FrancophonIA/ELRC3.0 huggingface dataset:
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Estonian: Raviperioodil alanud ja jälgimisperioodil kestva asteenia jätkumist täheldati 12 patsiendil (2,3%) TAC ravihaaras ja 4 patsiendil (0,8%) FAC ravihaaras.
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Estonian: Igas karbis on üks viaal, mis sisaldab 8 ml kontsentraati (160 mg dotsetakseeli).
English: Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe.
Estonian: Tõmmake aseptiliselt vajalik kogus infusioonilahuse kontsentraati kalibreeritud süstlasse.
English: At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Estonian: Kui jälgimisperioodi mediaanne kestus oli 77 kuud, leiti, et TAC ravihaara patsientide üldine elulemus (OS) oli oluliselt pikem; TAC-ravi saanud patsientide surma risk langes 24%, võrreldes FAC-ravi saanutega (riskide suhe = 0,76; 95% CI: 0,46...1,26; p=0,29).
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%);
Estonian: aste: 18%); Diarröa (3./4.
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Estonian: Dotsetakseel on kasvajatevastane aine, mille käsitsemisel ning lahuste valmistamisel tuleb sarnaselt teiste potentsiaalselt toksiliste ainetega olla ettevaatlik.
English: DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Estonian: DOCETAXEL KABI on näidustatud lokaalselt levinud või metastaatilise mitteväikerakk-kopsuvähi raviks eelneva keemiaravi ebaõnnestumisel.
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Estonian: Igas karbis on üks viaal, mis sisaldab 9 ml kontsentraati (180 mg dotsetakseeli).
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Estonian: Dotsetakseeli efektiivsus mao adenokartsinoomi ravis
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Estonian: Pea ja kaelapiirkonna lokaalselt levinud (tehniliselt mitteresetseeritav, kirurgilise ravi võimalikkus väike, eesmärgiks organsäästlikkus) lamerakk-kartsinoomiga (SCCHN) patsientide induktsioonraviks on soovitatav dotsetakseeli annus 75 mg/m2 1-tunnise infusioonina 1. päeval, millele järgneb tsisplatiin 100 mg/m2, manustatuna 30-minutilise kuni 3-tunnise infusioonina ja seejärel 5-fluorouratsiil püsiinfusioonina 1000 mg/m2 päevas 1. päevast 4. päevani.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Estonian: 4. raskusastme diarröa Esimene episood: vähendage dotsetakseeli ja 5-FU annust 20% võrra.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 180 mg/9 ml
English: For more details see summary of product characteristics of trastuzumab.
Estonian: Täpsemat informatsiooni saab trastuzumabi ravimi omaduste kokkuvõttest.
English: DOCETAXEL KABI in combination with doxorubicin
Estonian: DOCETAXEL KABI kombinatsioonis doksorubitsiiniga
English: In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Estonian: Uuringus TAX316 teatati asteeniast, mis algas raviperioodil ja püsis jälgimisperioodil, pärast raviperioodi lõppu 236 patsiendil 744-st (31,7%) TAC ravihaaras ja 180 patsiendil 736-st (24,5%) FAC ravihaaras.
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Estonian: Parim üldine ravivastus keemiaravile (%) (95% CI) ***p-väärtus
English: • inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
Estonian: Harv (võib esineda kuni 1 inimesel 1000st): - põletik käärsooles, peensooles, mis võib lõppeda surmaga (sagedus teadmata); soole mulgustumine (perforatsioon).
English: Anaemia (G3/4: 20.9%);
Estonian: aste: 20,9%);
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Estonian: Jälgimisperioodi lõpus (tegelik mediaanne jälgimisaeg 8 aastat) täheldati jätkuvat alopeetsiat 29 patsiendil (3,9%) TAC ravihaaras ja 16 patsiendil (2,2%) FAC ravihaaras.
English: One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Estonian: Üks 4 ml kontsentraadi viaal sisaldab 80 mg dotsetakseeli.
English: Rare cases of ileus and intestinal obstruction have been reported.
Estonian: Harvadel juhtudel on teatatud iileusest ja sooleobstruktsioonist.
English: Reporting of adverse effects
Estonian: Võimalikest kõrvaltoimetest teavitamine
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Estonian: Andmed dotsetakseeli kasutamisest kombinatsioonis doksorubitsiini ja tsüklofosfamiidiga üle 70-aastaste patsientide raviks on piiratud.
English: Diarrhoea grade 4
Estonian: 4. raskusastme stomatiit/mukosiit
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
Estonian: 10 ml selge, värvitu I tüüpi klaasist viaal, mis on suletud flurotec kummikorgi ja oranži äratõmmatava alumiiniumkattega ning sisaldab 9 ml kontsentraati.
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Estonian: Igas karbis on üks viaal, mis sisaldab 4 ml kontsentraati (80 mg dotsetakseeli).
English: DOCETAXEL KABI is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing the solution.
Estonian: 6.6 Erihoiatused ravimi hävitamiseks ja käsitlemiseks DOCETAXEL KABI on kasvajatevastane aine, mille käsitsemisel ning lahuste valmistamisel tuleb sarnaselt teiste potentsiaalselt toksiliste ainetega olla ettevaatlik.
English: Alopecia (G3/4: 4.0%)
Estonian: Alopeetsia (3./4.
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Estonian: aste: 63%); Aneemia (3./4.
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Estonian: aste: 32%); Aneemia (3./4.
English: Arrhythmia
Estonian: Kõhukinnisus
English: Fluid retention
Estonian: Seedetrakti reaktsioonid
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.
Estonian: Kombinatsioonravi trastuzumabiga põhjustas dotsetakseeli monoteraapiaga võrreldes enam tõsiste kõrvalnähtude teket (esinemissagedus vastavalt 40% vs 31%) ja 4. raskusastme kõrvalnähtude teket (vastavalt 34% vs 23%).
English: Myocardial ischemia (G3/4: 1.7%)
Estonian: Müokardi isheemia (3./4.
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Estonian: Enne kombinatsioonravi alustamist dotsetakseeli ja trastuzumabiga peab hindama patsiendi südame seisundit.
English: Anorexia (G3/4: 12.0%) Nervous system Dysgeusia/Parosmia
Estonian: aste: 0,6%) Närvisüsteemi häired
English: (G3/4: 1.7%)
Estonian: aste: 1,7%)
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/ or cyclophosphamide (see section 4.8).
Estonian: Patsientidel, keda on ravitud dotsetakseeliga osana kombinatsioonravist, mis sisaldab doksorubitsiini, 5-fluorouratsiili ja/või tsüklofosfamiidi, on teatatud ventrikulaarsest arütmiast, k.a ventrikulaarsest tahhükardiast, mis mõnikord on lõppenud surmaga (vt lõik 4.8).
English: DOCETAXEL KABI 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.
Estonian: DOCETAXEL KABI kombinatsioonis trastuzumabiga on näidustatud metastaseerunud HER2üleekspressiooniga rinnanäärmevähi raviks patsientidel, kes ei ole varem saanud keemiaravi metastaatilise haiguse raviks.
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Estonian: Uuringus GEICAM 9805 täheldati kestvat amenorröad, mis algas raviperioodil ja püsis jälgimisperioodil, 18 patsiendil (3,4%) TAC ravihaaras ja 5 patsiendil (1,0%) FAC ravihaaras.
English: DOCETAXEL KABI in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Estonian: DOCETAXEL KABI kombinatsioonis doksorubitsiiniga on näidustatud lokaalselt levinud või metastaatilise rinnanäärmevähi raviks patsientidel, kes ei ole varem saanud tsütotoksilist ravi selle haiguse raviks.
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Estonian: Harva on teatatud kiiritusjärgse tagasilöögi fenomenist.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 160 mg/8 ml
English: Lymphoedema (G3/4: 0%)
Estonian: Lümfiturse (3./4.
English: Prostate cancer
Estonian: Eesnäärmevähk
English: Peripheral motor neuropathy (G3/4: 0%)
Estonian: Perifeerne motoorne neuropaatia (3./4.
English: At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Estonian: Jälgimisperioodi lõpus (tegelik mediaanne jälgimisaeg 8 aastat) täheldati kestvat asteeniat 29 patsiendil (3,9%) TAC ravihaaras ja 16 patsiendil (2,2%) FAC ravihaaras.
English: In DOCETAXEL KABI 180 mg/9 ml vial the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon DOCETAXEL KABI 180 mg/9 ml infusioonilahuse kontsentraadi viaalis on 20 mg/ml.
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Estonian: Infektsioonid koos 4. astme neutropeeniaga (3./4.
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Estonian: Uuringus TAX316 teatati lümfitursest, mis algas raviperioodil ja püsis jälgimisperioodil, pärast raviperioodi lõppu 11 patsiendil 744-st (1,5%) TAC ravihaaras ja 1 patsiendil 736-st (0,1%) FAC ravihaaras.
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Estonian: Üks 1 ml kontsentraadi viaal sisaldab 20 mg dotsetakseeli.
English: General disorders and administration site conditions In study TAX316 peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
Estonian: Uuringus TAX316 teatati perifeersest tursest, mis algas raviperioodil ja püsis jälgimisperioodil, pärast raviperioodi lõppu 119 patsiendil 744-st (16,0%) TAC ravihaaras ja 23 patsiendil 736-st (3,1%) FAC ravihaaras.
English: Infections (G3/4: 5%)
Estonian: Infektsioonid (3./4.
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a green flip-off aluminium over seal containing 1 ml of concentrate.
Estonian: 6 ml selge, värvitu I tüüpi klaasist viaal, mis on suletud flurotec kummikorgi ja rohelise äratõmmatava alumiiniumkattega ning sisaldab 1 ml kontsentraati.
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Estonian: Jälgimisperioodi lõpuks (tegelik mediaanne jälgimisperiood 10 aastat ja 5 kuud) ei olnud ühelgi TAC ravihaara patsiendil südame paispuudulikkust ning FAC ravihaaras suri 1 patsient dilateeruva kardiomüopaatia tõttu; kestvat südame paispuudulikkust täheldati 1 patsiendil (0,2%) FAC ravihaaras.
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Estonian: Igas karbis on üks viaal, mis sisaldab 1 ml kontsentraati (20 mg dotsetakseeli).
English: G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
Estonian: astme bilirubiinisisalduse tõus veres (< 5%); 3./4.
English: Myalgia
Estonian: MedDRA
English: Lacrimation increased (G3/4: 0%)
Estonian: Suurenenud pisaravool (3./4.
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a yellow flip-off aluminium over seal containing 8 ml of concentrate.
Estonian: 10 ml selge, värvitu I tüüpi klaasist viaal, mis on suletud flurotec kummikorgi ja kollase äratõmmatava alumiiniumkattega ning sisaldab 8 ml kontsentraati.
English: In DOCETAXEL KABI 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon DOCETAXEL KABI 160 mg/8 ml infusioonilahuse kontsentraadi viaalis on 20 mg/ml.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Estonian: Parim üldine ravivastus uuringuravile [keemiaravi ± kiiritusravi] (%) (95% CI) ***p-väärtus
English: Diarrhoea grade 3
Estonian: 3. raskusastme stomatiit/mukosiit
English: Paediatric population
Estonian: Patsientide alarühm
English: DOCETAXEL KABI in combination with capecitabine
Estonian: DOCETAXEL KABI kombinatsioonis kapetsitabiiniga
English: 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).
Estonian: Patsientidel, kes said esmast profülaktikat G-CSF-iga, langes 4. raskusastme neutropeenia, febriilse neutropeenia ja neutropeeniliste infektsioonide esinemissagedus (vt lõik 4.8).
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Estonian: Pea ja kaelapiirkonna inoperaabelse lokaalselt levinud lamerakk-kartsinoomi (squamous cell carcinoma of the head and neck, SCCHN) induktsioonraviks on soovitatav dotsetakseeli annus 75 mg/m2 1-tunnise infusioonina, millele järgneb tsisplatiin 75 mg/m2 1 tunni jooksul 1. päeval ja seejärel 5-fluorouratsiil püsiinfusioonina 750 mg/m2 päevas viis päeva.
English: In DOCETAXEL KABI 120 mg/6 ml vial the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon DOCETAXEL KABI 120 mg/6 ml infusioonilahuse kontsentraadi viaalis on 20 mg/ml.
English: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Estonian: G-CSF profülaktilisel manustamisel patsientidele, kes said kombinatsioonravi dotsetakseeli, tsisplatiini ja 5-fluorouratsiiliga (TCF), tekkisid febriilne neutropeenia ja neutropeeniline infektsioon harvem.
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a red flip-off aluminium over seal containing 6 ml of concentrate.
Estonian: 6 ml selge, värvitu I tüüpi klaasist viaal, mis on suletud flurotec kummikorgi ja punase äratõmmatava alumiiniumkattega ning sisaldab 6 ml kontsentraati.
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Estonian: aste: < 1%); Paresteesia (3./4.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 120 mg/6 ml
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Estonian: aste: 0,6%); Köha (3./4.
English: In DOCETAXEL KABI 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon DOCETAXEL KABI 80 mg/4 ml infusioonilahuse kontsentraadi viaalis on 20 mg/ml.
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Estonian: TAC ravihaaras oli haigusvaba elulemus märkimisväärselt pikem võrreldes FAC ravihaaraga.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial, equivalent to 60 ml of beer or 24 ml wine.
Estonian: See ravim sisaldab 50 mahu% veevaba etanooli (alkoholi), st kuni 2,37 g veevaba etanooli igas viaalis, mis vastab 60 ml õllele või 24 ml veinile.
English: 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).
Estonian: Ägeda müeloidse leukeemia tõttu suri jälgimisperioodil (mediaanne jälgimisaeg 8 aastat) 1 patsient (0,1%) TAC ravihaaras ja 1 patsient (0,1%) FAC ravihaaras.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Estonian: See ravim sisaldab 50 mahu% veevaba etanooli (alkoholi), st kuni 3,16 g veevaba etanooli igas viaalis, mis vastab 80 ml õllele või 32 ml veinile.
English: In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon DOCETAXEL KABI 20 mg/1 ml infusioonilahuse kontsentraadi viaalis on 20 mg/ml.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial of 6 ml equivalent to 60 ml of beer or 24 ml wine.
Estonian: See ravimpreparaat sisaldab 50 mahu% veevaba etanooli (alkohol), st kuni 2,37 g veevaba etanooli igas viaalis, mis vastab 60 ml õllele või 24 ml veinile.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Estonian: See ravimpreparaat sisaldab 50 mahu% veevaba etanooli (alkohol), st kuni 1,58 g veevaba etanooli igas viaalis, mis vastab 40 ml õllele või 17 ml veinile.
English: (G3/4: 0.4%)
Estonian: aste: 0,4%)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Estonian: See ravimpreparaat sisaldab 50 mahu% veevaba etanooli (alkohol), st kuni 3,16 g veevaba etanooli igas viaalis, mis vastab 80 ml õllele või 32 ml veinile.
English: • haemorrhage
Estonian: Kehakaalu langus
English: Tabulated list of adverse reactions in head and neck cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Estonian: Kõrvaltoimete tabel pea ja kaelapiirkonna vähi kombinatsioonravi korral DOCETAXEL KABI-ga annuses 75 mg/m2 ning tsisplatiini ja 5-fluorouratsiiliga
English: DOCETAXEL KABI 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.
Estonian: DOCETAXEL KABI 160 mg/8 ml infusioonilahuse kontsentraati EI OLE VAJA eelnevalt lahustiga lahjendada, see on juba valmis infusioonilahusesse lisamiseks.
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/ odynophagia (G3/4: 0.7%)
Estonian: aste: 1,0%); Gastrointestinaalne valu (3./4.
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Estonian: raskusastme kõrvaltoimeid (55,4%) kui paklitakseeli rühmas (23,0%).
English: One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Estonian: Doksorubitsiini (50 mg/m2) ja dotsetakseeli (75 mg/m2) kombinatsioon (AT raviharu) versus doksorubitsiini (60 mg/m2) ja tsüklofosfamiidi (600 mg/m2) kombinatsiooniga (AC raviharu) on läbi viidud üks suur juhuslikustatud III faasi uuring, kus osales 429 eelnevalt mitteravitud metastaatilise haigusega patsienti.
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a blue flip-off aluminium over seal containing 4 ml of concentrate.
Estonian: 6 ml selge, värvitu I tüüpi klaasist viaal, mis on suletud flurotec kummikorgi ja sinise äratõmmatava alumiiniumkattega ning sisaldab 4 ml kontsentraati.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine .
Estonian: See ravim sisaldab 50 mahu% veevaba etanooli (alkoholi), st kuni 1,58 g veevaba etanooli igas viaalis, mis vastab 40 ml õllele või 17 ml veinile.
English: (G3/4: 2.0%);
Estonian: aste: 4,0%);
English: Very common adverse reactions Common adverse reactions disorders
Estonian: Üldised häired ja manustamiskoha reaktsioonid
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Estonian: Trastuzumabi annuse kohandamise kohta informatsiooni saamiseks lugege trastuzumabi ravimi omaduste kokkuvõtet.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomised, multi centre open-label, phase III, study (TAX324).
Estonian: Dotsetakseeli efektiivsust ja ohutust lokaalselt levinud pea ja kaelapiirkonna lamerakk-kartsinoomi (SCCHN) induktsioonravis hinnati III faasi mitmekeskuselises avatud juhuslikustatud uuringus (TAX 324).
English: Docetaxel is a substance derived from the needles of yew trees.
Estonian: Dotsetakseel on jugapuu okastest saadav aine.
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS DOCETAXEL KABI 180 mg/9 ml infusioonilahuse kontsentraat
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Estonian: Hematoloogilise toksilisuse vähendamiseks võib profülaktiliselt manustada granulotsüütide kolooniat stimuleerivat faktorit (G-CSF).