FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH was therefore of the view that the formulation of this immediate-release product will have only little influence on the bioavailability, which is supported by good point estimates for AUC and Cmax in study 2005-980.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zato menil, da bo imela formulacija tega zdravila s takojšnjim sproščanjem samo majhen vpliv na biološko uporabnost, kar podpirajo dobre točkovne ocene za AUC in Cmax v študiji 2005-980.
English: The CHMP also noted the MAH review of study 2005-980 and the quality of the bio-analytical report and the reported similarity between the results generated by Cetero Research and those found from repeated studies/analysis for other drug products.
Slovenian: Prav tako je upošteval pregled študije 2005-980, ki ga je predložil imetnik dovoljenja za promet z zdravilom, ter kakovost bioanalitičnega poročila in poročano podobnost med rezultati, ki jih je pridobila ustanova Cetero Research, in rezultati, ki so jih ugotovili pri ponovljenih študijah/analizah za druga zdravila.
English: However, for Cilazapril Teva, the MAH stated that no study samples were available for study 2005-980 and that there is therefore no possibility to reanalyse the data.
Slovenian: Vendar je imetnik dovoljenja za promet z zdravilom navedel, da za zdravilo Cilazapril Teva v študiji 2005-980 niso bili na voljo nobeni vzorci in da zaradi tega ni bilo možnosti za ponovno analizo podatkov.
English: In response to the CHMP list of questions, the MAH stated that the pivotal bioequivalence study 2005980 conducted for Cilazapril Teva met the bioequivalence criteria (point estimates of 93.4% and 100% for AUC0-4h and Cmax, respectively) with respect to the Guideline on the Investigation of Bioequivalence.
Slovenian: Kot odgovor na seznam vprašanj odbora CHMP je imetnik dovoljenja za promet z zdravilom navedel, da je ključna študija biološke enakovrednosti 2005-980, izvedena za zdravilo Cilazapril Teva, izpolnila merila (točkovni oceni 93,4 % za AUC-4h in 100 % za Cmax) glede smernice za proučevanje biološke enakovrednosti.
English: The CHMP assessed the MAH responses and noted that the MAH had repeated a number of studies, producing data in line with that obtained by Cetero Research, although no details of these studies were included in the response documentation to support this.
Slovenian: Odbor CHMP je ocenil odgovore imetnika dovoljenja za promet z zdravilom in ugotovil, da je imetnik dovoljenja za promet z zdravilom ponovil številne študije, ki so podale podatke, skladne s podatki, ki so bili pridobljeni v ustanovi Cetero Research, čeprav v dokumentacijo z odgovori niso bile vključene podrobnosti teh študij, ki bi to podprle.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Cilazapril Teva and associated names with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Slovenian: • Odbor je menil, da so razpoložljivi podatki povzročili resne dvome glede dokazov o biološki enakovrednosti zdravila Cilazapril Teva in povezanih imen ter referenčnega zdravila v EU zaradi pomislekov glede zanesljivosti podatkov, ki so bili izpostavljeni v ugotovitvah inšpekcijskega pregleda ustanove Cetero Research.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisation.
Slovenian: Na podlagi ocene razpoložljivih podatkov ima odbor CHMP še vedno resne dvome zaradi ugotovitev inšpekcijskega pregleda prostorov ustanove Cetero Research v Houstonu (Teksas, ZDA) glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti, predložene kot podpora za dovoljenje za promet z zdravilom.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Cilazapril Teva to its EU reference product, the benefit-risk balance of Cilazapril Teva cannot be considered to be favourable.
Slovenian: Zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravila Cilazapril Teva in referenčnega zdravila v EU, razmerja med tveganji in koristmi ni mogoče obravnavati kot pozitivnega.
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Cilazapril Teva and associated names cannot be confirmed.
Slovenian: • Odbor je mnenja, da zaradi resnih dvomov glede dokazov o biološki enakovrednosti ni mogoče potrditi razmerja med tveganji in koristmi zdravila Cilazapril Teva in povezanih imen.
English: The highly soluble nature of the drug substance over the physiological pH range and the dissolution similarity between Cilazapril Teva and the reference product was also acknowledged.
Slovenian: Upoštevali so tudi veliko topnost zdravilne učinkovine v fiziološkem razponu pH ter raztapljanje, ki je bilo podobno med zdravilom Cilazapril Teva in referenčnim zdravilom.
English: The MAH considered that the data described in this PSUR did not impact the benefit-risk balance of Cilazapril Teva.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da podatki v tem poročilu PSUR niso vplivali na razmerje med tveganji in koristmi pri zdravilu Cilazapril Teva.
English: The CHMP also noted that due to the lack of availability of samples, it was not possible to reanalyse the samples from the clinical study in order to check the validity of the original findings, but the CHMP acknowledged the MAH intention to repeat the study, with final results expected to be available by the end of June 2013.
Slovenian: Odbor CHMP je prav tako ugotovil, da zaradi pomanjkljive razpoložljivosti vzorcev ni bilo mogoče ponovno analizirati vzorcev iz klinične študije, da bi se preverila veljavnost izvirnih ugotovitev.
English: On 01 August 2012, the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC for the identified nationally authorised products.
Slovenian: Direktive 2001/83/ES za ugotovljena nacionalno odobrena zdravila.
English: The MAH considered that the satisfactory results of these re-analyses suggest that the final outcome of the Cilazapril Teva study was not influenced by the bioanalytical analyses carried out at Cetero Research, Houston.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da zadovoljivi rezultati ponovnih analiz kažejo, da bioanalitične analize, ki jih je opravila ustanova Cetero Research v Houstonu, niso vplivale na končni izid študije z zdravilom Cilazapril Teva.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Cilazapril Teva and associated names with the EU reference product.
Slovenian: • Odbor je menil, da odgovori imetnika dovoljenja za promet z zdravilom niso zadostni, da bi zavrnili resne dvome glede dokazov o biološki enakovrednosti zdravila Cilazapril Teva in povezanih imen ter referenčnega zdravila v EU.
English: In addition, the MAH stated that it had already carried out a number of repeats or re-assays of bioanalytical studies potentially affected by the Cetero Research findings for other Teva products in response to the concerns raised by the FDA.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom kot odziv na pomisleke urada FDA navedel, da je že izvedel številne ponovitve ali ponovne teste za bioanalitične študije, na katere so morebitno vplivale ugotovitve ustanove Cetero Research za druga zdravila Teva.
English: However, the CHMP did not consider these general data to be sufficient to provide re-assurances specifically regarding the bioequivalence of Cilazapril Teva to its EU reference product.
Slovenian: Odbor CHMP je menil, da ti splošni podatki niso zadostni za ponovno zagotovitev biološke enakovrednosti zdravila Cilazapril Teva in referenčnega zdravila v EU.
English: 44 mg;100 mg 1 vial
Slovenian: 44 mg;100 mg 1 viala
English: The main measure of effectiveness was survival.
Slovenian: Najpomembnejše merilo učinkovitosti je bilo preživetje.
English: London, 19 July 2007 Doc.
Slovenian: London, 19. julij 2007 Sklic dok.
English: The applicant requested a re-examination of the opinion.
Slovenian: Predlagatelj je zaprosil za ponovno preveritev mnenja.
English: International non-proprietary name (INN): oblimersen
Slovenian: Mednarodno nelastniško ime (INN): oblimersen
English: Ref. EMEA/321164/2007
Slovenian: EMEA/321164/2007
English: The company that applied for authorisation is Genta Development Limited.
Slovenian: Družba, ki je predložila vlogo za odobritev, je Genta Development Limited.
English: This was expected to slow down the growth of the tumour.
Slovenian: To naj bi upočasnilo rast tumorja.
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for GENASENSE
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo GENASENSE
English: The CHMP refusal was confirmed after reexamination.
Slovenian: Zavrnitev CHMP je bila potrjena po ponovnem preverjanju.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preizkušanje ali sodelujete v programu sočutne uporabe in potrebujete več podatkov o svojem zdravljenju, se obrnite za zdravnika, ki vam je predpisal zdravljenje.
English: This protein normally allows skin cancer cells to stay alive by preventing them from committing suicide (apoptosis).
Slovenian: Ta beljakovina celicam kožnega raka običajno omogoča, da ostanejo žive, in sicer tako, da prepreči, da bi se samouničile (apoptoza).
English: Genasense has also been studied in 771 patients with advanced or metastatic melanoma.
Slovenian: Zdravilo Genasense so poleg tega preučevali tudi pri 771 bolnikih z napredovalimi ali metastaznimi melanomi.
English: The effects of Genasense were first tested in experimental models before being studied in humans.
Slovenian: Učinka zdravila Genasense so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: On 26 April 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Genasense 30 mg/ml concentrate for solution for infusion, intended for the treatment of advanced or metastatic melanoma.
Slovenian: Dne 26. aprila 2007 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje, s katerim priporoča zavrnitev izdaje dovoljenja za promet za zdravilo Genasense 30 mg/ml koncentrat za raztopino za infundiranje, namenjeno za zdravljenje napredovalih ali metastaznih melanomov.
English: Therefore, the study did not demonstrate that Genasense was effective in treating melanoma.
Slovenian: Ta študija torej ni pokazala, da bi bilo zdravilo Genasense učinkovito pri zdravljenju melanomov.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 July 2007.
Slovenian: Po preučitvi podlage za to prošnjo je Odbor za zdravila za uporabo v humani medicini (CHMP) ponovno pregledal prvotno mnenje in 19. julija 2007 potrdil zavrnitev izdaje dovoljenja za promet z zdravilom.
English: Genasense was to be used to treat patients with melanoma (a type of skin cancer affecting cells called ‘melanocytes') whose disease is advanced (it cannot be removed by surgery alone) or metastatic (has spread to other parts of the body).
Slovenian: Zdravilo Genasense naj bi se uporabljalo za zdravljenje bolnikov z melanomom (vrsta kožnega raka, ki prizadene celice, imenovane „melanociti“), pri katerih je bolezen napredovala (prizadetega tkiva ni mogoče odstraniti samo s kirurškim posegom) ali je prišlo do metastaz (obolenje se je razširilo na druge dele telesa).
English: It is made up into a solution that is given as an intravenous infusion (drip into a vein).
Slovenian: Pripravljeno je v obliki raztopine, ki se daje kot intravenska infuzija (kapljanje v veno).
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Genasense?
Slovenian: Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Genasense?
English: It attaches to the ‘messenger RNA' (mRNA) that normally instructs the cell how to make Bcl-2.
Slovenian: Pritrdi se na „obveščevalno RNK“ (mRNA), ki običajno celicam daje navodila, kako tvoriti Bcl-2.
English: By blocking the production of Bcl-2, Genasense was expected to make the cancer cells more sensitive to factors that cause cell death, including anticancer medicines such as dacarbazine.
Slovenian: Z zavrtjem nastajanja Bcl-2 naj bi zdravilo Genasense povzročilo, da bi rakave celice postale bolj občutljive na dejavnike, ki povzročajo smrt celic, vključno z zdravili za zdravljenje rakavih obolenj, kot je na primer dakarbazin.
English: At that point in time, the CHMP was of the opinion that the benefits of Genasense in the treatment of advanced or metastatic melanoma did not outweigh its risks.
Slovenian: V tem času je bil CHMP mnenja, da koristi zdravila Genasense pri zdravljenju napredovalih ali metastaznih melanomov niso večje od z njim povezanih tveganj.
English: What is Genasense?
Slovenian: Kaj je zdravilo Genasense?
English: It is thought to work by preventing cells from producing the protein Bcl-2.
Slovenian: Delovalo naj bi tako, da bi celicam onemogočalo tvorbo beljakovine Bcl-2.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Genasense.
Slovenian: Družba je Odbor za zdravila za uporabo v humani medicini (CHMP) obvestila, da za bolnike, ki so trenutno vključeni v klinična preizkušanja ali sodelujejo v programih sočutne uporabe zdravila Genasense, ni nobenih posledic.
English: This stimulates the cell to destroy the mRNA, blocking the production of the protein.
Slovenian: To celico spodbudi k uničenju mRNA, s čimer je zavrto nastajanje beljakovine.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Slovenian: Kateri so bili glavni zadržki zaradi katerih je CHMP zavrnil dovoljenje za promet?
English: In the main study of patients with melanoma, survival rates were very similar in the patients receiving Genasense with dacarbazine and those receiving dacarbazine alone.
Slovenian: V najpomembnejši študiji pri bolnikih z melanomom je bil čas preživetja pri bolnikih, ki so prejemali zdravilo Genasense skupaj z dakarbazinom, zelo podoben času preživetja pri bolnikih, ki so prejemali samo dakarbazin.
English: Genasense was to be used in combination with dacarbazine (another anticancer medicine).
Slovenian: Zdravilo Genasense naj bi se uporabljalo v kombinaciji z dakarbazinom (drugim zdravilom za zdravljenje rakavih obolenj).
English: Hence, the CHMP recommended that Genasense be refused marketing authorisation.
Slovenian: Zato je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Genasense.
English: Genasense is a medicine containing the active substance oblimersen.
Slovenian: Genasense je zdravilo, ki vsebuje zdravilno učinkovino oblimersen.
English: What was Genasense expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Genasense uporabljalo?
English: There were side effects associated with treatment with Genasense.
Slovenian: V povezavi z zdravljenjem z zdravilom Genasense bili opaženi neželeni stranski učinki.
English: The active substance in Genasense, oblimersen, is an antineoplastic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Genasense, oblimersen, je antineoplastično zdravilo.
English: The effects of Genasense in combination with dacarbazine were compared with those of dacarbazine taken alone.
Slovenian: Učinke zdravila Genasense v kombinaciji z zdravilom dakarbazin so primerjali z učinki zdravila
English: How is Genasense expected to work?
Slovenian: Kako naj bi zdravilo Genasense delovalo?
English: Oblimersen is an ‘anti-sense oligonucleotide' medicine.
Slovenian: Oblimersen je zdravilo, ki učinkuje kot „protismiseln oligonukleotid“.
English: 2 February 2016 EMA/824095/2015
Slovenian: februar 2016 EMA/824095/2015
English: Centaury should only be used in adults and elderly.
Slovenian: Zel navadne tavžentrože se sme uporabljati samo pri odraslih in starejših.
English: Studies in laboratory tests indicate an effect as appetite and digestion stimulant, although the data available are very limited.
Slovenian: Študije z laboratorijskimi preskusi kažejo, da učinkuje kot sredstvo za spodbujanje apetita in prebave, čeprav je razpoložljivih podatkov zelo malo.
English: If symptoms last longer than 2 weeks during use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Slovenian: Če simptomi med uporabo zdravila trajajo dlje kot dva tedna, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Centaury EMA/824095/2015
Slovenian: Zel navadne tavžentrože EMA/824095/2015
English: Centaury is the common name for the plant Centaurium erythraea Rafn.
Slovenian: Navadna tavžentroža je splošno ime za rastlino Centaurium erythraea Rafn.
English: This summary is not intended to provide practical advice on how to use medicines containing centaury.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel navadne tavžentrože.
English: The HMPC noted the lack of clinical studies with centaury.
Slovenian: Odbor HMPC je ugotovil pomanjkanje kliničnih študij z zeljo navadne tavžentrože.
English: The HMPC conclusions on the use of centaury medicines for indigestion or other stomach and gut disorders, and in temporary loss of appetite are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo zel navadne tavžentrože, za prebavne motnje ali druge težave z želodcem in črevesjem ter začasno izgubo apetita temeljijo na njihovi „tradicionalni uporabi“.
English: Further information on the risks associated with centaury medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo zel navadne tavžentrože, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Centaury preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the aerial parts.
Slovenian: Pripravki iz zeli navadne tavžentrože se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) ali drobljenjem nadzemnih delov v prah.
English: Herbal medicines containing centaury are usually available as herbal teas to be drunk, or in liquid or solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zel navadne tavžentrože, so navadno na voljo kot zdravilni čaj, ki se popije, ali v tekoči ali trdni obliki za jemanje skozi usta.
English: Centaury medicines should not be taken by people with ulcers in the stomach.
Slovenian: Zdravil, ki vsebujejo zel navadne tavžentrože, ne smejo jemati osebe z želodčnimi razjedami.
English: The HMPC concluded that, on the basis of its long-standing use, centaury can be used for mild indigestion or other stomach and gut disorders as well as for temporary loss of appetite.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko zel navadne tavžentrože uporablja za blage prebavne težave ali druge težave z želodcem in črevesjem ter pri začasni izgubi apetita.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of centaury.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli navadne tavžentrože.
English: In some cases the solvent is partially evaporated to obtain a soft extract.
Slovenian: V nekaterih primerih se topilo delno odpari, s čimer se pridobi gosti ekstrakt.
English: Centaury can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Zel navadne tavžentrože je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: The HMPC conclusions are therefore based on the long-standing use of centaury.
Slovenian: Zaključki odbora HMPC zato temeljijo na dolgotrajni uporabi zeli navadne tavžentrože.
English: Any applications for the licensing of medicines containing centaury have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel navadne tavžentrože, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Information on the use and licensing of centaury medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo zel navadne tavžentrože, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Further information on the HMPC assessment of centaury medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo zel navadne tavžentrože, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing centaury.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel navadne tavžentrože.
English: How are centaury medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo zel navadne tavžentrože, odobrena v EU?
English: What evidence supports the use of centaury medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel navadne tavžentrože?
English: For more information about treatment with centaury medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel navadne tavžentrože, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using centaury medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Other information about centaury medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo zel navadne tavžentrože
English: What are the risks associated with centaury medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel navadne tavžentrože?