natgillin/translations-raw huggingface dataset:
PACKAGE LEAFLET: ERYSENG suspension for injection for pigs
Suspenzija za injiciranje Suspenzija belkaste barve
Tell them immediately if you notice any of these effects.
Nemudoma jim povejte, če opazite kateregakoli od teh učinkov.
• allergic reactions as described above
• alergijske reakcije, kot so opisane zgoraj
Unopened vial 24 months.
Neodprta viala 24 mesecev
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Datum prve odobritve: 28 avgust 2015
• change or absence of menstrual periods
• spremembe ali izostanek menstruacije
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojnodelovanje z drugimi zdravili in druge oblike interakcij
• hair loss: in most cases normal hair growth should return.
• izguba las in dlak: večinoma se obnovi njihova normalna rast.
Each box contains 1 vial.
Ena škatla vsebuje 1 vialo.
During treatment, you may be given other medicines to maintain the number of your blood cells.
Med zdravljenjem boste morda prejemali zdravila za ohranjanje števila krvnih celic.
• if the number of your white blood cells is too low.
• če imate premajhno število belih krvnih celic,
The first interim analysis was planned 3 years after the date when half of study enrollment was done.
Prva vmesna analiza je bila načrtovana 3 leta po datumu, ko je bila opravljena polovica vključevanja v študijo.
TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
(26,8-no) ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
• Risk Management Plan (RMP)
• Načrt za obvladovanjetveganj (RMP)
Frequency not known (cannot be estimated from available data):
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• loss of appetite (anorexia)
• izguba apetita (anoreksija)
After opening of the vial
Po odprtju viale
3 (see section 4.2).
3 (glejte poglavje 4.2).
• change in the colour of your nails, which may detach
• sprememba barve nohtov, ki lahko odstopijo
If the patient continues to experience these reactions at 60 mg/m 2, the treatment should be discontinued.
Če bolnik tudi pri odmerku 60 mg/m 2 še doživlja te reakcije, je treba zdravljenje prekiniti.
• bleeding from the nose
• krvavitev iz nosu
Its common name is docetaxel.
Njegovo splošno ime je docetaksel.
Name and address of the manufacturers responsible for batch release Hospira UK Limited
Ime in naslov izdelovalca, odgovornega za sproščanje serij Hospira UK Limited
Between infusions of Taxespira the following may occur, and the frequency may vary with the combinations of medicines that are received:
Med posameznimi infuzijami zdravila Taxespira se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
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).
If crystals appear, the solution must no longer be used and shall be discarded.
Če se v raztopini pojavijo kristali, raztopine ne smete več uporabiti in jo je treba zavreči.
Contraception in males and females An effective method of contraception should be used during treatment.
Kontracepcija pri moških in ženskah Med zdravljenjem se mora uporabljati učinkovita metodo kontracepcije.
The amount of alcohol in this medicinal product 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).
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).
Recommendations for the safe handling
Priporočila za varno ravnanje z zdravilom
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Vse materiale, uporabljene pri razredčevanju in aplikaciji, je treba odstraniti skladno s standardnimi postopki.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Taxespira.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Taxespira.
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 katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Before each treatment with Taxespira, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Taxespira.
Pred vsako uporabo zdravila Taxespira boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Taxespira.
The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Taxespira za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
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 kadarkoli in lahko povzroči smrt že prvi dan, ko se pojavi.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu
If this happens, you must tell your doctor immediately.
Če se to zgodi, morate nemudoma obvestiti zdravnika.
Ask your doctor for advice before being given any medicine.
Posvetujte se z zdravnikom, preden vzamete katerokoli zdravilo.
Taxespira will be given by infusion into one of your veins (intravenous use).
Zdravilo Taxespira boste dobili v infuziji v eno od ven (intravenska uporaba).
Older people treated with TCF should be closely monitored.
Starejše bolnike, ki dobivajo TCF, je treba natančno nadzirati.
Once added to the infusion bag
Po dodajanju v infuzijsko vrečo
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
razlika zdravljenj: 7,1 % [95 % IZ: 0,7; 13,5] *: Korigirano za multiple primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
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 %.
Taxespira contains alcohol.
Zdravilo Taxespira vsebuje alkohol.
Other medicines and Taxespira
Druga zdravila in zdravilo Taxespira
This is because Taxespira or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Bodisi zdravilo Taxespira 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.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanjastrojev
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaksel spada v skupino zdravil za zdravljenje raka, imenovanih taksoidi.
If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.
Če ste imeli alergijsko reakcijo na paklitaksel, se vam lahko pojavi tudi alergijska reakcija na docetaksel, ki pa je lahko hujša.
Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Stratificiran log-rang test *Prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
• 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)
Taxespira contains ethanol (alcohol)
Zdravilo Taxespira vsebuje etanol (alkohol)
This leaflet was last revised in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne mesec LLLL
Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, taksani, oznaka ATC: L01CD02
• infections, decrease in the number of red blood cells (anaemia), or white blood cells (which are important in fighting infection) and platelets (important in blood clotting)
• okužbe, zmanjšanještevila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov (pomembni za strjevanje krvi)
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
Use the vial immediately after its opening.
Vialo je treba uporabiti takoj po odprtju.
See also section “Taxespira contains ethanol (alcohol)” below.
Glejte tudi poglavje "Zdravilo Taxespira vsebuje etanol (alkohol)" spodaj.
3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
What you need to know before you use Taxespira
Kaj morate vedeti, preden boste uporabili zdravilo Taxespira
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Vnetje pljuč se lahko razvije tudi, če se zdravljenje z docetakselom uporablja sočasno z radioterapijo)
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Taxespira may be harmful for the unborn baby.
Med zdravljenjem z zdravilom Taxespira ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo Taxespira lahko škoduje vašemu nerojenemu otroku.
What Taxespira is and what it is used for
Kaj je zdravilo Taxespira in za kaj ga uporabljamo
Hazard ratio (TAC/FAC)
Razmerje ogroženosti (TAC/FAC)
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Docetaksel se metabolizira s CYP3A4, za prednizon pa je znano, da inducira CYP3A4.
Taxespira will be administered to you by a healthcare professional.
Zdravilo Taxespira vam bo dal pristojni zdravstveni delavec.
The name of this medicine is Taxespira.
To zdravilo se imenuje Taxespira.
The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive or use machines (see sections 4.4 and 4.8).
Količina alkohola v tem zdravilu in neželeni učinki zdravila lahko poslabšajo sposobnost vožnje in upravljanja s stroji (glejte poglavji 4.4 in 4.8).
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, pireksija, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
B. POGOJI ALI OMEJITVEGLEDE OSKRBE IN UPORABE
• decrease in blood pressure; irregular or rapid heart beat
• znižanje krvnega tlaka, nereden ali hiter srčni utrip
• Mitoxantrone 12 mg/m
• Mitoksantron12 mg/m
In case of white blood cells disturbances, you may experience associated fever or infections.
Če imate spremenjeno število belih krvnih celic, se lahko pojavijo zvišana telesna temperatura ali okužbe.
Taxespira was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Zdravilo Taxespira je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Nevtropenija (4. stopnje) Febrilna nevtropenija Nevtropenična okužba Nevtropenična okužba (3.-4. stopnja)
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Bolezni krvi in limfatičnega sistema Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
Discuss with your doctor if you suffer from alcohol dependency, epilepsy, or liver impairment.
Posvetujte se z zdravnikom, če ste odvisni od alkohola, imate epilepsijo ali okvaro jeter.
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Opravljene so bile eksplorativne analize podskupin glede preživetja brez bolezni pri bolnicah, ki izpolnjujejo St.-Gallenska merila 2009 za kemoterapijo (populacija ZNZ); predstavljene so spodaj
It is important that you read the entire contents of this guide prior to the preparation of the Taxespira infusion solution.
Pomembno je, da pred pripravo zdravila Taxespira v celoti preberete ta navodila.
It should be used within 6 hours (including the one hour
Porabiti jo je treba v 6 urah (ena ura infundiranja všteta).
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 follow-up before).
Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm
Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Opisani so redki primeri dehidracije zaradi dogodkov, povezanih s prebavili vključno z enterokolitisom in gastrointestinalno perforacijo.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali multiorgansko odpovedjo.
1,000 mg/m2 per day for 5 days.
(1000 mg/m2 na dan, 5 dni).
Each vial is for single use and should be used immediately after opening.
Vsaka viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
Patients who received docetaxel every three weeks demonstrated significantly longer OS compared to those treated with mitoxantrone.
Pri bolnikih, ki so prejemali docetaksel vsake tri tedne so prikazali značilno daljše skupno preživetje v primerjavi s tistimi, ki so bili zdravljeni z mitoksantronom.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• fever: if this happens you must tell your doctor immediately
• zvišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku
• Periodic safety update reports
• Redno posodobljenaporočila o varnosti zdravila (PSUR)
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Bolniki v obeh terapevtskih krakih so po indukcijski kemoterapiji dobili 7 tednov kemoradioterapije; najkrajši presledek je bil 3 tedne in ne več kot 8 tednov po začetku zadnjega ciklusa (22. do 56. dan zadnjega ciklusa).
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
• pneumonia (infection of the lungs)
• pljučnica (okužba pljuč)
95% CI p =
95 % IZ p =
• haemorrhage (bleeding)
• hemoragija (krvavitev)
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
• V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4. stopnje, odmerek docetaksela prekinite.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Če se pojavijo akutne težave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, težko dihanje/kratka sapa ali kašelj), takoj obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta.
Acute leukaemia /Myelodysplastic syndrome
Akutna levkemija / mielodisplastični sindrom
Hormonal receptor status
Stanje hormonskih receptorjev Negativno
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Če je potrebni odmerek večji od 190 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncetracije docetaksela 0,74 mg/ml.
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Poleg tega je ugotovljeno, da je docetaksel aktiven na nekaterih, ne pa na vseh celičnih linijah s hipereksprimiranim pglikoproteinom, ki ga kodira gen za rezistenco proti več zdravilom.
Meeting relative indication for chemotherapy No
Izpolnjena relativna indikacija za kemoterapijo
If you are a man being treated with Taxespira you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility.
Če ste moški, ki se zdravi z zdravilom Taxespira je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila Taxespira NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Stošestinosemdeset (186) bolnic je bilo randomiziranih na prejemanje docetaksela (100 mg/m2) s trastuzumabom ali brez njega; 60 % bolnic je prej dobilo adjuvantno kemoterapijo na osnovi antraciklinov.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA
Each vial is of single use and should be used immediately.
Vsaka viala je za enkratno uporabo in jo je treba uporabiti takoj.
If the vials are stored under refrigeration, allow the required number of boxes of Taxespira concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Če so viale shranjene v hladilniku, pred uporabo pustite potrebno število škatel zdravila Taxespira koncentrat za raztopino za infundiranje 5 minut stati na sobni temperaturi (do 25°C).
3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklusih zmanjšati na 65 mg/m2.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
In vivo docetaksel ni odvisen od sheme in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Zdravila Taxespira koncentrat za raztopino za infundiranje predhodno NI potrebno redčiti z vehiklom in je pripravljeno za dodajanje v infuzijsko raztopino.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
To shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
In non-clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
V predkliničnih študijah so opazili genotoksične učinke docetaksela in lahko prizadene moško plodnost (glejte poglavje 5.3).
3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
The European Medicines Agency has waived the obligation to submit the results of studies with Taxespira in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij z zdravilom Taxespira za vse skupine pediatrične populacije za raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, karcinom želodca in raka glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm