natgillin/translations-raw huggingface dataset:
Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Pred aplikacijo cisplatina morajo bolniki dobiti premedikacijo z antiemetiki in ustrezno hidracijo.
• blood clots.
• krvni strdki.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Ko je zdravilo enkrat dodano v infuzijsko vrečo, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25 °C.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Prednizon Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Za zmanjšanje tveganja za hematološke toksične učinke je treba profilaktično uporabiti G-CSF (glejte Prilagajanje odmerjanja med zdravljenjem).
• 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.
• 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.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
V kraku z docetakselom in trastuzumabom je 64 % bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta delež 55 %.
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja)
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m2 na tri tedne, kombiniran s kapecitabinom 1.250 mg/m2 dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Pri bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom so opazovali srčno popuščanje, še posebno, če je zdravljenje sledilo kemoterapiji z antraciklinom (doksorubicin ali epirubicin).
1060 patients were randomised to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).).
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila DOCETAKSEL KABI 75 mg/m2 1-uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
V redkih primerih so bili opisani akutni respiracijski distres sindrom, primeri intersticijske pljučnice/pnevmonitisa, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, včasih s smrtnim izidom.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
V tej študiji so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Opravljena je bila ena velika randomizirana študija III. faze, ki je vključevala 429 predhodno nezdravljenih bolnic z metastatsko boleznijo; v njej so kombinacijo doksorubicina (50 mg/m2) in docetaksela (75 mg/m2) (krak AT) primerjali s kombinacijo doksorubicina (60 mg/m2) in ciklofosfamida (600 mg/m2) (krak AC).
• inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
• vnetje debelega črevesa, tankega črevesa, ki je lahko smrtno (pogostnost ni znana) predrtje črevesa.
• chest tightness; difficulty in breathing
• tiščanje v prsih, težko dihanje,
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov docetaksela se lahko poveča, če se zdravilo daje v kombinaciji z drugimi kemoterapevtiki.
The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC
V kraku AT je bil celotni delež odziva 59,3 % (95 % IZ: 52,8-65,9) in v kraku AC 46,5 % (95 % IZ: 39,8-53,2).
Docetaxel infusion solution is supersaturated, therefore may cristallize over time.
Raztopina docetaksela je prenasičena raztopina, ki lahko čez čas kristalizira.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/m2 v monoterapiji.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Med monoterapijo z docetakselom so zabeležili več neželenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
• Za prilagoditve odmerka kapecitabina glejte povzetek glavnih značilnosti kapecitabina.
Patient subset
Podskupina bolnic
A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3-urni infuziji.
Tumor response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
število bolnikov odzivnost na bolečino (%) 95% IZ p- vrednost* število bolnikov odzivnost tumorja (%) 95% IZ p- vrednost* †stratificiran log-rang test *prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Opisani so hudi simptomi, npr. izpuščaji s poznejšo deskvamacijo, zaradi katerih je bilo treba zdravljenje z docetakselom prekiniti ali opustiti (glejte poglavje 4.2).
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Med bolniki, ki so docetaksel prejemali v kombinaciji s cisplatinom in 5-fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okužba redkeje pojavili pri bolnikih, ki so profilaktično prejemali G-CSF.
All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Vse tri načine zdravljenja so dajali nepretrgoma v kombinaciji s prednizonom ali prednizolonom 5 mg dvakrat na dan.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
• S kalibrirano brizgo aseptično odvzemite potrebno količino koncentrata za raztopino za injiciranje.
• 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
• 1.312 bolnikih, ki so v monoterapiji prejemali 100 mg/m2 docetaksela, 121 pa jih je prejemalo 75 mg/m2.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Pri bolnicah z neuspelim alkilirajočim zdravljenjem so docetaksel primerjali z doksorubicinom (75 mg/m2 na 3 tedne).
MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Fresenius Kabi Deutschland GmbH
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
Imetnik dovoljenja za promet z zdravilom Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
V kraku s TCF je bilo mediano število ciklov na bolnika 6 (razpon: od 1 do 16), v kraku s CF pa 4 (razpon: od 1 do 12).
Gastric adenocarcinoma
Adenokarcinom želodca
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Ušesne bolezni, vključno z motnjami labirinta: Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL
• če ste alergični na docetaksel ali katero koli sestavino zdravila DOCETAKSEL KABI
The following adverse reactions are frequently observed with docetaxel:
Z docetakselom so pogosto opažali naslednje neželene učinke:
Data from one multi-centre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Podatki multicentrične, randomizirane, kontrolirane klinične študije III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Za preživetje brez bolezni (DFS - disease-free survival) in celokupno preživetje (OS - overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Če je diagnosticiran CMO, je treba zdravljenje z docetakselom prekiniti in uvesti ustrezno zdravljenje (glejte poglavje 4.8)
- For the treatment of lung cancer, DOCETAXEL KABI could be administered either alone or in combination with cisplatin.
- Za zdravljenje pljučnega raka se zdravilo DOCETAKSEL KABI lahko uporablja sam ali v kombinaciji s cisplatinom.
• acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
• akutna mieloična levkemija in mielodisplastični sindrom (vrsti krvnega raka) se lahko pojavita pri bolnikih, ki se zdravijo z docetakselom v kombinaciji z nekatermi drugimi zdravili proti raku.
One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Zaradi AML je med obdobjem spremljanja umrla 1 bolnica v skupini TAC (0,1 %) in 1 bolnica v skupini FAC (0,1 %) (mediani čas spremljanja 8 let).
Non-small cell lung cancer
Nedrobnocelični pljučni rak
Docetaxel is administered as a one-hour infusion every three weeks.
Docetaksel apliciramo v enourni infuziji vsake tri tedne.
An open-label, multi-centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Narejena je bila odprta multicentrična randomizirana študija III. faze za primerjavo monoterapije docetaksela in paklitaksela pri zdravljenju napredovalega raka na dojki pri bolnicah, katerih predhodno zdravljenje je moralo vključevati nek antraciklin.
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Za spremembe odmerkov cisplatina in 5-fluorouracila glejte ustrezen povzetek glavnih značilnosti zdravila.
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Zato je pri bolnikih z zvišanimi vrednostmi testov jetrne funkcije priporočeni odmerek docetaksela 75 mg/m2, teste jetrne funkcije pa je treba opraviti na začetku in pred vsakim ciklom zdravljenja (glejte poglavje 4.2).
Both regimens were administered once every 3 weeks for 6 cycles.
Obe shemi so aplicirali enkrat na 3 tedne, in sicer 6 ciklov.
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Bolnice, ki dobivajo TAC, je treba natančno kontrolirati (glejte poglavji 4.2 in 4.8).
• nasal drainage; inflammation of the throat and nose; cough
• izcedek iz nosu, vnetje žrela in nosu, kašelj,
DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Zdravilo DOCETAKSEL KABI je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
Venous thromboembolic events have rarely been reported.
Žilne bolezni: Redko so poročali o venskih trombembolijah.
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Zdravilo DOCETAKSEL KABI je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic:
Prostate cancer
Rak prostate
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.
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo), kot so ciklosporin, ketokonazol, in eritromicin.
If DOCETAXEL KABI concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat ali raztopina za infundiranje zdravila DOCETAKSEL KABI v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 × ULN ter hkrati alkalno fosfatazo > 2,5 × ULN in bilirubinom > 1 × ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Docetaksel se je po oksidacijski presnovi terc-butilestrske skupine s posredovanjem citokroma P450 v sedmih dneh izločil v urin in blato.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
• operable node-negative breast cancer.
• z operabilnim rakom dojke z negativnimi bezgavkami.
G3/4 AST increased G3/4 ALT increased
zvišanje AST S3/4 zvišanje ALT S3/4
Bone marrow suppression and other haematologic adverse reactions have been reported.
Poročali so o supresiji kostnega mozga in drugih neželenih hematoloških učinkih.
Diarrhoea grade 4
stomatitis/mukozitis 4. stopnje
Description of selected adverse reactions for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Opis izbranih neželenih učinkov adjuvantne terapije z zdravilom DOCETAKSEL KABI 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
• Mix the infusion bag or bottle manually using a rocking motion.
• Infuzijsko vrečo ali steklenico ročno premešajte z nagibanjem sem in tja.
Second primary malignancies have been reported when docetaxel was given in combination with anticancer treatments known to be associated with second primary malignancies.
O pojavu drugih primarnih malignomov so poročali, če je bil docetaksel uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
- For the treatment of metastatic gastric cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje metastatskega raka želodca se zdravilo DOCETAKSEL KABI uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Pri zdravljenju raka dojke, nedrobnoceličnega pljučnega raka, raka želodca ter raka glave in vratu lahko kot premedikacijo dajemo peroralne kortikosteroide, kot je deksametazon 16 mg na dan (npr. 8 mg dvakrat na dan) v trajanju treh dni, in sicer 1 dan pred aplikacijo docetaksela, razen v primeru kontraindikacij (prosimo, glejte poglavje 4.4).
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide: adjuvant therapy
DOCETAKSEL KABI v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
• 255 patients who received docetaxel in combination with capecitabine.
• 255 bolnikih, ki so prejemali docetaksel v kombinaciji s kapecitabinom.
Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Podatki multicentrične, odprte randomizirane študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke s pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80 %.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolnice v kraku TAC so dobile antibiotično profilakso s ciprofloksacinom 500 mg peroralno dvakrat na dan 10 dni z začetkom 5. dan vsakega cikla ali ekvivalentno.
There is no known antidote for docetaxel overdose.
Za preveliko odmerjanje docetaksela ni znanega antidota.
Nail disorders (severe: 0.8%)
spremembe nohtov (hude: 0,8 %)
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Med bolnicami, ki so docetaksel prejemale v kombinaciji z doksorubicinom in ciklofosfamidom (TAC), sta se febrilna nevtropenija in/ali nevtropenična okužba redkeje pojavili pri bolnicah, ki so prejemale primarno profilakso z G-CSF.
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Po 8 letih spremljanja je bil delež preživetja v kraku TAC 93,7 % in v kraku FAC 91,4 %, po 10 letih spremljanja pa je bil v kraku TAC 91,3 % in v kraku FAC 89 %.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
Dobilo jo je 57,3 % bolnic, ki so prejemale TAC, in 51,2 % bolnic, ki so prejemale FAC.
Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Pri bolnikih, ki so sočasno dobivali radioterapijo, so bili opisani redki primeri radiacijskega pnevmonitisa.
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolniki na kraku TPF so prejemali antibiotično profilakso s ciprofloksacinom v odmerku 500 mg peroralno dvakrat na dan 10 dni z začetkom 5. dne vsakega cikla, ali enakovredno profilakso.
Mix the infusion bag or bottle manually using a rocking motion.
Infuzijsko vrečo ali steklenico ročno premešajte z nagibanjem sem in tja.