natgillin/translations-raw huggingface dataset:
Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) filgrastim*.
Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi En mililiter raztopine vsebuje 60 milijonov enot (M e.) (kar je enako 600 mikrogramom [µg]) filgrastima*.
How to store Zarzio
Shranjevanje zdravila Zarzio
Zarzio is a biosimilar medicinal product.
Zdravilo Zarzio je podobno biološko zdravilo.
• if you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe Filgrastim
Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi filgrastim
Pre-filled syringe without needle safety guard
Uporaba napolnjene injekcijske brizge brez varnostne zaščite za iglo
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml - The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi: Ena napolnjena injekcijska brizga vsebuje 48 milijonov enot filgrastima v 0,5 ml, kar ustreza 96 M e./ml.
For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Za izplavljanje krvotvornih matičnih celic v periferno kri pri bolnikih, pri katerih se izvaja mielosupresivno ali mieloablacijsko zdravljenje, ki mu sledi avtologna presaditev matičnih celic izplavljenih v periferno kri Odmerjanje
Glutamic acid Sorbitol (E420) Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glutaminska kislina sorbitol (E420) polisorbat 80 voda za injekcije
Zarzio 48 MU/0.5 ml injection or infusion Filgrastim
Zarzio 48 M e./0,5 ml raztopina za injiciranje ali infundiranje filgrastim s.c./i.v.
Talk to your doctor, pharmacist or nurse before using Zarzio.
Pred začetkom uporabe zdravila Zarzio se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Pre-filled syringe with needle safety guard
Uporaba napolnjene injekcijske brizge z varnostno zaščito za iglo
Zarzio 30 MU/0.5 ml injection or infusion Filgrastim
Zarzio 30 M e./0,5 ml raztopina za injiciranje ali infundiranje filgrastim s.c./i.v.
• tiredness (fatigue)
• slabost (navzea)
Permanently discontinue Zarzio in patients with clinically significant hypersensitivity.
Pri bolnikih s klinično pomembno preobčutljivostjo je treba z uporabo zdravila Zarzio trajno prenehati.
Muscle spasms Osteoporosis
- osteoporozo (bolezen kosti).
84 x 1 capsules (unit dose)
84x1 kapsul (enotni odmerek)
84 capsules
84 kapsul
EMA procedure number
Številka postopka EMA
If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the trial.
Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The methods for comparing results of the main studies with historical data were not satisfactory for showing that the medicine was effective.
Metode za primerjavo rezultatov glavne študije s preteklimi podatki niso bile zadovoljive za dokazovanje, da je bilo zdravilo učinkovito.
The company also compared the results of these studies with those from a variety of historical data.
Družba je rezultate teh študij primerjala tudi z rezultati iz izbora preteklih podatkov.
The company that applied for authorisation, AVI Biopharma International Ltd, requested a re-examination of the CHMP's opinion on 1 June 2018.
Družba, ki je vložila vlogo za pridobitev dovoljenja za promet z zdravilom, AVI Biopharma International Ltd, je 1. junija 2018 zahtevala ponoven pregled mnenja odbora CHMP.
Refusal of the marketing authorisation for Exondys (eteplirsen) EMA/621972/2018
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys (eteplirsen) EMA/621972/2018
After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 20 September 2018.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 20. septembra 2018 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
Refusal of the marketing authorisation for Exondys (eteplirsen)
Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys (eteplirsen)
Patients with DMD do not produce a protein called dystrophin.
Bolniki z DMD ne proizvajajo beljakovine, imenovane distrofin.
The company presented the results of two main studies involving 12 boys aged 7 to 13 years with DMD who had a genetic mutation amenable to exon 51 skipping.
Družba je predložila rezultate dveh glavnih študij, v kateri je bilo vključenih 12 dečkov z DMD, ki so bili stari med 7 in 13 let in so imeli genetsko mutacijo, ki je omogočala preskakovanje eksona 51.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Exondys.
Družba je obvestila odbor CHMP, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Exondys.
This shortened protein is expected to act in a similar way to normal dystrophin, helping the body to make up for the lack of dystrophin, and so relieve the symptoms of DMD.
Ta krajša oblika beljakovine naj bi delovala podobno kot običajni distrofin, tako da telesu pomaga nadomestiti pomanjkanje distrofina, in s tem lajšala simptome DMD.
On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Exondys, intended for the treatment of Duchenne muscular dystrophy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 31. maja 2018 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Exondys, namenjenim zdravljenju Duchennove mišične distrofije.
Exondys was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 December 2008 for the treatment of DMD.
Zdravilo Exondys je bilo 3. decembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje DMD.
Therefore, the CHMP was of the opinion that the balance of benefits and risks of Exondys in the treatment of DMD could not be established and recommended that the marketing authorisation be refused.
Zato je zaključil, da razmerja med koristmi in tveganji zdravila Exondys za zdravljenje DMD ni mogoče določiti, in priporočil zavrnitev vloge za izdajo dovoljenja za promet z zdravilom.
The medicine allows exon 51 to be skipped over and so promote the production of a shortened form of dystrophin.
Zdravilo omogoči preskok eksona 51 in tako spodbudi proizvodnjo krajše oblike distrofina.
The CHMP was concerned that the main study, which involved just 12 patients, did not compare Exondys with placebo beyond 24 weeks, during which there was no meaningful difference between Exondys and placebo in the 6-minute walking distance.
Odbor CHMP je izrazil zadržek, da v glavni študiji, v katero je bilo vključenih samo 12 bolnikov, zdravila Exondys niso primerjali s placebom dlje kot 24 tednov in da v njej niso opazili pomembne razlike glede prehojene razdalje v šestih minutah med bolniki, ki so prejemali zdravilo Exondys oziroma placebo.
The main measure of effectiveness was the change in the distance walked during a 6-minute walking test after 24 weeks.
Glavno merilo učinkovitosti je bila sprememba razdalje, ki jo je bolnik po 24 tednih zdravljenja lahko prehodil v šestih minutah.
It was to be available as a concentrate for solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
What was Exondys expected to be used for?
Za kaj naj bi se zdravilo Exondys uporabljalo?
The Committee considered further data were needed to show that the very low amounts of shortened dystrophin produced as a result of Exondys treatment bring lasting benefits relevant to the patient.
Odbor je menil, da so potrebni nadaljnji podatki, ki bi pokazali, da bolniku trajne koristi prinesejo prav majhne količine krajše oblike distrofina, ki so proizvedene kot rezultat zdravljenja z zdravilom Exondys.
In the first study, Exondys was compared with placebo (a dummy treatment) for the first 24 weeks, after which all patients were treated with Exondys.
V prvi študiji so zdravilo Exondys primerjali s placebom (zdravilom brez učinkovine) prvih 24 tednov, nato pa so vse bolnike zdravili z zdravilom Exondys.
Exondys was expected to be used for treating Duchenne muscular dystrophy (DMD) in patients aged from 4 years with mutation (change) in the DMD gene that allows treatment involving ‘exon 51 skipping'.
Zdravilo Exondys naj bi se uporabljalo za zdravljenje Duchennove mišične distrofije (DMD) pri bolnikih, starejših od štirih let, z mutacijo (spremembo) v genu za DMD, ki omogoča zdravljenje s „tehnologijo preskakovanja eksona 51“.
Exondys is a medicine that contains the active substance eteplirsen.
Zdravilo Exondys vsebuje učinkovino eteplirsen.
The second study, an extension of the first one, involved the same patients who were all treated with Exondys for another 4 years.
Druga študija je bila podaljšek prve in je vključevala iste bolnike, ki so bili z zdravilom Exondys zdravljeni nadaljnja štiri leta.
This means that the patients' DMD gene can make a working form of the dystrophin protein when a part of the gene called exon 51 is not used.
To pomeni, da lahko bolnikov gen za DMD izdela delovno obliko beljakovine distrofin, ko del gena, imenovanega ekson 51, ni v rabi.
What is Exondys?
Kaj je zdravilo Exondys?
What were the CHMP's main concerns that led to the refusal?
Kateri so bili glavni zadržki, zaradi katerih je odbor CHMP predlagal zavrnitev vloge za pridobitev dovoljenja za promet?
How does Exondys work?
Kako zdravilo Exondys deluje?
The financial impact of the scheme was in excess of € 140,000.
Finančni učinek programa je presežen za 140 000 EUR.
The workshop was successful with 170 delegates from around 50 countries attending.
Delavnice je bila uspešna, udeležilo pa se je je 170 delegatov iz približno 50 držav.
The draft conclusions concern the issue of relative effectiveness.
Ta osnutek se nanaša na vprašanje relativne učinkovitosti.
The policy will be published in November 2010.
Politika bo objavljena novembra 2010.
The Agency's revenue and expenditure for 2010 are also on target.
Prihodki in odhodki agencije za leto 2010 so tudi v skladu s cilji.
All bodies which had a role in responding to the pandemic participated.
V njej so sodelovali vsi organi, ki so imeli vlogo pri odzivanju na pandemijo.
The European Commission already gave its agreement to the draft policy in accordance with Article 110 of the Staff Regulations.
Evropski komisar je že dal soglasje k osnutku politike v skladu s členom 110 kadrovskih predpisov.
The European Commission is seeking a solution for the support and coordination of the EU level tasks.
Evropska komisija si prizadeva najti rešitev za podporo in usklajevanje nalog na ravni EU.
This aim can be achieved in the context of the transparency policy and the implementation of the pharmacovigilance legislation.
Ta cilj je mogoče doseči v okviru politike preglednosti in izvajanja zakonodaje o farmakovigilanci.
• Wider application of teleconferencing tools involving larger number of participants.
• širšo uporabo telekonferenčnih orodij, ki bodo zajela več udeležencev;
The amendment takes into account the size of the Agency and specialisation of staff.
V spremembi sta upoštevani velikost agencije in specializacija osebja.
The policy will be implemented in the second quarter of 2011 once practical arrangements have been put in place.
Politika se bo začela uvajati v drugem četrtletju leta 2011, ko bo uvedena praktična ureditev.
The existing and new responsibilities, notably the new responsibilities in the field of pharmacovigilance, will increase pressure on financial resources.
Zaradi sedanjih in novih pristojnosti, zlasti novih pristojnosti na področju farmakovigilance, se bo povečal pritisk na finančna sredstva.
The traceability is a complex issue, particularly for medicinal products due to their wide distribution.
Sledljivost je zapleteno vprašanje, zlasti pri zdravilih, zaradi njihove razširjenosti.
The rules come into effect on 7 October 2010 and will be published on the Agency's website.
Pravila so začela veljati 7. oktobra 2010 in bodo objavljena na spletni strani agencije.
The European Parliament hearing on H1N1 pandemic
Razprava v Evropskem parlamentu o pandemični gripi H1N1
The European Commission anticipates that an extraordinary meeting can be convened for the last week of February 2011.
Evropska komisija pričakuje, da bi bilo mogoče izredno sejo sklicati v zadnjem tednu februarja 2011.
The Board will review an interim report on experience with the revised policy in 6 months time and a full report in 18-24 months time.
Odbor bo pregledal vmesno poročilo o izkušnjah z revidirano politiko v 6 mesecih in celotno poročilo za 18-24 mesecev.
The regulation replaces the version provisionally adopted by the Board on 11 December 2008.
Uredba nadomešča različico, ki jo je upravni odbor začasno sprejel 11. decembra 2008.
4 October 2010.
4. oktobra 2010.
Minor Use Minor Species policy: Annual report 2010
Politika manjše uporabe in manj pomembnih živalskih vrst: Letno poročilo za leto 2010
The fee system should be re-examined to assure appropriate financing of the Agency and the network.
Znova je treba proučiti sistem pristojbin, da se zagotovi ustrezno financiranje agencije in mreže.
The amendment concerns the replacement of mandatory mobility with ex-post controls and/or focused audits every two years for sensitive functions.
Sprememba se nanaša na nadomestitev obvezne mobilnosti z naknadnimi kontrolami in/ali osredotočenimi presojami vsaki dve leti za občutljive funkcije.
The latter outlines how principles set out in the policy will be interpreted.
V tem dokumentu je opisano, kako se bodo razlagala načela, določena v politiki.
• The adoption of the draft Strategy Paper II 2011-2015 for public consultation.
• sprejetjem osnutka strateškega dokumenta II 2011-2015 za javno posvetovanje;
Preparation for written procedure on adoption of the Agency's policy on protecting the dignity of the person and preventing any form of psychological or sexual harassment
Priprava pisnega postopka o sprejetju politike agencije o varstvu človekovega dostojanstva in preprečevanju vseh oblik psihološkega ali spolnega nadlegovanja
The new policy is built with three principles in mind: robustness, efficiency and transparency.
Ta nova politika je oblikovana na treh glavnih načelih, in sicer stabilnosti, učinkovitosti in preglednosti.
9bis Transfer of appropriations in the budget 2010 in accordance with Article 23 (2) of the Financial Regulation
9 a) Prerazporejanje proračunskih sredstev v proračunu za leto 2010 v skladu s členom 23(2) finančne uredbe
The political process to examine the fee system will be lengthy and therefore it is important to proceed as soon as possible and envisage interim solutions.
Politični proces proučitve sistema pristojbin bo dolgotrajen, zato je treba z delom čim prej nadaljevati in predvideti začasne rešitve.
The Agency anticipates that the EU contribution for the Agency will not increase and is likely to decrease as a proportion of the Agency's budget.
Agencija pričakuje, da se prispevek EU za agencijo ne bo povečal in da se bo kot delež v proračunu agencije verjetno zmanjšal.
The role of patients and consumers in the different scientific committees of the Agency will also be defined.
Opredeljena bo tudi vloga bolnikov in potrošnikov v različnih znanstvenih odborih agencije.
Draft agenda for 7 October 2010 meeting
Osnutek dnevnega reda za sejo dne 7. oktobra 2010
A number of Board members felt that, while the final decision on appointment of a member lies with the Member State in accordance with Art. 61 of Regulation (EC) No 726/2004, only appropriately scientifically qualified members should be accepted.
Številni člani odbora so menili, da čeprav končno odločitev o imenovanju članov sprejme država članica v skladu s členom 61 Uredbe (ES) št. 726/2004, bi morali biti sprejeti le člani z ustreznimi znanstvenimi kvalifikacijami.
The Agency demonstrated good performance against objectives set in the work programme.
Agencija je bila uspešna glede na cilje, zastavljene v delovnem programu.
• The progress on the "pharmaceutical package"; pharmacovigilance legislation which is due to become applicable in mid-2012), legislative proposals on preventing entry into legal supply chain of falsified medicines and information to patients).
• napredkom pri „svežnju zdravil“; zakonodajo o farmakovigilanci, ki naj bi začela veljati sredi leta 2012; zakonodajnih predlogih o preprečevanju vstopa ponarejenih zdravil v zakonito dobavno verigo in obveščanju bolnikov;
The endorsed document follows the public consultation launched in December 2008 and takes into account recommendations from the European Ombudsman.
Potrjeni dokument izvira iz javne razprave, ki je potekala decembra 2008, in upošteva priporočila evropskega varuha človekovih pravic.
There should be an EU level interconnectivity between these areas to ensure a comprehensive approach to vigilance and traceability of products.
Ta področja morajo biti medsebojno povezana na ravni EU, da se zagotovi celovit pristop k stalnemu nadzoru in sledljivosti proizvodov.
By introducing the new policy, the Agency aims to ensure the widest possible access to its documents whilst respecting a number of principles set out in the policy, including the protection of commercial confidential information and personal data.
Agencija namerava z uvedbo nove politike zagotoviti najširši možni dostop do svojih dokumentov ob upoštevanju številnih načel, določenih v politiki, vključno z varstvom komercialno zaupnih informacij in osebnih podatkov.
The Board also endorsed the publication of the meeting document with a few amendments.
Upravni odbor je tudi potrdil objavo dokumenta o seji z nekaterimi spremembami.
The Board discussed that due to the nature of the Agency's operations any future options should provide for a maximum degree of flexibility for expansion or reduction.
Odbor je razpravljal, da bi glede na naravo delovanja agencije vse prihodnje možnosti morale zagotoviti kar najvišjo stopnjo prožnosti za njeno širitev ali zmanjševanje.
The organisations are also subject to regular re-evaluation of their eligibility.
Njihova upravičenost se tudi redno ponovno ocenjuje.
This practice reflected well on both agencies and needs to be maintained in future.
Obe agenciji menita, da je takšna praksa ustrezna in jo je treba ohraniti tudi v prihodnje.
Sponsoring of patients' organisations by pharmaceutical industry - proposed actions
Sponzoriranje farmacevtske industrije organizacij bolnikov - predlagani ukrepi
Proposed changes will be introduced and the report will be published on the website.
Sledila bo uvedba predlaganih sprememb, poročilo pa bo objavljeno na spletni strani.
The financial and workload impact of the scheme and the Agency's and the network's ability to respond will continue to be monitored and reviewed if needed.
Finančni učinek in učinek delovne obremenitve programa ter sposobnost odzivanja agencije in mreže se bosta po potrebi še naprej spremljala in pregledovala.
The transfer follows the evaluation of its budgetary situations as at 31 August 2010 which showed favourable budget trend.
Prerazporeditev je sledila oceni proračunskega stanja na dan 31. avgust 2010, ki je pokazala ugoden proračunski razvoj.
It aims at balancing out the need to secure Europe's best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality.
Njen namen je uravnotežiti potrebo po zagotavljanju najboljših evropskih strokovnjakov za vrednotenje in nadzor zdravil ob zagotavljanju, da ti strokovnjaki nimajo finančnih ali drugih interesov v farmacevtski industriji, ki bi lahko vplivali na njihovo nepristranskost.
It was emphasised that the same principles are applied for all experts, those from national authorities, academia and civil society representatives, working in the EMA's committees.
Poudarjeno je bilo, da se enaka načela uporabljajo za vse strokovnjake, to je strokovnjake iz nacionalnih organov, akademike in predstavnike civilne družbe, ki delajo v odborih agencije EMA.
The released part of the provisional appropriation will be used to finance and bring forward ICT projects that might be insufficiently financed in 2011 due to reductions in the EU contribution for 2011.
Sproščeni del začasnih sredstev bo uporabljen za financiranje in spodbujanje projektov informacijske in komunikacijske tehnologije, za katere bo morda v letu 2011 na voljo manj sredstev, ker se bodo znižali prispevki EU za leto 2011.
The Agency will meet with patients/consumers' and healthcare professionals' representatives to explain how the policy will be applied.
Agencija se bo srečala s predstavniki bolnikov/potrošnikov in zdravstvenih strokovnjakov, da bo pojasnila, kako se bo politika izvajala.
The new EMA Financial Regulation follows the revision of the Framework Financial Regulation (EC, EURATOM) No 2343/2002 in 2008 and takes into account comments made by the European Commission.
EMA temelji na pregledu okvirne finančne uredbe (ES, EURATOM) št. 2343/2002 iz leta 2008 in upošteva pripombe, ki jih je predložila Evropska komisija.
• The preparation for the third cycle of Benchmarking of European Medicines Agencies and endorsement of its continuation.
• pripravo tretjega cikla primerjalne analize evropskih agencij za zdravila in potrditvijo njenega nadaljevanja.
It is anticipated that the first meeting of the group will take place towards the end of 2010 or in early 2011.
Pričakuje se, da bo prvi sestanek skupine proti koncu leta 2010 ali na začetku leta 2011.
The EMA's involvement in this process relates to the fact that a part of substances of human origin are processed to advanced therapies, which are then covered by specific legislation.
Vključenost agencije EMA v ta proces se nanaša na dejstvo, da se del snovi človeškega izvora predela za napredno zdravljenje, ki je nato vključeno v posebno zakonodajo.
The European Commission had been informed of the proposal.
Evropska komisija je bila obveščena o predlogu.
The Committee for Medicinal Products for Human Use recommended the suspension of Avandia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je priporočil začasni umik zdravila Avandia.
Third report on the progress of the interaction with Patients' and Consumers' Organisations during 2009
Tretje poročilo o napredku medsebojnega delovanja med organizacijami bolnikov in potrošnikov v letu 2009
Members discussed whether the new policy may restrict participation of representatives of patients and academia in EMA activities, particularly in cases of smaller organisations.
Člani so razpravljali, ali nova politika lahko omeji sodelovanje predstavnikov bolnikov in akademikov v dejavnostih agencije EMA, zlasti v manjših organizacijah.