natgillin/translations-raw huggingface dataset:
In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Poleg tega je podvomil o predlagani metodi sterilizacije zdravila.
Sirolimus has been used for several years to prevent organ rejection following a transplant.
Sirolimus se je več let uporabljal za preprečevanje zavračanja organov po presaditvi.
The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness.
Vnetje lahko povzroči neprijeten občutek, bolečino in zamegljen vid ter lahko povzroči delno ali popolno slepoto.
The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bilo vnetje ozdravljeno po petih mesecih zdravljenja.
The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
Podatki iz klinične študije niso zadoščali za dokaz koristi zdravila Opsiria, zlasti pri evropskih bolnikih.
Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Opsiria (sirolimus)
Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Opsiria (sirolimus) EMA/358774/2016
Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Zdravilo Opsiria so proučevali v eni glavni študiji pri 347 bolnikih z neinfektivnim uveitisom.
In this study, Opsiria was not compared with any other treatment.
V tej študiji zdravila Opsiria niso primerjali z nobenim drugim zdravilom.
Opsiria is a medicine that contains the active substance sirolimus.
Opsiria je zdravilo, ki vsebuje zdravilno učinkovino sirolimus.
The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je odbor CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Družba Santen Oy je 20. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Opsiria, namenjenim zdravljenju neinfektivnega uveitisa.
Since mTOR is involved in the activation and proliferation of T lymphocytes (white blood cells that play a role in inflammation), sirolimus is expected to reduce the inflammation in chronic non-infectious uveitis.
Ker mTOR sodeluje pri aktivaciji in proliferaciji limfocitov T (belih krvnih celic, ki imajo pomembno vlogo pri vnetju), naj bi sirolimus zmanjšal vnetje pri kroničnem neinfektivnem uveitisu.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potem ko je ocenil odgovore družbe na zadnja vprašanja, so nekatera vprašanja še vedno ostala nerešena.
In its letter notifying the Agency of the withdrawal of application, the company acknowledged the need to submit additional data on the benefits of Opsiria from an ongoing clinical study.
V dopisu, v katerem družba agencijo obvešča o umiku vloge, družba priznava nujnost predložitve dodatnih podatkov o koristih zdravila Opsiria iz klinične študije, ki še poteka.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Opsiria could not have been approved for the treatment of non-infectious uveitis.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil odbor CHMP, je ta v času umika izrazil določene zadržke in je začasno menil, da zdravila Opsiria ni mogoče odobriti za zdravljenje neinfektivnega uveitisa.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Opsiria.
Opsiria was expected to be used for the treatment of non-infectious uveitis (inflammation of the uvea, the middle layer of the eye) in adults.
Zdravilo Opsiria naj bi se uporabljalo za zdravljenje infektivnega uveitisa (vnetja uvee, srednjega sloja očesa) pri odraslih.
What is Opsiria?
Kaj je zdravilo Opsiria?
Opsiria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 30 August 2011 for the treatment of chronic non-infectious uveitis.
Zdravilo Opsiria je bilo 30. avgusta 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje kroničnega neinfektivnega uveitisa.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Opsiria did not outweigh its risks.
Zato je v času umika menil, da koristi zdravila Opsiria ne odtehtajo z njim povezanih tveganj.
What was Opsiria expected to be used for?
Za kaj naj bi se zdravilo Opsiria uporabljalo?
The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR).
Zdravilna učinkovina v zdravilu Opsiria, sirolimus, naj bi delovala z zaviranjem encima, imenovanega „tarča rapamicina pri sesalcih“ (mTOR).
It was to be available as a solution to be injected into the eye.
Na voljo naj bi bilo v obliki raztopine za injiciranje v oko.
How is Opsiria expected to work?
Kako naj bi zdravilo Opsiria delovalo?
London, 25 October 2007 EMEA/CHMP/350251/2007
London, 25. oktober 2007 EMEA/CHMP/350251/2007
The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom.
Referenčna država članica je bila Nemčija, zadevne države članice pa Avstrija, Danska, Španija, Finska, Francija, Italija, Luksemburg, Norveška, Poljska, Portugalska, Švedska in Združeno kraljestvo.
The Mutual Recognition Procedure started on 24 October 2006.
Postopek medsebojnega priznavanja se je pričel 24. oktobra 2006.
The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Poročevalec je bil dr. Karl Broich, soporočevalec pa dr. Pierre Demolis.
A positive opinion was adopted by majority on 19 July 2007.
Pozitivno mnenje je bilo sprejeto z večino glasov dne 19. julija 2007.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Arbitražni postopek se je začel 26. aprila 2007 s sprejetjem seznama vprašanj.
The final opinion was converted into a Decision by the European Commission on 24 October 2007.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 24. oktobra 2007.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Omenjene države članice niso mogle doseči soglasja glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 25. maja 2007.
During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem od 16. do 19. julija 2007 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Xeomin ugodno, pri čemer ugovori, ki so jih predstavile Finska, Francija in Italija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom, ter da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice dopolniti.
On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies.
Glede na vprašanja, ki so jih izpostavile države članice, je moral CHMP obravnavati zadeve v zvezi z odmerjanjem zdravila, ponavljajočo se uporabo zdravila in varnostni profil zdravila v študijah faze III.
Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Nemčija je Evropski agenciji za zdravila dne 29. marca 2007 predložila razloge za nesoglasje.
Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005.
Podjetje Merz Pharmaceuticals GmbH je predložilo vloge za postopek medsebojnega priznavanja zdravila Xeomin, 100 LD50 enot, prašek za pripravo raztopine za injiciranje na osnovi dovoljenja za promet z zdravilom, ki ga je izdala Nemčija dne 31. maja 2005.
Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Zdravilo Xeomin, 100 LD50 enot, prašek za pripravo raztopine za injiciranje je indiciran za simptomatično zdravljenje blefarospazmov in cervikalne distonije pretežno rotacijske oblike (spastični tortikolis) pri odraslih.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A
Xeomin Mednarodno nelastniško ime (INN): Nevrotoksin bakterije Clostridium botulinum tipa A
The tablets should be taken with food.
Tablete je treba jemati sočasno s hrano.
The recommended dose is 4 tablets once a day for the first 2 weeks and then 2 tablets taken 3 times a week for the next 22 weeks.
Priporočeni odmerek je 4 tablete enkrat na dan prva 2 tedna, nadaljnjih 22 tednov pa 2 tableti 3-krat na teden.
The company will also provide longer term safety data on the medicine.
Prav tako bo predložila tudi dolgoročnejše podatke o varnosti zdravila.
The medicine is available as 100 mg tablets.
Zdravilo je na voljo v obliki 100-miligramskih tablet.
This means that there is more evidence to come about the medicine, which the company is required to provide.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu, ki jih mora zagotoviti družba.
This is a summary of the European public assessment report (EPAR) for Sirturo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sirturo.
Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Tuberkuloza je okužba, ki jo povzroča bakterija Mycobacterium tuberculosis.
Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove razpoložljive podatke in posodobila povzetek glavnih značilnosti zdravila, če bo to potrebno.
In addition, it is recommended that patients are directly observed by a healthcare professional as they take the medicine.
Poleg tega je priporočljivo, da bolnike med jemanjem zdravila neposredno nadzoruje zdravstveni delavec.
What measures are being taken to ensure the safe and effective use of Sirturo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sirturo?
It is given when combinations without Sirturo cannot be used, either because the disease is resistant to them or because of their side effects.
Uporablja se, kadar kombinacij brez zdravila Sirturo ni mogoče uporabiti bodisi zaradi odpornosti bolezni proti tem kombinacijam ali zaradi njihovih neželenih učinkov.
Without the ability to generate energy, the bacteria die and the patient's condition can start to improve.
Če bakterije ne morejo več pridobivati energije, odmrejo, bolnikovo stanje pa se začne izboljševati.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sirturo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Sirturo večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The summary of the opinion of the Committee for Orphan Medicinal Products for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Sirturo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
A risk management plan has been developed to ensure that Sirturo is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Sirturo je bil pripravljen načrt obvladovanja tveganj.
Although an analysis of these deaths did not support the conclusion that they were caused by Sirturo, the CHMP has required the company to provide more information from a long-term follow-up study to allay any concerns.
Čeprav analiza teh primerov ni podprla zaključka, da so bile smrti posledica uporabe zdravila Sirturo, je odbor CHMP zahteval, da družba pridobi več podatkov v dolgoročni študiji spremljanja, da se odpravijo morebitni zadržki.
It is not intended to provide practical advice on how to use Sirturo.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The most common side effects with Sirturo (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain).
Najpogostejši neželeni učinki zdravila Sirturo (ki lahko prizadenejo več kot 1 osebo od 10) so glavobol, omotica, navzea (slabost), bruhanje in artralgija (bolečine v sklepih).
Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Sirturo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Ker je bolnikov s tuberkulozo v EU malo, velja ta bolezen za redko, zato je bilo zdravilo Sirturo 26. avgusta 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Other information about Sirturo
Druge informacije o zdravilu Sirturo
The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients).
Študija je pokazala, da je bil po 24 tednih test na prisotnost bakterij v sputumu (izpljunku) negativen pri 79 % (52 od 66) bolnikov, ki so prejemali zdravilo Sirturo, v primerjavi z 58 % (38 od 66) bolnikov, ki so prejemali placebo.
The Committee highlighted the need for new medicines to treat multi-drug resistant tuberculosis and noted that Sirturo was the first of a new class of medicines for which cross-resistance with other medicines had not yet been seen.
Odbor je poudaril potrebo po novih zdravilih za zdravljenje tuberkuloze, odporne proti več zdravilom, in izpostavil, da je zdravilo Sirturo prvo zdravilo iz nove skupine, pri katerem še niso opazili navzkrižne odpornosti z drugimi zdravili.
Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines.
Ker je zdravilo Sirturo pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila dodatne podatke o koristih in varnosti zdravila pri njegovi uporabi skupaj z različnimi kombinacijami zdravil.
The active substance in Sirturo, bedaquiline, works by specifically blocking an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy.
Zdravilna učinkovina v zdravilu Sirturo, bedakilin, deluje tako, da specifično zavira encim v bakterijah M. tuberculosis, imenovan ATP-sintaza, ki ga bakterije potrebujejo za pridobivanje energije.
Sirturo increased the number of patients who tested negative for the tuberculosis bacteria and shortened the average time it took to clear the bacteria from the sputum.
Zdravilo Sirturo je povečalo število bolnikov, pri katerih je bil test na prisotnost bakterij tuberkuloze negativen, in skrajšalo povprečen čas, ki je bil potreben za to, da so se bakterije izločile iz sputuma.
The full EPAR and risk management plan summary for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Sirturo sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefits of Sirturo have been shown in studies?
Kakšne koristi je zdravilo Sirturo izkazalo v študijah?
With regard to safety, the side effects reported in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval).
Kar zadeva varnost, se neželeni učinki, o katerih so v glavni študiji poročali v skupini bolnikov, ki so jemali zdravilo Sirturo, niso bistveno razlikovali od tistih, ki so jih opazili v skupini, zdravljeni s placebom, vendar pa so zabeležili višje ravni jetrnih encimov in nekaj poročil o spremembah v električni aktivnosti srca (t. i. podaljšanju intervala QT).
For more information about treatment with Sirturo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sirturo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Cross-resistance is when bacteria develop resistance to a medicine after being exposed to another one, which is often the case with multi-drug resistant tuberculosis.
Navzkrižna odpornost pomeni, da bakterije razvijejo odpornost proti določenemu zdravilu, potem ko so bile izpostavljene drugemu zdravilu, kar se pogosto zgodi pri tuberkulozi, odporni proti več zdravilom.
What are the risks associated with Sirturo?
Kakšna tveganja so povezana z zdravilom Sirturo?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sirturo, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Sirturo in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is Sirturo and what is it used for?
Kaj je zdravilo Sirturo in za kaj se uporablja?
The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).
Poleg tega je bil tudi povprečni čas, ki je bil potreben za to, da so se bakterije izločile iz sputuma, krajši pri bolnikih v skupini, ki je prejemala zdravilo Sirturo, kot pri tistih v skupini, zdravljeni s placebom (83 dni v primerjavi s 125).
Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines).
Zdravilo Sirturo se uporablja v kombinaciji z drugimi zdravili za zdravljenje tuberkuloze pri odraslih bolnikih s tuberkulozo, ki prizadene pljuča in je odporna proti več zdravilom (vsaj proti izoniazidu in rifampicinu, ki sta standardni zdravili za zdravljenje tuberkuloze).
Sirturo has been given ‘conditional approval'.
Zdravilo Sirturo je pridobilo „pogojno dovoljenje za promet“.
Why is Sirturo approved?
Zakaj je bilo zdravilo Sirturo odobreno?
For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Sirturo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Sirturo is a tuberculosis medicine that contains the active substance bedaquiline.
Sirturo je zdravilo za zdravljenje tuberkuloze, ki vsebuje zdravilno učinkovino bedakilin.
Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Zdravljenje sme uvesti in spremljati le zdravnik, ki ima izkušnje z zdravljenjem tuberkuloze, odporne proti več zdravilom.
What information is still awaited for Sirturo?
Katere informacije o zdravilu Sirturo še pričakujemo?
Sirturo can only be obtained with a prescription.
Izdaja zdravila Sirturo je le na recept.
In a main study in adults with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines.
V glavni študiji pri odraslih bolnikih s tuberkulozo, ki je odporna proti več zdravilom in prizadene pljuča, so primerjali zdravilo Sirturo in placebo (zdravilo brez zdravilne učinkovine), ki so ju dodali kombiniranemu zdravljenju z drugimi standardnimi zdravili za tuberkulozo.
There was also a higher number of reported deaths in the Sirturo group.
Prav tako so v skupini, zdravljeni z zdravilom Sirturo, zabeležili večje število smrtnih primerov.
How does Sirturo work?
Kako zdravilo Sirturo deluje?
The European Commission granted a marketing authorisation valid throughout the European Union for Sirturo on 05/03/2014.
Evropska komisija je dovoljenje za promet z zdravilom Sirturo, veljavno po vsej Evropski uniji, izdala <datum izdaje dovoljenja za promet z zdravilom>.
How is Sirturo used?
Kako se zdravilo Sirturo uporablja?
List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev/imetnikov dovoljenja za promet z zdravilom v državah članicah
This summary was last updated in 10-2018.
Povzetek je bil nazadnje posodobljen 10-2018.
Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta.
Nadaljnje informacije o zdravilu Elocta so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Elocta.
The injection is given into a vein over several minutes.
Injicira se v veno v trajanju nekaj minut.
Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Zdravilo Elocta je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 19. novembra 2015.
The European Medicines Agency therefore decided that Elocta's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Elocta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Elocta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elocta?
Other information about Elocta
Druge informacije o zdravilu Elocta
As for all medicines, data on the use of Elocta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Elocta stalno spremljajo.