natgillin/translations-raw huggingface dataset:
In an active-controlled clinical study (MI-CP111) conducted with T/LAIV in comparison to the injectable influenza trivalent vaccine, an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants 6-11 months of age (6.1% T/LAIV versus 2.6% injectable influenza vaccine). 
V tej klinični študiji so pri dojenčkih v starosti od 6 do 11 mesecev v obdobju 180 dni po zadnjem odmerku cepiva opažali večji delež sprejemov v bolnišnico (zaradi katerega koli vzroka) (T/LAIV 6,1 %, cepivo proti gripi za injiciranje 2,6 %).
P/LAIV H5N1-primed subjects developed vigorous antibody responses to wild-type H5N1 virus upon subsequent exposure to the inactivated H5N1 vaccine, although such antibody responses were not detectable after the primary 2 doses in the majority of the subjects. 
Pri preiskovancih, ki so primarno prejeli P/LAIV H5N1, se je po nadaljnji izpostavljenosti inaktiviranemu cepivu H5N1 razvil intenziven odziv protiteles proti divjemu tipu virusa H5N1, čeprav takšen odziv po primarnih 2 odmerkih pri večini preiskovancev ni bil zaznaven.
In order to define the shelf life of Pandemic influenza vaccine H5N1 AstraZeneca on a strain-specific basis, the MAH should generate strain-specific stability data for the actual pandemic strain. 
Za določitev roka uporabnosti za Cepivo proti pandemski gripi H5N1 AstraZeneca specifično glede na seve mora imetnik dovoljenja za promet z zdravilom pripraviti za sev specifične podatke o stabilnosti za dejanski sev pandemije.
In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% T/LAIV versus 3.8% injectable influenza vaccine). 
Piskajoče dihanje pri otrocih, mlajših od 24 mesecev V isti študiji so v obdobju 42 dni opažali večji delež piskajočega dihanja pri dojenčkih in malčkih v starosti od 6 do 23 mesecev (T/LAIV 5,9 % in cepivo proti gripi za injiciranje 3,8 %).
Healthcare providers need to assess the benefits and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to these individuals. 
Zdravniki morajo oceniti koristi in možna tveganja uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca pri takšnih bolnikih.
After 1 or 2 doses of TCID50 vaccine, haemagglutination inhibition (HAI) and IgA seroresponses were each detected in 10% subjects, and nasal wash IgA responses were detected in 24% subjects. 
TCID50 cepiva so vsakega od seroloških odzivov (inhibicijo hemaglutinacije [HAI] in IgA odziv) ugotovili pri 10 % preiskovancev, IgA odziv v nosnem izpirku pa pri 24 % preiskovancev.
It is not known whether Pandemic influenza vaccine H5N1 AstraZeneca is excreted in human milk. 
Ni znano, ali se Cepivo proti pandemski gripi H5N1 AstraZeneca pri človeku izloča v materino mleko.
Vaccine recipients should be informed that Pandemic influenza vaccine H5N1 AstraZeneca is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. 
Prejemnikom Cepiva proti pandemski gripi H5N1 AstraZeneca je treba povedati, da je to cepivo z oslabljenim živim virusom, ki se lahko prenese na imunsko oslabele osebe, s katerimi ima prejemnik stik.
The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections. 
Druge sestavine so saharoza, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, želatina (svinjska, tip A), argininijev klorid, natrijev glutamat monohidrat in voda za injekcije.
If any of these apply, tell your doctor, nurse or pharmacist before vaccination. 
Če karkoli od tega velja za vas, morate pred cepljenjem obvestiti zdravnika, medicinsko sestro ali farmacevta.
Healthcare providers need to assess the benefit and potential risks of administering Pandemic influenza vaccine H5N1 AstraZeneca to pregnant women. 
Zdravniki morajo oceniti koristi in možna tveganja uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca pri nosečnicah.
Pandemic influenza vaccine H5N1 AstraZeneca vaccine virus is grown in chicken eggs. 
Virus v Cepivu proti pandemski gripi H5N1 AstraZeneca je pridobljen v kokošjih jajcih.
Improved efficacy (95% CI) matched strains 
Izboljšana učinkovitost (95 % IZ) ujemajoči se sevi
- If any of the side effects gets serious, talk to your doctor, nurse or pharmacist. 
- Če kateri koli neželen učinek postane resen, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
This medicine has been given “conditional approval”. 
Cepivo je pridobilo t. i. "pogojno dovoljenje za promet".
Excipients: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections. 
Pomožne snovi: saharoza, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, želatina (svinjska, tip A), argininijev klorid, natrijev glutamat monohidrat, voda za injekcije.
The MAH should conduct an observational prospective cohort safety study in a large sample of children and adolescents from 12 months to less than 18 years of age during the next declared pandemic. 
Imetnik dovoljenja za promet z zdravilom mora med naslednjo razglašeno pandemijo opraviti opazovalno prospektivno kohortno študijo z velikim vzorcem otrok in mladostnikov, starih od 12 mesecev do manj kot 18 let.
Check expiry date Product must be used before date on applicator label. 
Preverite rok uporabnosti Cepivo uporabite pred datumom navedenim na nalepki nosnika.
Rare (≥ 1/10,000 to < 1/1,000) 
Redki (≥ 1/10.000 do < 1/1.000)
What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca 
Kaj morate vedeti, preden boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca
• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils as described below. 
• Cepivo proti pandemski gripi H5N1 AstraZeneca se daje kot razdeljen odmerek v obe nosnici, kot je opisano spodaj.
Antibody response developed rapidly in P/LAIV H5N1-primed subjects. 
Odziv protiteles se je pri preiskovancih, ki so primarno dobili P/LAIV H5N1, razvil hitro.
Similarly from the VAERS, in 113 reports of pregnant women who had received AstraZeneca's (H1N1) 2009 Monovalent Vaccine Live, Intranasal, no unusual patterns of pregnancy complications or foetal outcomes were observed. 
Prav tako na podlagi VAERS niso ugotovili neobičajnih vzorcev zapletov med nosečnostjo ali izidov pri plodu v 113 poročilih o nosečnicah, ki so prejele AstraZenecino (H1N1) 2009 monovalentno živo cepivo intranazalno.
HAI responses were not detected in any of the subjects after either the first or second dose of the vaccine. 
Ne po prvem ne po drugem odmerku cepiva niso pri nobenem preiskovancu ugotovili odziva HAI.
Reassortant influenza virus (live attenuated) of the following strain: 
Reasortirani virus gripe (živ, oslabljen) seva:
Improved efficacy (95% CI) all strains regardless of match 
Izboljšana učinkovitost (95 % IZ) vsi sevi, ne glede na ujemanje
T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine. 
V 3 študijah, kontroliranih z aktivno učinkovino, se je T/LAIV izkazalo za superiorno glede na cepivo proti gripi za injiciranje.
Pandemic influenza vaccine H5N1 AstraZeneca Pandemic influenza vaccine 
Cepivo proti pandemski gripi H5N1 AstraZeneca cepivo proti pandemski gripi
No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 AstraZeneca on male and female fertility. 
O možnih vplivih Cepiva proti pandemski gripi H5N1 AstraZeneca na plodnost moških in žensk ni podatkov.
If any of these apply, tell your doctor, nurse or pharmacist. 
Če karkoli od tega velja za vas, morate obvestiti zdravnika, medicinsko sestro ali farmacevta.
median tissue culture infectious dose (TCID50) , with 18 of those subjects receiving a second dose 4-8 weeks later. 
median infektivni odmerek tkivne kulture(TCID50); 18 od teh preiskovancev je od
There are no data available on the use of Pandemic influenza vaccine H5N1 AstraZeneca in pregnant women. 
Nosečnost Podatkov o uporabi Cepiva proti pandemski gripi H5N1 AstraZeneca pri nosečnicah ni.
What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for 
Kaj je Cepivo proti pandemski gripi H5N1 AstraZeneca in za kaj ga uporabljamo
Pandemic influenza vaccine H5N1 AstraZeneca must not be injected. 
Cepiva proti pandemski gripi H5N1 AstraZeneca se ne sme injicirati.
How to store Pandemic influenza vaccine H5N1 AstraZeneca Contents of the pack and other information 
Shranjevanje Cepiva proti pandemski gripi H5N1 AstraZeneca Vsebina pakiranja in dodatne informacije
Very rare (may affect up to 1 in 1,000,000 people): 
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Efficacy (95% CI) matched strains 
Učinkovitost (95 % IZ) ujemajoči se sevi
Peak incidence of vaccine virus recovery occurred 1-2 days post-vaccination in clinical studies with Pandemic influenza vaccine H5N1 AstraZeneca. 
Največjo pojavnost virusa iz cepiva so v kliničnih študijah s Cepivom proti pandemski gripi H5N1 AstraZeneca ugotovili 1 do 2 dneva po cepljenju.
Your doctor, nurse or pharmacist will decide if Pandemic influenza vaccine H5N1 AstraZeneca can be given at the same time as other vaccines. 
Zdravnik, medicinska sestra ali farmacevt bo presodil, ali se cepivo lahko uporabi sočasno z drugimi cepivi.
Efficacy (95% CI) all strains regardless of match 
Učinkovitost (95 % IZ) vsi sevi, ne glede na ujemanje
Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca: 
Drugi možni neželeni učinki Cepiva proti pandemski gripi H5N1 AstraZeneca so:
Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections 
6.1 Seznam pomožnih snovi saharoza natrijev dihidrogenfosfat natrijev hidrogenfosfat želatina (svinjska, vrsta A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
Tell your doctor straightaway or seek urgent medical care if you experience any of the effects above. 
Če se vam pojavi kateri od zgoraj omenjenih učinkov, morate nemudoma obvestiti zdravnika ali poiskati nujno zdravniško pomoč.
Pandemic influenza vaccine H5N1 AstraZeneca will be given as a spray in each nostril. 
Cepivo proti pandemski gripi H5N1 AstraZeneca boste dobili kot pršilo v vsako nosnico.
M = months. 
l = let.
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. 
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).
General disorders and administration site conditions Very common: Malaise 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: splošno slabo počutje Pogosti: zvišana telesna temperatura
Antibody responses in P/LAIV H5N1-primed subjects were also broader. 
Širši je bil tudi odziv protiteles pri preiskovancih, ki so primarno dobili P/LAIV H5N1.
• Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils. 
• Cepivo proti pandemski gripi H5N1 AstraZeneca se aplicira kot razdeljen odmerek v obe nosnici.
• runny or stuffy nose 
• izcedek iz nosu ali zamašen nos
D153-P514 Europe 6 to 71 M 2,085 2002-2003 
6 do 71 m 2.085 2002-2003
Pandemic influenza vaccine H5N1 AstraZeneca is administered as a divided dose in both nostrils. 
Cepivo proti pandemski gripi H5N1 AstraZeneca se daje kot razdeljen odmerek v obe nosnici.
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal) 
Cepivo proti pandemski gripi H5N1 AstraZeneca, pršilo za nos, suspenzija cepivo proti pandemski gripi (H5N1) (živo, oslabljeno, nazalno)
Pandemic influenza vaccine H5N1 AstraZeneca must only be used as a nasal spray. 
Cepivo proti pandemski gripi H5N1 AstraZeneca se sme uporabljati le kot pršilo za nos.
Pandemic influenza vaccine H5N1 AstraZeneca is for nasal use only. 
Cepivo proti pandemski gripi H5N1 AstraZeneca je le za nazalno uporabo.
Pandemic influenza vaccine H5N1 AstraZeneca IS FOR NASAL USE ONLY. 
Cepivo proti pandemski gripi H5N1 AstraZeneca JE SAMO ZA NAZALNO UPORABO.
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. 
TCID50; 19 od teh preiskovancev je od 4 do 8 tednov pozneje prejelo drugi odmerek.
You should not be given Pandemic influenza vaccine H5N1 AstraZeneca: 
Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete dobiti:
What Pandemic influenza vaccine H5N1 AstraZeneca looks like and contents of the pack 
Izgled Cepiva proti pandemski gripi H5N1 AstraZeneca in vsebina pakiranja
Figure 1 Pandemic influenza vaccine H5N1 AstraZeneca Administration 
Slika 1 Uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca
Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (live attenuated, nasal) 
Cepivo proti pandemski gripi H5N1 AstraZeneca pršilo za nos, suspenzija cepivo proti pandemski gripi (živo, oslabljeno, nazalno)
Do not inject Pandemic influenza vaccine H5N1 AstraZeneca. 
Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete injicirati.
Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03 
Oznaka ATC: J07BB03
• Refer to the Pandemic influenza vaccine H5N1 AstraZeneca administration diagram (Figure 1) for step-by-step administration instructions. 
• Za navodila za uporabo po korakih glejte diagram uporabe Cepiva proti pandemski gripi H5N1 AstraZeneca (slika 1).
How to store Pandemic influenza vaccine H5N1 AstraZeneca 
Kako deluje Cepivo proti pandemski gripi H5N1 AstraZeneca
What Pandemic influenza vaccine H5N1 AstraZeneca contains 
Kaj vsebuje Cepivo proti pandemski gripi H5N1 AstraZeneca
How Pandemic influenza vaccine H5N1 AstraZeneca is given 
Kako se daje Cepivo proti pandemski gripi H5N1 AstraZeneca
You can breathe normally while you are given Pandemic influenza vaccine H5N1 AstraZeneca. 
Medtem, ko boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca, lahko normalno dihate.
The referral procedure started on 29 April 2005. 
Napotitveni postopek se je pričel 29. aprila 2005.
On 23 march 2005, Fujisawa 
23. marca 2005 je podjetje Fujisawa
A Decision was issued by the European Commission on 10/04/06. 
Evropska komisija je odločbo izdala dne 10/04/2006.
Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors. 
Takrolimus je makrolidni imunosupresiv, ki spada v farmakološki razred zaviralcev kalcinevrina.
The CHMP gave a positive opinion on 26 January 2006 recommending the harmonisation of the SPC for Prograf and associated names. 
CHMP je podal pozitivno mnenje 26. januarja 2006 in s tem priporočil uskladitev SPC za Prograf in z njim povezana imena.
GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion) 
GmbH v imenu vseh imetnikov dovoljenja za promet z zdravilom (glejte Dodatek I Mnenja)
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) 
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)
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: 
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:
International Non-Proprietary Name (INN): Tacrolimus BACKGROUND INFORMATION 
Mednarodno nelastniško ime (INN): takrolimus OSNOVNE INFORMACIJE
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. 
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.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. 
Zdravljenje zavrnitve alotransplantata pri rezistenci na druge imunosupresive.
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. 
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.
Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States. 
Na podlagi nacionalnih, razhajajočih se odločitev pristojnih organov v državah članicah EU so bili odobreni različni Povzetki glavnih značilnosti zdravila (SPC).
Pharmaceutical Form Route of administration Packaging 
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
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 
5 - 8 x 108 mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml 
mikrosfer s perflutrenom, s povprečnim premerom v razponu 2,5 - 4,5 µm.
The PFS results are given again below: 
Rezultati za PFS so znova prikazani spodaj:
Therefore, Annex III may not necessarily represent the current text. 
Zaradi tega je možno, da Dodatek III ne predstavlja trenutno veljavnega besedila.
There was no evidence of an overall excess mortality. 
Dokazov o preveliki celotni smrtnosti ni bilo.
The 4th analysis of the EPC data will also be provided when available. 
Četrta analiza podatkov o EPC bo predložena, takoj ko bo na razpolago.
Analysis population 
Populacija za analizo
However, the numbers of cases involved are relatively small, and there is no clear temporal relationship. 
Vendar je število vpletenih primerov relativno nizko, poleg tega pa manjka jasno razvidno časovno razmerje.
In the clinical studies this was severe in around 5% of patients. 
V kliničnih študijah sta bila ta neželena učinka posebej resna pri približno 5 % bolnikov.
Radical prostatectomy 179/870 (20.6) 
Radikalna prostatektomija 179/870 (20,6)
HU - Hungary Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44. 
HU - Madžarska Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/83/EC, as amended. 
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.
National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
Nacionalni pristojni organi, katerih delo usklajuje referenčna država članica (RMS), bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje:
These same data were considered by the UK, the Reference Member State (RMS) for the Mutual Recognition Procedure (MRP), in 2003. 
Iste podatke so leta 2003 pregledali tudi v Združenem kraljestvu, ki je referenčna država članica (MRP) za postopek medsebojnega priznavanja.
However, an association with bicalutamide cannot be ruled out. 
Kljub temu pa povezave z bikalutamidom ni mogoče izključiti.
CS - Czech Republic 
CS - Češka
Hazard ratio (95% CI) 
Razmerje tveganja (95 % CI)
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The need to further study cardiovascular morbidity and mortality remains. 
Potreba po nadaljnjem raziskovanju kardiovaskularne obolevnosti in smrtnosti ostaja.
Radical prostatectomy 
Radikalna prostatektomija
However, some trends were apparent in exploratory subgroup analyses. 
Vendar so eksplorativne analize podskupin pokazale nekatere trende.
EL - Greece Dermos Meπε -pharmaceitica 25 Paraschou str. 
Dermos Meπε -pharmaceitica 25 Paraschou str.
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. 
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.
How such patients are identified could be based on criteria such as PSA levels, Gleason score and stage of disease. 
Način razpoznavanja takih bolnikov bi lahko bil zasnovan na merilih, kakršna so ravni PSA, Gleasonov indeks in stadij bolezni.
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. 
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.
Gynaecomastia and breast pain have been highlighted (mainly in the 1st year of intake) and can be managed in many patients. 
Posebej poudarjena sta bili ginekomastija in bolečina v prsih (v glavnem v prvem letu jemanja zdravila), ki se ju da uravnavati pri številnih bolnikih.
NO - Norway AstraZeneca AS Boks 200 Vinderen 0319 Oslo 
NO - Norveška AstraZeneca AS Boks 200 Vinderen 0319 Oslo
PT - Portugal AstraZeneca Produtos Farmacêuticos, Lda. 
PT - Portugalska AstraZeneca Produtos Farmacêuticos, Lda.
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). 
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).
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. 
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.
Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables: 
Podatki o preživetju brez napredovanja in celotnem preživetju za bolnike z lokalno napredovalo boleznijo so povzeti v naslednjih dveh tabelah: