FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Omenjene države članice niso mogle doseči soglasja glede medsebojnega priznavanja dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: 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.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, povzetek glavnih značilnosti zdravila pa v Dodatku III.
English: The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 25. maja 2007.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Slovenian: Nemčija je Evropski agenciji za zdravila dne 29. marca 2007 predložila razloge za nesoglasje.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: Xeomin Mednarodno nelastniško ime (INN): Nevrotoksin bakterije Clostridium botulinum tipa A
English: The tablets should be taken with food.
Slovenian: Tablete je treba jemati sočasno s hrano.
English: 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.
Slovenian: Priporočeni odmerek je 4 tablete enkrat na dan prva 2 tedna, nadaljnjih 22 tednov pa 2 tableti 3-krat na teden.
English: The company will also provide longer term safety data on the medicine.
Slovenian: Prav tako bo predložila tudi dolgoročnejše podatke o varnosti zdravila.
English: The medicine is available as 100 mg tablets.
Slovenian: Zdravilo je na voljo v obliki 100-miligramskih tablet.
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Slovenian: To pomeni, da se pričakujejo dodatni dokazi o zdravilu, ki jih mora zagotoviti družba.
English: This is a summary of the European public assessment report (EPAR) for Sirturo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sirturo.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Slovenian: Tuberkuloza je okužba, ki jo povzroča bakterija Mycobacterium tuberculosis.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove razpoložljive podatke in posodobila povzetek glavnih značilnosti zdravila, če bo to potrebno.
English: In addition, it is recommended that patients are directly observed by a healthcare professional as they take the medicine.
Slovenian: Poleg tega je priporočljivo, da bolnike med jemanjem zdravila neposredno nadzoruje zdravstveni delavec.
English: What measures are being taken to ensure the safe and effective use of Sirturo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sirturo?
English: It is given when combinations without Sirturo cannot be used, either because the disease is resistant to them or because of their side effects.
Slovenian: Uporablja se, kadar kombinacij brez zdravila Sirturo ni mogoče uporabiti bodisi zaradi odpornosti bolezni proti tem kombinacijam ali zaradi njihovih neželenih učinkov.
English: Without the ability to generate energy, the bacteria die and the patient's condition can start to improve.
Slovenian: Če bakterije ne morejo več pridobivati energije, odmrejo, bolnikovo stanje pa se začne izboljševati.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A risk management plan has been developed to ensure that Sirturo is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Sirturo je bil pripravljen načrt obvladovanja tveganj.
English: 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.
Slovenian: 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.
English: It is not intended to provide practical advice on how to use Sirturo.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: Other information about Sirturo
Slovenian: Druge informacije o zdravilu Sirturo
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What benefits of Sirturo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Sirturo izkazalo v študijah?
English: 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).
Slovenian: 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).
English: For more information about treatment with Sirturo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What are the risks associated with Sirturo?
Slovenian: Kakšna tveganja so povezana z zdravilom Sirturo?
English: 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.
Slovenian: 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.
English: What is Sirturo and what is it used for?
Slovenian: Kaj je zdravilo Sirturo in za kaj se uporablja?
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Sirturo has been given ‘conditional approval'.
Slovenian: Zdravilo Sirturo je pridobilo „pogojno dovoljenje za promet“.
English: Why is Sirturo approved?
Slovenian: Zakaj je bilo zdravilo Sirturo odobreno?
English: For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Sirturo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Sirturo is a tuberculosis medicine that contains the active substance bedaquiline.
Slovenian: Sirturo je zdravilo za zdravljenje tuberkuloze, ki vsebuje zdravilno učinkovino bedakilin.
English: Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Slovenian: Zdravljenje sme uvesti in spremljati le zdravnik, ki ima izkušnje z zdravljenjem tuberkuloze, odporne proti več zdravilom.
English: What information is still awaited for Sirturo?
Slovenian: Katere informacije o zdravilu Sirturo še pričakujemo?
English: Sirturo bedaquiline
Slovenian: Sirturo bedakilin
English: Sirturo can only be obtained with a prescription.
Slovenian: Izdaja zdravila Sirturo je le na recept.
English: 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.
Slovenian: 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.
English: There was also a higher number of reported deaths in the Sirturo group.
Slovenian: Prav tako so v skupini, zdravljeni z zdravilom Sirturo, zabeležili večje število smrtnih primerov.
English: How does Sirturo work?
Slovenian: Kako zdravilo Sirturo deluje?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sirturo on 05/03/2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sirturo, veljavno po vsej Evropski uniji, izdala <datum izdaje dovoljenja za promet z zdravilom>.
English: How is Sirturo used?
Slovenian: Kako se zdravilo Sirturo uporablja?
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev/imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Mifepristone Linepharma 200 mg tablet
Slovenian: Mifepristone 200 mg tablet
English: This summary was last updated in 10-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2018.
English: Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta.
Slovenian: Nadaljnje informacije o zdravilu Elocta so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Elocta.
English: The injection is given into a vein over several minutes.
Slovenian: Injicira se v veno v trajanju nekaj minut.
English: Elocta received a marketing authorisation valid throughout the EU on 19 November 2015.
Slovenian: Zdravilo Elocta je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 19. novembra 2015.
English: 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.
Slovenian: 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.
English: What measures are being taken to ensure the safe and effective use of Elocta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elocta?
English: Elocta (efmoroctocog alfa) EMA/697822/2018
Slovenian: Elocta (efmoroktokog alfa) EMA/697822/2018
English: Other information about Elocta
Slovenian: Druge informacije o zdravilu Elocta
English: As for all medicines, data on the use of Elocta are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Elocta stalno spremljajo.
English: Elocta (efmoroctocog alfa)
Slovenian: Elocta (efmoroktokog alfa)
English: The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII.
Slovenian: Učinkovina v zdravilu Elocta, efmoroktokog alfa, deluje v telesu enako kot humani faktor VIII.
English: Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat.
Slovenian: Pri zdravljenju z zdravilom Elocta se redko pojavijo preobčutljivostne (alergijske) reakcije, ki vključujejo: otekanje obraza, izpuščaj, koprivnico, stiskanje v prsnem košu in težave z dihanjem, pekoč in zbadajoč občutek na mestu injiciranja, mrzlico, vročinske oblive, srbenje po vsem telesu, glavobol, nizek krvni tlak, otopelost, slabost, nemir in hiter srčni utrip.
English: Why is Elocta authorised in the EU?
Slovenian: Zakaj je zdravilo Elocta odobreno v EU?
English: What benefits of Elocta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Elocta izkazalo v študijah?
English: In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent' or ‘good' in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.
Slovenian: Poleg tega je bilo ob pojavu krvavitve zdravljenje z zdravilom Elocta v več kot 78 % primerih ocenjeno kot „odlično“ ali „dobro“, pri čemer so 87 % krvavitev obvladali z eno samo injekcijo.
English: An overview of Elocta and why it is authorised in the EU
Slovenian: Pregled zdravila Elocta in zakaj je odobreno v EU
English: What is Elocta and what is it used for?
Slovenian: Kaj je zdravilo Elocta in za kaj se uporablja?
English: What are the risks associated with Elocta?
Slovenian: Kakšna tveganja so povezana z zdravilom Elocta?
English: In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.
Slovenian: V študiji na 69 otrocih je bilo zdravilo Elocta podobno učinkovito: na leto sta se povprečno pojavili dve krvavitvi, pri čemer so 81 % krvavitev obvladali z eno samo injekcijo.
English: For more information about using Elocta, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Elocta glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Elocta are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Elocta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elocta have 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 Elocta upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: It contains the active substance efmoroctocog alfa.
Slovenian: Vsebuje učinkovino efmoroktokog alfa.
English: In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment.
Slovenian: V študiji s 165 odraslimi bolniki s hemofilijo A so imeli bolniki, ki so prejeli zdravilo Elocta kot prilagojeno preventivno zdravljenje, približno tri krvavitve na leto, bolniki, ki niso prejemali preventivnega zdravljenja, pa 37 krvavitev na leto.
English: The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Elocta uporablja za zdravljenje ali preprečevanje krvavitev, resnosti bolnikovega pomanjkanja faktorja VIII, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
English: Studies show that Elocta is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is in line with what is expected for medicines of its kind.
Slovenian: Študije kažejo, da je zdravilo Elocta učinkovito pri preprečevanju in zdravljenju krvavitev pri bolnikih s hemofilijo A, njegova varnost pa je v skladu s pričakovano varnostjo tovrstnih zdravil.
English: Elocta is available as a powder and solvent used to make a solution for injection.
Slovenian: Zdravilo Elocta je na voljo kot prašek in vehikel za pripravo raztopine za injiciranje.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Pri zdravilih s faktorjem VIII obstaja tudi tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvami.