FrancophonIA/ELRC3.0 huggingface dataset:
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Slovenian: * Razmerje tveganja manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
English: 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.
Slovenian: Če se pojavijo akutne težave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, težko dihanje ali kašelj), takoj obvestite svojega zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
English: Docetaxel plus trastuzumab1 n=92
Slovenian: parameter docetaksel in trastuzumab1 n = 92
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Slovenian: Podatki o reverzibilnosti so na voljo za 35,3 % bolnikov, pri katerih so se po zdravljenju z docetakselom kot samostojno učinkovino v odmerku 100 mg/m2 pojavili nevrotoksični učinki.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Slovenian: Opisali so redke primere dehidracije zaradi dogodkov, povezanih s prebavili, vključno z enterokolitisom in gastrointestinalno perforacijo.
English: The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Slovenian: Nadaljnje odmerke docetaksela so aplicirali nemudoma po koncu infuzije trastuzumaba, če so bolniki predhodni odmerek trastuzumaba dobro prenašali.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy because Docetaxel Teva may be harmful for the unborn baby.
Slovenian: Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati zanesljivo metodo kontracepcije, saj lahko zdravilo Docetaksel Teva škoduje nerojenemu otroku.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Slovenian: V tej študiji so 501 bolnika z lokalno napredovalim SCCHN in stanjem zmogljivosti 0 ali 1 po WHO naključno razvrstili v enega od dveh krakov.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Slovenian: Incidenca naslednjih neželenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okužbeje bila pri bolnikih, starih 65 let ali več, za ≥ 10 % večja kot pri mlajših bolnikih.
English: Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p=0.01, using the EORTC QLQ-C30 scale).
Slovenian: Pri bolnikih, zdravljenih s TPF, se je lestvica globalnega zdravja pomembno manj poslabšala kot pri tistih, ki so bili zdravljeni s PF (p = 0,01, uporabili so lestvico EORTC QLQ-C30).
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Slovenian: Pri bolnikih, ki so dobivali docetaksel vsake 3 tedne, so ugotovili značilno daljše celotno preživetje v primerjavi s tistimi, ki so se zdravili z mitoksantronom.
English: When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Slovenian: V kombinaciji z docetakselom je bil očistek karboplatina za približno 50 % večji od vrednosti, opisanih med monoterapijo s karboplatinom.
English: If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel which may be more severe.
Slovenian: Če ste imeli alergijsko reakcijo na paklitaksel, se vam lahko pojavi tudi alergijska reakcija na docetaksel, ki pa je lahko hujša.
English: The name of this medicine is Docetaxel Teva.
Slovenian: To zdravilo se imenuje Docetaksel Teva.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Slovenian: • če ste alergični (preobčutljivi) na docetaksel ali katero koli sestavino zdravila Docetaksel Teva
English: All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Slovenian: Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili kemoradioterapijo (KRT) po protokolu (TPF/KRT).
English: One hundred eighty six patients were randomised to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Slovenian: 186 bolnic so randomizirali na dobivanje docetaksela (100 mg/m2) s trastuzumabom ali brez njega; 60 % bolnic je prej dobilo adjuvantno kemoterapijo na osnovi antraciklinov.
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Slovenian: Podatke o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so zbrali pri:
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Slovenian: Opisali so zelo redke primere hepatitisa, včasih s smrtnim izidom, pri bolnikih z že prej obstoječo boleznijo jeter.
English: Docetaxel achieves high intracellular concentrations with a long cell residence time.
Slovenian: Docetaksel doseže visoko znotrajcelično koncentracijo in se dolgo zadržuje v celicah.
English: Docetaxel is more than 95% bound to plasma proteins.
Slovenian: Več kot 95 % docetaksela se veže na beljakovine v plazmi.
English: The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Slovenian: ali so prej dobile adjuvantne antracikline ali ne. Glavni test za ugotavljanje HER2-pozitivnosti v tem ključnem preskušanju je bila imunohistokemija (IHK).
English: ≥50 years
Slovenian: ≥50 let
English: Docetaxel Teva vials should not be stored above 25°C and should be protected from light.
Slovenian: Viale Docetaksel Teva morajo biti shranjene pri temperaturi do 25°C in zaščitene pred svetlobo.
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Slovenian: Absorpcija Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
English: • fever: if this happens you must tell your doctor immediately
Slovenian: • povišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku;
English: • pneumonia (infection of the lungs)
Slovenian: • pljučnica (okužba pljuč);
English: • dehydration
Slovenian: • dehidracija;
English: Docetaxel Teva contains alcohol.
Slovenian: Zdravilo Docetaksel Teva vsebuje alkohol.
English: What Docetaxel Teva is and what it is used for What you need to know before you use Docetaxel Teva How to use Docetaxel Teva Possible side effects
Slovenian: Kaj je zdravilo Docetaksel Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaksel Teva Kako uporabljati zdravilo Docetaksel Teva
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
Slovenian: Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P4503A ali jih ta presnavlja (in tako lahko kompetitivno inhibirajo encim), kot so ciklosporin, ketokonazol in eritromicin.
English: MARKETING AUTHORISATION NUMBER EU/1/09/611/002
Slovenian: EU/1/09/611/002
English: Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Slovenian: Kirurška resekcija je bila dovoljena po kemoterapiji, pred obsevanjem ali po njem.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Slovenian: Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali odpovedjo več organov.
English: 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.
Slovenian: Poleg tega so ugotovili, da docetaksel deluje na nekatere, ne pa na vse celične linije s prekomerno izraženim pglikoproteinom, ki ga kodira gen za odpornost proti več zdravilom.
English: Deutschland Teva GmbH Tel: +49 731 402 08
Slovenian: Teva GmbH Tel: +49 731 402 08
English: Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol (see leaflet for further information).
Slovenian: Viala s koncentratom docetaksela polisorbat 80, brezvodni etanol (za dodatne informacije glejte navodilo za uporabo)
English: Patients with operable node-positive breast cancer (TAX 316)
Slovenian: Bolnice z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316).
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental anti-tumour activity against advanced murine and human grafted tumours.
Slovenian: In vivo docetaksel ni odvisen od režima in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
English: For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Slovenian: Pri bolnikih, ki doživijo zapleteno nevtropenijo (podaljšano nevtropenijo, febrilno nevtropenijo ali okužbo) je treba razmisliti o uporabi G-CSF in zmanjšanju odmerka (glejte poglavje 4.2).
English: If you are a man being treated with Docetaxel Teva 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.
Slovenian: Če ste moški, ki se zdravi z zdravilom Docetaksel Teva 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.
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Slovenian: Zmeren oziroma hud zastoj se pozneje pojavi pri bolnikih, ki dobijo premedikacijo (srednji kumulativni odmerek: 818,9 mg/m2), kot pri tistih, ki je ne (srednji kumulativni odmerek: 489,7 mg/m2); vendar so ga pri nekaterih bolnikih opisali med zgodnjimi cikli zdravljenja.
English: In the case of severe neutropenia (<500 cells/mm3 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).
Slovenian: Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm3, ki traja sedem dni ali dlje), se med naslednjimi cikli priporoča zmanjšanje odmerka ali uporaba ustreznih simptomatskih ukrepov (glejte poglavje 4.2).
English: See also section ”Docetaxel Teva contains ethanol (alcohol)” below.
Slovenian: Glejte tudi poglavje "Zdravilo Docetaksel Teva vsebuje etanol (alkohol)" spodaj.
English: Patients previously treated with chemotherapy with or without radiotherapy
Slovenian: Bolniki, ki so se predhodno zdravili s kemoterapijo, z obsevanjem ali brez njega
English: Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Slovenian: Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat dnevno (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70-72 Gy).
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Slovenian: Med obsevanjem so vsak teden dobili karboplatin (AUC 1,5) v enourni intravenski infuziji do največ 7 odmerkov.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing docetaxel in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated 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).
Slovenian: Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij za zdravila, ki vsebujejo učinkovino docetaksel 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).
English: 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/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Slovenian: 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/mm3) pa 7 dni), anemija, alopecija, navzeja, bruhanje, stomatitis, driska in astenija.
English: Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Slovenian: Srednji čas do prvega poslabšanja stanja zmogljivosti po WHO je bil pomembno daljši v kraku TPH kot v kraku PF.
English: If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.
Slovenian: Če se to zgodi, ne vozite, ne uporabljajte orodij in ne upravljajte strojev, dokler se ne posvetujete z zdravnikom,
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Slovenian: Možna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, vendar medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatomin vitro ni vplivalo na vezavo docetaksela na beljakovine.
English: Docetaxel Teva contains ethanol (alcohol)
Slovenian: Zdravilo Docetaksel Teva vsebuje etanol (alkohol)
English: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Slovenian: Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši neželeni učinki (≥ 5 %), povezani z zdravljenjem, o katerih so poročali v fazi III preskušanja pri bolnicah z rakom dojke, pri katerih zdravljenje z antraciklini ni uspelo (glejte povzetek glavnih značilnosti kapecitabina).
English: Hormonal receptor status
Slovenian: Stanje hormonskih Receptorjev negativno pozitivno
English: Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Slovenian: Lokoregionalno terapijo z obsevanjem so aplicirali s konvecionalno frakcijo (1,8 Gy - 2,0 Gy enkrat dnevno, 5 dni na teden v celotnem odmerku 66 do 70 Gy) ali s pospešenimi/ hiperfrakcioniranimi režimi obsevalnega zdravljenja (dvakrat dnevno, z najkrajšim presledkom med frakcijama 6 ur, 5 dni na teden).
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Slovenian: • 300 bolnikih z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: • 174 in 251 bolnikih z rakom glave in vratu, ki so dobivali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
English: Efficacy results are presented in the table below:
Slovenian: Rezultati učinkovitosti so predstavljeni v spodnji razpredelnici.
English: How to use Docetaxel Teva
Slovenian: Kako uporabljati zdravilo Docetaksel Teva
English: In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Slovenian: kombinaciji s kapecitabinom se priporoča zmanjšanje začetnega odmerka kapecitabina pri bolnikih, starejših od 60 let, na 75 % (glejte povzetek glavnih značilnosti kapecitabina).
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Slovenian: • zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem);
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).
Slovenian: - Pomožni snovi sta polisorbat 80 in 25,1 % (m/m) brezvodnega etanola (glejte poglavje 2).
English: This volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Slovenian: Ta volumen je bil določen med razvojem docetaksela za nadomestitev tekočine, ki se izgubi med pripravo osnovne raztopine zaradi penjenja (glejte poglavje 4), adhezije na stene viale in »mrtvega volumna«.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Slovenian: Zdravilo je treba aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Slovenian: 4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaksel Teva.
English: Obligation to conduct post-authorisation measures Not applicable
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.
English: Teva (listed in section 6).
Slovenian: (navedeno v poglavju 6).
English: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Slovenian: • V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4. stopnje odmerjanje docetaksela prekinite.
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Slovenian: Sekundarna končna točka, preživetje brez napredovanja bolezni (PBN), je pokazala 29 % zmanjšanje tveganja za napredovanje ali smrt ter 22-mesečno izboljšanje povprečnega PBN (35,5 mesecev pri TPF in 13,1 pri PF).
English: • non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Slovenian: • ne-Hodgkinov limfom (rak ki napade imunski sistem) in druge vrste raka se lahko pojavijo pri bolnikih, ki se zdravijo z docetakselom v kombinaciji z nekatermi drugimi zdravili proti raku.
English: • For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
Slovenian: • Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo 0 ali 1 in znova uporabite 100 % izvirnega odmerka.
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Slovenian: Srednji kumulativni odmerek do prekinitve zdravljenja je bil več kot 1000 mg/m2 in srednji čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
English: • tiredness; or flu-like symptoms
Slovenian: • utrujenost ali gripi podobni simptomi;
English: The most commonly reported adverse reactions of Docetaxel Teva alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Slovenian: Najpogosteje opisani neželeni učinki na samo zdravilo Docetaksel Teva so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
English: For more details see summary of product characteristics of trastuzumab.
Slovenian: Za več podrobnosti glejte povzetek glavnih značilnosti trastuzumaba.
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Slovenian: Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaksel Teva.
English: Additional cautions for use in adjuvant treatment of breast cancer
Slovenian: Dodatna opozorila pri uporabi v adjuvantni terapiji raka dojke
English: If a dose greater than 200 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.
Slovenian: Če je potrebni odmerek docetaksela večji od 200 mg, uporabite več infuzijskega vehikla, tako da končna koncentracija ne preseže koncetracije docetaksela 0,74 mg/ml.
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Slovenian: Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate so ocenili v randomizirani multicentrični študiji faze III.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Bolniki, ki dobivajo TCF, morajo profilaktično dobivati G-CSF za zmanjšanje tveganja za zapleteno nevtropenijo (febrilno nevtropenijo, dolgotrajno nevtropenijo ali nevtropenično okužbo).
English: Tél: +33 1 55 91 78 00
Slovenian: Teva Santé Tél: +33 1 55 91 78 00
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Slovenian: Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da ponavljate obračanje viale vsaj 45
English: The median TTP was 37.3 weeks (95% CI:33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm.
Slovenian: Srednji čas do napredovanja je bil v kraku AT 37,3 tedna (95-% IZ: 33,4 - 42,1) in v kraku AC 31,9 tedna (95-% IZ: 27,4 - 36,0).