FrancophonIA/ELRC3.0 huggingface dataset:
English: The oral solution should be used in patients below three months of age.
Slovenian: Peroralna raztopina se uporablja pri bolnikih, mlajših od treh mesecev.
English: Zerit is used for as short a time as possible and only when other antiviral medicines cannot be used.
Slovenian: Zdravilo Zerit se uporablja kolikor je le mogoče malo časa in samo, če drugih protivirusnih zdravil ni mogoče uporabiti.
English: The patients' CD4 cell counts also rose from around 280 cells/mm3 before treatment by an average of around 185 cells/mm3.
Slovenian: Število celic CD4 pri bolnikih se je prav tako povečalo od približno 280 celic/mm3 pred zdravljenjem za povprečno vrednost okoli 185 celic/mm3.
English: This is a summary of the European public assessment report (EPAR) for Zerit.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zerit.
English: The dose to use is calculated based on the age and weight of the patient.
Slovenian: Odmerek, ki ga bo jemal bolnik, se izračuna na podlagi starosti in telesne mase bolnika.
English: The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T cells in the blood (CD4 cell count) after 48 weeks of treatment.
Slovenian: Glavna merila učinkovitosti so bile spremembe ravni virusa HIV v krvi (virusno breme) in števila T celic CD4 v krvi (števila celic CD4) po 48 tednih zdravljenja.
English: By blocking this enzyme, Zerit, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Z zaviranjem tega encima zdravilo Zerit v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: For more information about treatment with Zerit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zerit preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The studies showed that Zerit could reduce the rates of disease progression in HIV-infected patients.
Slovenian: Študije so pokazale, da lahko zdravilo Zerit upočasni hitrost napredovanja bolezni pri bolnikih, ki so okuženi z virusom HIV.
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Slovenian: T celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendar pa jih virus HIV ubija.
English: Zerit must not be used in people who are taking another HIV medicine called didanosine, which can also have toxic effects on mitochondria.
Slovenian: Zdravila Zerit ne smejo uporabljati osebe, ki že jemljejo drugo zdravilo za zdravljenje okužbe z virusom HIV, imenovano didanozin, ki ima prav tako lahko toksičen učinek na mitohondrije.
English: The CHMP decided that Zerit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila Zerit večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Zerit is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), to je virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Zerit does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Zerit ne zdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, povezanih z njim.
English: Since its authorisation, post-marketing reports and published literature regarding the side effects of Zerit have led the CHMP to update the prescribing information for Zerit, recommending that it should be used for as short a time as possible and only when other antiviral medicines cannot be used.
Slovenian: Po izdaji dovoljenja za promet je Odbor na podlagi poročil po dajanju v promet in objavljene literature glede neželenih učinkov zdravila Zerit posodobil informacije o predpisovanju tega zdravila, in priporočil, naj se uporablja čim krajši čas in samo, kadar ni mogoče uporabiti drugih protivirusnih zdravil.
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 Zerit.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zerit, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: These side effects are serious, usually appear with long-term use and are more commonly seen with Zerit than with other NRTI medicines.
Slovenian: Ti neželeni učinki so resni, navadno se pojavijo ob dolgotrajni uporabi in so bolj običajni ob uporabi zdravila Zerit kot drugih zaviralcev nukleozidne reverzne transkriptaze (NRTI).
English: Treatment with Zerit should be initiated by a doctor who has experience in the treatment of HIV infection.
Slovenian: Zdravljenje z zdravilom Zerit lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe s HIV.
English: Patients taking Zerit alone developed an AIDS-related disease or died at a similar rate to those taking zidovudine.
Slovenian: Bolniki, ki so jemali samo zdravilo Zerit, so razvili bolezni, povezane z aidsom, ali umrli podobno hitro kot tisti, ki so jemali zdravilo zidovudin.
English: The dose may need to be adjusted in patients who have problems with their kidneys or experience certain side effects.
Slovenian: Odmerek bo morda treba prilagoditi pri bolnikih z ledvičnimi težavami ali pri bolnikih, pri katerih se pokažejo nekateri neželeni učinki.
English: Its main measure of effectiveness was how long it took for the patients to develop a disease associated with AIDS or to die.
Slovenian: Glavno merilo učinkovitosti je bil čas, ki je pretekel, da so se pri bolnikih razvile bolezni, povezane z aidsom, ali pa da so umrli.
English: Why has Zerit been approved?
Slovenian: Zakaj je bilo zdravilo Zerit odobreno?
English: Zerit is to be used for as short a time as possible and the patients switched to appropriate alternatives whenever possible.
Slovenian: Zdravilo Zerit je namenjeno čim kratkotrajnejši uporabi, bolniki pa naj preidejo na drugo ustrezno zdravilo takoj, ko je mogoče.
English: Three side effects are possibly related to the medicine's toxic effect on mitochondria (the energyproducing components within cells): lipoatrophy, lactic acidosis (a build-up of lactic acid in the body) and peripheral neuropathy.
Slovenian: Trije neželeni učinki so verjetno povezani s toksičnim učinkom zdravila na mitohondrije (dele v celicah, ki proizvajajo energijo): lipoatrofija, aktacidoza (kopičenje mlečne kisline v telesu) in periferna nevropatija.
English: Adults weighing less than 60 kg and children weighing over 30 kg take a dose of 30 mg, and adults over 60 kg take 40 mg. Children over the age of 14 days receive 1 mg per kilogram body weight, unless they weigh more than 30 kg.
Slovenian: Odrasli, ki tehtajo manj kot 60 kg, in otroci, ki tehtajo več kot 30 kg, morajo vzeti 30-miligramski odmerek, odrasli, ki tehtajo več kot 60 kg, pa 40 mg.
English: When taken in combination with lamivudine and efavirenz, around 70% of the patients taking Zerit had viral loads below 400 copies/ml after 48 weeks.
Slovenian: Pri jemanju zdravila v kombinaciji z lamivudinom in efavirenzom je imelo po 48 tednih zdravljenja okoli 70 % bolnikov, ki so jemali tudi zdravilo Zerit, virusno breme pod 400 kopij/ml.
English: For the full list of side effects and restrictions with Zerit, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zerit glejte navodilo za uporabo.
English: Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz (other antiviral medicines) in 467 treatment-naïve patients (who had not taken treatment for HIV infection before).
Slovenian: V dveh nadaljnjih študijah so ocenjevali učinkovitost zdravila Zerit, ki so ga bolniki jemali v kombinaciji z lamivudinom in efavirenzom (drugima protivirusnima zdraviloma) pri 467 bolnikih, ki zaradi okužbe z virusom HIV še niso bili zdravljeni.
English: The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months.
Slovenian: V prvi študiji so primerjali učinke zdravila Zerit, ki so ga bolniki jemali kot samostojno zdravilo, z učinki zidovudina (drugega protivirusnega zdravila) pri 822 bolnikih, okuženih z virusom HIV, ki so zidovudin jemali vsaj šest mesecev.
English: The active substance in Zerit, stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Slovenian: Zdravilna učinkovina zdravila Zerit, stavudin, je nukleozidni zaviralec reverzne transkriptaze (NRTI).
English: Zerit is an antiviral medicine containing the active substance stavudine.
Slovenian: Zerit je zdravilo, ki vsebuje zdravilno učinkovino stavudin.
English: How is Zerit used?
Slovenian: Kako se zdravilo Zerit uporablja?
English: How has Zerit been studied?
Slovenian: Kako je bilo zdravilo Zerit raziskano?
English: Zerit is also available as a powder to make up into an oral solution.
Slovenian: Zdravilo Zerit je na voljo tudi v obliki praška za pripravo peroralne raztopine.
English: What is Zerit?
Slovenian: Kaj je zdravilo Zerit?
English: What is Zerit used for?
Slovenian: Za kaj se zdravilo Zerit uporablja?
English: Babies less than 13 days old should be given 0.5 mg/kg body weight.
Slovenian: Otroci, starejši od 14 dni, prejmejo 1 mg na kilogram telesne mase, razen če tehtajo več kot 30 kg. Dojenčki do 13. dne starosti smejo prejemati le 0,5 mg/kg telesne mase.
English: How does Zerit work?
Slovenian: Kako zdravilo Zerit deluje?
English: 12 January 2015
Slovenian: 12. januar 2015
English: Page 2/2
Slovenian: Vendar pa države stran 2/2
English: The European Commission issued an EU-wide legally binding decision on 12 January 2015.
Slovenian: Evropska komisija je 12. januarja 2015 izdala pravno zavezujoč sklep, veljaven po vsej Evropski uniji.
English: Why was Seasonique reviewed?
Slovenian: Zakaj je bilo zdravilo Seasonique pregledano?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view to granting a marketing authorisation that will be valid in that country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and
Slovenian: To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Francija) oceni zdravilo z namenom odobritve dovoljenja za promet z zdravilom, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Belgija, Nemčija, Italija, Poljska, Romunija, Slovaška in Slovenija).
English: On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique.
Slovenian: Evropska agencija za zdravila je 26. junija 2014 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve peroralnega kontraceptiva Seasonique.
English: After evaluating data from studies and post-marketing data from outside the EU, the CHMP was of the view that there was adequate evidence that Seasonique is an effective contraceptive.
Slovenian: Po oceni podatkov iz študij in podatkov, pridobljenih v obdobju trženja zdravila zunaj EU, je CHMP menil, da so na voljo ustrezni dokazi, da je zdravilo Seasonique učinkovit kontraceptiv.
English: It is available as blister packs containing 91 tablets to be taken once a day in the order shown on the pack.
Slovenian: Na voljo je v pretisnih omotih, ki vsebujejo 91 tablet, ki jih je treba vzeti enkrat dnevno v vrstnem redu, prikazanem na omotu.
English: Because the treatment cycle of 91 days is longer than that of most other combined contraceptives (which is normally 28 days), Seasonique is known as an extended cycle oral contraceptive.
Slovenian: Ker je cikel jemanja, ki traja 91 dni, daljši kot pri večini drugih kombiniranih kontraceptivih (običajno traja 28 dni), se zdravilo Seasonique uvršča med peroralne kontraceptive s podaljšanim ciklom.
English: For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.
Slovenian: Ženska 84 dni jemlje tablete, ki vsebujejo levonorgestrel in etinilestradiol, preostalih 7 dni pa tablete, ki vsebujejo le etinilestradiol.
English: However, the Member States were not able to reach an agreement and the French medicines agency referred the matter to the CHMP for arbitration on 3 February 2014.
Slovenian: članice niso uspele doseči soglasja, zato je francoska agencija za zdravila dne 3. februarja 2014 zadevo napotila na CHMP v arbitražo.
English: The Committee therefore concluded that the benefits of Seasonique outweigh its risks and recommended that marketing authorisation be granted in the reference and concerned Member States.
Slovenian: Odbor je zato zaključil, da so koristi zdravila Seasonique večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet v referenčni in zadevnih državah članicah.
English: Seasonique is an oral contraceptive for women.
Slovenian: Zdravilo Seasonique je peroralni kontraceptiv za ženske.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the following EU Member States: Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Seasonique večje od z njim povezanih tveganj ter da bi bilo treba zanj odobriti dovoljenje za promet v Franciji in v naslednjih državah članicah EU: Avstriji, Belgiji, Nemčiji, Italiji, na Poljskem, v Romuniji, na Slovaškem in v Sloveniji.
English: Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure.
Slovenian: Družba Teva Pharma je francoski agenciji za zdravila (ANSM) predložila vlogo za odobritev zdravila Seasonique po decentraliziranem postopku.
English: Women taking Seasonique will have longer intervals between withdrawal bleeding but may experience more irregular bleeding.
Slovenian: Ženske, ki jemljejo Seasonique, bodo imele daljše intervale med prekinitvenimi krvavitvami, vendar pa lahko pri njih pride do več nerednih krvavitev.
English: Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones and Seasonique is what is known as a ‘combined hormonal contraceptive'.
Slovenian: Tako levonorgestrel (progestogen) kot etinilestradiol (estrogen) sta hormona, zdravilo Seasonique pa je „kombiniran hormonski kontraceptiv“.
English: Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.
Slovenian: Kombinirani hormonski kontraceptivi delujejo tako, da ustavijo sproščanje jajčec iz jajčnikov ter povzročijo spremembe materničnega vratu in maternične sluznice, ki spermijem otežijo dostop do jajčeca, oplojenemu jajčecu pa otežijo ugnezditev v maternico.
English: What is Seasonique?
Slovenian: Kaj je zdravilo Seasonique?
English: The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.
Slovenian: Razlogi za napotitev so bili pomisleki nemške agencije za zdravila o učinkovitosti zdravila Seasonique pri preprečevanju nosečnosti in o nerednih krvavitvah pri ženskah, ki so ga jemale.
English: The Committee also noted that the irregular bleeding reported with Seasonique has not made women less likely to keep to their treatment and adequate information about the risk of irregular bleeding is included in the package leaflet.
Slovenian: Odbor je prav tako ugotovil, da se ženske zaradi nerednih krvavitev, o katerih so poročale pri zdravilu Seasonique, niso pogosteje odločale za prekinitev jemanja in da so ustrezne informacije o tveganju za neredne krvavitve vključene v navodilo za uporabo.
English: Treatment should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
Slovenian: mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
English: The dose and duration of treatment is based on the patient's body weight and on the medicine used in combination with it.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od bolnikove telesne mase in zdravila, ki je uporabljeno v kombinaciji z njim.
English: Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood.
Slovenian: Uporablja se pri bolnikih, ki se pred tem še niso zdravili zaradi katere koli vrste virusa hepatitisa C, razen genotipa 1, dokler jetra še delujejo normalno in je virus hepatitisa C prisoten v krvi.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Rebetol and do not need to be repeated for Ribavirin Teva Pharma B.V.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Rebetol, zato jih ni treba ponoviti za zdravilo Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V. must never be used on its own but only together with interferon alfa 2b (another medicine used in hepatitis).
Slovenian: se ne sme nikoli uporabljati samostojno, ampak samo v kombinaciji z interferonom alfa 2b (drugim zdravilom za zdravljenje hepatitisa).
English: Ribavirin Teva Pharma B.V. is taken with food each day in two divided doses (morning and evening).
Slovenian: se jemlje s hrano vsak dan v dveh deljenih odmerkih (zjutraj in zvečer).
English: Therefore, the CHMP's view was that, as for Rebetol, the benefits outweigh the identified risks.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Rebetol odtehtajo znana tveganja.
English: The full EPAR for Ribavirin 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: Ribavirin Teva Pharma B.V. is a medicine used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Slovenian: je zdravilo za zdravljenje dolgotrajnega hepatitisa C (bolezni jeter, ki nastane zaradi okužbe z virusom hepatitisa C) pri bolnikih, starejših od treh let.
English: This means that Ribavirin Teva Pharma B.V. contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Rebetol.
English: Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
Slovenian: se lahko uporablja tudi pri odraslih (starejših od 18 let), pri katerih se je bolezen po predhodnem zdravljenju ponovila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ribavirin Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. on 1 July 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ribavirin Teva Pharma B.V., veljavno po vsej Evropski uniji, izdala 1. julija 2009.
English: Because Ribavirin Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The dose may need to be adjusted for patients who experience side effects.
Slovenian: Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo morda treba odmerek prilagoditi.
English: What measures are being taken to ensure the safe and effective use of Ribavirin Teva Pharma B.V.?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ribavirin Teva Pharma B.V.
English: This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ribavirin Teva Pharma B.V.
English: The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Slovenian: Zdravilna učinkovina zdravila Ribavirin Teva Pharma B.V., ribavirin, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
English: Ribavirin Teva Pharma B.V. available as tablets (200 and 400 mg).
Slovenian: Na voljo je v obliki tablet (200 in 400 mg).
English: As for every medicine, the company provided studies on the quality of Ribavirin Teva Pharma B.V.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V. on its own has no effect on eliminating the hepatitis C virus from the body.
Slovenian: kot samostojno zdravilo nima nikakršnega učinka na odstranitev virusa hepatitisa C iz telesa.
English: What are the benefits and risks of Ribavirin Teva Pharma B.V.?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ribavirin Teva Pharma B.V.
English: For more information about treatment with Ribavirin Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Ribavirin Teva Pharma B.V.is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Slovenian: naj bi vplivalo na nastajanje ali delovanje virusnih DNK in RNK, brez katerih virusi ne morejo preživeti ali se razmnoževati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ribavirin Teva Pharma B.V. have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ribavirin Teva Pharma B.V.