natgillin/translations-raw huggingface dataset:
Glustin also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea. 
Zdravilo Glustin je izboljšalo tudi uravnavanje glukoze pri sladkorni bolezni tipa 2, če je bilo dodano obstoječemu zdravljenju s sulfonilsečnino, insulinom ali metforminom ali kombinaciji metformina in sulfonilsečnine.
• together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite treatment with two medicines by mouth; 
• skupaj z metforminom in sulfonilsečnino pri bolnikih, pri katerih kljub peroralnemu zdravljenju z obema zdraviloma ni vzpostavljeno zadovoljivo uravnavanje;
Why has Glustin been approved? 
Zakaj je bilo zdravilo Glustin odobreno?
Some studies also looked at combining Glustin with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea. 
V nekaterih študijah so proučevali tudi kombiniranje zdravila Glustin s sulfonilsečnino, insulinom ali metforminom ali s kombinacijo metformina in sulfonilsečnine.
For the full list of all side effects reported with Glustin, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Glustin, glejte navodilo za uporabo.
• in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone; 
• v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega uravnavanja ali s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren, pri bolnikih, pri katerih zgolj s sulfonilsečnino ni mogoče doseči zadovoljivega uravnavanja;
• together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin. 
• skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno uravnavana zgolj z insulinom in za katere metformin ni primeren.
At subsequent reviews prescribers should confirm that benefits to patients are maintained. 
Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
Glustin led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Glustin on its own was shown to be as effective as metformin and gliclazide. 
Zdravilo Glustin je povzročilo znižanje ravni HbA1c, kar pomeni, da so je raven glukoze v krvi znižala pri odmerkih 15 mg, 30 mg in 45 mg.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glustin have also been included in the summary of product characteristics and the package leaflet. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Glustin.
Glustin has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies. 
Zdravilo Glustin so v številnih študijah primerjali s placebom (zdravilom brez zdravilne učinkovine), metforminom ali gliklazidom (sulfonilsečnino).
What is Glustin used for? 
Za kaj se zdravilo Glustin uporablja?
How has Glustin been studied? 
Kako je bilo zdravilo Glustin raziskano?
What is Glustin? 
Kaj je zdravilo Glustin?
How is Glustin used? 
Kako se zdravilo Glustin uporablja?
How does Glustin work? 
Kako zdravilo Glustin deluje?
Mean follow-up was 569 days. 
Povprečno trajanje spremljanja je bilo 569 dni.
Adopted at the 8-11 April 2019 PRAC 
Sprejeto na seji odbora PRAC od 8. do 11. aprila 2019
It is not known if your medicine may harm your unborn baby. 
Ni znano, ali zdravilo škodi nerojenemu otroku.
[Product name] should not be used during pregnancy. 
Zdravilo [ime zdravila] se ne sme uporabljati med nosečnostjo.
These may cause increased blood levels of [active substance]. 
Povečajo lahko ravni [učinkovine] v krvi.
As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see sections 4.4 and 4.5). 
Ker lahko modafinil zmanjša učinkovitost peroralne kontracepcije, so zahtevane dodatne alternativne kontracepcijske metode (glejte poglavji 4.4 in 4.5).
What you need to know before you take Eliquis/Lixiana/Roteas Warnings and precautions 
Kaj morate vedeti, preden boste vzeli zdravilo Eliquis/Lixiana/Roteas Opozorila in previdnostni ukrepi
The trial was terminated prematurely after the enrolment of 120 patients due to an excess of events among patients in the rivaroxaban arm. 
Preskušanje so po vključitvi 120 bolnikov predčasno prekinili zaradi prevelikega števila dogodkov pri bolnikih v skupini, ki je prejemala rivaroksaban.
59 patients were randomized to rivaroxaban 20 mg (15 mg for patients with creatinine clearance (CrCl) <50 mL/min) and 61 to warfarin (INR 2.0- 3.0). 
59 bolnikov so randomizirali na rivaroksaban v jakosti 20 mg (15 mg pri bolnikih s kreatininskim očistkom (CrCl) < 50 ml/min), 61 pa na varfarin (INR 2,0-3,0).
Women of childbearing potential have to use effective contraception. 
Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception. 
Uporaba modafinila ni priporočljiva med nosečnostjo ali pri ženskah v rodni dobi, katere ne uporabljajo učinkovite kontracepcije.
Modafinil - Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US (EPITT no 19367) 
Modafinil - ovrednotenje podatkov o izidih pri plodu, vključno s prirojenimi nepravilnostmi, iz opazovalne študije v ZDA (št. EPITT 19367)
Based on limited human experience from a pregnancy registry and spontaneous reporting modafinil is suspected to cause congenital malformations when administered during pregnancy. 
Na podlagi omejenih izkušenj pri človeku iz registra nosečnosti in spontanih poročil obstaja sum, da modafinil v primeru uporabe med nosečnostjo povzroča prirojene malformacije.
A reduction in the dose of [active substance] may be necessary based on monitoring of side-effects during concomitant treatment (see section 4.4). 
Morda je na podlagi spremljanja neželenih učinkov med sočasnim zdravljenjem potrebno zmanjšanje odmerka [učinkovine] (glejte poglavje 4.4).
What you need to know before you take [product name] Pregnancy and breast-feeding 
Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila] Nosečnost in dojenje
What you need to know before you take Xarelto/Pradaxa Take special care with Xarelto/Pradaxa - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. 
Kaj morate vedeti, preden boste vzeli zdravilo Xarelto/Pradaxa Bodite posebno pozorni pri jemanju zdravila Xarelto/Pradaxa - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
Rivaroxaban/dabigatran etexilate 
Rivaroksaban/dabigatran eteksilat
Thromboembolic events occurred in 12% of patients randomized to rivaroxaban (4 ischaemic strokes and 3 myocardial infarctions). 
Trombembolični dogodki so se pojavili pri 12 % bolnikov, randomiziranih na rivaroksaban (4 ishemične možganske kapi in 3 miokardni infarkti).
No events were reported in patients randomized to warfarin. 
Pri bolnikih, randomiziranih na varfarin, niso poročali o nobenem dogodku.
Modafinil is suspected to cause birth defects if taken during pregnancy. 
Obstaja sum, da modafinil povzroča prirojene nepravilnosti, če se jemlje med nosečnostjo.
In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies). 
V randomizirani, odprti multicentrični študiji s slepo presojo opazovanega dogodka, ki so jo sponzorirali raziskovalci, so rivaroksaban primerjali z varfarinom pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ter z visokim tveganjem za trombembolične dogodke (pozitivnih pri vseh treh antifosfolipidnih preiskavah: za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I).
What you need to know before you take [Product name] Other medicines and [Product name] 
Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]
Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). 
Cimetidin, lansoprazol in omeprazol (ki se uporabljajo za zdravljenje želodčnih razjed), flukonazol (ki se uporablja za zdravljenje glivičnih okužb), fluvoksamin (antidepresiv) in tiklopidin (ki se uporablja za zmanjševanje tveganja za možgansko kap).
Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group. 
V skupini, ki je prejemala rivaroksaban, se je večja krvavitev pojavila pri 4 bolnikih (7 %), v skupini, ki je prejemala varfarin, pa pri 2 bolnikih (3 %).
In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy. 
Zlasti pri trojno pozitivnih bolnikih (za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I) je zdravljenje s peroralnimi antikoagulanti z neposrednim delovanjem v primerjavi z zdravljenjem z antagonisti vitamina K lahko povezano s povečano pogostnostjo ponavljajočih se trombotičnih dogodkov.
Selective serotonin reuptake inhibitors: citalopram; escitalopram - Drug interaction with fluconazole (EPITT no 
Selektivni zaviralci ponovnega privzema serotonina: citalopram; escitalopram - medsebojno delovanje s flukonazolom (št. EPITT 19327)
4.5 Interaction with other medicinal products and other forms of interaction Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. 
Zato je potrebna previdnost, kadar se uporablja sočasno z zaviralci CYP2C19 (npr. omeprazolom, esomeprazolom, flukonazolom, fluvoksaminom, lansoprazolom, tiklopidinom) ali cimetidinom.
Direct-acting oral anticoagulants (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Recurrent thrombosis in patients with antiphospholipid syndrome (EPITT no 19320) 
Peroralni antikoagulanti z neposrednim delovanjem: apiksaban, dabigatran eteksilat, edoksaban, rivaroksabanponavljajoča se tromboza pri bolnikih z antifosfolipidnim sindromom (št. EPITT 19320)
Direct acting Oral Anticoagulants (DOACs) including rivaroxaban/apixaban/edoxaban/dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. 
Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z rivaroksabanom/apiksabanom/edoksabanom/dabigatran eteksilatom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
There is limited data on the use of modafinil in pregnant women. 
Plodnost, nosečnost in dojenje Podatkov o uporabi modafinila pri nosečnicah je malo.
If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. 
Bodite posebno pozorni pri jemanju zdravila Eliquis/Lixiana/Roteas Če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
Take special care with Eliquis/Lixiana/Roteas 
Apiksaban/edoksaban
An updated RMP shall be submitted by 31 October 2019. 
Posodobljen RMP je treba predložiti do 31. oktobra 2019.
Tumour size 2 cm >2 cm 
Velikost tumorja  2 cm > 2 cm
75008 Paris 
75008 Pariz
(Harbor Park) 1, Campona utca Budapest 1225 
(Harbor Park) 1, Campona utca Budimpešta 1225
Harmful for those suffering from alcoholism. 
Škodljivo je za osebe, ki trpijo za alkoholizmom.
• change or absence of menstrual period 
• spremembe ali izostanek menstruacije
a From the GETUG AFU15 study 
a Iz študije GETUG AFU15.
(listed in section 6). 
(navedeno v poglavju 6).
None of these increases in frequency reached 10% difference with the control arm. 
Nobeno od teh povečanj pogostnosti ni doseglo 10-odstotne razlike v primerjavi s kontrolno skupino.
Each box contains one vial. 
Vsaka škatla vsebuje eno vialo.
(26.8-ne) TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached. 
ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
• if the number of white blood cells is too low. 
• če imate premajhno število belih krvnih celic.
Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored. 
Bolnike je treba seznaniti z znaki in simptomi resnih kožnih manifestacij in jih skrbno spremljati.
• 2 years. 
• 2 leti.
Alopecia (persisting: 
Alopecija (persistentna:
STAMPEDE study 
ŠTUDIJA STAMPEDE
The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Imetnik dovoljenja za promet z zdravilom PSUR za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portal o zdravilih.
Other medicines and TAXOTERE 
Druga zdravila in zdravilo TAXOTERE
The safety and efficacy of TAXOTERE in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established. 
Varnost in učinkovitost zdravila TAXOTERE za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
You must not be given TAXOTERE: 
Zdravila TAXOTERE ne smete dobiti:
Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE. 
Pred vsako uporabo zdravila TAXOTERE boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo TAXOTERE.
TAXOTERE will be given by infusion into one of your veins (intravenous use). 
Zdravilo TAXOTERE boste dobili v infuziji v eno od ven (intravenska uporaba).
What you need to know before you use TAXOTERE 
Kaj morate vedeti, preden boste uporabili zdravilo TAXOTERE
See accompanying preparation guide. 
Glejte priložena navodila za pripravo.
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles). 
G-CSF so uporabili za sekundarno profilakso pri 19,3 % bolnikov (10,7 % ciklusov).
TAXOTERE contains alcohol. 
Zdravilo TAXOTERE vsebuje alkohol.
• decrease of the potassium, calcium and/or phosphate in your blood. 
• znižanje kalija, kalcija in/ali fosfata v krvi.
Frequency not known (cannot be estimated from the available data): 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
CHAARTED study 
ŠTUDIJA CHAARTED
• raised liver enzymes (hence the need for regular blood tests) 
• zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi)
However, the distribution of OS was not significantly different between the 2 groups. 
Toda porazdelitev celotnega preživetja se med obema skupinama ni značilno razlikovala
Ask your doctor for advice before being given any medicine. 
Posvetujte se z zdravnikom preden vzamete katerokoli zdravilo.
a Time to event variables: Stratified log-rank test. 
a Spremenljivke časa do dogodka: stratificirani log-rang test.
Histological grade Grade1 (includes grade not assessed) Grade 2 
Histološka stopnja 1. stopnja (vključuje primere z neocenjeno stopnjo)
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received: 
Med infuzijami zdravila TAXOTERE se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
RECOMMENDATIONS FOR THE SAFE HANDLING 
PRIPOROČILA ZA VARNO RAVNANJE
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE. 
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo TAXOTERE.
Sanofi - Produtos Farmacêuticos, Lda. 
Portugal Sanofi - Produtos Farmacêuticos, Lda
Meeting relative indication for chemotherapy a 
Izpolnjena relativna indikacija za kemoterapijo a
The name of this medicine is TAXOTERE. 
To zdravilo se imenuje TAXOTERE.
This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect. 
Bodisi zdravilo TAXOTERE bodisi drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
Response rate variables: Fisher's Exact test * p-value for descriptive purpose. 
Spremenljivke deleža odziva: Fisherjev eksaktni test. *Vrednost p za opisen namen.
TAXOTERE will be administered to you by a healthcare professional. 
Zdravilo TAXOTERE vam bo dal pristojni zdravstveni delavec.
Time to clinical progressionc 
Čas do kliničnega napredovanjac
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02 
Farmakoterapevtska skupina: Taksani, oznaka ATC: L01CD02
TAXOTERE vials should be stored between 2°C and 25°C and protected from light. 
Viale zdravila TAXOTERE morajo biti shranjene pri temperaturi med 2°C in 25°C in zaščitene pred svetlobo.
• infection of the upper respiratory tract. 
• okužba zgornjih dihal.
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised. 
Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
Use immediately the medicine once added into the infusion bag. 
Zdravilo uporabite takoj potem, ko je dodano v infuzijsko vrečko.
Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005 
Datum prve pridobitve dovoljenja za promet z zdravilom: 27 November 1995 Datum zadnjega podaljšanja: 27 November 2005
What TAXOTERE is and what it is used for 
Kaj je zdravilo TAXOTERE in za kaj ga uporabljamo
A total of 790 male patients were allocated to the 2 treatment groups. 
Skupno 790 moških je bilo vključenih v 2 terapevtski skupini:
• infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets 
• okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov
The premix solution should be used immediately after preparation. 
Osnovno raztopino je treba uporabiti takoj po pripravi.
• ADT alone 
• ADT samo.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts. 
Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/m2 povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. 
Simptomi kot so: abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
• swelling caused by faulty lymphatic drainage 
• otekanje zaradi nepravilne limfatične drenaže
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders. 
V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če ni uporabljena takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
Do not store above 25°C or below 2°C. 
Ne shranjujte pri temperaturi nad 25°C ali pod 2°C.
Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone. 
Od 1776 randomiziranih bolnikov jih je 1086 (61 %) imelo metastatsko bolezen, 362 je bilo randomiziranih na docetaksel v kombinaciji s standardno oskrbo, 724 pa jih je prejemalo samo standardno oskrbo.
Once added to the infusion bag 
Potem, ko je zdravilo dodano v infuzijsko vrečko
Shelf life in infusion bag: see the leaflet. 
Rok uporabnosti v infuzijski vrečki: glejte navodilo.
Ready to add to infusion solution. 
Pripravljeno za dodatek raztopini za infundiranje.
Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4). 
Docetaksela se ne sme uporabljati pri bolnikih s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
• rises in blood sugar levels (diabetes) 
• zvišanje koncentracije krvnega sladkorja (sladkorna bolezen)
Do not store above 25°C. 
Ne shranjujte pri temperaturi nad 25°C.
• decrease of the sodium and/or magnesium in your blood (electrolyte balance disorders) 
• znižanje natrija in /ali magnezija v krvi (motnje ravnotežja elektrolitov)
TAXOTERE must NOT be administered if you are pregnant unless clearly indicated by your doctor. 
Zdravila TAXOTERE NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial. 
4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to followup before). 
Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10-letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional. 
Če se vam pojavi huda kožna reakcija ali kateri koli od zgoraj navedenih učinkov, se nemudoma posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE 
• če ste alergični na (preobčutljivi za) docetaksel ali katero koli sestavino zdravila TAXOTERE
** PSA response: Prostate-Specific Antigen response: PSA level <0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart. 
**Odziv PSA: Odziv za prostato specifičnega antigena: koncentracija PSA < 0,2 ng/ml na dveh zaporednih meritvah v presledku vsaj 4 tednov.