FrancophonIA/ELRC3.0 huggingface dataset:
English: 95% CI p-valuea
Croatian: 95% CI p-vrijednosta
English: • operable node-negative breast cancer .
Croatian: • operabilnim karcinomom dojke i negativnim limfnim čvorovima.
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Croatian: Infekcije i infestacije infekcija (G3/4: 2,4%); neutropenijska infekcija (G3/4: 2,6%)
English: The median overall survival was significantly longer in docetaxel treatment group than in the ADT alone group, with a median overall survival 13.6 months longer with the addition of docetaxel to ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.47-0.80, p=0.0003).
Croatian: Medijan ukupnog preživljenja bio je značajno duži u skupini liječenoj docetakselom nego u skupini liječenoj samo terapijom deprivacije androgena (ADT), s medijanom ukupnog preživljenja dužim za 13,6 mjeseci uz dodatak docetaksela terapiji deprivacije androgena (ADT) (omjer hazarda = 0,61; 95% interval pouzdanosti (CI) = 0,47-0,80; p=0,0003).
English: Pharyngitis (G3: 0%)
Croatian: faringitis (G3: 0%)
English: Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Croatian: Prijavljene su ozbiljne kožne nuspojave poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantemozne pustuloze (AGEP) povezane s liječenjem docetakselom.
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Croatian: Bolesnicima u kojih se pojavi stomatitis stupnja 3 ili 4 treba smanjiti dozu na 60 mg/m Kombinacija s cisplatinom
English: A multi-centre, open-label, randomised 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.
Croatian: Provedena je multicentrična, randomizirana studija otvorenog tipa da bi se procijenila sigurnost i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Croatian: U ispitivanju TAX 316 alopecija koja je i dalje bila prisutna tijekom perioda praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika (92,3%) u TAC skupini i 645 od 736 bolesnika (87,6%) u FAC skupini.
English: • Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.)
Croatian: • Akutna generalizirana egzantematozna pustuloza (AGEP) (crveni, ljuskasti široko rasprostranjeni osip s izbočinama ispod otečene kože (uključujući pregibe na koži, trup i gornje ekstremitete) i mjehuriće praćene vrućicom.)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/TAXOTERE 80 mg/2 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KONCENTRAT i OTAPALO/TAXOTERE 80 mg/2 ml
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Croatian: U ovom je ispitivanju, u dvije skupine bio randomiziran 501 bolesnik s lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1.
English: Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT.
Croatian: U bilo koje vrijeme nakon završetka CRT, mogla se razmotriti operacija primarnog sijela bolesti i/ili vrata.
English: Prednisone or prednisolone 5 mg orally twice daily may be administered continuously.
Croatian: Prednizon ili prednizolon u dozi od 5 mg oralno dva puta dnevno mogu se primjenjivati kontinuirano.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Croatian: • Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Croatian: Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m kao 30-minutnu do trosatnu intravensku infuziju na dan 1, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m dnevno od dana 1 do dana 5.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/TAXOTERE 20 mg/0.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KONCENTRAT i OTAPALO/TAXOTERE 20 mg/0,5 ml
English: A total of 1776 male patients were allocated to the treatment armss of interest: • Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
Croatian: Ukupno 1776 muških bolesnika bilo je raspodijeljeno u skupine: Standard liječenja + docetaksel 75 mg/m 2, primijenjen svaka 3 tjedna u 6 ciklusa
English: Lethargy; Pain
Croatian: letargija; bol
English: For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Croatian: Na primjer, za dozu od 140 mg docetaksela potrebno je 14 ml pripremljene otopine koncentrata docetaksela.
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3.
Croatian: 2. Bolesnici ne bi smjeli primiti sljedeći ciklus docetaksela dok se broj neutrofila ne vrati na razinu od > 1500 stanica/mm 3, a broj trombocita na > 100 000 stanica/mm 3. Liječenje se mora prekinuti ako toksičnost potraje (vidjeti dio 4.4).
English: 23 of 736 FAC patients (3.1%).
Croatian: skupini te u 125 od 736 bolesnica (17,0%) u FAC skupini.
English: 13% (w/w) ethanol 95% in water for injections Fill: 1.98 ml
Croatian: 13% (m/m) 95%-tnog etanola u vodi za injekcije Punjenje: 1,98 ml
English: 13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml
Croatian: 13% (m/m) 95%-tnog etanola u vodi za injekcije Punjenje: 7,33 ml
English: Cautions for use in adjuvant treatment of breast cancer There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Croatian: Upozorenja za primjenu u adjuvantnom liječenju karcinoma dojke Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
English: • Each vial is for single use and should be used immediately after opening.
Croatian: • Bočice su predviđene za jednokratnu primjenu te se trebaju primjeniti odmah nakon otvaranja.
English: Peripheral sensory neuropathy (≥G3: 2%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (≥G3: 2%)
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Croatian: Priprema za intravensku primjenu
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m followed by cisplatin (P) 75 mg/m followed by
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P)
English: One vial contains 80 mg/2 ml docetaxel.
Croatian: Jedna bočica sadržava 80 mg/2 ml docetaksela.
English: Cautions for use in gastric adenocarcinoma cancer 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.
Croatian: Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji sa cisplatinom i 5-fluoruracilom 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.
English: Nail changes (G3: 1%)
Croatian: a promjene na noktima (G3: 1%)
English: What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections.
Croatian: Što bočica s otapalom sadrži 13% (m/m) 95%-tnog etanola (vidjeti dio 2) u vodi za injekcije.
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Croatian: Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda =0 ,84, 95% CI (0,65-1,08), p=0,1646).
English: • blood clots
Croatian: • krvni ugrušci
English: More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Croatian: Ponekad je potrebno upotrijebiti više od jedne bočice TAXOTERE koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
English: Cautions for use in hormone-sensitive prostate cancer Of the 545 patients treated with docetaxel every 3 weeks in a hormone-sensitive prostate cancer study (STAMPEDE), 296 patients were 65 years of age or older, and 48 patients were 75 years of age or older.
Croatian: Upozorenja za primjenu kod karcinoma prostate osjetljivog na hormone Od 545 bolesnika koji su primali docetaksel svaka 3 tjedna u studiji liječenja karcinoma prostate osjetljivog na hormone (STAMPEDE), 296 bolesnika bilo je u dobi od 65 godina ili stariji, a 48 bolesnika bilo je u dobi od 75 godina ili stariji.
English: - For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje uznapredovalog karcinoma želuca TAXOTERE se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Croatian: Potrebno je uzeti u obzir kod trudnica ili dojilja, djece i visokorizičnih skupina, kao što su bolesnici s bolešću jetre ili epilepsijom.
English: The concentrate is a pale yellow to brownish-yellow solution.
Croatian: Koncentrat je blijedo žuta do smeđežuta otopina.
English: The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.
Croatian: Otapalo za TAXOTERE je 13% m/m otopina 95%-tnog etanola u vodi za injekcije.
English: The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study (CHAARTED).
Croatian: Sigurnost i djelotvornost docetaksela primijenjenog na početku terapije deprivacije androgena (ADT) u bolesnika s metastatskim karcinomom prostate osjetljivim na hormone ocijenjene su u randomiziranoj multicentričnoj studiji faze III (CHAARTED).
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Croatian: Infuzijska otopina treba se upotrijebiti unutar 6 sati, uključujući u to i jednosatnu intravensku infuziju bolesniku.
English: 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.
Croatian: Sljedeća tablica prikazuje da je incidencija neutropenije stupnja 4, febrilne neutropenije i neutropenijske infekcije smanjena u bolesnika koji su primali primarnu profilaksu s G-CSF nakon što je ona uvedena kao obavezna u TAC skupini - GEICAM studija.
English: Concentrate vial: Polysorbate 80 Citric acid.
Croatian: Bočica s koncentratom: polisorbat 80 citratna kiselina.
English: An open-label, multi-centre, randomised 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.
Croatian: Provedeno je multicentrično randomizirano ispitivanje faze III otvorenog tipa kako bi se usporedile monoterapija docetakselom i terapija paklitakselom u liječenju uznapredovalog karcinoma dojke kod bolesnika prethodno liječenih antraciklinima.
English: Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis
Croatian: Pri primjeni docetaksela zabilježeni su kožni lupus eritematodes, bulozne erupcije poput eritema multiforme i teških kožnih nuspojava poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantemozne pustuloze (AGEP).
English: Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED)
Croatian: Djelotvornost docetaksela i terapije deprivacije androgena (ADT) u liječenju bolesnika s metastatskim karcinomom prostate osjetljivim na hormone (CHAARTED)
English: How to store TAXOTERE Contents of the pack and otherinformation
Croatian: Kako TAXOTERE izgleda i sadržaj pakiranja
English: • one single-dose vial of solvent.
Croatian: • jednu jednodoznu bočicu s otapalom.
English: Data from a multi-centre open label randomised trial support the use of TAXOTERE for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Croatian: Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu lijeka TAXOTERE za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
English: - AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
Croatian: - Simptomi AGEP mogu uključivati crveni, ljuskasti široko rasprostranjeni osip s izbočinama ispod otečene kože (uključujući pregibe na koži, trup i gornje ekstremitete) i mjehuriće praćene vrućicom.
English: 75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Croatian: 75 mg/m cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m po danu u trajanju od 5 dana.
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m immediately followed by cisplatin 75 mg/m over 30-60 minutes.
Croatian: Za bolesnike koji nisu prethodno primali kemoterapiju za karcinom nemalih stanica pluća preporučeni režim doziranja iznosi 75 mg/m docetaksela, nakon čega odmah slijedi infuzija 75 mg/m cisplatina u trajanju od 30 do 60 minuta.
English: • The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.
Croatian: • Otapalo za TAXOTERE sadrži 13% m/m otopinu 95%-tnog etanola u vodi za injekcije.
English: • Mitoxantrone 12 mg/m every 3 weeks for 10 cycles.
Croatian: • Mitoksantron 12 mg/m svaka 3 tjedna tijekom 10 ciklusa.
English: The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Croatian: Sigurnost i djelotvornost docetaksela primijenjenog istodobno sa standardom liječenja (terapija deprivacije androgena, ADT) u bolesnika s visokorizičnim lokalno uznapredovalim ili metastatskim karcinomom prostate osjetljivim na hormone ocijenjene su u randomiziranom multicentričnom ispitivanju s više skupina i više stadija (engl. multi-arm multi-stage, MAMS) s dizajnom objedinjene faze II/III (engl. seamless phase II/III design)(STAMPEDE - MRC PR08).
English: • Docetaxel 30 mg/m administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Croatian: • Docetaksel 30 mg/m primijenjen tjedno prvih 5 tjedana u ciklusu liječenja od 6 tjedana, tijekom 5
English: G3/4 Blood bilirubin increased
Croatian: G3/4 povećanje bilirubina u krvi
English: • ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
Croatian: • Terapija deprivacije androgena (ADT) + docetaksel 75 mg/m primijenjen na početku terapije deprivacije androgena (ADT), primijenjen svaka 3 tjedna u 6 ciklusa.
English: If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Croatian: Ako je potrebna doza veća od 200 mg docetaksela, upotrijebite veći volumen infuzijskog sredstva, tako da koncentracija docetaksela ne prelazi 0,74 mg/ml docetaksela.
English: Neutropenic infection; Infection (G3/4: 11.7%)
Croatian: Infekcije i infestacije neutropenijska infekcija; infekcija (G3/4: 11,7%)
English: Time to castration-resistant prostate cancerb
Croatian: Vrijeme do karcinoma prostate rezistentnog na kastracijub
English: What TAXOTERE looks like and contents of the pack TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Croatian: TAXOTERE koncentrat za otopinu za infuziju je blijedo žuta do smeđežuta otopina.
English: Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m as a 1-hour infusion, followed by cisplatin
Croatian: Adenokarcinom želuca Preporučena doza docetaksela je 75 mg/m u obliku jednosatne infuzije, nakon čega slijedi infuzija
English: The infusion solution should be used within 4 hours at room temperature (below 25°C).
Croatian: Infuzijska otopina mora se upotrijebiti unutar 4 sata nakon priprave, uz čuvanje na sobnoj temperaturi (ispod 25°C).
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF
Croatian: U ovom je ispitivanju AT skupina u odnosu na AC skupinu pokazala veću incidenciju teške neutropenije (90% prema 68,6%), febrilne neutropenije (33,3.% prema 10%), infekcije (8% prema 2,4%), proljeva (7.5% prema 1,4%), astenije (8,5% prema 2,4%) i boli (2,8% prema 0%).
English: Infection (G3/4: 6.3%); Neutropenic infection
Croatian: Infekcije i infestacije infekcija (G3/4: 6,3%); neutropenijska infekcija
English: Metastatic hormone-sensitive prostate cancer
Croatian: Metastatski karcinom prostate osjetljiv na hormone
English: The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Croatian: TAXOTERE infuzijska otopina mora se upotrijebiti unutar 4 sata nakon priprave i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Croatian: Za kombinaciju s terapijom deprivacije androgena (ADT) i prednizonom ili prednizolonom (studija STAMPEDE), korištenjem CTCAE ljestvice ocjenjivanja, prikazani su štetni događaji koji su se javljali tijekom 6 ciklusa liječenja docetakselom i koji su imale barem 2% veću incidenciju u skupini liječenoj docetakselom u odnosu na kontrolnu skupinu.
English: (TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Croatian: (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m nakon kojeg slijedi fluorouracil 500 mg/m i ciklofosfamid 500 mg/m
English: For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4).
Croatian: Za metastatski karcinom prostate osjetljiv na hormone, neovisno o istodobnoj primjeni prednizona ili prednizolona, preporučeni režim premedikacije je oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.4).
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4:
Croatian: Poremećaji živčanog sustava disgeuzija/parosmija; periferna senzorna neuropatija (G3/4:
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
Croatian: Tablični popis nuspojava kod visokorizičnog lokalno uznapredovalog ili metastatskog karcinoma prostate osjetljivog na hormone za TAXOTERE 75 mg/m u kombinaciji s prednizonom ili prednizolonom i terapijom deprivacije androgena (ADT) (studija STAMPEDE) MedDRA klasifikacija organskih sustava
English: 4.2.4 The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Croatian: 4.2.4 TAXOTERE infuzijska otopina mora se upotrijebiti unutar 4 sata nakon pripreme i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
English: 1 vial of solvent for TAXOTERE
Croatian: 1 bočica otapala za TAXOTERE
English: Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with TAXOTERE: - SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Croatian: Teške kožne tegobe poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantematozne pustuloze (AGEP) prijavljene su kod primjene lijeka TAXOTERE: - Simptomi Stevens-Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize TEN) mogu uključivati pojavu mjehurića, guljenje ili krvarenje bilo kojeg dijela kože (uključujući usne, oči, usta, nos, genitalije, šake ili stopala) sa ili bez pojave osipa.
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Croatian: Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST više od 1,5 puta većim od GGN te alkalnom fosfatazom više od 2,5 puta većom od GGN i bilirubinom više od 1 puta većim od GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
English: 15 ml clear glass Type I vial with a transparent colourless flip-off cap.
Croatian: Prozirna staklena bočica od 15 ml (staklo tip I), s transparentnim bezbojnim "flip-off" zatvaračem.