FrancophonIA/ELRC3.0 huggingface dataset:
English: Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable.
Slovenian: Zdravilo Opsumit se je izkazalo za učinkovito pri zmanjševanju bolezni ali smrti zaradi PAH, neželeni učinki pa so podobni, kot jih vidimo pri drugih zdravilih tega razreda, in veljajo za obvladljive.
English: Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.
Slovenian: Opozorilne kartice za bolnike bodo vključevale opozorilo, da se to zdravilo ne sme nikoli uporabljati pri nosečih ženskah in da morajo ženske, ki bi lahko zanosile, uporabljati zanesljiva kontracepcijska sredstva in opravljati mesečne teste nosečnosti.
English: How is Opsumit used?
Slovenian: Kako se zdravilo Opsumit uporablja?
English: The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Slovenian: Učinkovina v zdravilu Opsumit, macitentan, deluje tako, da zavira receptorje za endotelin.
English: It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood.
Slovenian: Zdravilo se ne sme uporabljati pri doječih materah in bolnikih, ki imajo hude težave z jetri ali visoke vrednosti jetrnih encimov v krvi.
English: Opsumit contains the active substance macitentan.
Slovenian: Zdravilo Opsumit vsebuje učinkovino macitentan.
English: In PAH there is severe narrowing of the arteries of the lungs.
Slovenian: Pri PAH so pljučne arterije močno zožene.
English: Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years.
Slovenian: Bolniki v študiji so poleg drugih zdravil za zdravljenja te bolezni povprečno dve leti prejemali bodisi zdravilo Opsumit bodisi placebo (zdravilo brez učinkovine).
English: Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Slovenian: Zdravila Opsumit ne smejo uporabljati nosečnice, doječe matere ali ženske, ki bi lahko zanosile, ter ženske, ki ne uporabljajo zanesljivih kontracepcijskih sredstev.
English: For the full list of side effects reported with Opsumit, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Opsumit, glejte navodilo za uporabo.
English: However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Slovenian: Zdravilo Opsumit se ne sme nikoli uporabljati pri nosečnicah ali ženskah, ki bi lahko zanosile in ne uporabljajo zanesljivih kontracepcijskih sredstev.
English: How does Opsumit work?
Slovenian: Kako zdravilo Opsumit deluje?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Purevax RCPCh, veljavno po vsej Evropski uniji, izdala 23. februarja 2005.
English: The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Slovenian: Ta mu bodo pomagala pri zaščiti pred boleznimi, ki jih povzročajo ti virusi ali bakterije.
English: If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age.
Slovenian: Če ima mucka visoke ravni protiteles, ki jih je prejela od matere v maternici in z mlekom, je treba s prvim cepljenjem počakati do starosti 12 tednov.
English: They included young and adult cats of various breeds, but not young kittens.
Slovenian: V študije so vključili mlade in odrasle mačke različnih pasem, ne pa mladih muck.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“ obrambe pred boleznimi.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Slovenian: Glavno merilo učinkovitosti je bila raven protiteles v krvi proti virusom in bakterijam iz cepiva.
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Slovenian: Povišanja ravni protiteles proti C. felis zaradi visoke ravni protiteles pri mačkah ob začetku študije ni bilo mogoče zaznati.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Slovenian: Mačko je treba ponovno cepiti za vse sestavine cepiva eno leto po prvem cepljenju, nato pa vsako leto proti klamidiozi ter vsaka tri leta proti rinotraheitisu, kalicivirozi in panlevkopeniji.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Purevax RCPCh večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko mačko cepimo, imunski sistem prepozna oslabljene ali uničene viruse in oslabljene bakterije kot „tujke“ ter proti njim razvije protitelesa.
English: If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Slovenian: V primeru samo-injiciranja pri taki osebi zdravniku povejte, da je prišlo do samo-injiciranja z živim cepivom, ki vsebuje klamidijo.
English: In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
Slovenian: V laboratorijskih pogojih je bilo dokazano, da zdravilo Purevax RCPCh zagotavlja zaščito pred zgoraj navedenimi boleznimi.
English: Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Slovenian: Zdravilo Purevax RCPCh se uporablja za cepljenje mačk, starih osem tednov ali več, proti naslednjim boleznim:
English: In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Slovenian: V terenskih študijah zdravila Purevax RCPCh so preučevali osnovno shemo cepljenja (dve injekciji v tri- do štiritedenskem razmiku) in obnovitveno cepljenje.
English: Purevax RCPCh is a vaccine.
Slovenian: Zdravilo Purevax RCPCh je cepivo.
English: For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Purevax RCPCh, glejte navodilo za uporabo.
English: Purevax RCPCh should not be used in pregnant cats.
Slovenian: Zdravilo Purevax RCPCh se ne sme uporabljati pri brejih mačkah.
English: Other information about Purevax RCPCh:
Slovenian: Druge informacije o zdravilu Purevax RCPCh:
English: The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Slovenian: Učinkovitost zdravila Purevax RCPCh so preučevali v več preskušanjih v laboratorijskih pogojih, kjer so mačke cepili in okužili s herpesvirusom, kalicivirusom, C. felis ali parvovirusom.
English: Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Slovenian: Zdravilo Purevax RCPCh je na voljo v obliki liofilizata (pelet, posušenih v zamrznjenem stanju) in vehikla za pripravo suspenzije za injiciranje.
English: Purevax RCPCh is a veterinary vaccine that contains:
Slovenian: Zdravilo Purevax RCPCh je cepivo za uporabo v veterinarski medicini, ki vsebuje:
English: Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Slovenian: Zdravilo Purevax RCPCh vsebuje majhne količine oslabljenih ali uničenih virusov, ki povzročajo rinotraheitis, kalicivirozo, klamidiozo in panlevkopenijo mačk.
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
Slovenian: V študiji obnovitvenega cepljenja je bilo ugotovljeno, da so ravni protiteles proti herpesvirusu rinotraheitisa, okužbam s kalicivirusi, panlevkopeniji mačk in C. felis ostale stabilne na visoki ravni ali pa so se nekoliko zvišale.
English: What benefit has Purevax RCPCh shown during the studies?
Slovenian: Kakšne koristi je zdravilo Purevax RCPCh izkazalo v študijah?
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Slovenian: V terenski študiji osnovnega cepljenja je bilo ugotovljeno povečanje protiteles proti herpesvirusu rinotraheitisa mačk, okužbam s kalicivirusi in virusom panlevkopenije mačk.
English: Why has Purevax RCPCh been approved?
Slovenian: Zakaj je bilo zdravilo Purevax RCPCh odobreno?
English: What is the risk associated with Purevax RCPCh?
Slovenian: Kakšna tveganja so povezana z zdravilom Purevax RCPCh?
English: What is Purevax RCPCh?
Slovenian: Kaj je zdravilo Purevax RCPCh?
English: How has Purevax RCPCh been studied?
Slovenian: Kako je bilo zdravilo Purevax RCPCh raziskano?
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Slovenian: Cepivo proti virusnemu rinotraheitisu mačk, (živo oslabljeno) cepivo proti panlevkopeniji mačk in (inaktivirano) cepivo proti kalicivirozi mačk
English: What is Purevax RCPCh used for?
Slovenian: Za kaj se zdravilo Purevax RCPCh uporablja?
English: How does Purevax RCPCh work?
Slovenian: Kako zdravilo Purevax RCPCh deluje?
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati dne 20. julija 2015.
English: A further study was carried out in 15 female patients.
Slovenian: Dodatna študija je bila izvedena pri 15 ženskih bolnicah.
English: Replagal agalsidase alfa
Slovenian: Replagal agalsidaza alfa
English: The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Replagal, veljavno po vsej Evropski uniji, izdala 3. avgusta 2001.
English: Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Slovenian: Zdravilo Replagal so ocenili tudi v dodatnih študijah, v katerih je sodelovalo 38 otrok, starih sedem let ali več.
English: The full EPAR for Replagal 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 Replagal je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What benefit has Replagal shown during the studies?
Slovenian: Kakšne koristi je zdravilo Replagal izkazalo med študijami?
English: The effect of giving doses weekly rather than every two weeks was also investigated.
Slovenian: Proučevali so tudi učinke dajanja odmerkov vsak teden namesto vsaka dva tedna.
English: For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Replagal preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Replagal.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Replagal.
English: Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
Slovenian: Pri otrocih, ki so prejemali zdravilo Replagal, se srčna masa ni nepričakovano povečala, ravni Gb3 v krvi pa so se znižale.
English: The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Replagal (opaženi pri več kot 1 bolniku od 10) so reakcije, povezane z infundiranjem.
English: These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Slovenian: Med njimi so mrzlica, glavobol, slabost, pireksija (povišana telesna temperatura), bolečina in nelagodje, zardevanje in utrujenost in so redko resni.
English: Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Slovenian: Zdravilo se daje vsaka dva tedna v obliki 40-minutne infuzije v odmerku 0,2 mg/kg telesne mase.
English: Other information about Replagal
Slovenian: Druge informacije o zdravilu Replagal
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Slovenian: Bolniki s Fabryjevo boleznijo nimajo dovolj encima, imenovanega alfa-galaktozidaza A. Ta encim običajno razgrajuje maščobno snov, imenovano globotriaozilceramid (Gb3 ali GL-3 ).
English: What is the risk associated with Replagal?
Slovenian: Kakšna tveganja so povezana z zdravilom Replagal?
English: Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Slovenian: Zdravilo Replagal je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
English: The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Slovenian: Nadomestni encim pomaga razgraditi Gb3 in preprečiti njegovo kopičenje v celicah.
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Slovenian: Ljudje z Fabryjevo boleznijo imajo številne znake in simptome, vključno s hudimi zdravstvenimi težavami, kot so odpoved ledvic, težave s srcem in možganska kap.
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 Replagal.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Slovenian: V prvi študiji so merili učinke zdravila Replagal na bolečino, v drugi pa so proučevali njegov učinek na maso levega prekata (srčne mišice), kar je merilo količine Gb3 v srčnih celicah.
English: If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Slovenian: Če encima ni, se Gb3 ne more razgraditi in se začne kopičiti v telesnih celicah, kot so na primer ledvične celice.
English: Why has Replagal been approved?
Slovenian: Zakaj je bilo zdravilo Replagal odobreno?
English: It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Slovenian: Zdravilo Replagal so primerjali s placebom (zdravilom brez zdravilne učinkovine) v dveh glavnih študijah, ki so vključevale skupaj 40 bolnikov moškega spola.
English: Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Slovenian: Zdravilo Replagal je namenjeno nadomeščanju človeškega encima alfa-galaktozidaze A, ki ga primanjkuje osebam s Fabryjevo boleznijo.
English: The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Replagal večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Slovenian: Zdravilo Replagal je maso levega prekata zmanjšalo povprečno za 11,5 g, medtem ko se je masa levega prekata pri bolnikih, ki so prejemali placebo, povečala za 21,8 g. Učinki zdravila so bili pri ženskah in moških primerljivi.
English: The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Slovenian: Zdravilna učinkovina zdravila Fabrazyme, agalzidaza beta, je kopija človeškega encima, in se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori encim.
English: The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
Slovenian: CHMP je menil, da lahko zdravljenje z zdravilom Replagal bolnikom s Fabryjevo boleznijo zagotovi dolgotrajne klinične koristi.
English: After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Slovenian: Po šestih mesecih zdravljenja so imeli bolniki, ki so prejemali zdravilo Replagal, občutno manj bolečin kot tisti, ki so prejemali placebo.
English: For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Replagal glejte navodilo za uporabo.
English: Replagal is an enzyme replacement therapy.
Slovenian: Zdravilo Replagal je encimska nadomestna terapija.
English: Replagal is medicine that contains the active substance agalsidase alfa.
Slovenian: Replagal je zdravilo, ki vsebuje zdravilno učinkovino agalzidaza alfa.
English: Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Slovenian: Zdravilo Replagal se uporablja za zdravljenje bolnikov s Fabryjevo boleznijo, ki je redka dedna bolezen.
English: How has Replagal been studied?
Slovenian: Kako je bilo zdravilo Replagal raziskano?
English: Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Slovenian: Zdravilo Replagal lahko predpiše samo zdravnik, ki ima izkušnje z obravnavo bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
English: What is Replagal used for?
Slovenian: Za kaj se zdravilo Replagal uporablja?
English: How is Replagal used?
Slovenian: Kako se zdravilo Replagal uporablja?
English: What is Replagal?
Slovenian: Kaj je zdravilo Replagal?
English: How does Replagal work?
Slovenian: Kako zdravilo Replagal deluje?
English: Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
Slovenian: Ker ni bilo mogoče doseči soglasja, je (CMD(h)) postopek predal odboru CHMP.
English: Content (concentrati on)
Slovenian: Vsebnost (koncentraci ja)
English: In the Netherlands bleomycin is currently approved for the following indications:
Slovenian: Bleomicin je na Nizozemskem trenutno odobren za naslednje indikacije:
English: The CHMP therefore considered the indication to be acceptable.
Slovenian: CHMP je zato to indikacijo upošteval kot sprejemljivo.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BLEOMYCIN PHARMACHEMIE AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA BLEOMYCIN PHARMACHEMIE IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Pharmaceutical Form
Slovenian: Farmacetska oblika
English: The CHMP assessed the available data in order to establish whether the two indications can be supported.
Slovenian: CHMP je ovrednotil razpoložljive podatke, da bi ugotovil, ali je mogoče zadevni indikaciji podpreti.
English: The same is applicable for the indication penile cancer; the indication is supported by reports suggesting a modest efficacy for this disease.
Slovenian: Enako velja tudi za indikacijo raka penisa; indikacijo podpirajo poročila, ki nakazujejo na skromno učinkovitost pri tej bolezni.
English: In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/risk balance is positive.
Slovenian: Odbor CHMP je na koncu menil, da ta učinkovitost odtehta toksičnost zdravila in da je razmerje med koristmi in tveganji pozitivno.
English: GROUNDS FOR OPINION
Slovenian: PODLAGA ZA MNENJE
English: The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
Slovenian: Vloga za zdravilo Bleomycin Pharmachemie je bila predložena kot generična vloga, ki je temeljila na dovoljenju za promet z zdravilom, odobrenem za referenčno zdravilo na Nizozemskem dne 18. novembra 1997.
English: The CHMP noted that bleomycin is in clinical use since the 1960ies, thereby explaining the lack of a clinical development programme.
Slovenian: Odbor CHMP je ugotovil, da je bleomicin v klinični uporabi od šestdesetih let prejšnjega stoletja, in s tem pojasnil, zakaj ni kliničnega razvojnega programa.
English: (Invented) Name
Slovenian: (Lastniško) ime
English: Because the benefit/risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Slovenian: Ker je bilo ocena koristi in tveganj teh indikacij za originatorsko zdravilo negativno in ker so v Nemčiji te indikacije posledično izbrisali iz odobrenih indikacij vseh zdravil, ki vsebujejo bleomicin, so indikacije upoštevali kot nove indikacije, ugovarjajoča država članica pa je menila, da predloženi podatki ne zadostujejo za odobritev dovoljenja za promet z zdravilom za predlagane nove indikacije.