FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Translarna can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Translarna so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Despite the need for further data, the Agency considered that the evidence suggests that Translarna slows the progression of the disease and that its safety profile is not of major concern.
Slovenian: Kljub potrebi po dodatnih podatkih je agencija menila, da obstajajo dokazi, da zdravilo Translarna upočasni napredovanje bolezni, in da varnostni profil zdravila ni posebej skrb vzbujajoč.
English: In both studies, the beneficial effects of Translarna seemed more evident in patients with moderate decline of their disease.
Slovenian: V obeh študijah je bil učinek zdravila Translarna bolj očiten pri bolnikih z zmernim poslabšanjem bolezni.
English: Translarna has been given ‘conditional authorisation'.
Slovenian: Zdravilo Translarna je pridobilo „pogojno dovoljenje za promet“.
English: What benefits of Translarna have been shown in studies?
Slovenian: Kakšne koristi zdravila Translarna so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Translarna have 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 Translarna upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Since Translarna has been given conditional authorisation, the company that markets it will provide results of a new study comparing Translarna with placebo in order to confirm its effectiveness and safety.
Slovenian: Ker je zdravilo Translarna pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo rezultate nove študije o primerjavi zdravila Translarna s placebom za potrditev njegove učinkovitosti in varnosti.
English: However, data indicated that Translarna had a positive effect on different measures such as time to run or walk 10 metres, time to climb up and down 4 steps and time to loss of walking ability.
Slovenian: Vseeno so podatki pokazali, da je imelo zdravilo Translarna pozitiven učinek na različna merila, kot so na primer čas teka ali hoje na 10 metrov, čas vzpenjanja in spuščanja po štirih stopnicah ter čas izgube zmožnosti hoje.
English: Translarna seemed effective on an assessment of physical activity in 12 patients when compared with past records of 11 patients of similar age who had not been treated with Translarna.
Slovenian: Zdravilo Translarna je bilo učinkovito glede na oceno telesne dejavnosti pri 12 bolnikih v primerjavi s preteklimi poročili za 11 bolnikov podobne starosti, ki niso bili zdravljeni z zdravilom Translarna.
English: What is Translarna and what is it used for?
Slovenian: Kaj je zdravilo Translarna in za kaj se uporablja?
English: Why is Translarna authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Translarna odobreno v EU?
English: The most common side effects with Translarna (which may affect more than 5 in 100 people) are vomiting, diarrhoea, nausea (feeling sick), headache, stomach ache and flatulence.
Slovenian: Najpogostejši neželeni učinki zdravila Translarna (ki se lahko pojavijo pri več kot petih osebah od 100) so bruhanje, driska, navzeja (slabost), glavobol, bolečine v trebuhu in flatulenca.
English: An overview of Translarna and why it is authorised in the EU
Slovenian: Pregled zdravila Translarna in zakaj je odobreno v EU
English: What are the risks associated with Translarna?
Slovenian: Kakšna tveganja so povezana z zdravilom Translarna?
English: For more information about using Translarna, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Translarna glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Translarna are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Translarna, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: Translarna is taken three times a day, and the recommended dose is 10 mg/kg (10 mg per kilogram body weight) in the morning, 10 mg/kg at midday and 20 mg/kg in the evening (making a total daily dose of 40 mg/kg).
Slovenian: Jemlje se trikrat na dan, pri čemer je priporočeni odmerek 10 mg/kg (10 mg na kilogram telesne mase) zjutraj, 10 mg/kg opoldne in 20 mg/kg zvečer (kar je skupaj 40 mg/kg na dan).
English: Translarna must not be used at the same time as aminoglycoside antibiotics given by injection or infusion (drip) into a vein.
Slovenian: Zdravilo Translarna se ne sme uporabljati sočasno z aminoglikozidnimi antibiotiki, ki se dajejo z injiciranjem ali (kapalno) infuzijo v veno.
English: Before starting treatment with Translarna, patients will have a genetic test to confirm that their disease is due to a nonsense mutation and that they are therefore suitable for treatment with Translarna.
Slovenian: Pred začetkom zdravljenja z zdravilom Translarna bodo pri bolnikih opravili genetsko preiskavo, s katero bodo ugotovili, ali je njihova bolezen posledica nesmiselne mutacije in so torej primerni za zdravljenje z zdravilom Translarna.
English: What information is still awaited for Translarna?
Slovenian: Katere informacije o zdravilu Translarna še pričakujemo?
English: Translarna is available as granules (125, 250 and 1,000 mg) to be taken by mouth after mixing them with liquid or semi-solid food (such as yogurt).
Slovenian: Zdravilo Translarna je na voljo v obliki zrnc (125 mg, 250 mg in 1 000 mg), ki se jemljejo skozi usta, potem ko se zmešajo s tekočino ali mehko hrano (na primer z jogurtom).
English: Because this protein helps to protect muscles from injury as muscles contract and relax, in patients with Duchenne muscular dystrophy the muscles become damaged and eventually stop working.
Slovenian: Ker ta beljakovina pomaga ščititi mišice pred poškodbami ob njihovem krčenju in sproščanju, se mišice pri bolnikih z Duchennovo mišično distrofijo poškodujejo in sčasoma prenehajo delovati.
English: Duchenne muscular dystrophy is rare, and Translarna was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Slovenian: Duchennova mišična distrofija je redka bolezen, zato je bilo zdravilo Translarna 27. maja 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The Agency acknowledged that patients with Duchenne muscular dystrophy have an unmet need for treatment of this serious condition.
Slovenian: Agencija priznava, da imajo bolniki z Duchennovo mišično distrofijo neizpolnjeno potrebo po zdravljenju te težke bolezni.
English: Translarna is a medicine that is used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Slovenian: Translarna je zdravilo, ki se uporablja za zdravljenje bolnikov z Duchennovo mišično distrofijo, ki so starejši od dveh let in lahko hodijo.
English: Translarna is used in the small group of patients whose disease is caused by a specific genetic defect (called a ‘nonsense mutation') in the dystrophin gene.
Slovenian: Zdravilo Translarna se uporablja pri majhni skupini bolnikov, pri katerih je bolezen posledica posebne genetske okvare (imenovane „nesmiselna mutacija“) gena za distrofin.
English: Translarna can only be obtained with a prescription and treatment should be started by a specialist doctor experienced in the management of Duchenne/Becker muscular dystrophy.
Slovenian: Predpisovanje in izdaja zdravila Translarna je le na recept, zdravljenje z njim pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem Duchennove/Beckerjeve mišične distrofije.
English: Duchenne muscular dystrophy can be caused by a number of genetic abnormalities.
Slovenian: Duchennovo mišično distrofijo lahko povzročijo številne genetske nepravilnosti.
English: Translarna works in these patients by enabling the protein-making apparatus in cells to move past the defect, allowing the cells to produce a functional dystrophin protein.
Slovenian: Zdravilo Translarna pri teh bolnikih deluje tako, da omogoči mehanizmom v celicah, ki sodelujejo pri tvorbi beljakovine, da premostijo okvaro, s čimer omogoči celicam, da izdelajo funkcionalno beljakovino distrofin.
English: Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function.
Slovenian: Duchennova mišična distrofija je genetska bolezen, ki postopoma povzroči šibkost in prenehanje delovanja mišic.
English: The effect was more pronounced in a subgroup of patients whose ability to walk was worsening, where patients taking 40 mg/kg daily Translarna could walk on average 50 metres more than those taking placebo.
Slovenian: Učinek je bil izrazitejši v podskupini bolnikov, pri katerih se je zmožnost hoje poslabšala, pri čemer so bolniki, ki so jemali zdravilo Translarna v odmerku 40 mg/kg na dan, lahko prehodili v povprečju 50 metrov več kot tisti, ki so jemali placebo.
English: For the full list of side effects and restrictions of Translarna, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Translarna glejte navodilo za uporabo.
English: No improvement was seen with the higher dose (80 mg/kg daily).
Slovenian: Pri uporabi večjega odmerka (80 mg/kg/dan) niso opazili nobenega izboljšanja.
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene which prematurely stop the production of a normal dystrophin protein, leading to a shortened dystrophin protein that does not function properly.
Slovenian: Zdravilo Translarna je namenjeno za uporabo pri bolnikih, pri katerih je bolezen posledica prisotnosti določenih okvar (imenovanih nesmiselne mutacije) gena za distrofin, ki predčasno zaustavijo tvorbo normalne beljakovine distrofina, zaradi česar nastane skrajšana oblika beljakovine distrofin, ki ne deluje pravilno.
English: A small study in children aged 2 to 5 years with Duchenne muscular dystrophy found that the usual dose of Translarna 40 mg/kg daily was sufficient.
Slovenian: Z manjšo študijo pri otrocih z Duchennovo mišično distrofijo, starih od 2 do 5 let, je bilo ugotovljeno, da zadostuje običajni odmerek zdravila Translarna 40 mg/kg dnevno.
English: Although an initial analysis of the results of all the data from the study did not show a significant difference in the distances patients in the Translarna and placebo groups could walk, further analyses indicated that walking ability worsened to a lesser extent with 40 mg/kg daily Translarna than with placebo: after 48 weeks of treatment patients receiving 40 mg/kg daily Translarna could walk on average 32 metres more than those given placebo.
Slovenian: Čeprav prvotna analiza rezultatov vseh podatkov iz študije ni pokazala pomembne razlike med razdaljami, ki so jih lahko prehodili bolniki iz skupine, ki je jemala zdravilo Translarna, in bolniki iz skupine, ki je jemala placebo, so dodatne analize pokazale, da se je zmožnost hoje pri uporabi zdravila Translarna v odmerku 40 mg/kg na dan poslabšala manj kot pri uporabi placeba: po 48 tednih zdravljenja so bolniki, ki so prejemali zdravilo Translarna v odmerku 40 mg/kg na dan, v povprečju lahko prehodili 32 metrov več kot tisti, ki so prejemali placebo.
English: Patients with Duchenne muscular dystrophy lack normal dystrophin, a protein found in muscles.
Slovenian: Bolniki z Duchennovo mišično distrofijo imajo pomanjkanje normalnega distrofina, tj. beljakovine, ki je prisotna v mišicah.
English: How does Translarna work?
Slovenian: Kako zdravilo Translarna deluje?
English: In one main study, involving 174 patients aged 5 to 20 years with Duchenne muscular dystrophy who were able to walk, two doses of Translarna (40 mg/kg daily and 80 mg/kg daily) were compared with placebo (a dummy treatment).
Slovenian: V eni glavni študiji, v katero je bilo vključenih 174 bolnikov z Duchennovo mišično distrofijo, starih od 5 do 20 let, ki so lahko hodili, so dva odmerka zdravila Translarna (40 mg/kg na dan in 80 mg/kg na dan) primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: How is Translarna used?
Slovenian: Kako se zdravilo Translarna uporablja?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Raptiva to Serono Europe Ltd. on 20 September 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Raptiva, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Ltd. dne 20. septembra 2004.
English: Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.
Slovenian: Bolniki si lahko zdravilo injicirajo sami, pod pogojem da so bili za to ustrezno usposobljeni, če zdravnik meni, da je to primerno.
English: In the fifth study, 526 of the 793 patients were ‘high need', since they had failed to respond to or could not take other systemic treatments.
Slovenian: V peti raziskavi je bilo 526 izmed 793 bolnikov takih z „visoko potrebo“, saj se niso odzvali na ali niso mogli jemati drugih sistemskih zdravil.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RAPTIVA
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) RAPTIVA
English: It is given as a 12-week course, with a first dose of 0.7 mg per kilogram body weight followed by weekly injections of 1.0 mg/kg.
Slovenian: Daje se 12 tednov, začetni odmerek je 0,7 mg na kilogram telesne mase, čemur sledijo tedenske injekcije v odmerku 1,0 mg/kg.
English: The main measure of effectiveness was the proportion of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so se po 12 tednih odzvali na zdravljenje, kar je pomenilo, da so se ocene simptomov izboljšale za 75 % ali več.
English: The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘high-need' patients, and that the effectiveness of Raptiva is relevant for these patients.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je upošteval, da je bila psoriaza hujša pri bolnikih z „visoko potrebo“ in da je učinkovitost zdravila Raptiva pomembna za te bolnike.
English: The Committee recommended that Raptiva be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Raptiva odobri dovoljenje za promet.
English: How has Raptiva been studied?
Slovenian: Kako je bilo zdravilo Raptiva raziskano?
English: What benefit has Raptiva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Raptiva izkazalo med raziskavami?
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 on the surface of cells in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo oblikovano tako, da prepozna in se veže na specifično strukturo (imenovano antigen), ki se nahaja na površini celic v telesu.
English: Raptiva is given by injection under the skin.
Slovenian: Zdravilo Raptiva se daje z injekcijo pod kožo.
English: As LFA-1 is important in helping the lymphocytes to stick to cells in the skin, efalizumab reduces the inflammation in the skin that causes psoriasis.
Slovenian: Ker LFA-1 pomembno pomaga limfocitom, da se vežejo na celice v koži, efalizumab zmanjšuje vnetje kože, ki povzroča psoriazo.
English: Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
Slovenian: Zdravilo Raptiva so preučevali v petih glavnih študijah z več kot 3000 bolniki z zmerno do hudo psoriazo s plaki.
English: Raptiva was more effective than placebo at improving the symptoms of psoriasis.
Slovenian: Zdravilo Raptiva je bilo pri izboljšanju simptomov psoriaze učinkovitejše od placeba.
English: Looking only at the ‘high need' patients in this study, 30% of those receiving Raptiva responded to treatment, compared with 3% of those receiving
Slovenian: Če upoštevamo le bolnike z „visoko potrebo“ iz te študije, se je na zdravljenje odzvalo 30 % izmed tistih, ki so prejemali zdravilo Raptiva, v primerjavi s 3 % bolnikov, ki so prejemali placebo.
English: It contains the active
Slovenian: Vsebuje zdravilno
English: In the fifth study, overall, 166 (31%) of the 529 patients receiving Raptiva responded to treatment, compared with 11 (4%) of the 264 receiving placebo.
Slovenian: V peti študiji se je na zdravljenje odzvalo skupaj 166 (31 %) izmed 529 bolnikov, ki so prejemali zdravilo Raptiva, v primerjavi z 11 (4 %) izmed 264 bolnikov, ki so prejemali placebo.
English: Efalizumab has been designed to bind to part of a protein called LFA-1 on the surface of lymphocytes, a type of white blood cell that is involved in the inflammation process.
Slovenian: Efalizumab je zasnovan tako, da se veže na del beljakovine, imenovane LFA-1, na površini limfocitov, tj. na vrsto belih krvničk, ki sodeluje pri vnetnem procesu.
English: Looking at the results of the first four studies taken together, 320 (26%) of the 1,213 patients receiving 1.0 mg/kg Raptiva per week responded to treatment, compared with 25 (4%) of the 715 receiving placebo.
Slovenian: Če pogledamo rezultate prvih štirih študij skupaj, ugotovimo, da se je na zdravljenje odzvalo 320 (26 %) izmed 1213 bolnikov, ki so prejemali 1,0 mg/kg zdravila Raptiva tedensko, v primerjavi s 25 (4 %) izmed 715 bolnikov, ki so prejemali placebo.
English: The most common side effects with Raptiva (seen in more than 1 patient in 10) are mild to moderate flu-like symptoms including headache, fever, chills, nausea (feeling sick), myalgia (muscle pain), and leucocytosis and lymphocytosis (increased white blood cell counts).
Slovenian: Najpogostejši neželeni učinki pri jemanju zdravila Raptiva (opaženi pri več kot 1 izmed 10 bolnikov) so blagi do zmerni gripi podobni simptomi, kot so glavobol, povišana telesna temperatura, mrzlica, navzeja (slabost), mialgija (bolečina v mišicah) ter levkocitoza in limfocitoza (zvišana koncentracija belih krvničk).
English: It should also not be used in patients who have had cancer, who have active tuberculosis or another severe infection, who have other types of psoriasis, or who have low levels of
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki so imeli raka, ki imajo aktivno tuberkulozo ali druge hude okužbe, druge oblike psoriaze ali oslabljen imunski sistem.
English: Raptiva treatment should be initiated by a doctor who specialises in dermatology (the treatment of skin conditions).
Slovenian: Zdravljenje z zdravilom Raptiva mora uvesti zdravnik, specializiran za dermatologijo (zdravljenje kožnih obolenj).
English: The active substance in Raptiva, efalizumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Raptiva, efalizumab, je monoklonsko protitelo.
English: In all studies, the effectiveness of Raptiva was compared with that of placebo (a dummy treatment).
Slovenian: V vseh študijah so učinkovitost zdravila Raptiva primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine).
English: Raptiva should not be used in people who may be hypersensitive (allergic) to efalizumab or any of the other ingredients.
Slovenian: Zdravila Raptiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) efalizumab ali katero koli drugo sestavino zdravila.
English: Raptiva should be used with caution in patients who have problems with their liver or
Slovenian: Zdravilo Raptiva je treba pri bolnikih, ki imajo težave z jetri ali ledvicami, uporabljati previdno.
English: Raptiva is used for the treatment of adults with moderate to severe chronic (long-term) plaque psoriasis (a disease causing red, scaly patches on the skin).
Slovenian: Zdravilo Raptiva se uporablja za zdravljenje odraslih z zmerno do hudo kronično (dolgotrajno) psoriazo (luskavico) s plaki (bolezen, ki povzroča rdeče, luskaste spremembe na koži).
English: It is used in patients who have failed to respond to or cannot take other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Slovenian: Uporablja se pri bolnikih, ki se ne odzivajo na ali ne morejo jemati drugih sistemskih zdravil (zdravil, ki delujejo na celotno telo) za psoriazo, vključno s ciklosporinom, metotreksatom in PUVA (psoralen v kombinaciji z obsevanjem z UVA žarki).
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet
Slovenian: PUVA je vrsta zdravljenja, pri katerem prejme bolnik, preden je izpostavljen ultravijolični svetlobi, zdravilo, ki vsebuje spojino psoralen.
English: Raptiva is a powder and solvent that are made up into a solution for injection.
Slovenian: Zdravilo Raptiva je prašek in vehikel za pripravo raztopine za injiciranje.
English: Therefore, the Committee decided that Raptiva's benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Slovenian: Odbor je zato odločil, da so koristi zdravila Raptiva pri zdravljenju odraslih bolnikov z zmerno do hudo kronično psoriazo s plaki, ki se ne odzivajo na druga sistemska zdravljenja, vključno s ciklosporinom, metotreksatom in PUVA, oziroma imajo zanje kontraindikacije ali jih ne prenašajo, večje od z njim povezanih tveganj.
English: This improves
Slovenian: To izboljša simptome bolezni.
English: The full EPAR for Raptiva can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Raptiva je na voljo tukaj.
English: For the full list of all side effects reported with Raptiva, see the Package Leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila
English: The studies included patients who had not taken other treatments for psoriasis in the past, as well as those who had taken other treatments.
Slovenian: Rezultati so bili pri bolnikih, ki so predhodno prejemali sistemska zdravila za psoriazo, podobni kot pri bolnikih, ki teh zdravil niso prejemali.
English: Therapy should only be continued in patients who have responded to treatment.
Slovenian: Maksimalni posamični odmerek je 200 mg. Zdravljenje se sme nadaljevati samo pri bolnikih, ki so se odzvali na zdravljenje.
English: The main measure of effectiveness was the average change in the blood pressure.
Slovenian: Glavno merilo učinkovitosti je bila povprečna sprememba krvnega tlaka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exforge HCT on 16 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Exforge HCT, veljavno po vsej Evropski uniji, odobrila dne 16. oktobra 2009.
English: The full EPAR for Exforge HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exforge HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: amlodipine / valsartan / hydrochlorothiazide
Slovenian: amlodipin/valsartan/hidroklorotiazid
English: Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
Slovenian: Ker se kombinacija treh zdravilnih učinkovin uporablja že vrsto let, je družba predstavila študije, ki kažejo, da se tableta, ki vsebuje vse tri učinkovine, v telesu absorbira enako kot tablete z ločenimi učinkovinami.