FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5kratno 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.
English: The required volume of Docetaxel Zentiva 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.
Slovenian: Potrebno količino koncentrata za raztopino za infundiranje zdravila Docetaxel Zentiva je treba vbrizgati preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Slovenian: Zdravilo Docetaxel Zentiva je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic z:
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Slovenian: Pri bolnikih, zdravljenih s TCF, je bil v primerjavi s tistimi, ki so jih zdravili s CF, daljši tako čas do 5 % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ--C30 (p = 0,0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0,0088).
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Slovenian: TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in zdravilo je treba uporabiti takoj.
English: This regimen is administered every 3 weeks for 4 cycles.
Slovenian: Ta terapevtska shema se uporablja vsake 3 tedne za 4 cikle.
English: Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Zentiva: - SJS/TEN sympoms 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.
Slovenian: Med uporabo zdravila Docetaxel Zentiva so poročali o hudih težavah s kožo, kot so StevensJohnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP): - Med simptomi SJS/TEN so lahko mehurji, lupljenje ali krvavitev na katerem koli predelu kože (tudi na ustnicah, očeh, v ustih, nosu, na spolovilih, dlaneh in stopalih), z izpuščajem ali brez njega.
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Slovenian: Docetaxel je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem z njim in med pripravo njegovih raztopin potrebna previdnost.
English: - For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in combination with cisplatin.
Slovenian: - Za zdravljenje pljučnega raka se zdravilo Docetaxel Zentiva lahko uporablja sam ali v kombinaciji s cisplatinom.
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Slovenian: Stratificiran log-rang test *Prag statistične značilnosti=0,0175 **PSA: prostatični specifični antigen
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Slovenian: Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi bezgavkami in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 vsake tri tedne v 6 ciklusih (TAC režim) (glejte tudi
English: Docetaxel Zentiva in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormonesensitive prostate cancer.
Slovenian: Zdravilo Docetaxel Zentiva je v kombinaciji z zdravljenjem z deprivacijo androgenov (ADTandrogen-deprivation therapy) s prednizonom oz. prednizolonom ali brez njega, indicirano za zdravljenje bolnikov z metastatskim, hormonsko občutljivim rakom prostate.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Slovenian: Sočasna uporaba docetaksela, doksorubicina in ciklofosfamida ni vplivala na njihovo farmakokinetiko.
English: 1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 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).
Slovenian: 1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaxel Zentiva 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 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).
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Slovenian: zvečanje AST S3/4 zvečanje alkalne fosfataze v krvi S3/4
English: Docetaxel should be administered when the neutrophil count is  1,500 cells/mm3.
Slovenian: Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
English: Docetaxel Zentiva 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.
Slovenian: Zdravilo Docetaxel Zentiva je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.
Slovenian: - Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) MedDRA system organ classes
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX 323) Organski sistemi po
English: - For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Zentiva could be administered in combination with doxorubicin and cyclophosphamide.
Slovenian: - Za zdravljenje zgodnjega raka dojke s prizadetostjo bezgavk ali brez prizadetosti bezgavk se zdravilo Docetaxel Zentiva lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
English: Headache
Slovenian: bolečine
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%).
Slovenian: V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC (92,3%), in pri 645 od 736 bolnic, ki so prejemale FAC (87,6%).
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.
Slovenian: Previdnost pri uporabi pri adjuvantnem zdravljenju raka dojke Podatki o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
English: The recommended dose of docetaxel is 75 mg/m2 every 3 weeks for 6 cycles.
Slovenian: Priporočeni odmerek docetaksela je 75 mg/m2 na 3 tedne 6 ciklusov.
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Slovenian: V tej študiji so so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Slovenian: V kraku z docetaxel in trastuzumabom je 64 % bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta delež 55 %.
English: - For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje raka glave in vratu se zdravilo Docetaxel Zentiva uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Slovenian: Pomožne snovi: polisorbat 80, brezvodni etanol (za dodatne informacije glejte navodilo za uporabo) in citronska kislina.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Slovenian: Zdravilo Docetaxel Zentiva v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
English: More than one vial of Docetaxel Zentiva concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Slovenian: Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje zdravila Docetaxel Zentiva.
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Slovenian: • 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/m² zdravila docetaksel, 121 pa jih je prejemalo 75 mg/m².
English: - For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with prednisone or prednisolone.
Slovenian: - Za zdravljenje raka prostate se zdravilo Docetaxel Zentiva lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentratje bledorumena do rjavkastorumena raztopina.
English: - For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje metastatskega raka želodca se zdravilo Docetaxel Zentiva uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Slovenian: Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
English: Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
Slovenian: Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Logrank test ***Hi - kvadrat test
English: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Slovenian: Bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
English: - If you have any further questions, ask your doctor, your hospital pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/005
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/005
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Slovenian: Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetaksel 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3
English: Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Slovenian: Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila Docetaxel Zentiva za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
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.
Slovenian: Opravljena je bila multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaxel pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/004
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/004
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 (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel.
Slovenian: Pri zdravljenju z docetakselom so poročali o kožnem eritematoznem lupusu, o buloznih erupcijah, npr. o multiformnem eritemu in o hudih kožnih neželenih učinkih kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
English: Docetaxel Zentiva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Zentiva solutions.
Slovenian: Docetaxel Zentiva je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Docetaxel Zentiva potrebna previdnost.
English: How to use Docetaxel Zentiva
Slovenian: Kako uporabljati zdravilo Docetaxel Zentiva
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Slovenian: V kombinacijski roki s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40 % proti 31 %) in neželenih učinkov stopnje 4 (34 % proti 23 %) v primerjavi z monoterapijo z docetakselom .
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg docetaksela v obliki trihidrata.
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.
Slovenian: V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 × ULN ter hkrati alkalno fosfatazo > 2,5 × ULN in bilirubinom > 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
English: Median overall survival (months)
Slovenian: Mediano celokupno preživetje (meseci)
English: Neutropenic infection (Grade 3-4)
Slovenian: Nevtropenična okužba (3.-4.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/003
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/003
English: Neutropenic infection; Infection (G3/4: 11.7%)
Slovenian: Infekcijske in parazitske bolezni nevtropenična okužba; okužba (S3/4: 11,7 %)
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Slovenian: Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaxel (T) (75 mg/m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/m2 1. dan) in 5-fluorouracilom (F) (750 mg/m2 na dan, 5 dni), bodisi cisplatin (100 mg/m2 1. dan) in 5fluorouracil (1000 mg/m2 na dan, 5 dni).
English: Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by20%.
Slovenian: Prilagoditev odmerka driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora V redkih primerih so bili opisani akutni respiracijski distres sindrom in primeri, , intersticijske pljučnice/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so bili včasih usodni.
English: Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Slovenian: Zdravilo Docetaxel Zentiva je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim proti kastraciji odpornim rakom prostate.
English: Docetaxel + Cis + 5-FU n = 177
Slovenian: Končna točka docetaksel + Cis + 5-FU n = 177
English: Disease-free survival (DFS) was the primary efficacy endpoint and overall survival (OS) was the secondary efficacy endpoint.
Slovenian: Preživetje brez bolezni (DFS-Disease-free-survival) je bilo primarni, celokupno preživetje (OS-Overall survival) pa sekundarni opazovani dogodek učinkovitosti.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Slovenian: Letargija (G3/4: 3,4 %) pireksija (S3/4:0,6 %); retenca tekočine; edem
English: • operable node- positive breast cancer
Slovenian: • operabilnim rakom dojke s pozitivnimi bezgavkami
English: Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Slovenian: Zdravilo Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Slovenian: astenija (3. st.: 0 %) zastajanje tekočine zvišana telesna temperatura (3. st.: 1 %) oralna kandidoza hipokalciemija (3. st.: 0 %) hipofosfatemija (3.-4. st.: 1 %) hipokaliemija (3. st.: 0 %)
English: Aseptically withdraw the required amount of Docetaxel Zentiva concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Slovenian: S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila Docetaxel Zentiva.
English: Docetaxel Zentiva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Slovenian: Zdravilo Docetaxel Zentiva je indiciran v kombinaciji s trastuzumabom za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Slovenian: Bolniki v kraku z docetakselom so prejelidocetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5-fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
English: For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dosereduction can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
English: Docetaxel Zentiva in combination with doxorubicin
Slovenian: Zdravilo Docetaxel Zentiva v kombinaciji z doksorubicinom
English: Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Slovenian: Zdravilo Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: Docetaxel Zentiva in combination with capecitabine
Slovenian: Zdravilo Docetaxel Zentiva v kombinaciji s kapecitabinom