natgillin/translations-raw huggingface dataset:
Overall survival was also significantly longer (p=0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
• decreased number of red bloods cells (anaemia, with symptoms of such as paleness, weakness)
• okužbe, vključno s pljučnico in krvno zastrupitvijo • znižano število rdečih krvnih celic (slabokrvnost s simptomi kot so bledica, slabotnost);
AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
ULN hkrati z alkalno fosfatazo > 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
Excipients: the solvent contains 35.4% (w/w) ethanol.
Pomožne snovi: vehikel vsebuje 35,4 % (m/m) etanola.
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Parestezije, glavobol, disgevzija, hipestezija
Arrhythmia (no severe)
aritmija (nobene hude)
Do not use Docefrez after the expiry date which is stated on the carton and vial after EXP.
Zdravila Docefrez ne uporabljajte po preteku roka uporabe, ki je naveden na embalaži in steklenički po POTEKU.
4.2.2 Inject the required volume of reconstituted solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali raztopina natrijevega klorida 9 mg/ml (0.9%) za infundiranje.
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).
The solvent contains small amounts of ethanol (alcohol), less than 100 mg per dose.
To zdravilo vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
The reconstituted solution should be used immediately after preparation.
Pripravljeno raztopino uporabite nemudoma po pripravi.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
4.8 Neželeni učinki Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri:
Special handling precautions.
Posebni previdnosti ukrepi ob uporabi.
• 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 5-ih ciklih.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
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.
Primarni končni cilji v tej študiji, preživetje brez napredovanja bolezni (PFS), je bilo signifikantno daljše na kraku TPF kot na kraku PF, p = 0,0042 (mediano PFS: 11,4 proti 8,3 meseca), celotni mediani čas spremljanja pa je bil 33,7 meseca.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docefrez 20 mg
IME ZDRAVILA IN POT(I) UPORABE VEHIKEL za Docefrez 20 mg
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).
Docetaksel ni vplival na celotni čas preživetja (docetaksel 15 mesecev, doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa zvečal delež odziva (52 % v prim.
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica
• one single-dose solvent vial with 1 ml solvent for Docefrez
• viala z enim odmerkom vehikla, to je 1 ml vehikla za zdravilo Docefrez
In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT,
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST > 1,5-kratna
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Docetaksela se ne sme uporabljati pri bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Docefrez is used, either alone or in combination with other medicines, for the treatment of the following kinds of cancer: - advanced breast cancer, alone or with doxorubicin, or trastuzumab, or capecitabine - early breast cancer with or without lymph node involvement, with doxorubicin and cyclophosphamide - non-small cell lung cancer (NSCLC), alone or with cisplatin - prostate cancer, with prednisone or prednisolone - metastatic gastric cancer, with cisplatin and 5-fluorouracil - head and neck cancer, with cisplatin and 5-fluorouracil.
Docefrez se uporablja bodisi samostojno bodisi v kombinaciji z drugimi zdravili za zdravljenje naslednjih oblik raka: - za zdravljenje napredovalega raka dojke se lahko uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom; - za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se lahko uporablja v kombinaciji z doksorubicinom in ciklofosfamidom; - za zdravljenje pljučnega raka se lahko uporablja sam ali v kombinaciji s cisplatinom; - za zdravljenje raka prostate se lahko uporablja v kombinaciji s prednizonom ali prednizolonom; - za zdravljenje metastatskega raka želodca se uporablja v kombinaciji s cisplatinom in 5fluorouracilom; - za zdravljenje raka glave in vratu se zdravilo uporablja v kombinaciji s cisplatinom in 5fluorouracilom.
Special handling precautions
Posebni previdnosti ukrepi ob uporabi
Hypotension; Hypertension; Haemorrhage
Hipotenzija, hipertenzija, krvavitev
Docefrez contains the active substance docetaxel.
Zdravilo Docefrez vsebuje aktivno substanco docetaksel.
PREPARATION FOR INTRAVENOUS ADMINISTRATION Do not use any PVC equipment or device.
PRIPRAVA ZA INTRAVENSKO APLIKACIJO Ne uporabljajte PVC opreme ali naprav.
Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm.
Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF.
Disease free survival
Preživetje brez bolezni
It is important that you read the entire contents of this procedure prior to the preparation of either the Docefrez reconstituted solution or the Docefrez solution for infusion.
Pomembno je, da pred pripravo osnovne raztopine Docefrez ali raztopine za infundiranje Docefrez v celoti preberete ta navodila.
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 nad 75 let.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m2.
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
No of positive nodes
Št. pozitivnih bezgavk
G3/4 AST increased G3/4 ALT increased
zvečanje AST S3/4 zvečanje ALT S3/4
Adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Adjuvantno zdravljenje z zdravilom Docetaksel 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativni podatki:
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.
Možna medsebojna delovanja docetaksela s sočasno uporabljanimi medicinskimi izdelki in vivo sicer niso bila formalno raziskana, a medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatom - in vitro ni vplivalo na vezavo docetaksela na beljakovine.
(95%CI)
(95 % IZ)
More than one vial may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia
Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
Docefrez should not be used after the expiry date shown on the carton and vials.
Docefrez ne smete uporabljati po preteku roka uporabnosti, ki je naveden na ovojnini in vialah.
Docefrez is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docefrez solutions.
Docefrez je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je pri ravnanju in pripravi raztopin Docefrez potrebna previdnost.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Za hude reakcije so bili značilni hipotenzija in/ali bronhospazem ali generaliziran izpuščaj/eritem
Ask your doctor for advice before being given any medicine.
Pred uporabo kateregakoli zdravila se posvetujte z zdravnikom.
Data from a multicenter open label randomized 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, pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80 %.
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- 53,2).
4.1 Reconstitution of Docefrez Powder for Solution for Infusion 4.1.1 Allow the required number of Docefrez boxes which are stored in a refrigerator, to stand at room temperature (below 25ºC) for 5 minutes.
4.1 Priprava osnovne raztopine Docefrez (10 mg docetaksela/ml) 4.1.1 Če so viale shranjene v hladilniku, pustite potrebno število škatel Docefrez 5 minut stati na sobni temperaturi (do 25 °C).
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favor 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).
One large randomized 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).
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25.000 cells/mm3, 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.
Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m2 v kombinaciji s cisplatinom in imajo v predhodnem ciklusu zdravljenja najmanjše število trombocitov < 25.000 celic/mm3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklusih zmanjšati na 65 mg/m2.
• tiredness, pain, flu-like symptoms*
• utrujenost, bolečine, simptomi kot pri gripi*;
Tell your doctor or nurse if you have fever, diarrhoea, sores in the mouth, feeling of numbness or pins and needles.
Zdravnika ali medicinsko sestro obvestite o pojavu zvišane telesne temperature, diareje, vnetja v ustni votlini, občutka otrplosti ali mravljincev.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/ m2 to 75 mg/m2 and/or from 75 to 60 mg/ m2.
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
Nail disorders (severe 0.8%)
Spremembe nohtov (hude 0,8 %)
Both the reconstituted concentrate and the solution for infusion should be visually inspected prior to use.
Pred uporabo je treba pripravljen koncentrat in raztopino za infundiranje pregledati.
No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/10/630/001
Overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Tudi celotno preživetje je bilo v kraku TAC daljše: tveganje smrti je bilo med prejemnicami TAC za 24 % manjše kot med prejemnicami FAC (razmerje ogroženosti = 0,76, 95 % IZ (0,46-1,26), p = 0,29).
Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i.e. an absolute risk reduction by 7% (p=0.001).
Pogostost recidiva pri 5 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (25 % proti 32 %) t.j.
Read the package leaflet before use.
Pred uporabo preberite brošuro v embalaži.
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 ciklusa (22. do 56. dan zadnjega ciklusa).
Median overall survival was also significantly longer in favor 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 mediano celotno preživetje (OS) je bilo signifikantno daljše na kraku TPF kot na kraku PF (mediano OS: 18,6 proti 14,5 mesecev) z 28 % zmanjšanjem tveganja smrti, p = 0,0128.
• 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,
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.
Mediana časa do napredovanja je bila v kraku AT 37,3 tedna (95 % IZ: 33,4-42,1) in v kraku AC 31,9 tedna (95 % IZ:
• at the injection site; skin reactions, inflammation of the vein or swelling
• omedlevica; • na mestu vboda, kožne reakcije, vnetje žil ali otekanje;
Not applicable.
Navedba ni smiselno potrebna.
Docefrez powder and solvent for concentrate for solution for infusion is for single use only.
Prašek in raztopilo docefrez za koncentrat infuzijske tekočine je za enkratno uporabo.
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Pri bolnikih, zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih > 10 % večja v primerjavi z mlajšimi bolniki.
Response rate (95% CI)
Delež odziva (95 % IZ)
Alopecia; Skin reaction (G3/4: 0.8%)
Alopecija, kožna reakcija (S3/4: 0,8 %)
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Zvečanje AST S3/4 zvečanje alkalne fosfataze v krvi S3/4
Hypersensitivity (no severe)
Preobčutljivost (nobene hude)
MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/002
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/10/630/002
PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
FARMACEVTSKA OBLIKA Prašek in vehikel za pripravo koncentrata za raztopino za infundiranje.
Efficacy results are presented in the table below: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Rezultate učinkovitosti prikazuje spodnja tabela: Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja )
Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
*Meja statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
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 the 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 <
If a dose greater than 200 mg docetaxel is required, a larger volume of the infusion vehicle should be used, so that a concentration of 0.74 mg/ml docetaxel is not exceeded in the final solution for infusion.
Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncentracije docetaksela 0,74 mg /ml.
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.
% trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0,0088).
Myalgia (severe: 0.5%)
Mialgija (huda 0,5%)
Docetaxel 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.
Docefrez 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.
Data from one multicenter, 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.
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Prilagoditev odmerka Driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU
Alopecia (G3/4:
Alopecija (S3/4:
Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Febrilna nevtropenija se je pojavila pri 17,2 % bolnikov, nevtropenična okužba pa pri 13,5 %
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili kemoradioterapijo (KRT) po protokolu
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m2.
• Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom 55 mg/m2.
Store in a refrigerator (2°C - 8°C).
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (od 2°C do 8°C).
Amenorrhoea was observed to be ongoing during follow-up in 140 patients out of the 251 patients with amenorrhoea at the end of the chemotherapy.
Še prisotno amenorejo so pri spremljanju zabeležili pri 140 od 251 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
Alopecia; Nail disorders (no severe)
Alopecija, spremembe nohtov (nobenih hudih)
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 a 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
Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Splošno Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95%CI) ***p-value
Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % IZ) ***p-vrednost
The reconstituted solution contains approximately 24 mg/ml docetaxel and should be used immediately after preparation.
Pripravljena raztopina vsebuje približno 24 mg/ml docetaxela in jo je treba uporabiti nemudoma po pripravi.
≥50 years
<50 let
No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
nobeni izmed preiskovanih skupin pri bolnicah ni bil diagnosticiran mielodisplastični sindrom.
Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Med zdravljenjem morata in moški in ženska uporabljati kontracepcijsko zaščito, moški pa jo mora mora uporabljati še vsaj šest mesece po zdravljanja.