FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission issued a decision on this opinion on 09 October 2013.
Slovenian: Evropska komisija je sklep v zvezi s tem mnenjem izdala 09. oktobra 2013.
English: The company wanted the authorisation to be recognised in Belgium, France, Germany, Luxembourg, Malta, Netherlands, Sweden and United Kingdom (the ‘concerned Member States').
Slovenian: Družba je želela, da se dovoljenje za promet z zdravilom prizna v Belgiji, Franciji, Nemčiji, Luksemburgu, na Malti, Nizozemskem, Švedskem in v Združenem kraljestvu (zadevne države članice).
English: The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
Slovenian: Odbor je prav tako izpostavil, da je predlagatelj te študije opravil pred objavo zadnje posodobljene smernice 1za to vrsto zdravil.
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je danska regulativna agencija za zdravila 21. decembra 2012 zadevo napotila na CHMP v arbitražo.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Sandoz.
Slovenian: Evropska agencija za zdravila je 25. julija 2013 zaključila arbitražni postopek, do katerega je prišlo zaradi nesoglasja med državami članicami Evropske unije (EU) glede odobritve dovoljenja za promet z zdravilom Methylphenidate Sandoz.
English: Methylphenidate is a medicine that is used to treat children aged between 6 and 18 years of age who have ADHD (attention deficit/hyperactivity disorder), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Slovenian: Metilfenidat je zdravilo, ki se uporablja pri otrocih, starih od 6 do 18 let, za zdravljenje motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD), pri kateri so prisotni stalna nezmožnost koncentracije, hiperaktivnost in impulzivno vedenje.
English: Methylphenidate Sandoz is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Slovenian: Methylphenidate Sandoz je generično zdravilo na osnovi „referenčnega zdravila“ Concerta, ki je odobreno v vseh državah članicah EU.
English: Sandoz A/S submitted Methylphenidate Sandoz for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Cyprus, Finland, Poland, Portugal and Spain, as well as Iceland and Norway.
Slovenian: Družba Sandoz A/S je predložila vlogo za pridobitev dovoljenja za promet z zdravilom Methylphenidate Sandoz po postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet z zdravilom, izdanega 29. marca 2012 na Danskem in prav tako veljavnega na Cipru, Finskem, Poljskem, Portugalskem in v Španiji v skladu z decentraliziranim postopkom.
English: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party.
Slovenian: Odbor za zdravila za uporabo v humani medicini, Vprašanja in odgovori: stališča v zvezi z določenimi vprašanji, postavljenimi delovni skupini za farmakokinetiko.
English: Methylphenidate belongs to a group of medicines called ‘psychostimulants' and is thought to work by enhancing the activity of areas of the brain that control attention and concentration.
Slovenian: Metilfenidat spada v skupino zdravil, imenovanih „psihostimulansi“, ki delujejo tako, da izboljšajo delovanje delov možganov, ki nadzorujejo pozornost in koncentracijo.
English: Why was Methylphenidate Sandoz reviewed?
Slovenian: Zakaj je bilo zdravilo Methylphenidate Sandoz pregledano?
English: It is available as a modified-release tablet, which releases some of the active substance immediately (the ‘immediate-release phase') and the rest over several hours.
Slovenian: Na voljo je v obliki tablet s prirejenim sproščanjem, ki del zdravilne učinkovine sprostijo takoj (faza takojšnjega sproščanja), preostanek pa v več urah.
English: What is Methylphenidate Sandoz?
Slovenian: Kaj je zdravilo Methylphenidate Sandoz?
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Slovenian: Na voljo je od petdesetih let 20. stoletja v obliki tablet in kapsul s takojšnjim sproščanjem, ki takoj sprostijo metilfenidat, ter tablet s prirejenim sproščanjem, ki sprostijo del ali celotno zdravilno učinkovino počasneje, v več urah.
English: Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Methylphenidate Sandoz (metilfenidatijev klorid, tableta s podaljšanim sproščanjem, 18, 36 in 54 mg)
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Slovenian: Na podlagi razpoložljivih podatkov in znanstvene razprave znotraj odbora je ta ugotovil, da biološke enakovrednosti med zdravilom Methylphenidate Sandoz in referenčnim zdravilom v fazi s takojšnjim sproščanjem ni bilo mogoče dokazati zaradi razlik med bolniki glede učinkov obroka z veliko vsebnostjo maščob na to, kako telo obdela zdravila, in ne zaradi razlik v formulacijah teh dveh zdravil, zato je sklenil, da je bila biološka enakovrednost referenčnemu zdravilu dokazana.
English: Requirements for demonstration of bioequivalence for generics of biphasic modified release formulations for oral use.
Slovenian: Zahteve za dokazovanje biološke enakovrednosti generičnih zdravil pri dvofaznih peroralnih formulacijah s prirejenim sproščanjem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Methylphenidate Sandoz outweigh its risks, and the marketing authorisation granted in Denmark can be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Methylphenidate Sandoz večje od z njim povezanih tveganj ter da se lahko dovoljenje za promet, izdano na Danskem, odobri v drugih državah članicah EU.
English: The CHMP therefore concluded that the benefits of Methylphenidate Sandoz outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Slovenian: CHMP je zato zaključil, da koristi zdravila Methylphenidate Sandoz odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom odobri v zadevnih državah članicah.
English: The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Sandoz was bioequivalent for the immediate-release phase to its reference product.
Slovenian: Podlaga za napotitev so bili pomisleki Nemčije in Nizozemske, ki sta menili, da študija biološke enakovrednosti pri jemanju na poln želodec ni pokazala, da je faza takojšnjega sproščanja pri zdravilu Methylphenidate Sandoz biološko enakovredna referenčnemu zdravilu Ker je v informacijah o zdravilu navedeno, da se lahko tableta vzame s hrano ali brez nje, je bila za odobritev dovoljenja za promet z zdravilom potrebna študija o biološki enakovrednosti pri jemanju na poln želodec.
English: It is available as tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).
Slovenian: Na voljo je v obliki tablet (500 in 1 000 mg) in v obliki peroralne raztopine (100 mg/ml).
English: The total dose for the whole day should be less than 100 mg per kilogram body weight.
Slovenian: Skupni odmerek za cel dan mora biti manjši od 100 mg na kilogram telesne mase.
English: Over time, the excess iron can damage important organs such as the heart and liver.
Slovenian: Sčasoma lahko odvečno železo poškoduje pomembne organe, kot so srce in jetra.
English: Further information on Ferriprox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
Slovenian: Nadaljnje informacije za zdravilo Ferriprox so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
English: The doctor may interrupt treatment if iron levels get too low.
Slovenian: Zdravnik lahko prekine zdravljenje, če se ravni železa spustijo prenizko.
English: The main measure of effectiveness was the change in the levels of ferritin in the blood.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni feritina v krvi.
English: Patients with thalassaemia major need frequent blood transfusions.
Slovenian: Bolniki s talasemijo major pogosto potrebujejo transfuzijo krvi.
English: • on its own, when standard iron chelator treatment cannot be used or does not work well enough;
Slovenian: • samostojno, kadar standardnega zdravljenja s kelatorjem železa ni mogoče uporabiti ali ni dovolj učinkovito;
English: • in combination with another iron chelator, when treatment with one iron chelator on its own does not work or when iron levels need to be rapidly or intensively corrected to prevent or treat lifethreatening conditions (mainly affecting the heart).
Slovenian: • v kombinaciji z drugim kelatorjem železa, kadar zdravljenje z enim samim kelatorjem ne deluje ali kadar je treba ravni železa hitro ali intenzivno popraviti, da se prepreči ali zdravi življenjsko nevarno stanje (ki vpliva predvsem na srce).
English: Removing iron in this way helps to correct the iron overload and prevent damage from excess iron.
Slovenian: Odstranjevanje železa na ta način pomaga popraviti preobremenitev z železom in preprečiti škodo, ki nastane zaradi odvečnega železa.
English: What measures are being taken to ensure the safe and effective use of Ferriprox?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ferriprox?
English: Deferoxamine was given by injection under the skin overnight.
Slovenian: Deferoksamin je bil dan z injiciranjem pod kožo čez noč.
English: Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Slovenian: Manj pogosta, vendar resnejša neželena učinka, sta agranulocitoza (zelo nizka raven granulocitov, vrste belih krvničk) in nevtropenija (nizke ravni nevtrofilcev, vrste belih krvničk, ki se borijo proti okužbam).
English: The European Medicines Agency decided that Ferriprox'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 Ferriprox večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.
Slovenian: Bolniki morajo nemudoma obvestiti zdravnika, če opazijo simptome okužbe, kot so npr. vročina, vneto grlo in gripi podobni simptomi.
English: It attaches to iron in the body to form a compound that can be removed from the body, mainly in the urine, and to a lesser extent in the stools.
Slovenian: Veže se na železo v telesu in pri tem tvori spojino, ki jo telo lahko izloči, predvsem z urinom in v manjši meri z blatom.
English: The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests.
Slovenian: Zdravnik lahko prilagodi odmerek zdravila Ferriprox glede na to, kako dobro je nadzorovana bolnikova raven železa, ki jo je treba meriti vsaka dva do tri mesece s krvnimi testi.
English: There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.
Slovenian: Število bolnikov v študiji ni bilo zadostno, da bi bilo mogoče dokazati, ali je tak urnik res tako učinkovit kot samostojno jemanje deferoksamina.
English: Ferriprox (deferiprone)
Slovenian: Ferriprox (deferipron)
English: Ferriprox received a marketing authorisation valid throughout the EU on 25 August 1999.
Slovenian: Za zdravilo Ferriprox je bilo 25. avgusta 1999 izdano dovoljenje za promet, veljavno po vsej EU.
English: The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Slovenian: Podjetje, ki trži zdravilo Ferriprox mora bolnikom ali njihovim skrbnikom priskrbeti opozorilno kartico o pomembnosti rednega testiranja števila nevtrofilcev, opazovanja simtomov okužbe in za ženske, preprečevanja nosečnosti v času jemanja zdravila Ferriprox.
English: With repeated transfusions, the iron builds up because the body does not have a natural way of removing excess iron.
Slovenian: Zaradi večkratnih transfuzij se železo kopiči, ker telo ne more na naraven način odstraniti odvečnega železa.
English: When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Slovenian: Pri jemanju zdravila Ferriprox je treba redno preverjati število nevtrofilcev (vsak teden v prvem letu potem manj pogosto).
English: The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Slovenian: Priporočeni odmerek zdravila Ferriprox je 25 mg na kilogram telesne mase, ki se daje trikrat na dan.
English: As for all medicines, data on the use of Ferriprox are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ferriprox stalno spremljajo.
English: The average blood ferritin levels were similar in the two treatment groups.
Slovenian: Povprečne ravni feritina v krvi so bile v obeh skupinah podobne.
English: Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ferriprox, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often.
Slovenian: Če pri bolniku pride do okužbe, je treba zdravljenje z zdravilom Ferriprox začasno prekiniti in pogosteje preverjati število nevtrofilcev.
English: The blood ferritin level indicates how much iron is being stored in the body.
Slovenian: Raven feritina v krvi kaže, koliko železa je shranjenega v telesu.
English: Other information about Ferriprox
Slovenian: Druge informacije o zdravilu Ferriprox
English: The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Slovenian: Najpogostejši neželeni učinki zdravila Ferriprox (ki se lahko pojavijo pri več kot 1 bolniku od 10) so rdečkastorjav urin (kar kaže na izločanje železa z urinom), navzeja (siljenje na bruhanje), bolečine v trebuhu in bruhanje.
English: Transfused red cells bring iron into the body.
Slovenian: S transfuzijo rdečih krvnih celic se v telo dovaja železo.
English: Why is Ferriprox authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ferriprox odobreno v EU?
English: Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
Slovenian: Zdravilo Ferriprox so proučevali pri 247 bolnikih, starejših od šest let, s talasemijo major.
English: An overview of Ferriprox and why it is authorised in the EU
Slovenian: Pregled zdravila Ferriprox in zakaj je odobreno v EU
English: What benefits of Ferriprox have been shown in studies?
Slovenian: Kakšne koristi zdravila Ferriprox so se pokazale v študijah?
English: For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ferriprox glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
Slovenian: V drugi študiji, v katero je bilo vključenih 60 bolnikov, zdravljenih 12 mesecev, so kombinacijo zdravila Ferriprox in deferoksamina (zdravilo Ferriprox dajano pet dni in deferoksamin dva dni vsak teden) primerjali z deferoksaminom samim.
English: Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Slovenian: Zdravilo Ferriprox je „kelator železa“ (snov, ki se veže na železo), ki se uporablja za zdravljenje prenasičenosti z železom (prevelike količine železa v krvi) pri bolnikih s talasemijo major.
English: Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Slovenian: Ravni feritina v krvi so se v enakem obsegu znižale pri bolnikih, zdravljenih s kombinacijo kot pri tistih, zdravljenih z deferoksaminom samim.
English: What is Ferriprox and what is it used for?
Slovenian: Kaj je zdravilo Ferriprox in za kaj se uporablja?
English: However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Slovenian: Vendar pa se je zdelo, da se je povprečna koncentracija železa v jetrih bolnikov, zdravljenih z zdravilom Ferriprox, povečala bolj kot pri bolnikih, ki so jemali deferoksamin.
English: In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
Slovenian: V objavljeni študiji je zdravilo Ferriprox v kombinaciji z deferoksaminom povzročilo tudi večje zmanjšanje železa v srcu v primerjavi z bolniki, ki so jemali samo deferoksamin.
English: The active substance in Ferriprox, deferiprone, is an iron chelator.
Slovenian: Učinkovina zdravila Ferriprox, deferipron, je kelator železa.
English: Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis.
Slovenian: Zdravilo Ferriprox se poleg tega ne sme uporabljati skupaj z zdravili, ki bi lahko povzročila nevtropenijo ali agranulocitozo.
English: What are the risks associated with Ferriprox?
Slovenian: Kakšna tveganja so povezana z zdravilom Ferriprox?
English: Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia.
Slovenian: Predpisovanje in izdaja zdravila Ferriprox je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem talasemije.
English: For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov zdravila Ferriprox glejte navodilo za uporabo.
English: Ferriprox is used:
Slovenian: Zdravilo Ferriprox se uporablja:
English: Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Slovenian: Zdravila Ferriprox ne smejo uporabljati osebe, ki so imele ponavljajočo se nevtropenijo ali agranulocitozo.
English: In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own.
Slovenian: Poleg tega objavljene študije o uporabi zdravila Ferriprox z deferoksaminom kažejo na večje znižanje ravni feritina v krvi pri uporabi kombinacije obeh zdravil v primerjavi z uporabo vsakega zdravila samostojno.
English: The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
Slovenian: V glavni študiji, v katero je bilo vključenih 71 bolnikov, so zdravilo Ferriprox dve leti primerjali z deferoksaminom, drugim kelatorjem železa.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili prav tako vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo tega zdravila.
English: Ferriprox contains the active substance deferiprone.
Slovenian: Zdravilo Ferriprox vsebuje učinkovino deferipron.
English: How does Ferriprox work?
Slovenian: Kako zdravilo Ferriprox deluje?
English: How is Ferriprox used?
Slovenian: Kako se zdravilo Ferriprox uporablja?
English: Ferriprox must not be used in women who are pregnant or breastfeeding.
Slovenian: Nosečnice ali ženske, ki dojijo, zdravila Ferriprox ne smejo jemati.
English: This is the maximum dose per day.
Slovenian: To je največji odmerek na dan.
English: Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Slovenian: Datum prve odobritve: 14. junij 2010 Datum zadnjega podaljšanja: 08. januar 2018
English: This is known as a hypertensive crisis.
Slovenian: Takšno stanje je znano kot hipertenzivna kriza.
English: Periodic testing should then continue after month 4.
Slovenian: Po 4. mesecu se morajo nato nadaljevati redne kontrole.
English: The 95% confidence intervals for all subgroups include a hazard ratio of 1.
Slovenian: 95 % intervali zaupanja za vse podskupine vključujejo razmerje ogroženosti 1.
English: Overall efficacy results are summarised in Table 5.
Slovenian: Rezultati celokupne učinkovitosti so povzeti v preglednici 5.
English: Risk factors
Slovenian: Dejavniki tveganja
English: Take Votrient at about the same time each day.
Slovenian: Zdravilo Votrient vzemite vsak dan ob približno istem času.
English: The other objectives were to evaluate the overall response rate and duration of response.
Slovenian: Drugi cilji so bili še ovrednotiti skupni delež odziva in trajanje odziva.
English: A risk to the breast-fed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: 09400 Aranda De Duero, Burgos Spain
Slovenian: 09400 Aranda De Duero, Burgos Španija
English: Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Slovenian: Analize podskupin preživetja brez napredovanja so bile opravljene za 20 demografskih in prognostičnih dejavnikov.
English: Moreover it should not be used in children younger than 2 years of age because of safety concerns.
Slovenian: Poleg tega se ga zaradi varnostnih pomislekov ne sme uporabljati pri otrocih, mlajših od 2 let.
English: Your doctor will inform you of the results of the blood tests
Slovenian: Zdravnik vas bo seznanil z rezultati preiskav krvi.
English: One subject did not recover and follow-up data were not available for the other 5 subjects.
Slovenian: En preiskovanec ni okreval, podatkov o spremljanju za preostalih 5 preiskovancev pa ni.
English: Frequency (all grades)
Slovenian: Pogostnost (vse stopnje)
English: The following terms have been combined:
Slovenian: Združeni so naslednji izrazi: