natgillin/translations-raw huggingface dataset:
In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
V farmakokinetični študiji s 7 bolnicami je sočasna uporaba docetaksela in močnega zaviralca CYP3A4 ketokonazola zmanjšala očistek docetaksela za 49 %.
Renal insufficiency and renal failure have been reported.
Opisani sta bili ledvična insuficienca in odpoved ledvic.
• 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 za infundiranje pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Incidenca z zdravljenjem povezane povišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala ≥ 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Docetaksel je antineoplastična učinkovina in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem z njim in med pripravo njegovih raztopin potrebna previdnost.
• Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
• Mitoksantron 12 mg/m2 vsake 3 tedne, 10 ciklov.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Če se pojavijo nadaljnje epizode zapletene nevtropenije, je treba odmerek docetaksela zmanjšati s 60 na 45 mg/m2.
Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Mediani čas do prvega poslabšanja stanja zmogljivosti po WHO je bil signifikantno daljši v kraku TPH kot v kraku PF.
• dehydration
• dehidracija,
In patients treated with the TAC regimen for node positive breast cancer, the risk of CHF has been shown to be higher during the first year after treatment (see sections 4.8 and 5.1).
Bolnice, ki so bile zaradi raka dojke s pozitivnimi bezgavkami zdravljene s shemo TAC, so imele v prvem letu po zdravljenju večje tveganje kongestivnega srčnega popuščanja (glejte poglavji 4.8 in 5.1).
Your doctor may stop your treatment immediately.
Vaš zdravnik se bo morda odločil prekiniti zdravljenje.
What you need to know before you use DOCETAXEL KABI
Kaj morate vedeti, preden boste uporabili zdravilo DOCETAKSEL KABI
If the vials are stored under refrigeration, allow the required number of boxes of DOCETAXEL KABI concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Če so viale shranjene v hladilniku, pustite potrebno število škatel koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI pred uporabo 5 minut stati na temperaturi do 25°C.
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 zastajanjem tekočine podatkov ni.
• Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
• Potem jo vbrizgajte preko ene injekcije (en odmerek) v 250 ml infuzijsko vrečo ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
• inflammation of the eye or increased tearing of the eyes
• vnetje oči ali močnejše solzenje,
Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Do smrti zaradi zastrupitve je prišlo pri 1 bolnici v kraku AT (kongestivno srčno popuščanje) in 4 bolnicah v kraku AC (pri 1 zaradi septičnega šoka, pri 3 zaradi kongestivnega srčnega popuščanja).
Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Bolniki, ki so doživeli hudo preobčutljivostno reakcijo, ne smejo več dobiti docetaksela.
Neutropenic infection
Nevtropenična okužba
• 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.
• 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.
DOCETAXEL KABI contains ethanol (alcohol).
Zdravilo DOCETAKSEL KABI vsebuje etanol (alkohol).
Efficacy results are summarized in the following table:
Rezultate o učinkovitosti povzema naslednja tabela:
• From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
• Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in raztopino za infundiranje je treba uporabiti takoj.
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
• 1.276 bolnikih (744 v TAX 316 in 532 GEICAM 9805), ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Očistek docetaksela v kombinaciji s cisplatinom je bil podoben kot po monoterapiji.
In combination with capecitabine
V kombinaciji s kapecitabinom
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20 mg/m2-115 mg/m2 v študijah I. faze.
Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Infekcijske in parazitske bolezni okužbe (S3/4: 5,7 %; vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride v stik s sluznico, jo nemudoma in temeljito umijte z vodo.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m2.
Each vial is for single use and should be used immediately.
Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj.
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d. Höhe Nemčija
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
Both regimens were administered on day 1 every 3 weeks.
Obe kombinaciji so aplicirali 1. dan vsakega 3. tedna.
If pregnancy occurs during your treatment, you must immediately inform your doctor.
Če med zdravljenjem zanosite, o tem nemudoma obvestite svojega zdravnika.
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
• pljučna fibroza (brazgotinjenje in zadebelitve v pljučih s težkim dihanjem/kratko sapo),
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Preživetje je bilo boljše v kraku s kombinacijo docetaksel + kapecitabin (p = 0,0126).
Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
Opazili so hipokaliemijo, hipomagneziemijo in hipokalciemijo, običajno v povezavi z boleznimi prebavil, zlasti z drisko.
Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Za zmanjšanje tveganja za hematološke toksične učinke se lahko profilaktično uporabi G-CSF.
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Spodnja preglednica kaže, da se je incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF, potem ko je ta postala obvezna v kraku TAC - študija GEICAM.
Complicated neutropenia
Komplicirana nevtropenija
In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, 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).
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
The cycles were repeated every 3 weeks for 3 cycles.
Cikle so ponavljali 3 cikle vsake 3 tedne.
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 6 tednov in 6 mg/m2 na 3 tedne).
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Študija I. faze za oceno učinka kapecitabina na farmakokinetiko docetaksela in obratno ni odkrila, da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC), ali da bi docetaksel vplival na farmakokinetiko 5'-DFUR, pomembnega presnovka kapecitabina.
The most commonly reported adverse reactions of DOCETAXEL KABI alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Najpogosteje poročani neželeni učinki zdravila DOCETAKSEL KABI samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
V kombinaciji s kapecitabinom je priporočljivo začetni odmerek kapecitabina pri bolnikih, starejših od 60 let, zmanjšati na 75 % (glejte povzetek glavnih značilnosti kapecitabina).
• sores in the mouth
• razjede v ustih,
In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
V predkliničnih študijah so opazili genotoksične učinke docetaksela in lahko prizadene moško plodnost (glejte poglavje 5.3).
• ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting).
• prekatne motnje srčnega ritma ali prekatna tahikardija (ki se kaže z nerednim in/ali hitrim bitjem srca, zelo težkim dihanjem, omotico in/ali omedlevico).
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):
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in zdravilo je potrebno uporabiti takoj.
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.
There is no information on the use of docetaxel in pregnant women.
O uporabi docetaksela pri nosečnicah ni podatkov.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
• Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
Second primary malignancies
Drugi primarni malignomi
In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (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.
Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5-kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje se je zmanjšala pri bolnicah, ki so prejemale primarno profilakso z GCSF (glejte poglavje 4.8).
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samo docetaksel.
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Bolnike s hudim zastajanjem tekočine, npr. s plevralnim izlivom, perikardialnim izlivom ali ascitesom, je treba skrbno nadzorovati.
DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Zdravilo DOCETAKSEL KABI je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Izogibati se je treba sočasni uporabi docetaksela in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina in vorikonazola) (glejte poglavje 4.5).
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
V kraku s TCF je cikel zdravljenja trajal 3 tedne, v kraku s CF pa 4 tedne.
METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljeno za dodajanje raztopini za infundiranje.
Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Bolnike je treba skrbno nadzirati glede zgodnjih znakov resnih toksičnih učinkov na prebavila (glejte poglavja 4.2, 4.4 Hematologija in 4.8).
• Each vial is for single use and should be used immediately after opening.
• Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
Patients with severe liver impairment (see sections 4.2 and 4.4).
Bolnikih s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Organski sistemi po MedDRA
Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
Operacija na primarnem mestu bolezni in/ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
Reporting of adverse effects
Poročanje o neželenih učinkih
When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
V kombinaciji uporabljeni docetaksel ne vpliva ne na očistek doksorubicina ne na koncentracijo doksorubicinola (presnovka doksorubicina) v plazmi.
• difficulty or painful swallowing
• težave ali bolečine pri požiranju,
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Priporočene prilagoditve odmerka v primeru toksičnih učinkov pri bolnikih, ki prejemajo docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (5-FU):
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Po odkritju prevelikega odmerjanja mora bolnik čim prej dobiti terapevtski G-CSF.
Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Farmakokinetiko docetaksela v prisotnosti prednizona so proučevali pri bolnikih z metastatskim rakom prostate.
Cardiac failure; Arrhythmia (no severe)
Srčne bolezni srčno popuščanje, aritmija (nobene hude)
• 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 (predstavljeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
First episode: reduce 5-FU dose by 20%.
Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
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).
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).
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).
Pomožne snovi: polisorbat 80, brezvodni etanol (glejte navodilo za uporabo za več informacij), brezvodna citronska kislina (za uravnavanje pH).
Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Zelo redko so pri zdravljenju z docetakselom poročali o kožnem eritematoznem lupusu in o buloznih erupcijah, npr. o multiformnem eritemu, Stevens-Johnsonovem sindromu, toksični nekrolizi epidermisa.
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 ciklu 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 ciklih zmanjšati na 65 mg/m2.
Adjuvant therapy for breast cancer
Adjuvantna terapija raka dojke
For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Za izračun odmerka kapecitabina glede na telesno površino glejte povzetek glavnih značilnosti kapecitabina.
Subgroup analyses across age, gender and race consistently favoured 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.
Discontinue treatment if these toxicities persist (see section 4.4).
Če ti toksični učinki trajajo, zdravljenje prekinite (glejte poglavje 4.4).
Febrile neutropenia
febrilna nevtropenija
For more details see summary of product characteristics of trastuzumab.
Za nadaljnje podrobnosti glejte povzetek glavnih značilnosti trastuzumaba.
Previous therapy should have included an anthracycline.
Predhodna kemoterapija bi morala vključevati antraciklin.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats (see section 5.3).
Dokazano je, da je docetaksel pri kuncih in podganah embriotoksičen in fetotoksičen ter da pri podganah zmanjšuje plodnost (glejte poglavje 5.3).
Prednisone and dexamethasone
Prednizon in deksametazon
The required volume of DOCETAXEL KABI concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Potrebno količino koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI je treba vbrizgati preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečo ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
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.
• swelling of the hands, feet, legs
• otekanje dlani, stopal, nog,