FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovak: Taxespira v kombinácii s doxorubicínom je indikovaná na liečbu pacientok s lokálne pokročilým alebo metastatickým karcinómom prsníka, ktoré sa predtým nepodrobili cytotoxickej liečbe tohto stavu.
English: Cough (G3/4: 0%)
Slovak: Kašeľ (G3/4: 0%)
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Slovak: Ženám vo fertilnom veku liečeným docetaxelom sa má odporúčať, aby neotehotneli.
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.
Slovak: V kombinácii s cisplatinou a 5-fluóruracilom, na liečbu pacientov s adenokarcinómom žalúdka, boli z pivotnej klinickej štúdie vylúčení pacienti s hladinou ALT a/alebo AST >1,5-násobok ULN v spojení s hladinou alkalickej fosfatázy >2,5-násobok ULN a hladinou bilirubínu >1-násobok ULN.
English: 50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
Slovak: alebo na liečbu doxorubicínom v dávke 50 mg/m 2, po ktorom nasleduje fluóruracil v dávke 500 mg/m a cyklofosfamid v dávke 500 mg/m2 (FAC rameno).
English: Docetaxel increased response rate (33% vs. 12%, p <0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged OS (11 months vs. 9 months, p = 0.01).
Slovak: 0,0001), čas do progresie sa predĺžil (19 týždňov oproti 11 týždňom, p =
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Slovak: Docetaxel sa má znovu podať až po zvýšení počtu neutrofilov na hladinu ≥ 1 500 buniek/mm
English: Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovak: Taxespira je indikovaná na liečbu pacientov s lokálne pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc po zlyhaní predchádzajúcej chemoterapie.
English: • pain in the joints or muscles
Slovak: • pocit zníženej citlivosti alebo pichania, či bolesti kĺbov alebo svalov
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.
Slovak: Pacientom v skupine s docetaxelom sa podávala intravenózna infúzia 75 mg/m2 docetaxelu (T) v 1. deň, po ktorej nasledovala cisplatina (P) v dávke 100 mg/m2 podávaná vo forme 30-minútovej až 3-hodinovej intravenóznej infúzie a potom nasledovala kontinuálna intravenózna infúzia 5-fluóruracilu (F) v dávke 1 000 mg/m2/deň
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Slovak: Docetaxel sa vylúčil v priebehu 7 dní močom a stolicou po oxidačnej metabolizácii terciárnej butylesterovej skupiny, sprostredkovanej cytochrómom P450.
English: Each 1 ml of concentrate contains 20 mg docetaxel (as trihydrate).
Slovak: Každý 1 ml of koncentrátu obsahuje 20 mg docetaxelu (vo forme trihydrátu).
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
Slovak: 0 %); Neurotoxicita (G3/4: 0
English: Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Slovak: Injekčné liekovky s obsahom 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml a160 mg/8 ml sú dostupné v baleniach obsahujúcich 1 injekčnú liekovku.
English: Uncommon adverse reactions
Slovak: nežiaduce reakcie
English: Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Slovak: Každý ml infúzneho koncentrátu obsahuje 20 mg docetaxelu (vo forme trihydrátu).
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Slovak: Ak sa následne vyskytnú epizódy komplikovanej neutropénie, dávka docetaxelu sa má znížiť zo 60 na 45 mg/m V prípade trombocytopénie 4. stupňa sa má dávka docetaxelu znížiť zo 75 na 60 mg/m2.
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.
Slovak: Taxespira v kombinácii s trastuzumabom je indikovaná na liečbu pacientok s metastatickým karcinómom prsníka, u ktorých nádory nadmerne exprimujú HER2, a ktoré sa predtým nepodrobili chemoterapii pre metastatické ochorenie.
English: Preparation for the intravenous administration
Slovak: Príprava pre intravenózne podanie
English: Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Slovak: 0,38) alebo čas do progresie (docetaxel 27 týždňov oproti doxorubicínu 23 týždňov, p =
English: Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovak: Taxespira v monoterapii je indikovaná na liečbu pacientok s lokálne pokročilým alebo metastatickým karcinómom prsníka po zlyhaní cytotoxickej terapie.
English: 1,000 mg/m2 per day for 5 days.
Slovak: 5-fluóruracil v dávke 1 000 mg/m2 (PF) denne počas 5 dní.
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Slovak: Preto sa počas gravidity docetaxel nemá podávať, pokiaľ klinický stav ženy nevyžaduje liečbu docetaxelom.
English: G3/4 Blood bilirubin increased (<2%)
Slovak: G3/4 vzostup bilirubínu v krvi (<
English: 80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
Slovak: 80 mg/4 ml Každá 4 ml injekčná liekovka koncentrátu obsahuje 2 ml bezvodého etanolu (1 580 mg).
English: EU/1/15/1017/001 EU/1/15/1017/002 EU/1/15/1017/003 EU/1/15/1017/004 EU/1/15/1017/005
Slovak: EU/1/15/1017/005
English: 80mg/4 ml contains 4 ml of concentrate
Slovak: 80 mg/4 ml obsahuje 4 ml koncentrátu.
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.
Slovak: % bezvodého etanolu (alkohol), t.j. do 1 580 mg bezvodého etanolu v 4 ml injekčnej liekovke, čo zodpovedá 40 ml piva alebo 17 ml vína.
English: Vial label
Slovak: Koncový ukazovateľ
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%).
Slovak: V štúdii TAX316 sa u 687 zo 744 pacientov (92,3
English: Both regimens were administered on day 1 every 3 weeks.
Slovak: V obidvoch režimoch sa lieky podávali v 1. deň každé
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm 3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m 2 to 75 mg/m 2 and/or from 75 to
Slovak: 3 dlhšie ako jeden týždeň alebo u nich nastali závažné či kumulatívne kožné reakcie alebo závažná periférna neuropatia, má sa znížiť dávka docetaxelu zo 100 mg/m2 na
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovak: Ak dôjde ku kontaktu so sliznicami, ihneď dôkladne umyte postihnuté miesto vodou.
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.
Slovak: U pacientov s hladinou sérového bilirubínu vyššou ako ULN, a/alebo ak ALT a AST sú vyššie ako 3,5-násobok ULN a súčasne alkalická fosfatáza vyššia ako 6násobok ULN, nemožno odporučiť ani zníženie dávky a mimo striktne odôvodnené prípady docetaxel nie je možné podávať.
English: How to use Taxespira
Slovak: Ako uchovávať Taxespiru
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.
Slovak: V injekčnej liekovke Taxespiry 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml,140 mg/7 ml a 160 mg/8 ml je obsah docetaxelu 20 mg/ml.
English: Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Slovak: Taxespira v kombinácii s cisplatinou je indikovaná na liečbu pacientov s neoperovateľným, lokálne pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc, ktorí sa predtým nepodrobili chemoterapeutickej liečbe tohto stavu.
English: 120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
Slovak: 120 mg/6 ml Každá 6 ml injekčná liekovka koncentrátu obsahuje 3 ml bezvodého etanolu (2 370 mg).
English: Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Slovak: Prieskumná analýza sa vykonala u pacientok s dlhším prežívaním bez ochorenia, ktoré spĺňajú kritéria chemoterapie 2009 St.
English: Myocardial ischemia (G3/4:1.7%)
Slovak: Ischémia myokardu (v 1,7
English: The concentrate is a pale yellow to brownish-yellow solution.
Slovak: Koncentrát je matný, žltý až hnedožltý roztok.
English: Cis + 5-FU
Slovak: Cis+5-FU n =
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Slovak: 1/10 000, < 1/1 000); veľmi zriedkavé ( <
English: Eye disorders Respiratory, thoracic and mediastinal disorders
Slovak: Poruchy dýchacej sústavy, hrudníka a mediastína
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Slovak: Tieto reakcie sa opisujú pomocou NCI Common Toxicily Criteria (obvyklé kritéria toxicity) (3. stupeň =
English: Peripheral motor neuropathy (G3/4:
Slovak: Periférna motorická neuropatia (G3/4: 0
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.
Slovak: Odporúčaná dávka je 75 mg/m2 docetaxelu vo forme jednohodinovej infúzie, po ktorej nasleduje dávka 75 mg/m2 cisplatiny vo forme 1 až 3-hodinovej infúzie (obidva lieky len v 1. deň, potom nasleduje 5-fluóruracil v dávke 750 mg/m2 denne, podávaný vo forme 24-hodinovej kontinuálnej infúzie počas 5 dní, začínajúca na konci podania infúzie cisplatiny.
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).
Slovak: U pacientov liečených docetaxelom v kombinovaných režimoch, ktoré zahŕňajú doxorubicín, 5fluórouracil a/alebo cyklofosfamid (pozri časť 4.8), bola hlásená ventrikulárna arytmia vrátane ventrikulárnej tachykardie (niekedy fatálnej).
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Slovak: Ak teraz užívate alebo ste v poslednom čase užívali ďalšie lieky, vrátane liekov, ktorých výdaj nie je viazaný na lekársky predpis, oznámte to, prosím, svojmu lekárovi alebo nemocničnému lekárnikovi.
English: • chest tightness; difficulty in breathing
Slovak: tlak na hrudníku, ťažkosti pri dýchaní
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Slovak: %) Vzostup alkalickej fosfatázy v krvi G3/4 (0,3
English: • 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent
Slovak: 1 312 pacientov, ktorým sa podával docetaxel v monoterapii v dávke 100 mg/m2 a u 121
English: Number of patients
Slovak: Osobitné skupiny pacientov
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Slovak: Existuje potenciálne nebezpečenstvo významnej interakcie, preto si súbežná liečba pacientov týmito liečivami vyžaduje zvýšenú opatrnosť.
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab
Slovak: Opis vybraných nežiaducich účinkov pri karcinóme prsníka pre Taxespiru 100 mg/m² v kombinácii s trastuzumabom
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Slovak: Počas liečby a v odbobí ďalšieho sledovania sa majú u pacientok monitorovať symptómy kongestívneho zlyhávania srdca.
English: Taxespira 20 mg/1 ml concentrate for solution for infusion
Slovak: Taxespira 20 mg/1 ml infúzny koncentrát
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.
Slovak: Na indukčnú liečbu neoperovateľného, lokálne pokročilého, skvamocelulárneho karcinómu hlavy a krku (squamous cell carcinoma of the head and neck, SCCHN) sa odporúča dávka 75 mg/m docetaxelu vo forme jednohodinovej infúzie, po ktorej nasleduje dávka 75 mg/m2 cisplatiny vo forme 1- hodinovej infúzie v 1. deň, potom nasleduje 5-fluóruracil v dávke 750 mg/m2 denne vo forme kontinuálnej infúzie počas 5 dní.
English: The primary efficacy endpoint in this study, OS was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6
Slovak: Primárny koncový ukazovateľ účinnosti v tejto štúdii, celkové prežívanie (OS, overall survival), bol významne dlhší (log-rank test, p =
English: EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Slovak: EU/1/15/1017/005 160 mg/8 ml injekčná liekovka
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).
Slovak: % zníženie rizika relapsu v porovnaní s pacientkami liečenými FAC (hazard ratio = 0,84, 95 % IS (0,49-0,93), p =
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%).
Slovak: Na konci sledovaného obdobia (aktuálny medián času sledovania 8 rokov) sa pozorovalo pretrvávanie lymfoedému u 6 pacientov (0,8
English: • if the number of your white blood cells is too low.
Slovak: (uvedených v časti 6). - ak máte znížený počet bielych krviniek - ak máte závažné ochorenie pečene.
English: The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months.
Slovak: 0,0042) v skupine TPF (medián PFS: 11,4 mesiacov) v porovnaní so skupinou PF (medián PFS: 8,3 mesiacov)
English: G3/4 Blood alkaline phosphatase increased
Slovak: %) Vzostup alkalickej fosfatázy v krvi G3/4
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
Slovak: Taxespira 20 mg/1 ml infúzny koncentrát Taxespira 80 mg/4 ml infúzny koncentrát Taxespira 120 mg/6 ml infúzny koncentrát Taxespira 140 mg/7 ml infúzny koncentrát Taxespira 160 mg/8 ml infúzny koncentrát
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.
Slovak: % bezvodého etanolu (alkohol), t.j. do 2 370 mg bezvodého etanolu v 6 ml injekčnej liekovke, čo zodpovedá 60 ml piva alebo 25 ml vína.
English: 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovak: s bezprostredne podanou cisplatinou (Cis) v dávke 75 mg/m 2 počas 30 − 60 minút každé tri týždne, na liečbu docetaxelom v dávke 75 mg/m 2 v jednohodinovej infúzii v kombinácii s karboplatinou (AUC 6 mg/ml.min) počas 30 − 60 minút každé 3 týždne alebo na liečbu vinorelbínom (V) v dávke 25 mg/m 2 počas 6 −
English: Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Slovak: Stratifikovaný log-rank test *Prah štatistickej významnosti =
English: Disease free survival Hazard ratio*
Slovak: Prežívanie bez ochorenia Hazard ratio
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Slovak: Informácie o úprave dávkovania cisplatiny sú uvedené v súhrne charakteristických vlastností od jej výrobcu.
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
Slovak: Taxespira 80 mg/4 ml infúzny koncentrát Taxespira 120 mg/6 ml infúzny koncentrát Taxespira 140 mg/7 ml infúzny koncentrát Taxespira 160 mg/8 ml infúzny koncentrát docetaxel
English: 140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel.
Slovak: 140 mg/7 ml Jedna injekčná liekovka s objemom 7 ml koncentrátu obsahuje 140 mg docetaxelu.
English: See section 4.
Slovak: (Pozri časť 4.4).
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%)patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Slovak: Po 10 rokoch sledovania v štúdii GEICAM 9805 sa vyskytla akútna leukémia u 1 z 532 (0,2
English: Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Slovak: Ezofagitída/dysfágia/ odynofágia (v 0,6 % G3/4)
English: EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Slovak: EU/1/15/1017/003 120 mg/6 ml injekčná liekovka
English: G3/4 Blood bilirubin increased (2.1%);
Slovak: Vzostup bilirubínu v krvi G3/4 (2,1
English: 160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel.
Slovak: 160 mg/8 ml Jedna injekčná liekovka s objemom 8 ml koncentrátu obsahuje 160 mg docetaxelu.
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Slovak: Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa na svojho lekára alebo zdravotnú sestru.
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p <0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Slovak: 0,10), docetaxel predlžoval medián času do progresie (24,6 týždňov oproti 15,6 týždňov, p <
English: Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Slovak: Modelové farmakokinetické parametre sa veľmi blížili parametrom stanoveným na základe štúdií fázy I. Farmakokinetika docetaxelu sa nemenila s vekom alebo pohlavím pacienta.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Slovak: Opis vybraných nežiaducich účinkov pri adenokarcinóme žalúdka pre Taxespiru 75 mg/m² v kombinácii s cisplatinou a 5-fluóruracilom
English: EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
Slovak: EU/1/15/1017/004 140 mg/7 ml injekčná liekovka
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxespira administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Taxespira in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovak: Minimalizujú sa tým určité nežiaduce účinky, ktoré môžu nastať po infúzii Taxespiry, najmä alergické reakcie a zadržiavanie tekutín (opuch rúk, nôh, ramien alebo prírastok hmotnosti).
English: 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Slovak: 20 mg/1 ml Jedna injekčná liekovka s obsahom 1 ml koncentrátu obsahuje 20 mg docetaxelu.
English: Pfizer Kft. Tel: + 36 1 488 37 00
Slovak: Tel: + 36 1 488 37 00
English: 160mg/8 ml One vial of 8 ml concentrate contains 160 mg docetaxel.
Slovak: 160 mg/8 ml Jedna injekčná liekovka s obsahom 8 ml koncentrátu obsahuje 160 mg docetaxelu.
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.
Slovak: %) v ramene FAC.V štúdii GEICAM 9805 periférna senzorická neuropatia, ktorá sa objavila počas liečebného obdobia, pretrvávala počas sledovaného obdobia u 10 pacientov (1,9
English: In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10 % higher in patients who were 65 years of age or greater compared to younger patients.
Slovak: U pacientov liečených docetaxelom každé tri týždne bol výskyt súvisiacich zmien na nechtoch o ≥
English: 140mg/7 ml One vial of 7 ml concentrate contains 140 mg docetaxel.
Slovak: 140 mg/7 ml Jedna injekčná liekovka s obsahom 7 ml koncentrátu obsahuje 140 mg docetaxelu.
English: • blood clots.
Slovak: • krvné zrazeniny.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab
Slovak: Tabuľkový súhrn nežiaducich účinkov pri karcinóme prsníka pre Taxespiru 100 mg/m² v kombinácii s trastuzumabom
English: Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovak: Tabuľkový súhrn nežiaducich účinkov pri karcinóme hlavy a krku pre Taxespiru 75 mg/m² v kombinácii s cisplatinou a 5-fluóruracilom
English: • For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
Slovak: Rakoviny prostaty; Taxespira sa používa v kombinácii s prednizónom alebo prednizolónom.
English: Hypotension (G3/4:
Slovak: Hypotenzia (G3/4: 0