FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP concluded that Ipreziv belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Slovenian: CHMP je zaključil, da spada zdravilo Ipreziv v skupino uveljavljenih zdravil za zdravljenje hipertenzije ter da so njegova tveganja podobna tveganju pri drugih zdravilih v tej skupini.
English: The studies also showed that Ipreziv, when taken in combination with other medicines, can produce additional decreases in blood pressure compared with when these medicines are taken without Ipreziv.
Slovenian: Študije so tudi pokazale, da lahko zdravilo Ipreziv v kombinaciji z drugimi zdravili povzroči še dodatno znižanje krvnega tlaka v primerjavi z znižanjem tlaka, ki ga ta zdravila dosežejo brez kombiniranja z zdravilom Ipreziv.
English: Ipreziv on its own was more effective than placebo.
Slovenian: Zdravilo Ipreziv je bilo pri samostojni uporabi učinkovitejše od placeba.
English: EPAR summary for the public azilsartan medoxomil
Slovenian: Povzetek EPAR za javnost medoksomilazilsartanat
English: Three studies investigated the effects of Ipreziv in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Slovenian: V treh študijah so proučevali učinke zdravila Ipreziv v kombinaciji z drugim zdravili proti hipertenziji (klortalidon, amlodipin in hidroklorotiazid).
English: In the two studies with Ipreziv taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Ipreziv 40 mg and a fall of about 14.5 mmHg on Ipreziv 80 mg after 6 weeks.
Slovenian: V dveh študijah, v katerih so zdravilo Ipreziv kot samostojno zdravilo primerjali s placebom, se je pri bolnikih, ki so jemali 40-miligramski odmerek zdravila Ipreziv, po šestih tednih sistolični krvni tlak v povprečju znižal za okoli 13,5 mmHg, pri bolnikih, ki so jemali 80-miligramski odmerek zdravila Ipreziv, pa za okoli 14,5 mmHg.
English: By blocking the receptors to which angiotensin II normally attaches, azilsartan medoxomil stops the hormone from having an effect,
Slovenian: Medoksomilazilsartanat z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, zaustavlja delovanje tega hormona,
English: For the full list of all side effects reported with Ipreziv, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ipreziv, glejte navodilo za uporabo.
English: Why has Ipreziv been approved?
Slovenian: Zakaj je bilo zdravilo Ipreziv odobreno?
English: Ipreziv must not be used in people who are hypersensitive (allergic) to azilsartan medoxomil or any of the other ingredients.
Slovenian: Zdravila Ipreziv ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) medoksomilazilsartanat ali katero koli drugo sestavino zdravila.
English: When Ipreziv alone was compared with other medicines, 80 mg of Ipreziv was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Slovenian: Pri primerjavi samostojne uporabe zdravila Ipreziv z drugimi zdravili je bil 80-miligramski odmerek zdravila Ipreziv učinkovitejši pri zniževanju krvnega tlaka kot največji odobreni odmerek valsartana (320 mg) in medoksomilolmesartanata (40 mg).
English: What is Ipreziv used for?
Slovenian: Za kaj se zdravilo Ipreziv uporablja?
English: Five studies investigated the effects of Ipreziv taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Slovenian: V petih študijah so proučevali učinke zdravila Ipreziv pri samostojni uporabi tega zdravila v primerjavi s placebom (zdravilom brez zdravilne učinkovine) ali z drugimi zdravili proti hipertenziji (ramipril, valsartan in medoksomilolmesartanat).
English: What is Ipreziv?
Slovenian: Kaj je zdravilo Ipreziv?
English: Ipreziv is a medicine that contains the active substance azilsartan medoxomil.
Slovenian: Ipreziv je zdravilo, ki vsebuje zdravilno učinkovino medoksomilazilsartanat.
English: How is Ipreziv used?
Slovenian: Kako se zdravilo Ipreziv uporablja?
English: How has Ipreziv been studied?
Slovenian: Kako je bilo zdravilo Ipreziv raziskano?
English: How does Ipreziv work?
Slovenian: Kako zdravilo Ipreziv deluje?
English: Levact 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Slovenian: (bendamustin hidroklorid, 2,5 mg/ml, prašek za koncentrat za raztopino za infundiranje)
English: Conclusion
Slovenian: Poročevalec:
English: GROUNDS FOR POSITIVE OPINION
Slovenian: Datum izdaje mnenja:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LEVACT AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Levact in povezanimi imeni
English: Bendamustine has been used clinically as an antineoplastic agent in the German Democratic Republic since 1971 and there is therefore substantial clinical experience with bendamustine in Germany.
Slovenian: Bendamustin se v Nemčiji v zdravilih proti raku uporablja od začetka sedemdesetih let prejšnjega stoletja.
English: Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
Slovenian: • ne-Hodgkinovega limfoma (raka limfnega tkiva, dela imunskega sistema) pri bolnikih, pri katerih se je rak poslabšal med zdravljenjem z zdravilom, ki vsebuje rituksimab (drugo zdravilo proti raku), ali po njem;
English: “First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
Slovenian: • kronične limfocitne levkemije (rak belih krvnih celic, imenovanih limfociti) pri bolnikih, pri katerih zdravljenje s fludarabinom (drugim zdravilom proti raku) ni ustrezno;
English: The procedure was subsequently referred to the CHMP.
Slovenian: Do kakšnih zaključkov je prišel CHMP?
English: Based on the submitted data and in view of the adequate commitments, the CHMP considered the referred indications to be approvable.
Slovenian: Na podlagi ocene teh podatkov in znanstvene razprave v Odboru je CHMP menil, da koristi zdravila Levact odtehtajo njegova tveganja pri obeh indikacijah, pri katerih so se pojavili zadržki.
English: According to the CHMP anticancer guideline (CPMP/EWP/205/95/Rev.3/Corr.
Slovenian: EMA/CHMP/735863/2009 rev. EMEA/H/A-29/1238
English: France
Slovenian: 7. julij 2010
English: Applicant company name, address
Slovenian: Odgovori družbe, poslani dne:
English: Austria
Slovenian: 18. marec 2010
English: The CHMP noted the submitted trials assessing the role of bendamustine in CLL, MM and rituximabrefractory NHL.
Slovenian: CHMP je ocenil dve klinični študiji, ki ju je družba predložila v podporo indikacijama multipli mielom in ne-Hodgkinov limfom.
English: A number of concerned member states raised potential serious risks to public health with regards to the efficacy of the medicinal product in these indications, considering that non-inferiority or superior efficacy when compared to the efficacy of well established chemotherapy regimens recommended in international guideline had not been demonstrated.
Slovenian: Podlaga za napotitev je bila, da ena država članica, Združeno kraljestvo, ni mogla odobriti indikacije ne-Hodgkinov limfom, dve državi članici, Belgija in Francija, pa nista mogli odobriti indikacije multipli mielom, saj ni bilo dovolj podatkov glede učinkovitosti tega zdravila pri teh indikacijah.
English: Levact contains bendamustine, an alkylating anti-tumour agent which acts by impairing DNA matrix functions and DNA synthesis and repair.
Slovenian: Zdravilna učinkovina v zdravilu Levact, bendamustin hidroklorid, spada v skupino zdravil proti raku, imenovanih „alkilirajoče učinkovine“.
English: Efficacy of bendamustine in multiple myeloma (MM)
Slovenian: Jean-François Baurain (Belgija)
English: Therefore, the CHMP considered that the benefit-risk ratio is positive for all applied indications, albeit with different degrees of certainty.
Slovenian: Odbor je tako priporočil odobritev dovoljenja za promet z zdravilom Levact v Nemčiji in v vseh zadevnih državah članicah za vse indikacije, za katere je bila vložena vloga.
English: SCIENTIFIC CONCLUSIONS
Slovenian: Soporočevalec:
English: The Applicant presented an abstract of the final analysis of a trial in first line setting, comparing bendamustine in combination with rituximab (B-R) to R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin (Adriamycin), Oncovin (vincristine), and prednisone) treatment, allowing the contribution of bendamustine vs CHOP to be deduced.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Levact odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji ter v navedenih državah članicah EU: Avstrija, Belgija, Danska, Finska, Francija, Irska, Italija, Luksemburg, Norveška, Poljska, Španija in Združeno kraljestvo.
English: Finally, the Applicant noted the characteristic neurotoxicity profiles of recently authorised drugs and emphasized the non-overlapping and well-established toxicity profile of bendamustine (no neurotoxicity) for patients not eligible for thalidomide or bortezomib.
Slovenian: 65 let, ki niso primerni za presaditev matičnih celic in jih ni mogoče zdraviti s talidomidom ali bortezomibom (drugima vrstama zdravil proti raku).
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Levact and associated names (see Annex I).
Slovenian: Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Levact in povezanih imen.
English: The CR rate was significantly higher for the B-R group (40.1 vs. 30.8%), PFS was higher (54.8 vs. 34.8 months) and the Hazard Ratio (HR) was 0.5765.
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Levact in povezanimi imeniF F (bendamustin hidroklorid, 2,5 mg/ml, prašek za koncentrat za raztopino za infundiranje) EMA/CHMP/735863/2009
English: In conclusion, the CHMP adopted the following indications:
Slovenian: Uporablja se za zdravljenje naslednjih vrst raka:
English: International Non-proprietary Name (INN): Rubitecan
Slovenian: Mednarodno nelastniško ime (INN): rubitekan
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Slovenian: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Alkaloids are substances that are naturally found in plants.
Slovenian: Alkaloidi so snovi, ki so naravno prisotne v rastlinah.
English: However, if you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving you the treatment.
Slovenian: Če pa ste vključeni v klinično preizkušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: Orathecin was designated as an orphan medicinal product on 10 June 2003.
Slovenian: Zdravilo Orathecin je bilo 10. junija 2003 določeno kot zdravilo sirota.
English: London, 26 January 2006 Doc.Ref.
Slovenian: London, 26. januar 2006 Sklic dok.
English: No information has been given by the Company on the future development of the product.
Slovenian: Podjetje ni predložilo podatkov o prihodnjem razvoju zdravila.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for Orathecin
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo Orathecin
English: On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency's Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).
Slovenian: Podjetje EuroGen Pharmaceuticals Ltd je 19. januarja 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji, da so se odločili umakniti vlogo za dovoljenje za promet z zdravilom Orathecin (rubitekan).
English: When cells are growing, as in the case for cancer cells, the genetic material (DNA) inside the cell may become twisted.
Slovenian: Ko celice rastejo (kar se dogaja pri rakavih celicah), se lahko genetski material (DNA) v celici navije v navoje.
English: Link to the withdrawal letter.
Slovenian: Povezava do dopisa o umiku.
English: Link to withdrawal EMEA press release.
Slovenian: Povezava do tiskovnega sporočila EMEA o umiku.
English: This avoids that the DNA breaks, which would damage the cells.
Slovenian: S tem preprečijo lomljenje DNA, ki bi poškodovalo celice.
English: The CHMP was assessing the responses given by the Company to a list of questions.
Slovenian: CHMP je ocenjeval odgovore, ki jih je podjetje podalo na vprašanja s seznama vprašanj.
English: Orathecin has been investigated in two main clinical studies.
Slovenian: Zdravilo Orathecin so preizkusili v dveh glavnih kliničnih raziskavah.
English: Certain camptothecins are used in medicine as anti-cancer agents.
Slovenian: Določeni kamptotecini se uporabljajo v medicini kot zdravila proti raku.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da koristni učinki niso bili zadostno dokazani in niso večji od znanih tveganj.
English: Orathecin contains 0.5 or 1.25 of the active substance rubitecan.
Slovenian: Zdravilo Orathecin vsebuje 0,5 mg ali 1,25 mg zdravilne učinkovine rubitekan.
English: In the studies presented by the Company, it could not be shown that Orathecin extends the life of patients nor improves their quality of life.
Slovenian: Raziskave, ki jih je predložilo podjetje, niso pokazale, da zdravilo Orathecin podaljša življenje bolnikov ali izboljša kakovost njihovega življenja.
English: This protein is called topoisomerase I. By blocking this protein, Orathecin is expected to damage the cancer cells.
Slovenian: Tej beljakovini pravimo topoizomeraza I. Z blokiranjem te beljakovine naj bi zdravilo Orathecin poškodovalo rakave celice.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orathecin?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe z zdravilom Orathecin?
English: Moreover, patients treated with Orathecin experienced many side effects, including serious ones.
Slovenian: Razen tega so imeli bolniki, ki so bili zdravljeni z zdravilom Orathecin, veliko neželenih učinkov, vključno z resnimi neželenimi učinki.
English: The effects of orathecin were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Orathecin so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: Orathecin belongs to a group of alkaloids called camptothecins.
Slovenian: Zdravilo Orathecin spada v skupino alkaloidov, ki jim pravimo kamptotecini.
English: Based on the review of the data and the Company's response to the CHMP list of questions, at the time the withdrawal, the CHMP had concerns and was of the provisional opinion that Orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo ni mogoče odobriti dovoljenja za zdravljenje bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
English: The Company informed the Agency that at the time of the withdrawal, all clinical trials in the European Union are closed to enrolment and there is no ongoing compassionate use programmes.
Slovenian: Podjetje je obvestilo Evropsko agencijo za zdravila, da se v času umika v nobeno klinično preizkušanje v Evropski uniji več ne vključuje bolnikov ter da programi sočutne uporabe ne potekajo več.
English: The application was at Day 172 days, when the Company withdrew it.
Slovenian: Podjetje je umaknilo vlogo na dan 172.
English: Orathecin was to be used to treat patients with advanced cancer of the pancreas, who cannot be operated or who have metastasis (cancer cells that spread from the original site to other parts of the body), and who do not respond to the other anticancer drugs used for the treatment of their disease.
Slovenian: Zdravilo Orathecin naj bi se uporabljalo za zdravljenje bolnikov z napredovalim rakom trebušne slinavke, pri katerih kirurški poseg ni možen ali pa imajo metastaze (rakave celice, ki so se zasejale izven prvotnega mesta v drugih delih telesa) in ki se ne odzivajo na druga zdravila proti raku, ki se uporabljajo za zdravljenje te bolezni.
English: Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
English: The studies included approximately 800 patients with advanced or metastatic cancer of the pancreas.
Slovenian: V raziskave je bilo vključenih približno 800 bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
English: Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.
Slovenian: Zdravilo Orathecin so dajali bolnikom, dokler rak ni napredoval ali dokler niso več prenesli zdravljenja.
English: What documentation has been presented by the Company to support the application to the CHMP?
Slovenian: Kakšno dokumentacijo je podjetje predložilo CHMP za podkrepitev svoje vloge?
English: The studies looked at how long the patients survived after receiving orathecin, compared to those receiving the standard medicines used to treat pancreatic cancer, including 5-fluorouracil (5-FU) or gemcitabine.
Slovenian: Čas preživetja teh bolnikov so primerjali s časom preživetja bolnikov, ki so prejemali zdravila, ki se običajno uporabljajo za zdravljenje raka trebušne slinavke, med drugim 5-fluorouracil (5-FU) ali gemcitabin.
English: Camptothecins are able to block one of the proteins that can remove twists in the DNA.
Slovenian: Kamptotecini lahko blokirajo eno izmed beljakovin, ki odvijajo navoje na DNA.
English: Orathecin is a capsule to be taken orally.
Slovenian: Zdravilo Orathecin so kapsule, ki se jemljejo peroralno.
English: What is Orathecin?
Slovenian: Kaj je zdravilo Orathecin?
English: The indication applied for was the treatment of patients with advanced or metastatic pancretic cancer.
Slovenian: Indikacija, navedena v vlogi, je bila zdravljenje bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
English: What was Orathecin expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Orathecin uporabljalo?
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before give an opinion, ask any remaining questions (at day 180) to the Company.
Slovenian: Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za
English: How is Orathecin expected to work?
Slovenian: Kako naj bi zdravilo Orathecin delovalo?
English: Cells have several proteins, which help to remove any twists in the DNA.
Slovenian: Celice imajo več beljakovin, ki odvijajo navoje na DNA.
English: The recommended dose is one capsule taken three times a day.
Slovenian: Priporočeni odmerek je ena kapsula trikrat na dan.
English: Patients should be assessed every six months and treatment should be stopped if no improvement is seen.
Slovenian: Bolnike je treba ocenjevati vsakih šest mesecev in zdravljenje prekiniti, če ni vidnega izboljšanja.
English: No major safety concerns were identified, and the possible risk of bleeding can be minimised with appropriate precautions.
Slovenian: Večjih varnostnih zadržkov niso ugotovili, morebitno tveganje za krvavitev pa se lahko zmanjša z ustreznimi previdnostnimi ukrepi.
English: What measures are being taken to ensure the safe and effective use of Elmiron?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elmiron?
English: The full EPAR for Elmiron 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) za zdravilo Elmiron je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU.
Slovenian: Sindrom bolečega mehurja je mučno stanje, za katero v EU še ni bilo odobrenih zdravil.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Elmiron'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) pri agenciji je zato zaključil, da so koristi zdravila Elmiron večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Elmiron.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Elmiron.
English: This reinforcement of the protective layer may reduce inflammation and bladder pain.
Slovenian: Okrepitev zaščitnega sloja morda zmanjša vnetje in bolečino v mehurju.
English: Other information about Elmiron
Slovenian: Druge informacije o zdravilu Elmiron
English: The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall.
Slovenian: Študije so skupaj vključevale 454 bolnikov z majhnimi krvavitvami in lezijami na steni mehurja.
English: Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature.
Slovenian: Ker je natrijev pentosan polisulfat dobro znana snov in njegova uporaba pri sindromu bolečega mehurja dobro uveljavljena, je družba za zdravilo Elmiron predložila podatke iz znanstvene literature.
English: Since Elmiron may have a weak anticoagulant effect (i.e. it may stop the blood from clotting properly), it must not be used in patients who actively bleed (but this does not include women during menstrual cycle).
Slovenian: Ker ima zdravilo Elmiron šibek antikoagulacijski učinek (kar pomeni, da lahko prepreči pravilno strjevanje krvi), se ne sme uporabljati pri bolnikih z aktivno krvavitvijo (kar pa ne vključuje žensk v času menstruacije).
English: A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
Slovenian: Pregled štirih glavnih študij iz literature je pokazal, da je natrijev pentosan polisulfat učinkovit pri zmanjševanju simptomov, kot sta bolečina in nujnost pogostega uriniranja.