natgillin/translations-raw huggingface dataset:
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
• Vrijeme do progresije bolesti (engl. time to progression, TTP) bilo je značajno dulje u AT skupini u odnosu na AC skupinu, p=0,0138.
Rare cases of myocardial infarction have been reported.
Rijetko su zabilježeni slučajevi infarkta miokarda.
Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Klirens docetaksela u kombiniranoj terapiji s cisplatinom bio je sličan onom nakon monoterapije.
G3/4 ALT increased
G3/4 povećanje ALT
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Svi bolesnici koji nisu imali progresiju bolesti, liječeni su kemoradioterapijom (CRT) prema protokolu (TPF/CRT).
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).
U kombinaciji s kapecitabinom bolesnicima od 60 godina i starijima preporučuje se smanjiti početnu dozu kapecitabina na 75% (vidjeti sažetak opisa svojstava lijeka za kapecitabin).
Other medicines and DOCETAXEL KABI
Drugi lijekovi i DOCETAXEL KABI
In addition, dexamethasone did not affect protein binding of docetaxel.
Osim toga, deksametazon nije utjecao na vezanje docetaksela za proteine.
METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Spremno za dodavanje u infuzijsku otopinu.
Interruption of docetaxel therapy is recommended until diagnosis is available.
Preporučuje se privremeni prekid terapije docetakselom do postavljanja dijagnoze.
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Bolesnicima u kojih se pojavila komplicirana neutropenija (produljena neutropenija, febrilna neutropenija ili infekcija) treba razmotriti primjenu G-CSF i smanjenje doze (vidjeti dio 4.2.).
Neutropenic complications
Neutropenijske komplikacije
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Više nuspojava stupnja 3/4 zabilježeno je u monoterapiji docetakselom (55,4%) u usporedbi s paklitakselom (23,0%).
In combination with cisplatin
Kombinacija s cisplatinom
Scleroderma-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Promjene slične sklerodermiji, kojima obično prethodi periferni limfedem, zabilježeni su s docetakselom.
Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Reakcije preosjetljivosti (učestalost nije poznata) su prijavljene u bolesnika liječenih docetakselom koji su prethodno doživili reakcije preosjetljivosti na paklitaksel.
Patients with operable node-positive breast cancer (TAX 316)
Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316)
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 11.1 h, respectively.
Kinetički profil docetaksela neovisan je o dozi i u skladu je s farmakokinetičkim modelom tri odjeljka, s poluvijekom za alfa, beta i gama fazu od 4 minute, 36 minuta i 11,1 sati.
Tumor response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Stopa tumorskog odgovora (%) 95% CI p-vrijednost* † Stratificirani log- rank test * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
Women of childbearing potential/ Contraception in males and females Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene reproduktivne dobi koje primaju docetaksel treba savjetovati da izbjegavaju trudnoću te da odmah obavijeste svog liječnika ako zatrudne.
One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Jedan bolesnik (0,1%) u TAC skupini i 1 bolesnik (0,1%) u FAC skupini preminuli su zbog akutne mijeloične leukemije (AML) tijekom perioda praćenja (medijan vremena praćenja iznosio je 8 godina).
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).
Ako se ne može izbjeći istovremena primjena snažnog CYP3A4 inhibitora (npr. ketokonazola, itrakonzola, klaritromicina, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola), nužan je poman klinički nadzor, a može biti potrebna i prilagodba doze docetaksela za vrijeme terapije snažnim inhibitorima CYP3A4 (vidjeti dio 4.4).
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Zabilježeni su rijetki slučajevi enterokolitisa, uključujući kolitis, ishemijski kolitis i neutropenijski enterokolitis s potencijalnim smrtnim ishodom (nepoznata učestalost).
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
U obje skupine, nakon poslijednjeg ciklusa kemoterapije, bolesnici sa ER+ i/ili PgR+ tumorima primali su tamoksifen 20 mg jednom dnevno u razdoblju do 5 godina.
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Febrilna neutropenija i neutropenijska infekcija javile su se u 17,2% odnosno 13,5% bolesnika, bez obzira na primjenu G-CSF.
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Bolesnike s teškom retencijom tekućine, poput pleuralnog i perikardijalnog izljeva te ascitesa, treba pažljivo nadzirati.
DOCETAXEL KABI must NOT be administered if you are pregnant unless clearly indicated by your doctor.
DOCETAXEL KABI NE smijete primati ako ste trudni, osim ako Vam ga je izričito propisao liječnik.
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF Ujedinjeno Kraljevstvo
Preparation for the intravenous administration
Priprema za intravensku primjenu
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Zabilježena je diseminirana intravaskularna koagulacija (DIK), često udružena sa sepsom ili multiorganskim zatajenjem.
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Preporučene modifikacije doziranja u slučajevima toksičnosti u bolesnika liječenih docetakselom u kombinaciji s cisplatinom i 5-fluorouracilom (5-FU):
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats (see section 5.3).
Docetaksel je pokazao embriotoksičnost i fetotoksičnost u kunića i štakora, kao i smanjenje plodnosti u štakora (vidjeti dio 5.3).
No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Nije zabilježen statistički značajan učinak prednizona na farmakokinetiku docetaksela.
What you need to know before you use DOCETAXEL KABI
Što morate znati prije nego počnete primati DOCETAXEL KABI
There is no relevant use of DOCETAXEL KABI in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Nema relevantne primjene lijeka DOCETAXEL KABI u pedijatrijskoj populaciji za indikacije karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma prostate, karcinoma želuca i karcinoma glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Medijan trajanja odgovora na kemoterapiju  radioterapiju (mjeseci) (95% CI)
Post-marketing experience
Iskustva nakon stavljanja lijeka u promet
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.
Medijan broja ciklusa primijenjenih po bolesniku bio je 6 (s rasponom od 1 do 16) za TCF skupinu u odnosu na 4 (s rasponom od 1 do 12) za CF skupinu.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Na primjer, za dozu od 140 mg docetaksela potrebno je 7 ml koncentrata docetaksela za otopinu.
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).
Treba izbjegavati istovremenu primjenu docetaksela sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, klaritromicinom, indinavirom, nefazodonom, nelfinavirom, ritonavirom, sakvinavirom, telitromicinom i vorikonazolom) (vidjeti dio 4.5).
Venous thromboembolic events have rarely been reported.
Rijetko su zabilježeni venski tromboembolički događaji.
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
In vitro ispitivanja pokazala su da metabolizam docetaksela može promijeniti istodobna primjena tvari koji induciraju, inhibiraju ili se metaboliziraju (i tako kompetitivno mogu inhibirati enzim) pomoću citokroma P450-3A, kao što su ciklosporin, ketokonazol i eritromicin.
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Omjer hazarda: 1,122 [97,2% CI: 0,937; 1,342]*
Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
U bolesnika s oštećenjem vida treba odmah provesti sveobuhvatan oftalmološki pregled.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETAXEL KABI administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of DOCETAXEL KABI in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Od Vas će se tražiti da uzmete premedikaciju koja se sastoji od oralnih kortikosteroida, poput deksametazona, dan prije primjene lijeka DOCETAXEL KABI te još dan ili dva nakon toga, kako bi se smanjile određene nuspojave, koje se mogu pojaviti nakon infuzije lijeka DOCETAXEL KABI, osobito alergijske reakcije i zadržavanje tekućine u tijelu (oticanje ruku, stopala, nogu ili povećanje tjelesne težine).
Tell your doctor, hospital pharmacist or nurse if you have vision problems.
Obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru ako imate problema s vidom.
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Radioterapija zahvaćene regije provodila se ili konvencionalnim frakcioniranjem (1,8 Gy-2,0 Gy jednom dnevno, 5 dana tjedno do ukupne doze od 66 do 70 Gy), ili akceleriranim/hiperfrakcioniranim režimom zračenja (dva puta dnevno, s minimalnim razmakom između frakcija od 6 sati, 5 dana tjedno).
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 Njemačka
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Utjecaj prednizona na farmakokinetiku docetaksela primijenjenog s deksametazonom kao standardnom premedikacijom ispitivao se u 42 bolesnika.
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Razvoj teške periferne neurotoksičnosti zahtijeva smanjenje doze (vidjeti dio 4.2 i 4.4).
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Rjeđe su zabilježeni teški simptomi poput erupcija praćenih deskvamacijom što je rijetko dovelo do prekida ili prestanka liječenja docetakselom (vidjeti dio 4.2 i 4.4).
See also section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Također pogledajte dio „ DOCETAXEL KABI sadrži etanol (alkohol)“ niže.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Docetaksel se pokazao mutagenim u in vitro mikronukleusnom testu i testu kromosomske aberacije na CHO-K1 stanicama te u in vivo mikronukleusnom testu na miševima.
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Svi bolesnici koji su tijekom ispitivanja bili u docetaksel skupini primali su profilaktički antibiotike.
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Upala pluća može se razviti i kada se docetaksel primjenjuje istodobno s radioterapijom)
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Pojava umjerene i teške retencije je odgođena (medijan kumulativne doze: 818,9 mg/m2) u bolesnika koji su primili premedikaciju u odnosu na bolesnike koji nisu primili premedikaciju (medijan kumulativne doze: 489,7 mg/m2).
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.
Najčešće prijavljivane nuspojave na lijek DOCETAXEL KABI u monoterapiji su: pad broja crvenih ili bijelih krvnih stanica, gubitak kose, mučnina, povraćanje, ranice u ustima, proljev i umor.
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Sav otpadni materijal korišten za razrjeđivanje ili primjenu lijeka treba zbrinuti sukladno standardnim procedurama.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Poremećaji uha i labirinta Zabilježeni su rijetki slučajevi ototoksičnosti, oštećenja i/ili gubitka sluha.
Complicated neutropenia
Komplicirana neutropenija
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Adjuvantno radioterapijsko liječenje provođeno je sukladno smjernicama ustanova u kojima je provođeno ispitivanje i provedeno je u 69% bolesnika koji su primili TAC i u 72% bolesnika koji su primili FAC.
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.
U bolesnika koji primaju docetaksel u dozi od 100 mg/m2 kao jedinu terapiju te imaju vrijednosti transaminaza (ALT i/ili AST) u serumu više od 1,5 puta veće od GGN te serumsku alkalnu fosfatazu više od 2,5 puta veću od GGN, postoji viši rizik od razvoja teških nuspojava poput toksične smrti uključujući sepsu i gastrointestinalno krvarenje koje može biti fatalno, febrilne neutropenije, infekcije, trombocitopenije, stomatitisa i astenije.
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 ishod ove studije, preživljenje bez progresije bolesti (PFS), bio je značajno dulji u korist TPF skupine u odnosu na PF skupinu p=0,0042 (medijan PFS: 11,4 prema 8,3 mjeseci) s ukupnim medijanom praćenja od 33,7 mjeseci.
The following adverse reactions are frequently observed with docetaxel:
Kod primjene docetaksela često su primijećene sljedeće nuspojave:
• tiredness; or flu-like symptoms
• umor; ili simptomi nalik gripi
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).
U bolesnika koji su neuspješno liječeni antraciklinima, docetaksel se uspoređivao s kombinacijom mitomicina C i vinblastina (12 mg/m2 svakih 6 tjedana i 6 mg/m2 svaka 3 tjedna).
Following chemotherapy, patients should receive radiotherapy.
Nakon kemoterapije bolesnici se moraju liječiti radioterapijom.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Manje su se davali morfinski analgetici (p<0,01), ne morfinski analgetici (p<0,01), ostali lijekovi povezani s bolešću (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom 75 mg/m2 nego onima iz skupine BSC.
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 mjestu primjene infuzije općenito su bile blage i sastojale su se od hiperpigmentacije, upale, crvenila ili suhoće kože, flebitisa ili ekstravazacije te otoka vene.
• 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 i 251 bolesnika s karcinomom glave i vrata koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem).
Before each treatment with DOCETAXEL KABI, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive DOCETAXEL KABI.
Prije svake primjene lijeka DOCETAXEL KABI , obavit ćete krvne pretrage kako bi se provjerilo imate li dovoljno krvnih stanica te odgovarajuću funkciju jetre kako biste mogli primiti DOCETAXEL KABI.
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Stopa preživljenja bila je 93,7% u TAC skupini i 91,4% u FAC skupini, u točki praćenja od 8 godina te 91,3% u TAC skupini i 89% u FAC skupini, u točki praćenja od 10 godina.
• 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.
• Zatim ga odjednom injicirajte (jedno injiciranje) u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Svi bolesnici koji nisu imali progresiju bolesti liječeni su CRT-om prema protokolu (PF/CRT).
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji s cisplatinom i 5-fluorouracilom u studiji koja je uključivala bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starijih, a 4 ih je bilo u dobi od 75 godina ili starijih.
The name of this medicine is DOCETAXEL KABI.
Ovaj lijek se zove DOCETAXEL KABI.
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Preživljenje je bilo dulje u skupini koja je primala kombinaciju docetaksela i kapecitabina (p=0,0126).
Some cases of anaphylactic shock, sometimes fatal, have been reported.
Zabilježeno je nekoliko slučajeva anafilaktičkog šoka, ponekad sa smrtnim ishodom.
This is because DOCETAXEL KABI or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Može se dogoditi da u tom slučaju DOCETAXEL KABI ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
Age category 2 <35 years ≥35 years
Dobna skupina 2 <35 godina ≥35 godina
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Incidencija povrata bolesti u 10 godina smanjena je u bolesnika koji su primili TAC u odnosu na FAC (39% prema 45%), što znači da je apsolutni rizik smanjen za 6% (p=0,0043).
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.
Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
One hundred eighty six patients were randomised to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Randomizirano je 186 bolesnika koji su primali docetaksel (100 mg/m2) s trastuzumabom ili bez trastuzumaba, a 60% bolesnika ranije je primalo adjuvantnu terapiju temeljenu na antraciklinima.
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.
Potrebni volumen DOCETAXEL KABI koncentrata za otopinu za infuziju mora se injicirati jednokratnom injekcijom (jedno injiciranje) u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida.
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Vrlo često: hematološka toksičnost bila je povećana u bolesnika koji su primali trastuzumab i docetaksel u usporedbi s bolesnicima koji su primali docetaksel u monoterapiji (32% neutropenija stupnja 3/4 u odnosu na 22%, prema kriterijima NCI-CTC).
• inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
• upala debelog crijeva, tankog crijeva, koja može biti smrtonosna (nepoznata učestalost);
Clinical benefit parameters
Pokazatelji kliničke koristi