FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Navodilo za uporabo ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: See section 4.
Slovenian: Priloga IV
English: Excipients
Slovenian: Docetaksel
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100-mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Common Constipation
Slovenian: Pogosto Konjunktivitis
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Any Grade 3 or 4 toxicities except mucositis
Slovenian: Katerekoli toksičnosti stopnje 3 ali
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Slovenian: 100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500-mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Constipation
Slovenian: luščenje
English: All grades toxicity
Slovenian: Toksičn ost vseh stopenj
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Slovenian: Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
English: Time to treatment failure (months) (95 % CI)
Slovenian: Čas do neuspeha zdravljenja (meseci)
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da se na navedeni način varno uporabljajo že vsaj 30 let (najmanj 15 let tudi v EU).
English: Hop strobile EMA/304459/2016
Slovenian: Cvet navadnega hmelja EMA/304459/2016
English: Hop strobile medicines should only be used in adults and adolescents over the age of 12 years.
Slovenian: Zdravila, ki vsebujejo cvet navadnega hmelja, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
English: Hop strobile is the common name for the flowers of the plant Humulus lupulus L.
Slovenian: Cvet navadnega hmelja je splošno ime za cvetove rastline Humulus lupulus L.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/304459/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: This summary is not intended to provide practical advice on how to use medicines containing hop strobile.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet navadnega hmelja.
English: The HMPC conclusions only cover hop strobile preparations which are obtained by comminuting (reducing into tiny pieces) or by drying and powdering the flowers or as dry or liquid extracts.
Slovenian: Zaključki odbora HMPC zajemajo samo pripravke s cvetom navadnega hmelja, ki se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) ali s sušenjem in drobljenjem cvetov v prah ter kot suhi ali tekoči ekstrakti.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of hop strobile.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta navadnega hmelja.
English: The solvent is then partially or completely evaporated to obtain a dry extract.
Slovenian: Topilo se nato delno ali v celoti odpari, s čimer se pridobi suhi ekstrakt.
English: Further information on the risks associated with these hop strobile medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo cvet navadnega hmelja, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing these hop strobile preparations are usually available as herbal tea to be drunk or in liquid or solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo te pripravke s cvetom navadnega hmelja, so navadno na voljo kot zdravilni čaj, ki se popije, ali v tekoči ali trdni obliki za jemanje skozi usta.
English: Extracts are obtained by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Slovenian: Ekstrakti se pridobivajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
English: Hop strobile preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki s cvetom navadnega hmelja so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Any applications for the licensing of medicines containing hop strobile have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo cvet navadnega hmelja, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: In its assessment, the HMPC considered laboratory studies which supported the use of hop strobile for aiding sleep.
Slovenian: V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so podprle uporabo cveta navadnega hmelja za pomoč pri spanju.
English: Further information on the HMPC assessment of hop strobile medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo cvet navadnega hmelja, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Information on the use and licensing of hop strobile medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo cvet navadnega hmelja, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: How are hop strobile medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo cvet navadnega hmelja, odobrena v EU?
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing hop strobile.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo cvet navadnega hmelja.
English: If symptoms last more than two weeks or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Slovenian: Če simptomi med uporabo zdravila trajajo dlje kot dva tedna ali se poslabšajo, se
English: What is hop strobile?
Slovenian: Kaj je cvet navadnega hmelja?
English: The HMPC conclusions on the use of these hop strobile medicines for relief of mental stress and to aid sleep are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo cvet navadnega hmelja, za lajšanje duševne obremenitve in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“.
English: The HMPC concluded that, on the basis of its long-standing use, these hop strobile preparations can be used for relief of mild symptoms of mental stress and to aid sleep.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo cvet navadnega hmelja, uporabljajo za lajšanje blagih simptomov duševne obremenitve in kot pomoč pri spanju.
English: What evidence supports the use of hop strobile medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo cvet navadnega hmelja?
English: Detailed instructions on how to take hop strobile medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo cvet navadnega hmelja, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Other information about hop strobile medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo cvet navadnega hmelja
English: Therefore, the HMPC conclusions on the use of these hop strobile medicines are based on their long-standing use.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo cvet navadnega hmelja, zato temeljijo na njihovi dolgotrajni uporabi.
English: For more information about treatment with hop strobile medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo cvet navadnega hmelja, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using hop strobile medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: What are the risks associated with hop strobile medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo cvet navadnega hmelja?
English: Hop strobile
Slovenian: Cvet navadnega hmelja
English: The HMPC also considered clinical studies but since these studies used combinations of hop strobile and valerian root preparations to aid sleep, firm conclusions on the effects of hop strobile could not be drawn.
Slovenian: Ker pa so bile v teh študijah uporabljene kombinacije pripravka s cvetom navadnega hmelja in pripravka s korenino zdravilne špajke, ni bilo možno sprejeti trdnih zaključkov o učinkovitosti cveta navadnega hmelja.
English: This overview was last updated in 09-2018.
Slovenian: Pregled je bil nazadnje posodobljen 09-2018.
English: The recommended dose is one inhalation per day at the same time each day.
Slovenian: Priporočeni odmerek je en vdih na dan vedno ob istem času.
English: Further information on Rolufta Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Rolufta Ellipta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Rolufta Ellipta was investigated in four main studies involving over 4,000 patients.
Slovenian: Zdravilo Rolufta Ellipta so proučevali v štirih glavnih študijah, ki so vključevale več kot 4 000 bolnikov.
English: Rolufta Ellipta received a marketing authorisation valid throughout the EU on 20 March 2017.
Slovenian: Za zdravilo Rolufta Ellipta je bilo 20. marca 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: Rolufta Ellipta1 (umeclidinium bromide)
Slovenian: Rolufta Ellipta1 (umeklidinijev bromid)
English: The European Medicines Agency decided that Rolufta Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Rolufta Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet or contact your doctor or pharmacist.
Slovenian: Za podrobnejše informacije o pravilni uporabi inhalatorja glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Rolufta Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
Slovenian: Najpogostejši neželeni učinki zdravila Rolufta Ellipta (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, nazofaringitis (vnetje nosu in žrela), okužba zgornjih dihal (okužba nosu in žrela), sinuzitis (vnetje sinusov), kašelj, okužba sečil (okužba struktur za odvajanje urina) in tahikardija (povečan srčni utrip).
English: changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Slovenian: Glavno merilo učinkovitosti je bila sprememba bolnikovega forsiranega ekspiracijskega volumna (FEV1 - največja količina zraka, ki jo oseba lahko izdihne v eni sekundi).
English: Each inhalation provides 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium.
Slovenian: Z enim vdihom se dovede 65 mikrogramov umeklidinijevega bromida, kar je enakovredno 55 mikrogramom umeklidinija.
English: What measures are being taken to ensure the safe and effective use of Rolufta Ellipta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rolufta Ellipta?
English: As medicines of the same class as Rolufta Ellipta may have an effect on the heart and blood vessels, the company that markets Rolufta Ellipta will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium.
Slovenian: Ker lahko zdravila, ki spadajo v isti razred kot zdravilo Rolufta Ellipta, vplivajo na srce in krvne žile, bo podjetje, ki trži zdravilo Rolufta Ellipta, pri bolnikih izvedlo dolgoročno študijo, da bo zbralo dodatne informacije o njegovi varnosti v primerjavi s tiotropijem.
English: The studies also showed an improvement in symptoms such as breathlessness and wheezing.
Slovenian: V študijah so opazili tudi izboljšanje simptomov, kot je težko ali piskajoče dihanje.
English: This authorisation was based on the authorisation granted to Incruse Ellipta in 2014 (‘informed consent').
Slovenian: Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Incruse Ellipta, ki je bilo izdano leta 2014 (uporaba dokumentacije s soglasjem).
English: A double dose of Rolufta Ellipta only showed small improvements compared with a single dose, which were not considered relevant.
Slovenian: Z dvojnim odmerkom zdravila Rolufta Ellipta je bilo v primerjavi z enkratnim odmerkom doseženo le majhno izboljšanje tega rezultata, ki se ne šteje za pomembno.
English: Rolufta Ellipta is used for maintenance (regular) treatment.
Slovenian: Zdravilo Rolufta Ellipta se uporablja za vzdrževalno (redno) zdravljenje.
English: Results showed that Rolufta Ellipta improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment.
Slovenian: Rezultati so pokazali, da je zdravilo Rolufta Ellipta po 12 tednih zdravljenja izboljšalo delovanje pljuč v smislu povečanja povprečne vrednosti FEV1 za 127 ml več kot placebo, po 24 tednih pa za 115 ml več.
English: Side effects reported with Rolufta Ellipta are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Rolufta Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: It works by blocking the action of so-called muscarinic receptors, which control the contraction of muscles.
Slovenian: Deluje tako, da zavira receptorje, imenovane muskarinski receptorji, ki nadzorujejo krčenje mišic.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rolufta Ellipta have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rolufta Ellipta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The Agency also noted that there were no major safety concerns with Rolufta Ellipta, with side effects being manageable and similar to other medicines of the same class (antimuscarinic bronchodilators).
Slovenian: Ugotovila je tudi, da ni večjih pomislekov glede varnosti zdravila Rolufta Ellipta, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih zdravilih iz istega razreda (antimuskarinski bronhodilatatorji).
English: As for all medicines, data on the use of Rolufta Ellipta are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rolufta Ellipta stalno spremljajo.
English: In the study comparing Rolufta Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
Slovenian: V študiji, v kateri so zdravilo Rolufta Ellipta primerjali s tiotropijem, so bila izboljšanja vrednosti FEV1 v obdobju 24 tednov pri obeh zdravilih podobna.
English: An overview of Rolufta Ellipta and why it is authorised in the EU
Slovenian: Pregled zdravila Rolufta Ellipta in zakaj je odobreno v EU
English: Other information about Rolufta Ellipta
Slovenian: Druge informacije o zdravilu Rolufta Ellipta
English: Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Slovenian: Zdravilo Rolufta Ellipta se uporablja za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
English: What benefits of Rolufta Ellipta have been shown in studies?
Slovenian: Kakšne koristi zdravila Rolufta Ellipta so se pokazale v študijah?
English: The Agency concluded that Rolufta Ellipta was shown to be effective at improving the lung function and symptoms of COPD.
Slovenian: Zaključila je, da se je zdravilo Rolufta Ellipta izkazalo za učinkovito pri izboljševanju delovanja pljuč in simptomov KOPB.
English: What is Rolufta Ellipta and what is it used for?
Slovenian: Kaj je zdravilo Rolufta Ellipta in za kaj se uporablja?
English: Why is Rolufta Ellipta authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Rolufta Ellipta odobreno v EU?
English: The active substance in Rolufta Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist.
Slovenian: Učinkovina v zdravilu Rolufta Ellipta, umeklidinijev bromid, je antagonist muskarinskih receptorjev.
English: Rolufta Ellipta is available as an inhalation powder in a portable inhaler device.
Slovenian: Zdravilo Rolufta Ellipta je na voljo v obliki praška za inhaliranje v prenosnem inhalatorju.
English: What are the risks associated with Rolufta Ellipta?
Slovenian: Kakšna tveganja so povezana z zdravilom Rolufta Ellipta?
English: For the full list of side effects and restrictions with Rolufta Ellipta, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Rolufta Ellipta glejte navodilo za uporabo.
English: Three studies compared Rolufta Ellipta with placebo (a dummy treatment), while one study compared Rolufta Ellipta with tiotropium (another medicine for COPD).
Slovenian: V treh študijah so zdravilo Rolufta Ellipta primerjali s placebom (zdravilom brez učinkovine), v eni študiji pa s tiotropijem (drugim zdravilom za zdravljenje KOPB).
English: This helps to keep the airways open and allows the patient to breathe more easily.
Slovenian: Ko bolnik vdihne umeklidinijev bromid, se mišice dihalnih poti sprostijo, kar pomaga ohranjati dihalne poti prehodne in bolniku omogoča, da lažje diha.
English: How is Rolufta Ellipta used?
Slovenian: Kako se zdravilo Rolufta Ellipta uporablja?
English: Previously known as Rolufta.
Slovenian: Predhodno znano kot zdravilo Rolufta.
English: Rolufta Ellipta contains the active substance umeclidinium bromide.
Slovenian: Zdravilo vsebuje učinkovino umeklidinijev bromid.
English: How does Rolufta Ellipta work?
Slovenian: Kako zdravilo Rolufta Ellipta deluje?
English: What measures are being taken to ensure the safe and effective use of Translarna?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Translarna?
English: A further study in 230 patients aged 7 to 14 years with worsening walking ability was completed after initial approval, but its results were considered inconclusive.
Slovenian: Nadaljnja študija, v katero je bilo vključenih 230 bolnikov, starih od 7 do 14 let, pri katerih se je zmožnost hoje poslabšala, je bila zaključena po prvotni odobritvi, vendar so bili njeni izidi obravnavani kot neopredeljivi.
English: The beneficial effect of the lower dose was also supported by improvements in other measures of effectiveness, including those directly linked to patients' daily activities.
Slovenian: Koristen učinek manjšega odmerka so potrdila tudi izboljšanja pri drugih merilih za oceno učinkovitosti, vključno s tistimi, ki so bila neposredno povezana z vsakodnevnimi dejavnostmi bolnikov.
English: The European Medicines Agency decided that Translarna's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Translarna večje od z njim povezanih tveganj in da se odobri za uporabo v EU.
English: Translarna received a conditional marketing authorisation valid throughout the EU on 31 July 2014.
Slovenian: Za zdravilo Translarna je bilo 31. julija 2014 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: As for all medicines, data on the use of Translarna are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Translarna stalno spremljajo.
English: The main measure of effectiveness was the change in the distance the patient could walk in six minutes after 48 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba razdalje, ki jo je bolnik po 48 tednih zdravljenja lahko prehodil v šestih minutah.
English: Other information about Translarna
Slovenian: Druge informacije o zdravilu Translarna