natgillin/translations-raw huggingface dataset:
More severe reactions may occur. 
Pojavijo se lahko tudi hujše reakcije.
• change or absence of menstrual period 
• spremembe ali izostanek menstruacije,
One primary analysis and one updated analysis were performed. 
Opravljena je bila ena primarna analiza in ena posodobljena analiza.
Recommendations for the safe handling 
Priporočila za varno ravnanje
73% of the cutaneous reactions were reversible within 21 days. 
73 % kožnih reakcij je bilo reverzibilnih v 21 dneh.
The infusion will last approximately one hour during which you will be in the hospital. 
Infundiranje bo trajalo približno eno uro in med tem časom boste v bolnišnici.
Consideration should be given to possible effects on the central nervous system. 
Upoštevati je treba možnost učinkov na osrednje živčevje.
During treatment, you may be given other medicines to maintain the number of your blood cells. 
Med zdravljenjem boste morda prejemali druga zdravila za ohranjanje števila krvnih celic.
Summary of the safety profile for all indications 
Povzetek varnostnih značilnosti za vse indikacije
The hospital staff will monitor your condition closely during treatment. 
Bolnišnično osebje bo med zdravljenjem natančno spremljalo vaše stanje.
Unopened vial 2 years. 
Neodprta viala 2 leti
Early use of supportive care measures may help improve the condition. 
K izboljšanju stanja lahko pripomore zgodnja uporaba podpornih ukrepov.
Such information will allow her/him to decide whether a dose reduction is needed. 
Te informacije bodo zdravniku pomagale pri odločitvi, ali je odmerek treba zmanjšati.
However, the distribution of OS was not significantly different between the 2 groups. 
Toda porazdelitev celokupnega preživetja se med obema skupinama ni značilno razlikovala.
These reactions sometimes appear during the infusion of the medicinal product. 
Te reakcije se včasih pojavijo med infundiranjem zdravila.
Very rare: one case of alopecia non-reversible at the end of the study. 
Zelo redki: en primer alopecije, ki na koncu študije ni bila reverzibilna.
Number of patients in TAC group 
Število bolnic v skupini s TAC
• loss of appetite (anorexia) 
• izguba apetita (anoreksija),
The first interim analysis was planned 3 years after the date when half of study enrolment was done. 
Prva vmesna analiza je bila načrtovana 3 leta po datumu, ko je bila opravljena polovica vključevanja v študijo.
Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive. 
Zdravnik bo izračunal vašo telesno površino v kvadratnih metrih (m2) in določil odmerek, ki ga morate dobiti.
The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed. 
Vrednotenje učinkovitosti in varnosti je obravnavalo izključno točko preživetja, uspeha ohranitve organov ni obravnavalo.
Two interim analyses and one final analysis were performed. 
Opravljeni sta bili dve vmesni in ena končna analiza.
An effective method of contraception should be used during treatment. 
Med zdravljenjem se mora uporabljati učinkovita metoda kontracepcije.
Date of latest renewal: 23 February 2017 
Datum zadnjega podaljšanja: 23. 02. 2017
• raised liver enzymes (hence the need for regular blood tests). 
• zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi).
Second episode: discontinue treatment. 
Drugi pojav: prekinite zdravljenje.
• low blood pressure. 
• nizek krvni tlak.
• if the number of white blood cells is too low. 
• če imate premajhno število belih krvnih celic;
In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. 
V primeru prevelikega odmerjanja je treba bolnika pridržati v specializirani enoti in natančno spremljati njegove vitalne funkcije.
Quality of life parameters 
Parametri kvalitete življenja
Cases of electrolyte imbalance have been reported. 
Poročali so o primerih neravnovesja elektrolitov.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
6.2 Inkompatibilnosti Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
Median time to progression (weeks): 
mediana časa do napredovanja (tedni):
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če ni uporabljeno takoj, so čas in pogoji shranjevanja med uporabo odgovornost uporabnika.
Its common name is docetaxel. 
Njegovo generično ime je docetaksel.
Pain intensity score improved during treatment in both groups indicating adequate pain management. 
Lestvica intenzivnosti bolečine se je med zdravljenjem izboljšala v obeh skupinah, kar kaže na ustrezno zdravljenje bolečine.
If crystals appear, the solution must no longer be used and shall be discarded. 
Če se pojavijo kristali, raztopine ne smete več uporabiti in jo morate zavreči.
Your doctor should address them immediately. 
Zdravnik jih bo obravnaval nemudoma.
FAC Hazard ratio (TAC/FAC) 
TAC FAC Razmerje ogroženosti (TAC/FAC)
Histological grade 
Histološka stopnja
The events were spontaneously reversible within 3 months. 
Motnje so spontano izginile v 3 mesecih.
Eruptions generally occurred within one week after the docetaxel infusion. 
Erupcije so se ponavadi pojavile v enem tednu po infuziji docetaksela.
There were a few reports of overdose. 
Obstaja nekaj poročil o prevelikem odmerjanju.
In some cases concomitant factors may have contributed to the development of these effects. 
V nekaterih primerih so k nastanku teh sprememb morda pripomogli drugi spremljajoči dejavniki.
• injection site reactions at the site of a previous reaction. 
• reakcije na mestu injiciranja na mestu predhodne reakcije.
No statistical differences were observed between treatment groups for Global Quality of Life. 
Med skupinami zdravljenja niso opazovali statističnih razlik po oceni globalnega vprašalnika o kvaliteti življenja (»Global Quality of Life«).
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal. 
Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• change in the colour of your nails, which may detach 
• sprememba barve nohtov, ki lahko odstopijo,
Use the vial immediately after its opening. 
Vialo uporabite takoj po odprtju.
The dose will depend on your weight and your general condition. 
Odmerek bo odvisen od vaše telesne mase in vašega splošnega stanja.
Usual dose 
Običajni odmerek
No of positive nodes Overall 
št. pozitivnih bezgavk celotno
Cardiac function should be further monitored during treatment (e.g. every three months) to help identify patients who may develop cardiac dysfunction. 
Srčno funkcijo je med zdravljenjem potrebno nadalje nadzorovati (npr. vsake tri mesece), da bi prepoznali bolnice, ki bi se jim lahko razvila srčna okvara.
A final analysis was performed with an actual median follow up of 96 months. 
Končna analiza je bila opravljena, ko je dejansko mediano spremljanje doseglo 96 mesecev.
In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up. 
V obeh krakih je bila kakovost življenja, ocenjena z vprašalnikom EORTC, med zdravljenjem in poznejšim sledenjem primerljiva in stabilna.
In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined. 
V primeru težav z vidom, zlasti zamegljenega vida, morate takoj opraviti pregled oči in vida.
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord). 
Količina alkohola v tem zdravilu lahko vpliva na osrednje živčevje (del živčevja, ki obsega možgane in hrbtenjačo).
During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people): 
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data). 
Opredelitev pogostnosti je: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10); občasno (≥ 1/1.000 do < 1/100); redko (≥ 1/10.000 do < 1/1.000); zelo redko (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders). 
• znižanje natrija, kalija, magnezija in/ali kalcija v krvi (motnje ravnotežja elektrolitov).
Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk. 
Docetaksel je lipofilna snov, vendar ni znano, ali se izloča v materino mleko.
This may be moderate to severe and has been associated with death (see section 4.8). 
Le-to je lahko zmerne do hude narave in je bilo povezano s smrtjo (glejte poglavje 4.8).
(26.8-ne) 
(26,8-no)
The binding of docetaxel to microtubules does not alter the number of protofilaments. 
Vezava docetaksela na mikrotubule ne spremeni števila protofilamentov.
If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued. 
Če bolnik tudi pri odmerku 60 mg/m2 še doživlja te reakcije, je treba zdravljenje prekiniti.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription. 
Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
Fluid retention has not been accompanied by acute episodes of oliguria or hypotension. 
Zastoja tekočine niso spremljale akutne epizode oligurije ali hipotenzije.
• if you have a severe liver disease. 
• če imate hudo bolezen jeter.
Median survival (months) 
mediana preživetja (meseci)
These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal. 
Ti simptomi so lahko prvi znaki resnih toksičnih učinkov na prebavila, ki lahko povzročijo smrt.
• bleeding from the nose 
• krvavitev iz nosu,
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks. 
Pri ocenljivih bolnikih je bil celotni delež odziva 6,8 %, mediana trajanja odziva pa 26,1 tednov.
The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation. 
Študijska populacija je obsegala bolnike s tehnično neresektabilno boleznijo, bolnike z majhno verjetnostjo kirurške ozdravitve in bolnike, ki so stremeli k ohranitvi organov.
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 % ciklov).
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures. 
Vse materiale, uporabljene pri razredčenju in dajanju zdravila, je treba odstraniti skladno s standardnimi postopki.
All except one patient in each arm were diagnosed with CHF more than 30 days after the treatment period. 
Pri vseh razen eni bolnici v vsakem kraku so kongestivno srčno popuščanje diagnosticirali več kot 30 dni po obdobju zdravljenja.
Although majority of cases occurred during the first or second cycle of docetaxel containing regimen, enterocolitis could develop at any time, and could lead to death as early as on the first day of onset. 
Večina primerov se je sicer pojavila med prvim ali drugim ciklusom sheme, ki je vključevala docetaksel, toda enterokolitis se lahko razvije kadar koli in lahko povzroči smrt že prvi dan, ko se pojavi.
Women of childbearing potential/ Contraception in males and females 
Ženske v rodni dobi/ Kontracepcija pri moških in ženskah
The benefit of resuming docetaxel treatment must be carefully evaluated. 
Koristi nadaljevanja zdravljenja z docetakselom je treba skrbno ovrednotiti.
PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size > 5 cm 
PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week. 
Glede na to, da je docetaksel tedensko pokazal nekoliko boljši profil varnosti kot docetaksel vsake tri tedne, je možno, da bi določenim bolnikom koristil docetaksel tedensko.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to DOCETAXEL KABI. 
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo DOCETAKSEL KABI.
Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions. 
Bolnike je treba skrbno opazovati glede preobčutljivostnih reakcij, zlasti med prvim in drugim infundiranjem.
Ask your doctor for advice before being given any medicine. 
Posvetujte se z zdravnikom preden vzamete katero koli zdravilo.
You should usually receive your infusion once every 3 weeks. 
Praviloma morate infuzijo dobivati enkrat na 3 tedne.
The carcinogenic potential of docetaxel has not been studied. 
Kancerogeni potencial docetaksela ni raziskan.
The peripheral oedema usually starts at the lower extremities and may become generalised with a weight gain of 3 kg or more. 
Periferni edemi se ponavadi začnejo na nogah in lahko postanejo generalizirani; telesna masa se lahko poveča za 3 kg ali več.
Frequency not known (cannot be estimated from the available data): 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
Therefore, patients should be warned of the potential impact of the amount of alcohol and the side effects of this medicinal product on the ability to drive or use machines, and be advised not to drive or use machines if they experience these side effects during treatment. 
Zato je treba bolnike opozoriti na možen vpliv količine alkohola in neželene učinke tega zdravila na sposobnost vožnje in upravljanja strojev ter jim naročiti, naj ne vozijo in ne upravljajo strojev, če se jim med zdravljenjem pojavijo ti neželeni učinki.
A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes. 
Za pospešene sheme so priporočili celotni odmerek 70 Gy, za hiperfrakcionirne sheme pa 74 Gy.
If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist. 
Če se to zgodi, ne vozite, ne uporabljajte orodij in ne upravljajte strojev, dokler se ne posvetujete z zdravnikom, medicinsko sestro ali bolnišničnim farmacevtom.
The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF. 
Lestvica stanja zmogljivosti s podlestvicama za glavo in vrat (PSS-HN), namenjenima merjenju razumljivosti govora, sposobnosti uživanja hrane na javnem mestu in normalnosti hrane, je signifikantno govorila v korist TPF v primerjavi s PF.
Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status. 
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti življenja z EuroQoL-5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
Clinical benefit parameters 
Parametri klinične koristnosti
The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment. 
Pozna faza je deloma posledica razmeroma počasnega prehajanja docetaksela iz perifernega prostora.
Grade1 (includes grade not assessed) 
1. stopnja (vključuje primere z neocenjeno stopnjo)
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed. 
Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj) poročani v ≥ 10 %.
Docetaxel is more than 95% bound to plasma proteins. 
Docetaksel je v več kot 95 % vezan na plazemske beljakovine.
Neuro-motor events are mainly characterised by weakness. 
Glavna značilnost motoričnih motenj je šibkost.
Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin. 
Omejeni podatki iz ene same nekontrolirane študije so nakazovali interakcijo med docetakselom in karboplatinom.
Elderly treated with TCF should be closely monitored. 
Starejše bolnike, ki dobivajo TCF, je treba natančno nadzirati.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje
As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction. 
Zato je med sočasnim zdravljenjem s temi zdravili potrebna previdnost, saj obstaja možnost pomembnega medsebojnega delovanja.
For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis. 
Za kombinacijo docetaksel/karboplatin v primerjavi z referenčno terapevtsko kombinacijo VCis ni bilo mogoče dokazati niti enakovredne niti neinferiorne učinkovitosti.
Cisplatin and 5-fluorouracil 
Cisplatin in 5-fluorouracil
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table: 
Podatke o preživetju, mediano časa do napredovanja in delež odziva v dveh krakih te raziskave prikazuje naslednja preglednica:
The estimated hazard ratio was using Cox proportional hazard model with treatment group as the factor. 
Razmerje ogroženosti je ocenjeno s Coxovim modelom sorazmernih ogroženosti in terapevtsko skupino kot faktorjem.
Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6). 
Med zdravljenjem morata tako moški kot ženska in moški vsaj še 6 mesecev po koncu zdravljenja uporabljati kontracepcijsko zaščito (glejte poglavje 4.6).
A minority of patients were tested using fluorescence in-situ hybridization (FISH). 
Manjši del bolnic so testirali z uporabo fluorescenčne hibridizacije in situ (FISH).
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay. 
Ni pa izzval mutagenosti v Amesovem testu ali preskusu genske mutacije CHO/HGPRT.
Use immediately the medicine once added into the infusion bag. 
Zdravilo uporabite takoj potem, ko je dodano v infuzijsko vrečo.
Cases of permanent alopecia (frequency not known) have been reported. 
Opisani so bili primeri trajne alopecije (pogostnost ni znana).
Age category 2 <35 years ≥35 years 
Starostna kategorija 2 < 35 let ≥ 35 let
In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive. 
V tej študiji je imelo 87 % bolnic bolezen, ki je bila IHK 3+, 95 % vključenih bolnic pa je imelo bolezen, ki je bila IHK 3+ in/ali FISH-pozitivna.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22nd May 2012 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 22. 5. 2012
Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC. 
V celoti rezultati študije dokazujejo ugodno razmerje koristi in tveganja TAC v primerjavi s FAC.
Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies. 
Z modelom dobljeni farmakokinetični parametri so bili zelo blizu parametrom, ocenjenim v študijah I. faze.
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, npr. sočasnih nefrotoksičnih zdravil ali bolezni prebavil.
If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated. 
Če se pojavijo novi simptomi ali pride do poslabšanja pljučne funkcije, je treba bolnike skrbno spremljati, nemudoma preiskati in ustrezno zdraviti.
For storage conditions of the diluted medicinal product, see section 6.3. 
Za pogoje shranjevanje raztopljenega zdravila glejte poglavje 6.3.
• 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,
This leaflet was last revised in {MM/YYYY} 
Navodilo je bilo nazadnje revidirano dne
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product. 
Približno 80 % radioaktivnosti v blatu se izloči v prvih 48 urah v obliki enega pomembnega in treh manj pomembnih neaktivnih presnovkov; zelo malo zdravila se izloči nespremenjenega.
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because DOCETAXEL KABI may be harmful for the unborn baby. 
Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo DOCETAKSEL KABI lahko škoduje vašemu nerojenemu otroku.
Method of administration For instructions on preparation and administration of the product, see section 6.6. 
Način uporabe Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
Docetaxel1 n = 94 
docetaksel1 n = 94
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up. 
Ponovna analiza preživetja, narejena pri medianem času spremljanja 41,6 mesecev, ni več pokazala statistično značilne razlike, čeprav je bila shema s TCF še vedno ugodnejša; pokazala pa je, da so koristi TCF v primerjavi s CF jasno opazne med 18. in 30. mesecem spremljanja.
Treatment is repeated every three weeks. 
Terapija se ponavlja na tri tedne.
• redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) 
• pordelost in otekanje dlani ali podplatov, ki lahko povzroči olupljenje kože (to se lahko pojavi tudi na rokah, obrazu ali telesu),
The incidence of serious adverse events was higher in older people compared to younger patients. 
Incidenca resnih neželenih učinkov je bila pri starejših bolnikih večja kot pri mlajših.
If this happens, you must tell your doctor immediately 
Če se to zgodi, morate nemudoma obvestiti zdravnika.
Hormonal receptor status 
Stanje hormonskih receptorjev
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004. 
Tudi to je bilo statistično značilno: RO 0,71, 95 % IZ 0,56-0,90, log-rang test p = 0,004.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC 
*Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.