natgillin/translations-raw huggingface dataset:
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
• 174 in 251 bolnikih z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Aseptično izvlecite ustrezno količino zdravila Taxespira koncentrat za raztopino za infundiranje in uporabite kalibrirane injekcijske brizge z iglo velikosti 21G.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m
Docetaxel + Cis + 5-FU n = 177
Docetaksel+ Cis+5-FU n = 177
As with all parenteral products, 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 raztopino docetaksela za infundiranje pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Second episode: stop 5-FU only, at all subsequent cycles.
Drugi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Benigne in maligne neoplazme (vključno s cistami in polipi) Poročali so o primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Docetaksel 30 mg/m 2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
If Taxespira 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 Taxespira v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
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.
Nervous system The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
Živčevje Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavje 4.2).
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Pomožne snovi: polisorbat 80, brezvodni etanol (opozorila so navedena v navodilu za uporabo), citronska kislina monohidrat.
versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Ob tem so pri shemi z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95 % interval zaupanja (IZ) = 0,54-0,90); celotni mediani čas spremljanja je bil 41,9 meseca.
Docetaxel is highly protein bound (>95%).
Docetaksel je v veliki meri (> 95 %) vezan na beljakovine.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Raztopino v infuzijski vrečki je treba uporabiti v 6 urah, če je hranjena pri temperaturi do 25°C, ena ura infundiranja zdravila bolniku je všteta v ta čas.
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).
Elderly people
Starejši bolniki
The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila Taxespira se lahko poveča, če dobivate zdravilo Taxespira v kombinaciji z drugimi kemoterapevtiki.
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom(predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
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 kliničnega 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.
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
• oesophagitis (inflammation of the gullet)
• ezofagitis (vnetje požiralnika)
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Najpogosteje opisani simptomi so zardevanje, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja ter zvišanje telesne temperature ali mrzlica.
Median OS 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 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 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/m
The events were spontaneously reversible within 3 months.
Motnje so spontano izginile v 3
• chest tightness; difficulty in breathing
• tiščanje v prsih, težko dihanje
Vascular disorders Venous thromboembolic events have rarely been reported.
Žilne bolezni Redko so poročali o venskih trombembolijah.
Mix the infusion bag or bottle manually using a rocking motion.
• Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjemsem in tja.
Clear glass (type I) vial with a chlorobutyl rubber stopper and an aluminium seal with a flip-off cap.
Viala iz prozornega stekal (tipa I) z zamaškom iz klorobutilne gume in aluminijasto dvižno zaporko.
More than one vial of Taxespira concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala zdravila Taxespira koncentrat za raztopino za infundiranje.
An open-label, multicenter, randomized 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.
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
In the case of severe neutropenia (<500 cells/mm
Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Pri bolnikih, ki se zdravijo z docetakselom, doksorubicinom in ciklofosfamidom (TAC), je zaradi tveganja mieolodisplazije ali mieloične levkemije potrebno hematološko spremljanje.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
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: 27,4-36,0).
50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m 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 Taxespira 75 mg/m 2 1 -uro po doksorubicinu 50 mg/m 2 in ciklofosfamidu 500 mg/m 2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m 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).
In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m
Kot zdravljenje prvega izbora se docetaksel 75 mg/m 2 daje v kombinaciji z doksorubicinom (50 mg/m
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
V tem preskušanju so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3
• Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle.
• Potrebni odmerek (v mg) naenkrat (z enim pritiskom) vbrizgajte v 250-ml infuzijsko vrečko, katere material ne vsebuje PVC, in ki vsebuje bodisi 5% raztopino glukoze bodisi raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali v ali steklenico, v kateri je 5 % raztopina glukoze za infundiranje.
A multicenter, open-label, randomized 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.
Opravljeno je bilo multicentrična, odprta, randomizirana študija 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 prejemali kemoterapije.
Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Zdravilo Taxespira je v kombinaciji z doksorubicinom in ciklofosfamidom indicirano za adjuvantno zdravljenje bolnic:
Taxespira in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Zdravilo Taxespira v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
A total of 449 patients were randomized 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.
Patients with baseline neutrophil count of <1,500 cells/mm
Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza znamenom-zdravljenja)
• For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
• Za zdravljenjenapredovalegaraka dojke se lahko zdravilo Taxespira uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
Both regimens were administered once every 3 weeks for 6 cycles.
Obe shemi so dajali enkrat na 3 tedne 6 ciklusov.
Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Zdravilo Taxespira je v kombinaciji s prednizonom ali prednizolonom indicirano za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up timepoint.
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 %.
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/m2 na 3 tedne).
You must not be given Taxespira
Zdravila Taxespira ne smete dobiti:
Data from a multicenter open label randomized trial support the use of Taxespira for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila Taxespira za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
This is equivalent to 80 ml of beer or 33 ml of wine.
To ustreza 80 ml piva ali 33 ml vina.
Vial label
Nalepka na viali
• flushing, skin reactions, itching
• zardevanje, kožne reakcije, srbenje
As the benefit observed in patients with 4 + nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4 + nodes was not fully demonstrated at the final analysis.
Korist za preživetje brez bolezni in celokupno preživetje 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+.
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Toksičen učinek Prilagoditevodmerka driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by
Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5
General disorders and administration site conditions 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.
Reakcije na mestu infundiranja so bile praviloma blage; obsegale so hiperpigmentacijo, vnetje, pordelost ali suhost kože, flebitis ali ekstravazacijo oz. otekanje vene.
Hazard Ratio: 1.032 [95% CI: 0.876; 1.216]
razmerje tveganj: 1,032 [95 % IZ: 0,876; 1,216]
Very common (may affect more than 1 in 10 people):
Zelo pogosto (pojavijo se lahko pri več kot 1 od 10 bolnikov):
• oral candidiasis (thrush)
• oralna kandidoza (sor)
30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Druga je na 3 tedne dobivala docetaksel 75 mg/m 2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml•min) v 30-60 minutah, tretja (VCis) pa na 4 tedne vinorelbin (V) 25 mg/m 2 v 6-10 minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklusov sledil cisplatin 100 mg/m
Taxespira 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 Taxespira je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Pri zdravljenju raka prostate je premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (prosimo, glejte poglavje 4.2).
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/mm
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/mm
• For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.
• Za zdravljenjeraka glave in vratu se zdravilo Taxespira uporablja v kombinaciji s cisplatinomin 5fluorouracilom.
In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to
Poleg tega je bilo dokazano, da je infuzijska raztopina med uporabo, če je pripravljena z raztopino natrijevega klorida 9 mg/ml (0,9 %) ali s 5% raztopino glukoze v vrečah, ki ne vsebujejo PVC ali s 5% raztopino glukoze v steklenih steklenicah, kemijsko in fizikalno stabilna 48 ur pri temperaturi od 2-8 °C in do 6 ur, če je shranjena pri temperaturi do 25 °C.
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
• Indukcijska kemoterapija in nato kemoradioterapija(TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP) nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
Without affecting OS 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.
Taxespira concentrate for solution for infusion is a pale yellow to brownish-yellow solution provided in glass vials.
Zdravilo Taxespira koncentrat za raztopino za infundiranje je bledo rumena do rjavo-rumena raztopina.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanjein ravnanje z zdravilom
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 ciklusov na bolnika 6 (razpon: od 1 do 16), v kraku s CF pa 4 (razpon: od 1 do 12).
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m 2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m 2, infundiran 1 uro dolgo prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m 2 na dan pet dni.
Docetaxel + Cis + 5-FU n = 255
Docetaksel + Cis +5-FU n = 255
G3/4 AST increased
zvečanje AST S3/4
• Induction chemotherapy followed by chemoradiotherapy (TAX 324)
• Indukcijska kemoterapija in nato kemoradioterapija(TAX 324)
Patients with hepatic impairment Based on pharmacokinetic data with docetaxel at 100 mg/m2 as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of 2 (see sections 4.4 and 5.2).
Bolniki z okvaro jeter Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75 mg/m2 (glejte poglavji 4.4 in 5.2).
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended in non-PVC bags or bottles has been demonstrated up to 48 hours when stored between 2°C to 8°C, and for up to 6 hours when stored below 25°C.
Poleg tega je bilo dokazano, da je skladno spriporočili pripravljena infuzijska raztopina v vrečkah, ki ne vsebujejo PVC, ali v steklenicah med uporabo kemijsko in fizikalno stabilna 48 ur pri temperaturi od 2-8 °C in do 6 ur, če je shranjena pri temperaturi do 25 °C.