FrancophonIA/ELRC3.0 huggingface dataset:
English: Pandemic influenza vaccine H5N1 AstraZeneca Pandemic influenza vaccine
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca cepivo proti pandemski gripi
English: No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 AstraZeneca on male and female fertility.
Slovenian: O možnih vplivih Cepiva proti pandemski gripi H5N1 AstraZeneca na plodnost moških in žensk ni podatkov.
English: If any of these apply, tell your doctor, nurse or pharmacist.
Slovenian: Če karkoli od tega velja za vas, morate obvestiti zdravnika, medicinsko sestro ali farmacevta.
English: median tissue culture infectious dose (TCID50) , with 18 of those subjects receiving a second dose 4-8 weeks later.
Slovenian: median infektivni odmerek tkivne kulture(TCID50); 18 od teh preiskovancev je od
English: There are no data available on the use of Pandemic influenza vaccine H5N1 AstraZeneca in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi Cepiva proti pandemski gripi H5N1 AstraZeneca pri nosečnicah ni.
English: What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for
Slovenian: Kaj je Cepivo proti pandemski gripi H5N1 AstraZeneca in za kaj ga uporabljamo
English: Pandemic influenza vaccine H5N1 AstraZeneca must not be injected.
Slovenian: Cepiva proti pandemski gripi H5N1 AstraZeneca se ne sme injicirati.
English: How to store Pandemic influenza vaccine H5N1 AstraZeneca Contents of the pack and other information
Slovenian: Shranjevanje Cepiva proti pandemski gripi H5N1 AstraZeneca Vsebina pakiranja in dodatne informacije
English: Very rare (may affect up to 1 in 1,000,000 people):
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: Efficacy (95% CI) matched strains
Slovenian: Učinkovitost (95 % IZ) ujemajoči se sevi
English: Peak incidence of vaccine virus recovery occurred 1-2 days post-vaccination in clinical studies with Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: Največjo pojavnost virusa iz cepiva so v kliničnih študijah s Cepivom proti pandemski gripi H5N1 AstraZeneca ugotovili 1 do 2 dneva po cepljenju.
English: Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines.
Slovenian: Zdravnik, medicinska sestra ali farmacevt bo presodil, ali se cepivo lahko uporabi sočasno z drugimi cepivi.
English: Efficacy (95% CI) all strains regardless of match
Slovenian: Učinkovitost (95 % IZ) vsi sevi, ne glede na ujemanje
English: Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca:
Slovenian: Drugi možni neželeni učinki Cepiva proti pandemski gripi H5N1 AstraZeneca so:
English: Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Slovenian: 6.1 Seznam pomožnih snovi saharoza natrijev dihidrogenfosfat natrijev hidrogenfosfat želatina (svinjska, vrsta A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
English: Tell your doctor straightaway or seek urgent medical care if you experience any of the effects above.
Slovenian: Če se vam pojavi kateri od zgoraj omenjenih učinkov, morate nemudoma obvestiti zdravnika ali poiskati nujno zdravniško pomoč.
English: Pandemic influenza vaccine H5N1 AstraZeneca will be given as a spray in each nostril.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca boste dobili kot pršilo v vsako nosnico.
English: M = months.
Slovenian: l = let.
English: Data regarding co-administration of the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) with live attenuated vaccines (measles, mumps, and rubella vaccine (MMR), varicella vaccine, and orally-administered poliovirus) are available and suggest that concomitant admininstration of Pandemic influenza vaccine H5N1 AstraZeneca with these live vaccines may be acceptable.
Slovenian: Na voljo so podatki o sočasni uporabi sezonskega trivalentnega živega cepiva proti gripi intranazalno (T/LAIV) z živimi oslabljenimi cepivi (proti ošpicam, mumpsu in rdečkam (MMR), cepivom proti noricam in peroralnim s poliovirusom).
English: General disorders and administration site conditions Very common: Malaise
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti: splošno slabo počutje Pogosti: zvišana telesna temperatura
English: Antibody responses in P/LAIV H5N1-primed subjects were also broader.
Slovenian: Širši je bil tudi odziv protiteles pri preiskovancih, ki so primarno dobili P/LAIV H5N1.
English: • Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils.
Slovenian: • Cepivo proti pandemski gripi H5N1 AstraZeneca se aplicira kot razdeljen odmerek v obe nosnici.
English: • runny or stuffy nose
Slovenian: • izcedek iz nosu ali zamašen nos
English: D153-P514 Europe 6 to 71 M 2,085 2002-2003
Slovenian: 6 do 71 m 2.085 2002-2003
English: Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca se daje kot razdeljen odmerek v obe nosnici.
English: Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca, pršilo za nos, suspenzija cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno)
English: Pandemic influenza vaccine H5N1 AstraZeneca must only be used as a nasal spray.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca se sme uporabljati le kot pršilo za nos.
English: Pandemic influenza vaccine H5N1 AstraZeneca is for nasal use only.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je le za nazalno uporabo.
English: Pandemic influenza vaccine H5N1 AstraZeneca IS FOR NASAL USE ONLY.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca JE SAMO ZA NAZALNO UPORABO.
English: Twenty-one additional subjects received one dose of the vaccine virus at TCID50, with 19 of those subjects receiving a second dose 4-8 weeks later.
Slovenian: TCID50; 19 od teh preiskovancev je od 4 do 8 tednov pozneje prejelo drugi odmerek.
English: You should not be given Pandemic influenza vaccine H5N1 AstraZeneca:
Slovenian: Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete dobiti:
English: What Pandemic influenza vaccine H5N1 AstraZeneca looks like and contents of the pack
Slovenian: Izgled Cepiva proti pandemski gripi H5N1 AstraZeneca in vsebina pakiranja
English: Figure 1 Pandemic influenza vaccine H5N1 AstraZeneca Administration
Slovenian: Slika 1 Uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca
English: Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (live attenuated, nasal)
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca pršilo za nos, suspenzija cepivo proti pandemski gripi (živo, oslabljeno, nazalno)
English: Do not inject Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete injicirati.
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Slovenian: Oznaka ATC: J07BB03
English: • Refer to the Pandemic influenza vaccine H5N1 AstraZeneca administration diagram (Figure 1) for step-by-step administration instructions.
Slovenian: • Za navodila za uporabo po korakih glejte diagram uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca (slika 1).
English: How to store Pandemic influenza vaccine H5N1 AstraZeneca
Slovenian: Kako deluje Cepivo proti pandemski gripi H5N1 AstraZeneca
English: What Pandemic influenza vaccine H5N1 AstraZeneca contains
Slovenian: Kaj vsebuje Cepivo proti pandemski gripi H5N1 AstraZeneca
English: How Pandemic influenza vaccine H5N1 AstraZeneca is given
Slovenian: Kako se daje Cepivo proti pandemski gripi H5N1 AstraZeneca
English: You can breathe normally while you are given Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: Medtem, ko boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca, lahko normalno dihate.
English: The referral procedure started on 29 April 2005.
Slovenian: Napotitveni postopek se je pričel 29. aprila 2005.
English: On 23 march 2005, Fujisawa
Slovenian: 23. marca 2005 je podjetje Fujisawa
English: A Decision was issued by the European Commission on 10/04/06.
Slovenian: Evropska komisija je odločbo izdala dne 10/04/2006.
English: Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors.
Slovenian: Takrolimus je makrolidni imunosupresiv, ki spada v farmakološki razred zaviralcev kalcinevrina.
English: The CHMP gave a positive opinion on 26 January 2006 recommending the harmonisation of the SPC for Prograf and associated names.
Slovenian: CHMP je podal pozitivno mnenje 26. januarja 2006 in s tem priporočil uskladitev SPC za Prograf in z njim povezana imena.
English: GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion)
Slovenian: GmbH v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I Mnenja)
English: London, 10 April 2006 EMEA/85997/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR Prograf and associated names (See Annex I)
Slovenian: London, 10. aprila 2006 EMEA/85983/2006 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) POVZETEK MNENJA IZ NAPOTITVENEGA POSTOPKA V SKLADU S ČLENOM 30 DIREKTIVE SVETA 2001/83/ES ZA Prograf in z njim povezana imena (glejte Dodatek I)
English: The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of Prograf and associated names is considered to be positive in the following indications:
Slovenian: Upoštevaje poročila o oceni poročevalca in soporočevalca, znanstveno razpravo v okviru Odbora ter pojasnila imetnika dovoljenja za promet z zdravilom je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Prograf in z njim povezana imena pozitivno za naslednje indikacije:
English: International Non-Proprietary Name (INN): Tacrolimus BACKGROUND INFORMATION
Slovenian: Mednarodno nelastniško ime (INN): takrolimus OSNOVNE INFORMACIJE
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Slovenian: Seznam zadevnih imen izdelkov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
Slovenian: Zdravljenje zavrnitve alotransplantata pri rezistenci na druge imunosupresive.
English: presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.
Slovenian: pri EMEA sprožilo napotitveni postopek za obravnavo v skladu s členom 30 Direktive 2001/83/ES, kot je bila spremenjena, da bi tako uskladili nacionalne Povzetke glavnih značilnosti zdravila za zdravilo Prograf in z njim povezana imena.
English: Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
Slovenian: Na podlagi nacionalnih, razhajajočih se odločitev pristojnih organov v državah članicah EU so bili odobreni različni Povzetki glavnih značilnosti zdravila (SPC).
English: Pharmaceutical Form Route of administration Packaging
Slovenian: Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: 5 - 8 x 108 perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
Slovenian: 5 - 8 x 108 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
English: perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
Slovenian: mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
English: The PFS results are given again below:
Slovenian: Rezultati za PFS so znova prikazani spodaj:
English: Therefore, Annex III may not necessarily represent the current text.
Slovenian: Zaradi tega je možno, da Dodatek III ne predstavlja trenutno veljavnega besedila.
English: There was no evidence of an overall excess mortality.
Slovenian: Dokazov o preveliki celotni smrtnosti ni bilo.
English: The 4th analysis of the EPC data will also be provided when available.
Slovenian: Četrta analiza podatkov o EPC bo predložena, takoj ko bo na razpolago.
English: Analysis population
Slovenian: Populacija za analizo
English: However, the numbers of cases involved are relatively small, and there is no clear temporal relationship.
Slovenian: Vendar je število vpletenih primerov relativno nizko, poleg tega pa manjka jasno razvidno časovno razmerje.
English: In the clinical studies this was severe in around 5% of patients.
Slovenian: V kliničnih študijah sta bila ta neželena učinka posebej resna pri približno 5 % bolnikov.
English: Radical prostatectomy 179/870 (20.6)
Slovenian: Radikalna prostatektomija 179/870 (20,6)
English: HU - Hungary Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
Slovenian: HU - Madžarska Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
English: Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/83/EC, as amended.
Slovenian: Zaradi tega je Belgija dne 27. julija 2006 odboru CHMP predložila sporno vprašanje na napotitveni postopek po členu 31 Direktive 2001/83/ES z vsemi spremembami.
English: National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica (RMS), bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
English: These same data were considered by the UK, the Reference Member State (RMS) for the Mutual Recognition Procedure (MRP), in 2003.
Slovenian: Iste podatke so leta 2003 pregledali tudi v Združenem kraljestvu, ki je referenčna država članica (MRP) za postopek medsebojnega priznavanja.
English: However, an association with bicalutamide cannot be ruled out.
Slovenian: Kljub temu pa povezave z bikalutamidom ni mogoče izključiti.
English: CS - Czech Republic
Slovenian: CS - Češka
English: Hazard ratio (95% CI)
Slovenian: Razmerje tveganja (95 % CI)
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: The need to further study cardiovascular morbidity and mortality remains.
Slovenian: Potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.
English: Radical prostatectomy
Slovenian: Radikalna prostatektomija
English: However, some trends were apparent in exploratory subgroup analyses.
Slovenian: Vendar so eksplorativne analize podskupin pokazale nekatere trende.
English: EL - Greece Dermos Meπε -pharmaceitica 25 Paraschou str.
Slovenian: Dermos Meπε -pharmaceitica 25 Paraschou str.
English: However, these data do support the Committee's position that the indication should be restricted to selected patients with locally advanced prostate cancer at high risk of disease progression.
Slovenian: Vendar pa ti podatki podpirajo stališče Odbora, da bi morala biti indikacija omejena na izbrane bolnike z lokalno napredovalim rakom prostate in z visokim tveganjem za napredovanje bolezni.
English: How such patients are identified could be based on criteria such as PSA levels, Gleason score and stage of disease.
Slovenian: Način razpoznavanja takih bolnikov bi lahko bil zasnovan na merilih, kakršna so ravni PSA, Gleasonov indeks in stadij bolezni.
English: 89079 Ulm
Slovenian: 89079 Ulm Germany
English: These are also not arbitrary subgroups, but are implicit in the proposed indication, correspond to the way prostate cancer is classified, managed and studied, and the results are consistent with what might be expected.
Slovenian: Poleg tega te podskupine niso poljubne, temveč so vpletene v predlagano indikacijo, ustrezajo načinu razvrščanja, vodenja in raziskovanja raka prostate, rezultati pa so skladni s pričakovanji.
English: Gynaecomastia and breast pain have been highlighted (mainly in the 1st year of intake) and can be managed in many patients.
Slovenian: Posebej poudarjena sta bili ginekomastija in bolečina v prsih (v glavnem v prvem letu jemanja zdravila), ki se ju da uravnavati pri številnih bolnikih.
English: NO - Norway AstraZeneca AS Boks 200 Vinderen 0319 Oslo
Slovenian: NO - Norveška AstraZeneca AS Boks 200 Vinderen 0319 Oslo
English: FI - Finland Alternova Oy Ab Rajatorpantie 41 C 01640 Vantaa
Slovenian: Alternova Oy Ab Rajatorpantie 41 C 01640 Vantaa
English: PT - Portugal AstraZeneca Produtos Farmacêuticos, Lda.
Slovenian: PT - Portugalska AstraZeneca Produtos Farmacêuticos, Lda.
English: No overall survival difference was seen at 7.4 years median follow up with 22.9% mortality (HR=0.99; 95% CI 0.91 to1.09).
Slovenian: Po mediano 7,4 leta spremljanja ni bilo razlik v celotnem preživetju; umrljivost je bila 22,9% (RO = 0,99; 95% IZ: 0,91-1,09).
English: Patients and clinicians should decide on the most appropriate treatment on an individual basis, discussing efficacy and tolerability aspects of all available treatments, all available risk factors for disease progression, and taking into account the lifestyle of the patient.
Slovenian: Bolniki in zdravniki bi se morali o najbolj ustreznem zdravljenju odločiti glede na vsaki posamezni primer posebej in se pri tem pogovoriti o vprašanjih učinkovitosti in prenašanju vseh razpoložljivih oblik zdravljenja, o vseh faktorjih tveganja za napredovanje bolezni, ob tem pa upoštevati življenjski stil bolnika.
English: Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Slovenian: Podatki o preživetju brez napredovanja in celotnem preživetju za bolnike z lokalno napredovalo boleznijo so povzeti v naslednjih dveh tabelah:
English: FI - Finland Synthon B V Microweg 22
Slovenian: Synthon B V Microweg 22
English: - For all MAHs, in addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include:
Slovenian: - Vsi imetniki dovoljenj za promet z zdravilom bi morali poleg rutinskih aktivnosti farmakovigilance za poostreno opazovanje izpostaviti tudi prepoznana in morebitna tveganja, ki vključujejo:
English: For patients with localised disease receiving CASODEX alone, there was no significant difference in progression free survival.
Slovenian: Pri bolnikih z lokalizirano boleznijo, ki so dobivali samo zdravilo CASODEX, ni bilo bistvenih razlik pri preživetju brez napredovanja.
English: In 2004, 2 publications were published detailing a pre-planned 2nd analysis of the Casodex (bicalutamide) Early Prostate Cancer (EPC) study programme.
Slovenian: V letu 2004 sta bili izdani dve publikaciji, ki podrobno opisujeta predhodno načrtovano drugo analizo raziskovalnega programa za zdravilo Casodex (bikalutamid) pri zgodnjem raku prostate (EPC).
English: Due to a small number of relevant subjects, no conclusions could be drawn regarding the contribution of tamoxifen or radiotherapy to cardiovascular outcomes, or on whether tamoxifen exposure had a synergistic effect on efficacy.
Slovenian: Zaradi majhnega števila oseb, udeleženih na testiranju, ni bilo mogoče priti do zaključka o prispevku tamoksifena ali radioterapije k kardiovaskularnim rezultatom ali glede vprašanja, ali ima izpostavljenost tamoksifenu sinergijski vpliv na učinkovitost.
English: Benefit/ Risk considerations
Slovenian: Pomisleki ob razmerju med koristmi in tveganji
English: However, it is not possible to entirely “rule out” thromboembolic events as contributory explanation of increased cardiovascular mortality.
Slovenian: Kljub temu pa ni mogoče povsem izključiti vpliva tromboemboličnih dogodkov, kot razlage za povečano kardiovaskularno smrtnost.
English: To address this concern, a new epidemiological study will be performed, as part of an agreed Risk Management Plan.
Slovenian: Za odgovor na to vprašanje se bo izvedla nova študija, ki bo del dogovorjenega načrta za obvladovanje tveganja.
English: FI - Finland Avansor Pharma Oy Tekniikantie 14
Slovenian: Avansor Pharma Oy Tekniikantie 14
English: Disease progression may be associated with problems such as painful bone metastases, cord compression, pathological fractures and urinary obstruction.
Slovenian: Napredovanje bolezni je lahko povezano s težavami, kakršne so boleče kostne metastaze, stiskanje hrbtenjače, patološki zlomi in oviranje urinarnega pretoka.
English: The median PSA levels on initiation of active therapy for each subgroup are above the thresholds in current European Association of Urology (EAU) guidance.
Slovenian: Mediane ravni PSA ob uvajanju aktivnega zdravljenja so pri vsaki izmed podskupin nad pražnimi vrednostmi, opredeljenimi v trenutno veljavnih smernicah Evropskega združenja za urologijo (EAU).
English: As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics, set out in Annex III of the Opinion.
Slovenian: Kot posledica tega je CHMP predlagal, da družba zadrži dovoljenja za promet za vsa zdravila in da se ji odobri dovoljenja za vse aplikacije, ki so bile omenjene v Dodatku I mnenja, v skladu z dopolnili predmetnih poglavij Povzetka glavnih značilnosti zdravila, kot so bile zastavljene v Dodatku III mnenja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO BIKALUTAMID 150 mg (glejte Dodatek I)
English: Bicalutamide 150 mg is marketed in the EU following national and Mutual Recognition application procedures.
Slovenian: Bikalutamid 150 mg se trži v EU po odobritvi vloge za dovoljenje za promet v skladu z nacionalnimi postopki in postopki medsebojnega priznavanja.
English: In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16; 95% CI 0.99 to 1.37).
Slovenian: Pri teh bolnikih je obstajal trend h krajšemu preživetju v primerjavi z bolniki, ki so dobivali placebo (RO = 1,16; 95% IZ: 0,99 - 1,37).
English: Astrazeneca S.P.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (MI)
Slovenian: Palazzo Volta Via F. Sforza 20080 - Basiglio (MI)
English: None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.
Slovenian: V nobenem od preizkušanj EPC niso zahtevali, da bi bolnikom v placebo skupini odrekli zdravljenje do kliničnega napredovanja bolezni.
English: Whilst the pattern of adverse events argues against a role for raised oestrogen levels, it is known that the myocardium has androgen receptors, and it might be affected by long-term androgen deprivation.
Slovenian: Čeprav vzorec neželenih dogodkov ne podpira vloge povišanih ravni estrogena pri tem, pa je znano, da ima miokard androgene receptorje in da nanj lahko vpliva dolgotrajna odtegnitev androgena.