FrancophonIA/ELRC3.0 huggingface dataset:
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF, (see section 4.2).
Slovenian: Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z G-CSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed (see table below):
Slovenian: Podskupine bolnic, zdravljenih s TAC,so analizirali po prospektivno opredeljenih prognostičnih dejavnikih (glejte spodnjo preglednico):
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Slovenian: Zato se docetaksela med nosečnostjo ne sme uporabljati, razen če se jasno ne indicira.
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Slovenian: primeru blažjih preobčutljivostnih reakcij, npr. pordevanja ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
English: METHOD OF ADMINISTRATION Read the package leaflet before use EXPIRY DATE
Slovenian: POSTOPEK UPORABE Pred uporabo preberite brošuro v embalaži DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
English: Intravenous use
Slovenian: Docetaksel Intravenska uporaba
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
English: 79199 Kirchzarten Germany tel. +49 (0) 7661 90 91 58-0
Slovenian: Germany tel. +49 (0) 7661 90 91 58-0
English: Myalgia (severe: 1.4%) Arthralgia
Slovenian: Mialgija (huda: 1,4 %) Artralgija
English: Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Slovenian: V redkih primerih so bili opisani akutni respiracijski distres sindrom, intersticijska pljučnica in pljučna fibroza.
English: Ethanol This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Slovenian: Ta medicinski izdelek vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
English: of patients
Slovenian: bolnikov
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO
English: The Netherlands tel: +31-23-5685501 fax: +31-23-5685505
Slovenian: Nizozemska tel: +31-23-5685501 faks: +31-23-5685505
English: Peripheral oedema was observed to be ongoing during follow-up time in 18 patients out of the 112 patients with peripheral oedema at the end of the chemotherapy in study TAX 316, whereas lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy in the study GEICAM 9805.
Slovenian: Še prisotne periferne edeme so pri spremljanju zabeležili pri 18 od 112 bolnicah, ki so imeli periferne edeme ob koncu kemoterapije v študiji TAX 316, limfedem pa je še trajal pri 4 od 5 bolnicah z limfedemom na koncu kemoterapije v študiji GEICAM 9805.
English: Median duration of response to chemotherapy ± radiotherapy (months) (95%CI)
Slovenian: Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci) (95 % IZ)
English: Using a syringe with a needle, the entire contents of the correct vial of solvent for Docefrez is to be withdrawn and injected into the respective Docefrez powder vials.
Slovenian: Z injekcijsko brizgo z nameščeno iglo izvlecite celotno vsebino ustrezne viale z vehiklom za Docefrez in jo vbrizgajte v ustrezne viale s praškom Docefrez.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138.
Slovenian: • Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
English: total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Slovenian: V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Slovenian: Prejemnice TAC so imele 32 % manjše tveganje recidiva kot prejemnice FAC (razmerje ogroženosti = 0,68, 95 % IZ (0,49-0,93), p = 0,01).
English: Docetaxel every week Mitoxantrone every 3 weeks
Slovenian: Mitoksantron vsake 3 tedne
English: Any solution containing a precipitate should be discarded.
Slovenian: Če raztopina vsebuje precipitat, jo je treba zavreči.
English: This volume of concentrate should be injected into a 250 ml infusion bag or bottle containing either glucose 50 mg/ml (5%) solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: To količino koncentrata je treba injicirati v 250-mililitrsko infuzijsko vrečko ali steklenico, v kateri je bodisi 5-odstotna raztopina glukoze (50 mg/ml) ali 0,9-odstotna raztopina natrijevega klorida (9 mg/ml) za infundiranje.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
English: (TAX 316)
Slovenian: III (TAX323).
English: You must not use Docefrez if you are pregnant unless clearly indicated by your doctor.
Slovenian: Docefrez NE smete dobiti, če ste noseči, razen čav vam zdravnik tako izrecno naloži.
English: No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Slovenian: Nobenih sprememb niso zabeležili pri bolnicah, ki so prejemale fluorouracil, doksorubicin in ciklofosfamid.
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and
Slovenian: Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze a 4 minute, P 36 minut in y 11,1 ure.
English: Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemoterapy agents and/or radiotherapy.
Slovenian: Poročali so o zelo redkih primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
English: Powder vial:
Slovenian: Viala z vehiklom:
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 z zdravljenjem povezani neželeni učinki (> 5 %), o katerih so poročali v fazi III klinične študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
English: For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs.
Slovenian: Na primer, za odmerek od 140 mg docetaksela bo potreben en 80 miligramskoi pakiranje in tri 20 miligramska pakiranja.
English: Keep out of the reach and sight of children.
Slovenian: Hranite izven dosega otrok.
English: Infusion site reaction
Slovenian: Reakcija na mestu infundiranja
English: The Netherlands.
Slovenian: Nizozemska.
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 od 0 do 1 ter znova uporabite 100 % izvirnega odmerka.
English: Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes.
Slovenian: Docetaksel se pridobiva iz iz iglic tise in spada v skupino zdravil proti raku, imenovanih taksoidi.
English: Pain response rate (%)
Slovenian: Odzivnost na bolečino (%)
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
Slovenian: • Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0,009.
English: Keep the vial in the outer carton in order to protect from light
Slovenian: Vialo hranite v zunanji embalaži, da jo zaščitite pred svetlobo
English: Overall
Slovenian: celotno
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docefrez vial by partially inverting the vial.
Slovenian: 4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docefrez iz viale tako, da vialo delno obrnete.
English: Abdominal pain upper; Dry mouth
Slovenian: Bolečine v zgornjem delu trebuha, suha usta
English: The docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1 hour infusion under room temperature and normal lighting conditions.
Slovenian: Infuzijsko raztopino docetaksela je treba uporabiti v 4 urah, odmeriti pa jo je treba aseptično v 1 uri pri sobni temperaturi in pri normalni osvetlitvi.
English: Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Slovenian: Opisani so redki primeri dehidracije zaradi prebavnih motenj, gastrointestinalne perforacije, ishemični kolitis, kolitis in nevtropenični enterokolitis.
English: Overall survival was also significantly longer (p=0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
Slovenian: V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
English: • decreased number of red bloods cells (anaemia, with symptoms of such as paleness, weakness)
Slovenian: • okužbe, vključno s pljučnico in krvno zastrupitvijo • znižano število rdečih krvnih celic (slabokrvnost s simptomi kot so bledica, slabotnost);
English: 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).
Slovenian: ULN hkrati z alkalno fosfatazo > 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
English: Excipients: the solvent contains 35.4% (w/w) ethanol.
Slovenian: Pomožne snovi: vehikel vsebuje 35,4 % (m/m) etanola.
English: Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Slovenian: Parestezije, glavobol, disgevzija, hipestezija
English: Arrhythmia (no severe)
Slovenian: aritmija (nobene hude)
English: Do not use Docefrez after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Zdravila Docefrez ne uporabljajte po preteku roka uporabe, ki je naveden na embalaži in steklenički po POTEKU.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: To shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (> 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
English: The solvent contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Slovenian: To zdravilo vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
English: The reconstituted solution should be used immediately after preparation.
Slovenian: Pripravljeno raztopino uporabite nemudoma po pripravi.
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Slovenian: 4.8 Neželeni učinki Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri:
English: Special handling precautions.
Slovenian: Posebni previdnosti ukrepi ob uporabi.
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Slovenian: • Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docefrez 20 mg
Slovenian: IME ZDRAVILA IN POT(I) UPORABE VEHIKEL za Docefrez 20 mg
English: 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).
Slovenian: 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.
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Slovenian: Astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica
English: • one single-dose solvent vial with 1 ml solvent for Docefrez
Slovenian: • viala z enim odmerkom vehikla, to je 1 ml vehikla za zdravilo Docefrez
English: In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT,
Slovenian: Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST > 1,5-kratna
English: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Slovenian: Docetaksela se ne sme uporabljati pri bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
English: 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.
Slovenian: 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.
English: Special handling precautions
Slovenian: Posebni previdnosti ukrepi ob uporabi
English: Hypotension; Hypertension; Haemorrhage
Slovenian: Hipotenzija, hipertenzija, krvavitev
English: Docefrez contains the active substance docetaxel.
Slovenian: Zdravilo Docefrez vsebuje aktivno substanco docetaksel.
English: PREPARATION FOR INTRAVENOUS ADMINISTRATION Do not use any PVC equipment or device.
Slovenian: PRIPRAVA ZA INTRAVENSKO APLIKACIJO Ne uporabljajte PVC opreme ali naprav.
English: Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm.
Slovenian: Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF.
English: Disease free survival
Slovenian: Preživetje brez bolezni
English: 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.
Slovenian: Pomembno je, da pred pripravo osnovne raztopine Docefrez ali raztopine za infundiranje Docefrez v celoti preberete ta navodila.
English: 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.
Slovenian: 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih nad 75 let.
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m2.
Slovenian: Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
English: No of positive nodes
Slovenian: Št. pozitivnih bezgavk
English: G3/4 AST increased G3/4 ALT increased
Slovenian: zvečanje AST S3/4 zvečanje ALT S3/4
English: 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
Slovenian: 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:
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 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.
English: (95%CI)
Slovenian: (95 % IZ)
English: More than one vial may be necessary to obtain the required dose for the patient.
Slovenian: Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia
Slovenian: Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
English: Docefrez should not be used after the expiry date shown on the carton and vials.
Slovenian: Docefrez ne smete uporabljati po preteku roka uporabnosti, ki je naveden na ovojnini in vialah.
English: Docefrez is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docefrez solutions.
Slovenian: Docefrez je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je pri ravnanju in pripravi raztopin Docefrez potrebna previdnost.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Slovenian: Za hude reakcije so bili značilni hipotenzija in/ali bronhospazem ali generaliziran izpuščaj/eritem
English: Ask your doctor for advice before being given any medicine.
Slovenian: Pred uporabo kateregakoli zdravila se posvetujte z zdravnikom.
English: 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.
Slovenian: 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 %.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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).
English: 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.
Slovenian: V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: • tiredness, pain, flu-like symptoms*
Slovenian: • utrujenost, bolečine, simptomi kot pri gripi*;
English: Tell your doctor or nurse if you have fever, diarrhoea, sores in the mouth, feeling of numbness or pins and needles.
Slovenian: Zdravnika ali medicinsko sestro obvestite o pojavu zvišane telesne temperature, diareje, vnetja v ustni votlini, občutka otrplosti ali mravljincev.