FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine is given to puppies from eight to nine weeks of age as an injection, under the skin, and repeated once the puppies reach twelve weeks of age.
Slovenian: Cepivo se daje pasjim mladičem, starim od osem do devet tednov, z injiciranjem v podkožje, cepljenje pa je treba ponoviti, ko so mladiči stari dvanajst tednov.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus DHPPi/L4R on 7 May 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Versican Plus DHPPi/L4R, veljavno po vsej Evropski uniji, izdala 7. maja 2014.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Slovenian: Najpogostejši neželeni učinek cepiva Versican Plus DHPPi/L4R (opažen pri več kot 1 psu od 100) je kratkotrajna oteklina v velikosti do 5 cm, ki se lahko po cepljenju pojavi na mestu injiciranja.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila.
English: • canine adenovirus, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
Slovenian: • pasjim adenovirusom tipa 1, ki povzroča akutno okužbo jeter, pri kateri se lahko pojavijo znaki zlatenice (porumenelost kože in oči);
English: Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus.
Slovenian: Zatem so bile izvedene laboratorijske študije za proučitev trajanja zaščite pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter parvovirusom.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4R exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4R be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Versican Plus DHPPi/L4 večje od z njim povezanih tveganj, kadar se zdravilo uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
English: In these studies dogs were vaccinated twice with a three week interval and were challenged with canine distemper virus, canine adenovirus and canine parvovirus three years after the second vaccination.
Slovenian: V teh študijah so bili psi cepljeni dvakrat v razmiku treh tednov, zatem pa so bili tri leta po drugem cepljenju izpostavljeni virusu pasje kuge, pasjega adenovirusa, pasjega parvovirusa.
English: When Versican Plus DHPPi/L4R is given to dogs the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko psi prejmejo cepivo Versican Plus DHPPi/L4R, imunski sistem živali viruse in bakterije prepozna kot „tujke“ ter začne proti njim tvoriti protitelesa.
English: • canine distemper, an infectious disease which is sometimes called hard pad since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting and diarrhoea, excessive salivation and in some cases fits;
Slovenian: • pasjo kugo, tj. infekcijsko boleznijo, ki jo včasih imenujemo tudi bolezen trdih blazinic, saj se lahko pri psih pojavi odebeljena koža na blazinicah na šapah, poleg tega pa tudi izcedek iz smrčka, kašelj, povišana telesna temperatura, bruhanje in driska, čezmerno slinjenje ter v nekaterih primerih krči;
English: • rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death.
Slovenian: • steklino, tj. virusno zoonozo (prenaša se lahko na ljudi), ki prizadene osrednje živčevje (možgane in hrbtenjačo) ter povzroči smrt.
English: Versican Plus DHPPI/L4R is used to protect dogs against:
Slovenian: Zdravilo Versican Plus DHPPi/L4R se uporablja za zaščito psov pred:
English: The field study showed that vaccination with Versican Plus DHPPi/L4R resulted in levels of antibodies that were sufficient to protect against canine distemper virus and canine adenovirus in all dogs.
Slovenian: Terenska študija je pokazala, da so bile po cepljenju s cepivom Versican Plus DHPPi/L4R ravni protiteles pri vseh psih dovolj visoke za zaščito pred virusom pasje kuge in pasjim adenovirusom.
English: This will help protect them against distemper, adenovirus, parvovirosis, kennel cough, leptospirosis and rabies.
Slovenian: To pomaga zaščititi pse pred kugo, adenovirusom, parvovirozo, kužnim kašljem, leptospirozo in steklino.
English: Versican Plus DHPPi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria and rabies virus.
Slovenian: Zdravilo Versican Plus DHPPi/L4R je cepivo za uporabo v veterinarski medicini, ki vsebuje živ atenuiran (oslabljen) virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus tipa 2b in virus pasje parainfluence tipa 2 ter inaktivirane (uničene) seve bakterij Leptospira in virus stekline.
English: • canine parainfluenza virus, the cause of kennel cough;
Slovenian: • virusom pasje parainfluence, ki povzroča kužni kašelj;
English: Versican Plus DHPPi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Slovenian: Cepivo Versican Plus DHPPi/L4R vsebuje adjuvans (aluminijev hidroksid), ki spodbuja imunski odziv.
English: • canine parvovirus disease, an infection that may severely affect puppies, resulting in lethargy, fever, vomiting and bloody diarrhoea;
Slovenian: • boleznijo, ki jo povzroča pasji parvovirus, tj. okužbo, ki lahko močno prizadene pasje mladiče in povzroči letargijo, povišano telesno temperaturo, bruhanje in krvavo drisko;
English: Versican Plus DHPPi/L4R is a vaccine.
Slovenian: Zdravilo Versican Plus DHPPi/L4R je cepivo.
English: Versican Plus DHPPi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Slovenian: Zdravilo Versican Plus DHPPi/L4R je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) z vehiklom za injiciranje.
English: Canine distemper, adenovirus, parvovirus, parainfluenza virus (live attenuated), canine leptospirosis, rabies (inactivated) vaccine
Slovenian: cepivo proti pasji kugi, pasjemu adenovirusu, pasjemu parvovirusu, virusu pasje parainfluence (živo, atenuirano), pasji leptospirozi, virusu stekline (inaktivirano)
English: Annual revaccination is required for protection against parainfluenza virus, leptospirosis and rabies.
Slovenian: Za zaščito pred virusom parainfluence, leptospirozo in steklino je ponovno cepljenje potrebno vsako leto.
English: What benefit has Versican Plus DHPPi/L4R shown during the studies?
Slovenian: Kakšne koristi je zdravilo Versican Plus DHPPi/L4R izkazalo med študijami?
English: The laboratory studies showed the period of protection to be three years for canine distemper, canine adenovirus and canine parvovirus.
Slovenian: Laboratorijske študije so pokazale, da traja obdobje zaščite pred pasjo kugo, pasjim adenovirusom in pasjim parvovirusom tri leta.
English: The canine distemper virus, canine adenovirus, canine parvovirus and canine parainfluenza virus in Versican Plus DHPPi/L4R are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria and rabies virus.
Slovenian: Virus pasje kuge, pasji adenovirus, pasji parvovirus in virus pasje parainfluence v cepivu Versican Plus DHPPi/L4R so živi, vendar so atenuirani (oslabljeni), tako da ne povzročajo bolezni.
English: Other information about Versican Plus DHPPi/L4R:
Slovenian: Druge informacije o zdravilu Versican Plus DHPPi/L4R:
English: What is the risk associated with Versican Plus DHPPi/L4R?
Slovenian: Kakšna tveganja so povezana z zdravilom Versican Plus DHPPi/L4R?
English: Why has Versican Plus DHPPi/L4R been approved?
Slovenian: Zakaj je bilo zdravilo Versican Plus DHPPi/L4R odobreno?
English: For revaccination, a single dose of Versican Plus DHPPi/L4R is required every three years for distemper, canine adenovirus (type 1 and 2) and parvovirus.
Slovenian: Za zaščito pred pasjo kugo, pasjim adenovirusom (tipa 1 in 2) ter pasjim parvovirusom je vsaka tri leta potrebno ponovno cepljenje z enkratnim odmerkom cepiva Versican Plus DHPPi/L4R.
English: What is Versican Plus DHPPi/L4R?
Slovenian: Kaj je zdravilo Versican Plus DHPPi/L4R?
English: How has Versican Plus DHPPi/L4R been studied?
Slovenian: Kako je bilo zdravilo Versican Plus DHPPi/L4R raziskano?
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation);
Slovenian: • leptospirozo, tj. bakterijsko boleznijo, ki se lahko prenaša z okuženim urinom in povzroči krvavitve,
English: What is Versican Plus DHPPi/L4R used for?
Slovenian: Za kaj se zdravilo Versican Plus DHPPi/L4R uporablja?
English: How does Versican Plus DHPPi/L4R work?
Slovenian: Kako zdravilo Versican Plus DHPPi/L4R deluje?
English: This summary was last updated in 03-2007.
Slovenian: Ta povzetek je bil nazadnje posodobljen 03-2007.
English: It is used to treat adults with the following diseases:
Slovenian: Uporablja se pri zdravljenju odraslih z naslednjimi boleznimi:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trudexa to Abbott Laboratories Ltd. on 1 September 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Trudexa, veljavno po vsej Evropski uniji, odobrila družbi Abbott Laboratories Ltd. dne 1. septembra 2003.
English: Other information about Trudexa:
Slovenian: Druge informacije o zdravilu Trudexa:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRUDEXA EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TRUDEXA Povzetek EPAR za javnost
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
Slovenian: Monoklonsko protitelo je vrsta protitelesa (vrsta beljakovine), ki je bilo zasnovano za prepoznavanje in vezanje na določeno strukturo (imenovano antigen), ki jo najdemo na določenih celicah telesa.
English: It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg of adalimumab.
Slovenian: Na voljo je kot raztopina za injiciranje v viali, napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku, vse oblike pa vsebujejo po 40 mg adalimumaba.
English: For more information, see the Package Leaflet.
Slovenian: Za več informacij si oglejte Navodilo za uporabo.
English: Patients who take Trudexa must be given the special alert card that summarises the safety information about the medicine.
Slovenian: Bolniki, ki prejemajo zdravilo Trudexa, morajo dobiti posebno opozorilno izkaznico, ki povzema varnostne podatke o zdravilu.
English: The medicines were taken alone or in combination with another anti-inflammatory medicine such as methotrexate.
Slovenian: Zdravilo so dajali samostojno ali v povezavi z drugim protivnetnim zdravilom, kot je metotreksat.
English: In all five studies, the main measure of effectiveness was the change in symptoms after 6 months to a year of treatment.
Slovenian: Glavno merilo učinkovitosti v vseh petih raziskavah je bila sprememba simptomov po šestih mesecih do enega leta zdravljenja.
English: For both diseases, the patients had had an inadequate response to previous therapy, and the main measure of effectiveness was the change in symptoms after 12 weeks of treatment.
Slovenian: V primeru obeh bolezni so se bolniki pred tem neustrezno odzvali na prejšnje oblike zdravljenja, glavno merilo učinkovitosti pa je bila sprememba simptomov po 12 tednih zdravljenja.
English: Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis.
Slovenian: Zdravilo Trudexa so raziskovali v petih raziskavah, ki so vključevale skoraj 2900 bolnikov z zmernim do hudim revmatoidnim artritisom.
English: In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]).
Slovenian: V raziskavah zdravila Trudexa so bili najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) vnetje zgornjih dihal (prehladi) in reakcije na mestu vbrizganja (vključno z bolečino, otekanjem, rdečino ali srbenjem).
English: The recommended dose of Trudexa is 40 mg given every 2 weeks as a single subcutaneous injection (under the skin).
Slovenian: Priporočeni odmerek zdravila Trudexa znaša 40 mg vsake dva tedna v obliki ene same podkožne injekcije.
English: The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo.
Slovenian: Največja zmanjšanja so opazili pri raziskavah, v katerih so raziskovali zdravilo Trudexa kot dodatek zdravljenju z metotreksatom: v dveh raziskavah skupaj sta po šestih mesecih približno dve tretjini bolnikov, ki so kot dodatno zdravljenje prejemali 40 mg zdravila Trudexa vsake dva tedna, pokazali 20 % zmanjšanje jakosti simptomov, v primerjavi s četrtino tistih bolnikov, ki so kot dodatek prejemali placebo.
English: The fifth study included 799 patients, none of whom had taken methotrexate in the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone.
Slovenian: Peta raziskava je vključevala 799 bolnikov, ki v preteklosti še niso prejemali metotreksata, v raziskavi pa so primerjali kombinacijo zdravila Trudexa in metotreskata s samostojnim dajanjem metotreksata ali zdravila Trudexa.
English: What benefit has Trudexa shown during the studies?
Slovenian: Kakšne koristi je zdravilo Trudexa izkazalo med raziskavami?
English: By blocking TNF, adalimumab improves the inflammation and other symptoms of the diseases.
Slovenian: Z zaviranjem TNF učinkovina adalimumab izboljša stanje vnetij in druge simptome bolezni.
English: Trudexa should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
Slovenian: Zdravila Trudexa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) adalimumab ali katerokoli drugo sestavino zdravila.
English: The committee recommended that Trudexa be given marketing authorisation.
Slovenian: Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Trudexa.
English: Some patients with rheumatoid arthritis who are taking Trudexa without methotrexate may benefit from taking this dose every week.
Slovenian: Nekaterim bolnikom z revmatoidnim artritisom, ki prejemajo samo zdravilo Trudexa brez metotreksata, lahko koristi isti odmerek, apliciran enkrat na teden.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Slovenian: • revmatoidnim artritisom (bolezen imunskega sistema, ki povzroča vnetje sklepov).
English: The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa's benefits are greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so koristni učinki zdravila Trudexa večji od z njim povezanih tveganj pri zdravljenju zmernega do hudega revmatoidnega artritisa, psoriatičnega artritisa in ankilozirajočega spondilitisa pri odraslih, če se druge oblike zdravljenja niso izkazale za primerne.
English: Treatment with Trudexa must be initiated and supervised by a doctor who has experience in the treatment of the diseases that Trudexa is used to treat.
Slovenian: Zdravljenje z zdravilom Trudexa mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju bolezni, ki se zdravijo s tem zdravilom.
English: What is the risk associated with Trudexa?
Slovenian: Kakšna tveganja so povezana z zdravilom Trudexa?
English: Trudexa is used in combination with methotrexate (a medicine that acts on the immune system) in patients with moderate or severe disease who have not responded adequately to other treatments, or patients with severe disease who have not taken methotrexate before.
Slovenian: Zdravilo Trudexa se uporablja v povezavi z metotreksatom (zdravilom, ki vpliva na imunski sistem) pri bolnikih z zmerno ali hudo boleznijo, ki se ne odzivajo zadostno na druge oblike zdravljenj, ali pri bolnikih s hudo obliko bolezni, ki še niso prejemali metotreksata.
English: For the other two diseases, Trudexa produced a greater improvement in symptoms than placebo.
Slovenian: Pri drugih dveh boleznih je zdravilo Trudexa povzročilo večje izboljšanje simptomov kot placebo.
English: In the patients who had not taken methotrexate before, more patients taking Trudexa and methotrexate had a 50% reduction in symptoms than those taking methotrexate alone over a year of treatment (62% and 46%, respectively).
Slovenian: Pri bolnikih, ki predhodno še niso prejemali metotreksata, je 50 % zmanjšanje jakosti simptomov po enem letu zdravljenja pokazalo več bolnikov, ki so prejemali zdravili Trudexa in metotrexat, kot tistih, ki so jemali samo metotreksat (62 % oziroma 46 %).
English: Trudexa is a medicine containing the active substance adalimumab.
Slovenian: Trudexa je zdravilo, ki vsebuje zdravilno učinkovino adalimumab.
English: Due to an increased risk of infection, patients must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment with Trudexa.
Slovenian: Zaradi povečanega tveganja okužbe je treba med zdravljenjem z zdravilom Trudexa in do pet mesecev po zaključku le-tega bolnike skrbno opazovati zaradi morebitnih okužb, ki vključujejo tudi tuberkulozo.
English: In four of these studies (involving over 2,000 patients), the effectiveness of Trudexa, alone or as an as add-on to other anti-inflammatory medicines, including methotrexate, was compared with that of a placebo (a dummy treatment) in patients who generally had taken anti-arthritis medicines in the past.
Slovenian: V štirih od teh raziskav (vključevale so več kot 2000 bolnikov) so učinkovitost zdravila Trudexa, ki so ga dajali samostojno ali kot dodatek zdravljenju z drugim protivnetnim zdravilom, vključno z metotreksatom, primerjali z učinkom placeba (zdravilom brez zdravilne učinkovine) pri bolnikih, ki so v preteklosti že prejemali zdravilo proti artritisu.
English: Adalimumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor (TNF).
Slovenian: Učinkovina adalmumab je bila zasnovana tako, da se veže na obveščevalno molekulo v telesu, ki jo imenujemo tumor nekrotizirajoči faktor (TNF).
English: Trudexa should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure.
Slovenian: Zdravila Trudexa se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi boleznimi ali zmerno do hudim popuščanjem srca.
English: For the full list of all side effects reported with Trudexa, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Trudexa, glejte Navodilo za uporabo.
English: Why has Trudexa been approved?
Slovenian: Zakaj je bilo zdravilo Trudexa odobreno?
English: Trudexa can be used alone if the patient cannot take methotrexate.
Slovenian: Zdravilo Trudexa se lahko uporablja samostojno pri bolnikih, ki ne prenašajo metotreksata;
English: In rheumatoid arthritis, Trudexa was more effective than placebo in reducing symptoms.
Slovenian: V primeru revmatoidnega artritisa je bilo zdravilo Trudexa pri manjšanju jakosti simptomov bolj učinkovito kot placebo.
English: • severe ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) in patients who have not responded adequately to other treatments.
Slovenian: • hudim ankilozirajočim spondilitisom (bolezen, k povzroča vnetje in bolečine sklepov hrbtenice) pri bolnikih, ki se niso ustrezno odzvali na druge oblike zdravljenj.
English: Patients adding Trudexa also had less joint damage and experienced less reduction in physical function than those adding placebo after a year of treatment.
Slovenian: Bolniki, ki so kot dodatek prejemali zdravilo Trudexa, so imeli po enem letu zdravljenja tudi manjši obseg poškodb sklepov in so bili bolj telesno zmožni kot tisti, ki so prejemali placebo.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in patients who have not responded adequately to other treatments,
Slovenian: • psoriatičnim artritisom (bolezen, ki povzroča nastajanje rdečih in luskinastih zaplat na koži in vnetje sklepov) pri bolnikih, ki se niso ustrezno odzvali na druge oblike zdravljenj;
English: After training, patients may inject themselves with Trudexa if their doctor agrees.
Slovenian: Ob soglasju zdravnika si lahko bolniki po opravljenem usposabljanju sami vbrizgavajo zdravilo Trudexa.
English: The active substance in Trudexa, adalimumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina adalimumab v zdravilu Trudexa je monoklonsko protitelo.
English: The full EPAR for Trudexa can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trudexa je na voljo tukaj.
English: Trudexa is an anti-inflammatory medicine.
Slovenian: Zdravilo Trudexa je protivnetno zdravilo.
English: In rheumatoid arthritis, Trudexa has been shown to reduce the rate at which joint damage gets worse and to improve physical function, when given in combination with methotrexate.
Slovenian: Dokazano je bilo, da zdravilo Trudexa upočasni hitrost kvarjenja sklepov in izboljša telesne zmožnosti, če se ga daje v povezavi z metotreksatom.
English: What is Trudexa used for?
Slovenian: Za kaj se zdravilo Trudexa uporablja?
English: How has Trudexa been studied?
Slovenian: Kako je bilo zdravilo Trudexa raziskano?
English: How does Trudexa work?
Slovenian: Kako zdravilo Trudexa deluje?
English: What is Trudexa?
Slovenian: Kaj je zdravilo Trudexa?
English: For ankylosing spondylitis, Trudexa and placebo as an add-on to existing treatment were compared in two studies involving 397 patients.
Slovenian: V dveh raziskavah, ki sta vključevali 397 bolnikov z ankilozirajočim spondilitisom, so primerjali zdravilo Trudexa in placebo, ki so ju uporabili kot dodatka že obstoječemu zdravljenju.
English: and is found at high levels in patients with the diseases that Trudexa is used to treat.
Slovenian: Ta obveščevalna molekula sodeluje pri vnetjih in je prisotna v visokih koncentracijah pri bolnikih, ki jih zdravijo z zdravilom Trudexa.
English: How is Trudexa used?
Slovenian: Kako se zdravilo Trudexa uporablja?
English: For psoriatic arthritis, Trudexa was compared to placebo in two studies including 413 patients.
Slovenian: V dveh raziskavah, ki sta vključevali 413 bolnikov s psoriatičnim artritisom, so zdravilo Trudexa primerjali s placebom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tybost on 19 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tybost, veljavno po vsej Evropski uniji, odobrila dne 19. septembra 2013.
English: Tybost is available as tablets (150 mg).
Slovenian: Zdravilo Tybost je na voljo v obliki tablet (150 mg).
English: The recommended dose is one tablet per day, taken with food.
Slovenian: Priporočeni odmerek je ena tableta na dan, ki se jemlje skupaj s hrano.
English: What measures are being taken to ensure the safe and effective use of Tybost?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tybost?