FrancophonIA/ELRC3.0 huggingface dataset:
English: Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (intent-to-treat analysis)
Estonian: Alarühmade analüüs - lümfisõlm-siireteta rinnanäärmevähiga patsientide adjuvantravi (hinnatuna ravikavatsuse alusel)
English: You must not breast-feed while you are treated with Taxespira.
Estonian: Ravi ajal Taxespira'ga ei tohi te last rinnaga toita.
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Estonian: Asteenia (tõsine: 12,4%); Vedelikupeetus (tõsine: 0,8%); Valu
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Estonian: 65-aastastel või vanematel patsientidel oli järgnevate kõrvaltoimete (kõik raskusastmed) esinemissagedus ≥ 10% suurem kui noorematel patsientidel: letargia, stomatiit, neutropeeniline infektsioon.
English: 80mg/4 ml contains 4 ml of concentrate
Estonian: 80 mg/4 ml sisaldab 4 ml kontsentraati.
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: In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Estonian: Uuringus TAX 316 teatati amenorröast, mis algas raviperioodil ja püsis järelkontrolliperioodini pärast keemiaravi lõppu, TAC rühmas 202 patsiendil 744-st (27,2%) ja FAC rühmas 125 patsiendil 736-st (17,0%).
English: Stomatitis/Pharyngitis (G3/4:
Estonian: Stomatiit/farüngiit (G3./4.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Estonian: Dotsetakseeli haara patsiendid said 75 mg/m2 dotsetakseeli (T) intravenoosse infusioonina ravi esimesel päeval, millele järgnes tsisplatiin (P) 100 mg/m2, manustatuna 30-minutilise kuni 3-tunnise intravenoosse infusioonina ja seejärel 5-fluorouratsiil (F) 1000 mg/m2 päevas intravenoosse püsiinfusioonina
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/m 2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Estonian: Opereeritava lümfisõlm-siiretega ja lümfisõlm-siireteta rinnanäärmevähi adjuvantses ravis on dotsetakseeli soovitatav annus 75 mg/m2, manustatuna 1 tund pärast doksorubitsiini manustamist annuses 50 mg/m2 6 ravitsükli jooksul 3-nädalaste vahedega (TAC raviskeem) (vt Annuste kohandamine ravi käigus).
English: 140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel.
Estonian: 140 mg/7 ml Üks 7 ml kontsentraadi viaal sisaldab 140 mg dotsetakseeli.
English: Median PFS (months) (95% CI)
Estonian: Keskmine PFS (kuud) (95% CI)
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Estonian: Järelkontrolliperioodi lõpus (järelkontrolli mediaankestus 8 aastat) täheldati kestvat lümfiturset TAC rühma 6 patsiendil (0,8%) ja FAC rühma 1 patsiendil (0,1%).
English: Lacrimation increased Conjunctivitis
Estonian: Suurenenud pisaraeritus
English: • If you have any further questions, ask your doctor, hospital pharmacist or nurse.
Estonian: - Kui teil on lisaküsimusi, pidage nõu oma arsti, haiglaapteekri või meditsiiniõega.
English: 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Estonian: 20 mg/1 ml Üks 1 ml kontsentraadi viaal sisaldab 20 mg dotsetakseeli.
English: Taxespira 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: Taxespira kombinatsioonis trastuzumabiga on näidustatud metastaseerunud HER2-üleekspressiooniga rinnanäärmevähi raviks patsientidel, kes ei ole varem saanud keemiaravi metastaatilise haiguse raviks.
English: Taxespira 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: Taxespira kombinatsioonis doksorubitsiiniga on näidustatud lokaalselt levinud või metastaatilise rinnanäärmevähi raviks patsientidel, kes ei ole varem saanud tsütotoksilist ravi selle haiguse raviks.
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.
Estonian: Varem keemiaravi mittesaanud mitteväikerakk-kopsuvähiga patsientidele soovitatakse järgmist raviskeemi: dotsetakseeli annuses 75 mg/m2, millele koheselt järgneb tsisplatiin 75 mg/m2 kestvusega
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine.
Estonian: Ravim sisaldab mahuliselt 50% veevaba etanooli (alkoholi), st kuni 3160 mg veevaba etanooli 8 ml viaalis, mis vastab 80 ml õllele või 33 ml veinile.
English: Taxespira in combination with trastuzumab
Estonian: Taxespira kombinatsioonis trastuzumabiga
English: What Taxespira is and what it is used for 2.
Estonian: 1. Mis ravim on Taxespira ja milleks seda kasutatakse 2. Mida on vaja teada enne Taxespira kasutamist 3.
English: 1-year Survival (%)
Estonian: aste: 1%)
English: 50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
Estonian: 500 mg/m2 ja tsüklofosfamiidi annuses 500 mg/m2.
English: Hypotension (G3/4:
Estonian: Hüpotensioon (G3./4.
English: 160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel.
Estonian: 160 mg/8 ml Üks 8 ml kontsentraadi viaal sisaldab 160 mg dotsetakseeli.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Estonian: Eelneva plaatinat sisaldanud keemiaravi ebaõnnestumisel on soovitatav annus 75 mg/m
English: For patients with serum bilirubin levels > ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Estonian: Patsientidele seerumi bilirubiinisisaldusega > ULN ja/või ALT ja AST > 3,5 korra suurem kui ULN ning alkaalse fosfataasi aktiivsus > 6 korra kõrgem kui ULN, ei saa annuse vähendamist soovitada ja dotsetakseeli ei tohiks neil patsientidel kasutada, väljaarvatud juhul, kui see on rangelt näidustatud.
English: 120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
Estonian: 120 mg/6 ml Üks 6 ml kontsentraadi viaal sisaldab 120 mg dotsetakseeli.
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 patsiendi südame seisundit uurima.
English: Taxespira 20 mg/1 ml concentrate for solution for infusion
Estonian: Taxespira 20 mg/1 ml infusioonilahuse kontsentraat
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and 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: GEICAM 9805 uuringus püsis raviperioodil alanud amenorröa järelkontrolliperioodini ning selle jätkumist täheldati 18 patsiendil (3,4%) TAC rühmas ja 5 patsiendil (1,0%) FAC rühmas.
English: Peripheral sensory neuropathy Peripheral motor neuropathy
Estonian: Närvisüsteemi häired Perifeerne sensoorne neuropaatia (G3.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine.
Estonian: Ravim sisaldab mahuliselt 50% veevaba etanooli (alkoholi), st kuni 1580 mg veevaba etanooli 4 ml viaalis, mis vastab 40 ml õllele või 17 ml veinile.
English: • For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
Estonian: - Eesnäärmevähi ravis manustatakse Taxespira't kombinatsioonis prednisooni või prednisolooniga.
English: In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
Estonian: Dotsetakseeli kontsentratsioon Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml ja 160 mg/8 ml viaalis on 20 mg/ml.
English: Toxicity Diarrhoea grade 3
Estonian: 3. raskusastme stomatiit/mukosiit
English: 80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
Estonian: 80 mg/4 ml Üks 4 ml kontsentraadi viaal sisaldab 80 mg dotsetakseeli.
English: Weight decreased
Estonian: astme ALT tõus
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 TAX 316 teatati asteeniast, mis algas raviperioodil ja püsis järelkontrolliperioodini pärast keemiaravi lõppu, TAC rühmas 236 patsiendil 744-st (31,7%) ja FAC rühmas 180 patsiendil 736-st (24,5%).
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Estonian: Dotsetakseeliga ravitud patsientidel on teatatud tsüstilisest maakula ödeemist (CMO).
English: • Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Estonian: Dotsetakseeli efektiivsust ja ohutust pea ja kaelapiirkonna lamerakk-kartsinoomi (SCCHN) induktsioonravis hinnati III faasi mitmekeskuselises avatud randomiseeritud uuringus (TAX 323).
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Estonian: Infektsioonid koos 4. astme neutropeeniaga (G3./4.
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy, or liver impairment.
Estonian: Kui teil on sõltuvus alkoholist, epilepsia või maksakahjustus, rääkige sellest oma arstiga.
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, sh ventrikulaarsest tahhükardiast (mõnikord surmaga lõppev) (vt lõik 4.8).
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine.
Estonian: Ravim sisaldab mahuliselt 50% veevaba etanooli (alkoholi), st kuni 2765 mg veevaba etanooli 7 ml viaalis, mis vastab 70 ml õllele või 29 ml veinile.
English: Oesophagitis (severe:
Estonian: Ösofagiit (tõsine:
English: Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Estonian: Ösofagiit/düsfaagia/odünofaagia (G3./4.
English: Neutropenia (G3/4:
Estonian: Neutropeenia (G3./4.
English: No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Estonian: Dotsetakseeli kasutamise kohta maksakahjustusega patsientidel kombinatsioonravi osana teistel näidustustel puuduvad andmed.
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Estonian: Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti, haiglaapteekri või meditsiiniõega.
English: In study TAX316, peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Estonian: Uuringus TAX 316 algas perifeerne sensoorne neuropaatia raviperioodil ja püsis järelkontrolliperioodil TAC rühma 84 patsiendil (11,3%) ja FAC rühma 15 patsiendil (2%).
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine.
Estonian: Ravim sisaldab mahuliselt 50% veevaba etanooli (alkoholi), st kuni 395 mg veevaba etanooli 1 ml viaalis, mis vastab 10 ml õllele või 4 ml veinile.
English: Taxespira in combination with capecitabine
Estonian: Taxespira kombinatsioonis kapetsitabiiniga
English: G3/4 Blood bilirubin increased (<2.5%);
Estonian: astme bilirubiinisisalduse tõus veres (< 5%);
English: Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Estonian: Taxespira on näidustatud lokaalselt levinud või metastaatilise mitteväikerakk-kopsuvähi raviks eelneva keemiaravi ebaõnnestumisel.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Estonian: Kõrvaltoimete tabel mitteväikerakk-kopsuvähi monoteraapia korral Taxespira'ga annuses 75 mg/m
English: Peripheral sensory neuropathy (G3: 0.4%)
Estonian: Perifeerne sensoorne neuropaatia (G3./4.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
Estonian: Ravim sisaldab mahuliselt 50% veevaba etanooli (alkoholi), st kuni 2370 mg veevaba etanooli 6 ml viaalis, mis vastab 60 ml õllele või 25 ml veinile.
English: MedDRA system organ classes Very common adverse reactions Common adverse reactions Blood and lymphatic system disorders
Estonian: MedDRA organsüsteemi klass Väga sagedased kõrvaltoimed Sagedased kõrvaltoimed Vere ja lümfisüsteemi häired Neutropeenia (G3./4.
English: Diarrhoea (G3/4:
Estonian: Diarröa (G3./4.
English: 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Estonian: 750 mg/m päevas püsiinfusioonina 5 päeva (TPF).
English: As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Estonian: - Sarnaselt kõigi parenteraalselt manustatavate preparaatidega tuleb infusioonilahust enne kasutamist visuaalselt kontrollida.
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/m 2 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 (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: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).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).
Estonian: Relapsi risk langes TAC ravihaara patsientidel 32%, võrreldes FAC ravihaara patsientidega (riskide suhe = 0,68; 95% CI: 0,49...0,93; p=0,01).
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Estonian: Kõrvaltoimete valikuline kirjeldus mao adenokartsinoomi kombinatsioonravi korral Taxespira'ga annuses 75 mg/m² ning tsisplatiini ja 5-fluorouratsiiliga
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%).
Estonian: TAX 316 uuringu TAC rühma 687 patsiendil 744-st (92,3%) ja FAC rühma 645 patsiendil 736-st (87,6%) oli püsiv alopeetsia pärast keemiaravi lõppu kuni järelkontrolliperioodini.
English: 75 mg/m2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Estonian: Dotsetakseeli soovitatav annus on 75 mg/m2, manustatuna 1-tunnise infusioonina, millele järgneb tsisplatiin 75 mg/m2, manustatuna 1…3-tunnise infusioonina (mõlemad 1. päeval), millele järgneb 5-fluorouratsiil 750 mg/m2 päevas, manustatuna 5 päeva 24-tunnise püsiinfusioonina, mis algab pärast tsisplatiini infusiooni lõppu.
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: A multicenter, open-label, randomized 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.
Estonian: Dotsetakseeli efektiivsust ja ohutust metastaatilise mao adenokartsinoomi, sh gastroösofageaalliidese adenokartsinoomi ravis patsientidel, kes ei olnud varem saanud keemiaravi metastaatilise haiguse raviks, hinnati paljukeskuselises avatud randomiseeritud uuringus.
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 asteenia püsis järelkontrolliperioodini ning selle jätkumist täheldati 12 patsiendil (2,3%) TAC rühmas ja 4 patsiendil (0,8%) FAC rühmas.
English: Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Estonian: Taxespira 20 mg/1 ml infusioonilahuse kontsentraat Taxespira 80 mg/4 ml infusioonilahuse kontsentraat Taxespira 120 mg/6 ml infusioonilahuse kontsentraat Taxespira 140 mg/7 ml infusioonilahuse kontsentraat Taxespira 160 mg/8 ml infusioonilahuse kontsentraat
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 järelkontrolliperioodil 1 patsient (0,1%) TAC rühmas ja 1 patsient (0,1%) FAC rühmas.
English: Taxespira 80 mg/4 ml concentrate for solution for infusion.
Estonian: Taxespira 80 mg/4 ml infusioonilahuse kontsentraat
English: Lacrimation increased (G3/4:
Estonian: Suurenenud pisaravool (G3./4.
English: • hair loss: in most cases normal hair growth should return.
Estonian: iiveldus, oksendamine ja kõhulahtisus, kõhukinnisus - kõhuvalu - seedehäire - juuste väljalangemine (enamusel juhtudest peaks normaalne juuksekasv taastuma); mõnikord
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Estonian: aste: 0,3%); Müalgia (G3./4.
English: Psychiatric disorders Nervous system disorders
Estonian: Närvisüsteemi häired Perifeerne sensoorne
English: One large randomized 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: Taxespira kombinatsioonis doksorubitsiiniga Doksorubitsiini (50 mg/m2) kombinatsioon (AT raviharu) versus doksorubitsiini (60 mg/m2) ja tsüklofosfamiidi (600 mg/m2) kombinatsiooniga (AC raviharu) on läbi viidud üks suur randomiseeritud III faasi uuring, kus osales 429 eelnevalt mitteravitud metastaatilise haigusega patsienti.
English: Arrhythmia (G3/4:
Estonian: Kõhukinnisus (G3./4.
English: Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Estonian: Taxespira 80 mg/4 ml infusioonilahuse kontsentraat Taxespira 120 mg/6 ml infusioonilahuse kontsentraat Taxespira 140 mg/7 ml infusioonilahuse kontsentraat Taxespira 160 mg/8 ml infusioonilahuse kontsentraat
English: PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION
Estonian: TAXESPIRA INFUSIOONILAHUSE KONTSENTRAADI KASUTUSJUHIS
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Estonian: aste: 0,6%); Köha (G3./4.
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Estonian: aste: 1,2%); Düsgeusia (G3./4.
English: Taxespira has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
Estonian: Teie arst määras teile Taxespira rinnanäärme vähi, kopsuvähi erivormi (mitteväikerakk-kopsuvähk), eesnäärmevähi, maovähi või pea ja kaelapiirkonna vähi raviks: - Kaugelearenenud rinnanäärmevähi raviks võib Taxespira't manustada kas üksinda, kombinatsioonis doksorubitsiiniga, kombinatsioonis trastuzumabiga või kombinatsioonis kapetsitabiiniga.
English: • For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Estonian: - Kopsuvähi raviks võib Taxespira't manustada kas üksinda või kombinatsioonis tsisplatiiniga.
English: In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Estonian: Uuringus GEICAM 9805 algas perifeerne sensoorne neuropaatia raviperioodil ja jätkus järelkontrolliperioodil TAC rühma 10 patsiendil (1,9%) ja FAC rühma 4 patsiendil (0,8%).
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 TAX 316 teatati lümfitursest, mis algas raviperioodil ja püsis järelkontrolliperioodini pärast keemiaravi lõppu, TAC rühmas 11 patsiendil 744-st (1,5%) ja FAC rühmas 1 patsiendil 736-st (0,1%).
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC
Estonian: *riskide suhe alla 1 näitab, et haigusvaba ja üldine elulemus TAC ravihaaras on pikemad kui FAC ravihaaras.