you can easily describe what you have taken.
Slovenian: S seboj imejte embalažo zdravila, da boste zlahka opisali, kaj ste zaužili.
English: - It is recommended that the tablet be swallowed whole with water.
Slovenian: - Priporočamo, da tableto pogoltnete celo, z vodo.
English: Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Slovenian: Nekateri bolniki imajo hujše simptome, ki lahko vplivajo na njihovo razpoloženje ali zmožnost jasnega razmišljanja.
English: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Slovenian: Teva B.V., Swensweg 5, 2031GA Haarlem, Nizozemska
English: It is used by adults, adolescents and children 3 years of age and older.
Slovenian: Uporablja se pri odraslih, mladostnikih in otrocih, starih 3 leta ali več.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Slovenian: Posvetujte se z zdravnikom o potrebnih previdnostnih ukrepih, da se izognete okužbi drugih ljudi.
English: It is important to tell your doctor or pharmacist if you are taking any of the following: - Other medicines used for HIV infection:
Slovenian: Pomembno je, da zdravniku ali farmacevtu poveste, če jemljete kar koli od naštetega: - Druga zdravila, ki se uporabljajo pri okužbi s HIV:
English: (CYP3A induction - effect on boceprevir) *0-8 hours
Slovenian: (indukcija CYP3A - vpliv na boceprevir) *0-8 ur
English: It must always be taken in combination with other anti-HIV medicines.
Slovenian: Vedno ga jemljite le v kombinaciji z drugimi zdravili proti HIV.
English: ATC code: J05AG03
Slovenian: Oznaka ATC: J05AG03
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Kakršne koli vnetne simptome je potrebno obravnavati in uvesti zdravljenje, kadar je potrebno.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Take reakcije so značilno opazili v prvih nekaj tednih ali mesecih po uvedbi
English: Efavirenz is highly bound (approximately 99.5-99.75%) to human plasma proteins, predominantly albumin.
Slovenian: Efavirenz se močno veže (približno 99,5 - 99,75 %) na človeške plazemske beljakovine, predvsem na albumin.
English: - If your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Slovenian: - če vam je zdravnik povedal, da imate visok ali nizek nivo elektrolitov, kot sta kalij ali magnezij, v krvi.
English: The standard doses of NRTIs given every 12 hours were used in each of these studies.
Slovenian: V vsaki od teh študij so uporabili standardne odmerke NRTI na vsakih 12 ur.
English: See below and section 5.3.
Slovenian: Glejte v nadaljevanju in poglavje 5.3.
English: - unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly - suicide
Slovenian: - nepojasnjeni občutki stiske, ki niso povezani s halucinacijami, lahko pa povzročajo težave pri jasnem ali razumnem razmišljanju - samomor
English: Study ACTG 364 48 weeks
Slovenian: Študija ACTG 48 tednov
English: This may stop the medicines from working properly, or may make any side effects worse.
Slovenian: To lahko prepreči pravilno delovanje zdravila ali poslabša neželene učinke.
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Slovenian: Opazili so tudi substitucije na RT na položajih 98, 100, 101, 108, 138, 188, 190 ali 225, vendar redkeje in pogosto le v kombinaciji s K103N.
English: - If you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na efavirenz ali katero koli od sestavin tega zdravila (navedeno v poglavju 6).
English: - Medicines used to treat malaria:
Slovenian: - Zdravila za zdravljenje malarije:
English: Undesirable effects in children were generally similar to those of adult patients.
Slovenian: Pediatrična populacija Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
English: (UDP-G induction)
Slovenian: (indukcija UDP-G)
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Slovenian: da so ti simptomi posledica izboljšanja telesnega imunskega odgovora, ki omogoča telesu, da se brani pred okužbami, ki so bile prej prisotne brez očitnih simptomov.
English: While effective viral suppression with antiretroviral therapy, has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Slovenian: Čeprav se je izkazalo, da učinkovita virusna supresija s protiretrovirusno terapijo bistveno zmanjša tveganje spolnega prenosa, preostalega tveganja ni mogoče izključiti.
English: - The dose for adults is 600 mg once daily.
Slovenian: - Odmerek za odrasle je 600 mg enkrat na dan.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Efavirenz Teva or by other medicines that you are taking at the same time, or by the HIV disease itself.
Slovenian: Pri zdravljenju okužbe s HIV je včasih težko reči, ali se nekateri neželeni učinki pojavijo zaradi zdravila Efavirenz Teva, drugih zdravil, ki jih jemljete sočasno, ali zaradi bolezni HIV same.