natgillin/translations-raw huggingface dataset:
4.2.5 As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docetaksel Teva pred uporabo pregledati; če vsebuje oborino, jo je treba zavreči.
• 258 patients who received docetaxel in combination with doxorubicin.
• 258 bolnikih, ki so dobivali docetaksel v kombinaciji z doksorubicinom;
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Po mediano 77 mesecih spremljanja terapije je bilo preživetje brez bolezni v kraku TAC dokazano značilno daljše kot v kraku FAC.
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p=0.0121) and a longer time to definitive worsening of Karnofsky performance status (p=0.0088) compared to patients treated with CF.
5 % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja indeksa zmogljivosti po Karnofskem (p = 0,0088).
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
In vitro so ugotovili, da docetaksel v klonogenih preskusih deluje citotoksično proti različnim linijam mišjih in človeških tumorskih celic in proti sveže odstranjenim človeškim tumorskim celicam.
Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
Docetaksel Teva koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina.
Docetaxel Teva will be administered to you by a healthcare professional.
Zdravilo Docetaksel Teva vam bo dal pristojni zdravstveni delavec.
The following adverse reactions are frequently observed with docetaxel:
Pri docetakselu so pogosto opažali naslednje neželene učinke:
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravili so multicentrično, odprto, randomizirano preskušanje za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso dobivali kemoterapije.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih več kot 75 let.
• inflammation of the colon, small intestine, which could be fatal (frequency not known);
• vnetje debelega črevesa, tankega črevesa, ki je lahko smrtno (pogostnost ni znana) predrtje črevesa.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala za ≥ 10 % večkrat pri bolnikih, starejših od 75 let, v primerjavi z mlajšimi od
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 kemoterapije na podlagi platine je priporočeni odmerek 75 mg/m2 kot samostojna učinkovina.
• The solvent for Docetaxel Teva composition is water for injections.
• Vehikel za zdravilo Docetaksel Teva sestavlja voda za injekcije.
As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docetaksel Teva pred uporabo pregledati; če vsebuje oborino, jo je treba zavreči.
VIAL LABEL - CONCENTRATE 80 mg/2.88 ml
NALEPKA NA VIALI - KONCENTRAT 80 mg/2,88 ml
• one vial of 1.28 ml solvent (water for injections).
• eno vialo z 1,28 ml vehikla (voda za injekcije).
Congestive heart failure (CHF)
Zastojno srčno popuščanje (KSP)
The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
preživetje brez napredovanja bolezni (PFS), je bilo pomembno daljše v kraku TPF kot v kraku PF, p = 0,0042 (srednje PFS: 11,4 proti 8,3 meseca), celotni srednji čas spremljanja pa je bil 33,7 meseca.
- If you have any further questions, ask your doctor, hospital pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
This regimen is administered every 3 weeks for 3 cycles.
Ta režim zdravljenja se uporabi v 3 ciklih na vsake 3 tedne.
• one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.
• eno 15 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 5,12 ml vehikla.
Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Splošne težave in spremembe na mestu aplikacije Reakcije na mestu infundiranja so bile praviloma blage; obsegale so hiperpigmentacijo, vnetje, pordelost ali suhost kože, flebitis ali ekstravazacijo in otekanje vene.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 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 cyclophosphamide 500 mg/m2 (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1491 bolnic naključno razvrščenih 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).
Abdominal pain upper; Dry mouth
dispepsija bolečine v zgornjem delu trebuha, suha usta
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.
kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
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 večcentričnega, randomiziranega, nadzorovanega kliničnega preskušanja 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.
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).
Opravili so eno veliko randomizirano študijo 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).
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Neželene učinke so opisali po splošnih merilih NCI Common Toxicity Criteria (3. stopnja = S 3, 3.- 4. stopnja = S 3/4, 4. stopnja = S 4) z izrazi COSTART in MedDRA.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1,250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m2 na 3 tedne, kombiniran s kapecitabinom 1250 mg/m2 dvakrat dnevno (v 30 minutah po obroku) 2 tedna, čemur sledi enotedenski premor.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Opazili niso nobenih učinkov prednizona na farmakokinetiko docetaksela.
Docetaxel Teva 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 Teva v kombinaciji s cisplatinom in 5-fluorouracilom je indicirano za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki se predhodno niso zdravili s kemoterapijo za metastatsko bolezen.
Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
ezofagitis / disfagija / odinofagija (S 3/4: 0,7 %)
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 v kraku TPF so 10 dni dobivali antibiotično profilakso s ciprofloksacinom 500 mg peroralno dvakrat dnevno, z začetkom na peti dan vsakega kroga ali ekvivalentno.
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 so naključno razvrstili na monoterapijo z docetakselom 100 mg/m2 v enourni infuziji ali na paklitaksel 175 mg/m2 v triurni infuziji.
• 255 patients who received docetaxel in combination with capecitabine.
• 255 bolnikih, ki so dobivali docetaksel v kombinaciji s kapecitabinom;
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo Docetaksel Teva iz viale tako, da vialo delno obrnete.
Hazard ratio*
tveganja*
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 arm.
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
A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1,000 mg/m2 per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z indeksom zmogljivosti po Karnofskem > 70; dobivali so docetaksel (T) (75 mg/m2 prvi dan) v kombinaciji s cisplatinom (C) (75 mg/m2 prvi dan) in 5-fluorouracilom (F) (750 mg/m2 na dan, 5 dni) ali pa cisplatin (100 mg/m2 prvi dan) in 5-fluorouracil (1000 mg/m2 na dan, 5 dni).
(ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
2,5-kratno ZMRO, obstaja večja nevarnost hudih neželenih učinkov, kot so smrt zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilna nevtropenija, okužbe,
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.
Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF. Ponovna analiza preživetja, narejena pri srednjem času spremljanja 41,6 meseca, ni več pokazala statistično značilne razlike, čeprav je bil režim s TCF še vedno ugodnejši; pokazala pa je, da so koristi
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Pri adjuvantnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 vsake 3 tedne po 6 ciklov(TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
In this study, 87% of patients had disease that was IHC 3+,
V tem preskušanju je imelo 87 % bolnic bolezen, ki je bila
Complicated neutropenia
Zapletena nevtropenija
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Tudi srednje celotno preživetje je bilo pomembno daljše v kraku TPF kot v kraku PF (srednje CP: 18,6 proti 14,5 meseca) z 28 % zmanjšanjem tveganja smrti, p = 0,0128.
• feeling of numbness or pins and needles or pain in the joints or muscles
• nespečnost; • občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah;
1Full analysis set (intent-to-treat)
1 celotna množica za analizo (z namenom zdravljenja)
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 se lahko kot premedikacija uporabijo peroralni kortikosteroidi, kot je deksametazon v odmerku 16 mg dnevno (npr. 8 mg dvakrat dnevno), v trajanju treh dni, in sicer en dan pred aplikacijo docetaksela, razen v primeru kontraindikacij (glejte poglavje 4.4).
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).
najkrajši presledek je bil 3 tedne in ne več kot 8 tednov po začetku zadnjega cikla (22. do 56. dan zadnjega cikla).
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Redki: krvavitve, povezane s trombocitopenijo stopnje 3/4.
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 (1,250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
V tem preskušanju so 255 bolnic naključno razvrstili na zdravljenje z docetakselom (75 mg/m2 v enourni intravenski infuziji na 3 tedne) in kapecitabinom (1250 mg/m2 dvakrat dnevno 2 tedna s sledečim enotedenskim premorom).
Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila Docetaksel Teva NE smete dobiti, če ste noseči, razen če je to nujno potrebno.
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 ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 x ZMRO ter hkrati alkalno fosfatazo > 2,5 x ZMRO in bilirubinom > 1 x ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni strogo indiciran.
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 povprečno število ciklov na bolnika 6 (razpon: od 1 do 16), v kraku s CF pa 4 (razpon: od 1 do 12).
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 10 dni dobivale antibiotično profilakso s ciprofloksacinom 500 mg peroralno dvakrat dnevno, z začetkom na peti dan vsakega cikla ali ekvivalentno.
TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih v primarni analizi (po mediano 77 mesecih spremljanja) (glejte spodnjo preglednico): Analize podskupine - adjuvantno zdravljenje bolnic v študiji raka dojke z negativnimi bezgavkami (analiza z-namenom-zdravljenja)
Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Zdravilo Docetaksel Teva v kombinaciji s prednizonom ali prednizolonom je indicirano za zdravljenje bolnikov z metastatskim, hormonsko neodzivnim rakom prostate.
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
Ena viala koncentrata vsebuje 25,1 % (m/m) brezvodnega etanola (181 mg brezvodnega etanola).
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docetaksel Teva iz viale tako, da vialo delno obrnete.
Dry skin; Desquamation
srbeč izpuščaj suha koža, luščenje
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 strojev (glejte poglavji
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Za blage do zmerne senzorične motnje so značilne parestezije, disestezije ali bolečina s pekočim občutkom.
• Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
• Ena viala z vehiklom vsebuje 1,28 ml voda za injekcije (polnilni volumen: 1,71 ml).
Without affecting the primary endpoint, overall response rate (32% vs 25%, p=0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p<0.01) and median survival (15.3 months vs 12.7 months; p=0.03).
Docetaksel ni vplival na primarno končno točko, celotni delež odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je srednji čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna,
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
* model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) ** test log-rank *** test hi-kvadrat
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• kožne reakcije, flebitis (vnetje vene) ali otekanje na mestu injiciranja;
Anaemia (G3/4: 6.9%); Thrombocytopenia (G4:
anemija (S 3/4: 6,9 %), trombocitopenija (S 4:
• flushing, skin reactions, itching
• pordelost, kožne reakcije, srbenje;
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multi-centre, open-label, randomised study (TAX323).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v multicentričnem odprtem randomiziranemu preskušanju faze III (TAX323).
Neuropathy peripheral
periferna motorična nevropatija
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Za prilagoditve odmerkov cisplatina in 5-fluorouracila glejte ustrezni povzetek glavnih značilnosti zdravila.
Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4:
bruhanje (S 3/4: 8,4 %), driska (S 3/4: 6,8 %), ezofagitis / disfagija / odinofagija (S 3/4:
The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Pri bolnikih, ki so se zdravili s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/nevtropenične sepse (23 % v primerjavi s 17 % pri bolnikih,
Headache (G3/4: <1%); Neuropathy peripheral
omotica, glavobol (S 3/4: < 1 %), periferna nevropatija
• Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at room temperature (below 25°C).
• Raztopina za infundiranje: dokazano je, da je kemijsko in fizikalno stabilna 4 ure, če je shranjena pri sobni temperaturi (do 25°C).
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 multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in indeksom telesne zmogljivosti po Karnofskem ≥ 80 %.
• 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
• 1312 bolnikih, ki so v monoterapiji dobivali 100 mg/m2 docetaksela, 121 pa jih je dobivalo
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
C. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
Infection associated with G4 neutropenia (G3/4: 4.6%)
okužba, povezana z nevtropenijo S 4 (S3/4: 4,6 %)
• 92 patients treated with docetaxel in combination with trastuzumab.
• 92 bolnicah, ki so dobivale docetaksel v kombinaciji s trastuzumabom;
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
bolečina nekardialne bolečine v prsih (hude: 0,4 %)
Overall survival (Primary end-point):
(primarna končna točka):
C.
s
Following chemotherapy, patients should receive radiotherapy.
Po kemoterapiji se morajo bolniki zdraviti z obsevanjem.
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p=0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p=0.54), docetaxel increased response rate (52% vs. 37%, p=0.01) and shortened time to response (12 weeks vs. 23 weeks, p=0.007).
doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja bolezni (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa povečal delež odziva (52 % v prim.
Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
dispneja (S 3/4: 1 %), kašelj (S 3/4: < 1 %), epistaksa (S 3/4: < 1 %)
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m2, ki mu je sledil 5-fluorouracil (F) 1000 mg/m2