FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Slovenian: Glavno merilo učinkovitosti v teh petih študijah je bila sprememba simptomov po šestih tednih, ocenjenih po standardni lestvici za merjenje depresije, imenovani Hamiltonova lestvica za merjenje depresije (HAM D).
English: Thymanax is a medicine used to treat major depression in adults.
Slovenian: Thymanax je zdravilo, ki se uporablja za zdravljenje hude depresije pri odraslih.
English: Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Slovenian: Zdravljenje je treba nemudoma prekiniti, če bolnik kaže simptome ali znake morebitne okvare jeter.
English: What measures are being taken to ensure the safe and effective use of Thymanax?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Thymanax?
English: Therefore, the CHMP decided that Thymanax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Thymanax večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
English: However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Slovenian: Vendar je druga študija pokazala, da so se simptomi ponovno pojavili pri 21 % (34 od 165) bolnikov, ki so 24 tednov jemali zdravilo Thymanax, medtem ko je ta delež pri bolnikih, ki so jemali placebo, znašal 41 % (72 od 174).
English: Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Slovenian: Predpisovanje in izdaja zdravila Thymanax je le na recept, na voljo pa je v obliki tablet (25 mg).
English: Most side effects were mild or moderate in intensity, happened within the first two weeks of treatment and were temporary.
Slovenian: Večina neželenih učinkov je bila blagih ali zmernih, pojavili pa so se v prvih dveh tednih zdravljenja in polagoma izzveneli.
English: However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Slovenian: Vendar je glede na to, da v dveh študijah niso bili ugotovljeni nobeni učinki fluoksetina ali paroksetina, te rezultate težko pojasniti.
English: Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Slovenian: Tri od teh študij so vključevale nekaj bolnikov, zdravljenih z drugimi antidepresivi, in sicer s fluoksetinom ali paroksetinom kot „aktivnim primerjalnim zdravilom“.
English: The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Slovenian: Skupine bolnikov, ki so prejemali aktivno primerjalno zdravilo, so vključili zato, da bi preverili, ali je bilo v študiji mogoče izmeriti učinkovitost zdravil pri zdravljenju depresije.
English: In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
Slovenian: V prvi študiji ni bilo razlik med zdravilom Thymanax in placebom pri preprečevanju ponovnega pojava simptomov v 26 tednih zdravljenja.
English: This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
Slovenian: To gradivo vsebuje pojasnila glede varnosti zdravila in medsebojnega delovanja z drugimi zdravili ter napotke za spremljanje delovanja jeter in obvladovanje morebitnih simptomov težav z jetri.
English: Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Slovenian: Zdravilo Thymanax so primerjali s placebom (zdravilom brez zdravilne učinkovine) v petih glavnih kratkoročnih študijah, ki so vključevale skupaj 1 893 bolnikov odraslih s hudo obliko depresije.
English: The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Slovenian: Družba, ki trži zdravilo Thymanax, bo zdravnikom, ki predpisujejo zdravilo Thymanax, priskrbela izobraževalno gradivo.
English: The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Slovenian: Najpogostejši neželeni učinki zdravila Thymanax (opaženi pri več kot 1 bolniku od 100) so glavobol, navzeja (slabost) in omotica.
English: Thymanax might also help to normalise the patient's sleep patterns.
Slovenian: Zdravilo Thymanax lahko pomaga tudi pri uravnavanju bolnikovega vzorca spanja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax's benefits in terms of treating depression might be lower than seen with other antidepressants.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da so koristi zdravila Thymanax pri zdravljenju depresije morda manjše kot pri drugih antidepresivih.
English: The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Slovenian: Družba je predstavila tudi rezultate dodatne študije, v kateri so zdravilo Thymanax primerjali s sertralinom (drugim antidepresivom), ki je pokazala, da je bilo zdravilo Thymanax učinkovitejše od sertralina, saj so se rezultati na lestvici HAM D po šestih tednih zmanjšali.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thymanax have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Thymanax upoštevati zdravstveni delavci in bolniki, so tudi vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Slovenian: Vendar je glede na drugačen način delovanja zdravila, majhno število neželenih učinkov in drugačen varnostni profil v primerjavi z obstoječimi antidepresivi, zaključil, da bi bilo zdravilo Thymanax lahko pomembno za zdravljenje nekaterih bolnikov, pri čemer pa bi bilo treba redno preverjati delovanje jeter.
English: For more information about treatment with Thymanax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Thymanax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The active substance in Thymanax, agomelatine, is an antidepressant.
Slovenian: Zdravilna učinkovina v zdravilu Thymanax, agomelatin, je antidepresiv.
English: Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Slovenian: Zdravilo Thymanax se ne sme uporabljati pri bolnikih, ki imajo težave z jetri, kot sta ciroza (brazgotinjenje jeter) ali aktivna jetrna bolezen, in pri bolnikih, katerih ravni transaminaz (jetrnih encimov) v krvi so trikrat višje od normalnih.
English: A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Slovenian: Informativno knjižico bodo prav tako prejeli bolniki, katerim je bilo predpisano zdravilo Thymanax, da bi se zavedali tveganj za jetra, pomena nadzora delovanja jeter ter prepoznavanja znakov, ki kažejo na težave z njimi.
English: Other information about Thymanax
Slovenian: Druge informacije o zdravilu Thymanax
English: Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Slovenian: V dveh drugih glavnih študijah so učinkovitost zdravila Thymanax in placeba pri preprečevanju ponovnega pojava simptomov primerjali pri 706 bolnikih, pri katerih so depresijo že nadzorovali z zdravilom Thymanax.
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, ki upočasnjujejo presnovo zdravila Thymanax v telesu, kot sta fluvoksamin (drug antidepresiv) in ciprofloksacin (antibiotik).
English: In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
Slovenian: V drugih treh študijah, ki so vključevale aktivno primerjalno zdravilo, razlik v rezultatih med bolniki, ki so jemali zdravilo Thymanax, in tistimi, ki so jemali placebo, ni bilo.
English: What benefits of Thymanax have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Thymanax izkazalo v študijah?
English: For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Thymanax naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: What is Thymanax and what is it used for?
Slovenian: Kaj je zdravilo Thymanax in za kaj se uporablja?
English: What are the risks associated with Thymanax?
Slovenian: Kakšna tveganja so povezana z zdravilom Thymanax?
English: Why is Thymanax approved?
Slovenian: Zakaj je bilo zdravilo Thymanax odobreno?
English: In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
Slovenian: V dveh študijah, v katerih niso uporabili nobenega aktivnega primerjalnega zdravila, so opazili, da je bilo zdravilo Thymanax učinkovitejše od placeba.
English: For the full list of all side effects reported with Thymanax, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thymanax, glejte navodilo za uporabo.
English: Thymanax contains the active substance agomelatine.
Slovenian: Zdravilo Thymanax vsebuje zdravilno učinkovino agomelatin.
English: It is not intended to provide practical advice on how to use Thymanax.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later.
Slovenian: Ob začetku zdravljenja in ob povečanju odmerka, nato pa ponovno po približno treh, šestih, 12 in 24 tednih zdravljenja je treba s krvnimi preiskavami preveriti delovanje bolnikovih jeter.
English: How is Thymanax used?
Slovenian: Kako se zdravilo Thymanax uporablja?
English: How does Thymanax work?
Slovenian: Kako zdravilo Thymanax deluje?
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Slovenian: Pri bolnikih z nenormalno količino jetrnih encimov v krvi (za več kot trikratne normalne vrednosti) se zdravljenje ne sme začeti ali se mora prekiniti.
English: This summary was last updated in 01-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 01-2009.
English: The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
Slovenian: Dovoljenje za promet je bilo obnovljeno dne 23. aprila 2002 in 23. aprila 2007.
English: This disease can cause loss of vision.
Slovenian: To obolenje lahko povzroči izgubo vida.
English: Other information about Vistide:
Slovenian: Druge informacije o zdravilu Vistide:
English: In both studies, the main measure of effectiveness was the time taken for the disease to get worse.
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti čas do poslabšanja bolezni.
English: It should only be used when other medicines are unsuitable.
Slovenian: Zdravilo se lahko uporablja le takrat, kadar druga zdravila niso primerna.
English: When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Slovenian: Če virus ne more tvoriti DNK, se ne more razmnoževati, kar upočasni širjenje okužbe.
English: Then, during the ‘maintenance' phase, it is given once every two weeks.
Slovenian: Nato se med vzdrževalnim obdobjem daje enkrat vsaka dva tedna.
English: Vistide should not be injected directly into the eye.
Slovenian: Zdravilo Vistide se ne sme injicirati neposredno v oko.
English: The marketing authorisation holder is Gilead Sciences International.
Slovenian: Imetnik dovoljena za promet je družba Gilead Sciences International.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vistide, veljavno po vsej Evropski uniji, odobrila dne 23. aprila 1997.
English: It contains the active substance cidofovir (75 mg/ml).
Slovenian: Vsebuje zdravilno učinkovino cidofovir (75 mg/ml).
English: What benefit has Vistide shown during the studies?
Slovenian: Kakšne koristi je zdravilo Vistide izkazalo med študijami?
English: What is the risk associated with Vistide?
Slovenian: Kakšna tveganja so povezana z zdravilom Vistide?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VISTIDE EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) VISTIDE Povzetek EPAR za javnost
English: The Committee recommended that Vistide be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Vistide odobri dovoljenje za promet.
English: To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Slovenian: Da bi zmanjšali tveganje za okvare ledvic, morajo bolniki dobivati tudi drugo zdravilo, imenovano probenecid (2 g tri ure pred infuzijo in nato 1 g dve in osem ur po infuziji), ter prejeti infuzijo enega litra fiziološke raztopine eno uro pred infuzijo zdravila Vistide.
English: Why has Vistide been approved?
Slovenian: Zakaj je bilo zdravilo Vistide odobreno?
English: The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
Slovenian: Najpogostejši neželeni učinki zdravila Vistide (opaženi pri več kot 1 bolniku od 10) so nevtropenija (nizko število belih krvničk), glavobol, navzeja (slabost), bruhanje, alopecija (izpadanje las), izpuščaji, proteinurija (beljakovine v urinu), povečane ravni kreatinina v krvi (produkt metabolizma mišic), astenija (šibkost) in povišana telesna temperatura.
English: In the maintenance study, the 5-mg/kg dose was more effective than the 3-mg/kg dose (115 days and 49 days, respectively).
Slovenian: V vzdrževalni študiji je bil odmerek 5 mg/kg učinkovitejši od odmerka 3 mg/kg (115 oziroma 49 dni do napredovanja bolezni).
English: It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘sulfa-containing' medicines.
Slovenian: Zdravila prav tako ne smejo uporabljati bolniki z ledvičnimi obolenji, bolniki, ki jemljejo druga zdravila, ki lahko škodujejo ledvicam, ali bolniki, ki ne morejo jemati probenecida ali drugih zdravil, ki vsebujejo žveplo.
English: The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
Slovenian: V vzdrževalni študiji so primerjali dva vzdrževalna odmerka zdravila Vistide (5 in 3 mg/kg telesne mase) pri 100 bolnikih, ki so se nehali odzivati na druga zdravila za citomegalovirusni retinitis (ganciklovir ali foskarnet) ali pa teh niso mogli jemati.
English: It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
Slovenian: V povprečju se je citomegalovirusni retinitis pri bolnikih, ki so jemali Vistide, poslabšal v 120 dneh, v primerjavi z 22 dnevi pri bolnikih, ki zdravljenja niso prejemali.
English: Vistide should not be used in people who may be hypersensitive (allergic) to cidofovir or any of the other ingredients.
Slovenian: Zdravila Vistide ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) cidofovir ali katero koli drugo sestavino zdravila.
English: The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
Slovenian: Učinke zdravila Vistide pri bolnikih z aidsom in citomegalovirusnim retinitisom so raziskovali v eni študiji zdravljenja in eni študiji vzdrževanja.
English: Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
Slovenian: Zdravljenje z zdravilom Vistide lahko predpiše le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom človeške imunske pomanjkljivosti (HIV).
English: The active substance in Vistide, cidofovir, is an antiviral medicine that belongs to the class ‘nucleotide analogues'.
Slovenian: Zdravilna učinkovina v zdravilu Vistide, cidofocir, je protivirusno zdravilo, ki spada v razred „nukleotidnih analogov“.
English: In the treatment study, Vistide was more effective than no treatment.
Slovenian: V študiji zdravljenja je bilo jemanje zdravila Vistide učinkovitejše od nejemanja.
English: Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Slovenian: Zdravilo Vistide se uporablja pri bolnikih s sindromom pridobljene imunske pomanjkljivosti (AIDS), ki nimajo obolenja ledvic.
English: Before receiving Vistide, the patient's kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Slovenian: Pred začetkom jemanja zdravila Vistide je treba preveriti delovanje ledvic bolnika, saj bolniki z ledvičnimi obolenji zdravila ne smejo jemati.
English: Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Slovenian: Probenecid se uporablja za preprečevanje kopičenja cidofovirja v ledvicah, fiziološka raztopina pa se uporablja za preprečevanje dehidracije.
English: For the full list of all side effects reported with Vistide, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vistide, glejte navodilo za uporabo.
English: The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
Slovenian: V študiji zdravljenja so primerjali jemanje in nejemanje zdravila Vistide pri 48 bolnikih, ki se pred tem še niso zdravili zaradi citomegalovirusnega retinitisa.
English: It blocks the activity of enzymes called ‘DNA polymerases' in CMV, which the virus uses to produce DNA.
Slovenian: Zavira aktivnost encimov v citomegalovirusu, imenovanih DNK polimeraze, ki jih virus uporablja za tvorjenje DNK.
English: Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
Slovenian: Trajanje zdravljenja mora biti usklajeno z lokalnimi priporočili za zdravljenje bolnikov, okuženih z virusom HIV.
English: During the ‘induction' phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Slovenian: Med obdobjem uvajanja se zdravilo Vistide prva dva tedna daje enkrat tedensko kot eno uro trajajoča infuzija v odmerku 5 mg na kilogram telesne mase.
English: Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the lightsensitive surface at the back of the eye).
Slovenian: Zdravilo Vistide se uporablja za zdravljenje citomegalovirusnega (CMV) retinitisa, virusne okužbe mrežnice (površine na zadnji steni očesa, ki je občutljiva na svetlobo).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Vistide pri zdravljenju citomegalovirusnega retinitisa pri bolnikih z AIDS-om, ki nimajo obolenja ledvic, večje od z njim povezanih tveganj.
English: The full EPAR for Vistide is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vistide je na voljo tukaj.
English: Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Vistide je koncentrat, ki se pripravi v raztopino za infundiranje (kapalno infuzijo v veno).
English: What is Vistide used for?
Slovenian: Za kaj se zdravilo Vistide uporablja?
English: How has Vistide been studied?
Slovenian: Kako je bilo zdravilo Vistide raziskano?
English: How is Vistide used?
Slovenian: Kako se zdravilo Vistide uporablja?
English: What is Vistide?
Slovenian: Kaj je zdravilo Vistide?
English: How does Vistide work?
Slovenian: Kako zdravilo Vistide deluje?
English: treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Slovenian: Paket za začetno zdravljenje: 14 tablet + 14 tablet + 14 tablet + 14 tablet
English: Syrup
Slovenian: mg
English: 1 bottle + 1 measuring cup + 1 oral syringe
Slovenian: 1 steklenica + 1 merica + 1 brizga za peroralno odmerjanje
English: Oral use bottle (glass)
Slovenian: Steklenica (steklena) 200 ml
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: 7 July 2011
Slovenian: 7. julija 2011
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Slovenian: Izid postopka v skladu s členom 29 Direktive 2001/83/ES, kakor je bila spremenjena
English: The European Commission issued a decision on 7 July 2011.
Slovenian: Evropska komisija je odločbo izdala dne 7. julija 2011.
English: What are the conclusions of the CHMP?
Slovenian: Kakšni so zaključki CHMP?