natgillin/translations-raw huggingface dataset:
Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥80%, between 18 and 70 years of age. 
Podatki multicentrične, odprte randomizirane študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80 %.
120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg). 
120 mg/6 ml Ena 6 ml viala koncentrata vsebuje 3 ml brezvodnega etanola (2370 mg).
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5. 
Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji 1. dan in nato stalno intravensko infuzijo 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 5. dneva.
Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value 
Najboljši celotni odziv (CR + PR) na kemoterapijo (%) (95 % IZ) ***Vrednost p
Neutropenic complications 
Nevtropenični zapleti
Blood and lymphatic system disorders neutropenia 
Bolezni krvi in limfatičnega sistema febrilna nevtropenija
In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years. 
V obeh krakih so bolnice s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji po zadnjem ciklu kemoterapije do 5 let dobivale tamoksifen 20 mg na dan. Adjuvantna radioterapija je bila predpisana v skladu z veljavnimi smernicami v sodelujočih ustanovah.
What Taxespira looks like and contents of the pack 
Izgled zdravila in vsebina pakiranja
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69 % of patients who received TAC and 72% of patients who received FAC. 
Dobilo jo je 69 % bolnic, ki so prejemale TAC, in 72 % bolnic, ki so prejemale FAC.
• alteration in sense of taste 
• spremenjeno okušanje
Patients previously treated with chemotherapy with or without radiotherapy In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care. 
Bolniki, predhodno zdravljeni s kemoterapijo z radioterapijo ali brez nje V študiji III. študije pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim.
4.2 Posology and method of administration 
4.2 Odmerjanjein način uporabe
Patients with renal impairment There are no data available in patients with severely impaired renal function treated with docetaxel. 
Bolniki z okvaro ledvic O zdravljenju z docetakselom pri bolnikih s hudo okvaro ledvic ni podatkov.
Patients with severe liver impairment (see sections 4.2 and 4.4). 
Bolniki s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
Constipation (severe: 0.2%); Abdominal pain (severe: 1%); 
zaprtje (hudo 0,2 %), bolečine v trebuhu (hude 1 %), gastrointestinalna krvavitev (huda 0,3 %)
combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period. 
V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m 2 na tri tedne, kombiniran s kapecitabinom 1.250 mg/m2 dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
Gastrointestinal haemorrhage (severe: 
vnetje požiralnika (hudo:
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. 
Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5fluorouracila (F) 1000 mg/m2/dan od 1. do 4. dneva.
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients and 4 FAC patients (0.5%). 
Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) je v kraku TAC periferne edeme še vedno imelo 19 bolnic, v kraku FAC pa 4 bolnice (0,5 %).
OS at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002). 
Tudi celotno preživetje pri 10 letih je bilo značilno povečano pri TAC v primerjavi z FAC (76 % proti 69 %) t.j.
• muscle aches and pains; back pain or bone pain 
• bolečine v mišicah, bolečine v hrbtu ali kosteh
160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg). 
160 mg/8 ml Ena 8 ml viala koncentrata vsebuje 4 ml brezvodnega etanola (3160 mg).
• 92 patients treated with docetaxel in combination with trastuzumab. 
• 92 bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom.
Dyspepsia (G3/4: 
dispepsija (S3/4:
Myocardial ischemia (G3/4:1.7%) 
Srčne bolezni miokardna ishemija (S3/4:1,7 %)
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. 
Zdravilo Taxespira v kombinaciji s cisplatinom je indicirano za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500cells/mm 3 and platelets recover to a level >100,000 cells/mm 3. 
Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm
The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (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. 
vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali raztopina 9 mg/ml (0,9%) natrijevega klorida za infundiranje
80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg). 
80 mg/4 ml Ena 4 ml viala koncentrata vsebuje 2 ml brezvodnega etanola (1580 mg).
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm 
Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm
Distribution Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml. 
Po aplikaciji odmerka 100 mg/m µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C. 
Dokazano je bilo, da je v skladu z navodili pripravljena infuzijska raztopina v infuzijskih vrečkah, ki ne vsebujejo PVC, med uporabo kemijsko in fizikalno stabilna do 48 ur pri temperaturi od 2-8 °C.
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%). 
Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajoč limfedem opažali pri 6 bolnicah v kraku TAC (0,8 %) in pri 1 bolnici v kraku FAC (0,1 %).
This regimen is administered every 3 weeks for 3 cycles. 
Ta terapevtska shema se uporablja vsake 3 tedne po 3 cikluse.
How to store Taxespira 
Shranjevanje zdravila Taxespira
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy. 
Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek: 818,9 mg/m2), kot pri tistih, ki je ne
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. 
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.
There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide. 
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah, starih > 70 let, je malo.
Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Zdravilo Taxespira v kombinaciji s kapecitabinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
• If you have any further questions, ask your doctor, hospital pharmacist or nurse. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, bolnišničnimfarmacevtomali medicinsko sestro.
Docetaxel is a substance derived from the needles of yew trees. 
Docetaksel je snov, pridobljena iz iglic tise.
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. 
Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
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. 
V vialah zdravila Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml in 160 mg/8 ml je koncentracija docetaksela 20 mg/ ml.
If you get any side effects talk to your doctor, hospital pharmacist or nurse. 
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
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 
CP je bilo značilno daljše (log-rang test, p = 0,0058) pri shemi z docetakselom kot s PF (mediano CP: shema z docetakselom 70,6, PF 30,1 meseca).
Toxicity Diarrhoea grade 3 
stomatitis/mukozitis 3. stopnje
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 
Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje Taxespira 80 mg/4 ml koncentrat za raztopino za infundiranje Taxespira 120 mg/6 ml koncentrat za raztopino za infundiranje Taxespira 140 mg/7 ml koncentrat za raztopino za infundiranje Taxespira 160 mg/8 ml koncentrat za raztopino za infundiranje
Taxespira 140 mg/7 ml concentrate for solution for infusion. 
Taxespira 140 mg/7 ml koncentrat za raztopino za infundiranje docetaksel
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients 
Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC
80mg/4 ml contains 4 ml of concentrate 
80 mg/4 ml vsebuje 4 ml koncentrata.
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). 
Namen tega je minimaliziranje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Taxespira , zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
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. 
Zdravilo Taxespira je indicirano 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.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him the results of your blood tests. 
Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. 
Zdravilo Taxespira je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). 
Pomožne snovi z znanim učinkom20 mg/1 ml Ena 1 ml viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
• operable node-negative breast cancer. 
• z operabilnimrakom dojke z negativnimi bezgavkami.
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%). 
V študiji TAX316 so amenorejo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 202 od 744 bolnic v kraku TAC (27,2 %) in pri 125 od 736 bolnic v kraku FAC (17,0 %).
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). 
Pri bolnikih, zdravljenih z docetakselom v kombiniranih shemah, ki so vključevale doksorubicin, 5fluorouracil in/ali ciklofosfamid, so poročali o prekatnih motnjah srčnega ritma, vključno s prekatno tahikardijo (včasih s smrtnim izidom) (glejte poglavje 4.8).
Full analysis set (intent-to-treat) 
celotna množica za analizo (z-namenom-zdravljenja) ocenjeno mediano preživetje
Ethanol (anhydrous) Citric acid monohydrate 
6.1 Seznam pomožnih snovi polisorbat 80 etanol (brezvodni) citronska kislina monohidrat
Myalgia (G3/4: 0.6%) 
aritmija (S3/4: 0,6 %)
Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%) 
omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4:
• operable node-positive breast cancer 
• z operabilnimrakom dojke s pozitivnimi bezgavkami
Taxespira 160 mg/8 ml concentrate for solution for infusion. 
Taxespira 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
Docetaxel 
C-docetakselom.
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years. 
V obeh krakih so bolnice s tumorji, ki so imeli pozitivne ER in/ali PgR, po zadnjem ciklusu kemoterapije do 5 let prejemale tamoksifen 20 mg enkrat na dan. Adjuvantna radioterapija je bila uporabljenav skladu z veljavnimi smernicami v sodelujočih ustanovah.
Taxespira in combination with platinum agents in chemotherapy-naïve patients In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over 
V študiji III. faze so 1.218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, randomizirali v tri skupine.
Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); 
Splošne težave in spremembe na mestu aplikacije astenija (huda: 8,1 %), zastajanje tekočine (hudo: 1,2 %), bolečine reakcija na mestu infundiranja
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks. 
Zdravilo Taxespira v monoterapiji Z docetakselom sta bili v priporočenem odmerku in shemi 100 mg/m2 na 3 tedne opravljeni dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
Peripheral motor neuropathy (G3/4: 
Bolezni živčevja periferna motorična nevropatija (S3/4:
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. 
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 3160 mg brezvodnega etanola na 8 ml vialo, kar ustreza 80 ml piva oziroma 33 ml vina.
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. 
Zdravilo Taxespira v kombinaciji z doksorubicinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
Metabolism and nutrition disorders Nervous system disorders 
Presnovne in prehranske motnje Bolezni živčevja
Taxespira 120 mg/6 ml concentrate for solution for infusion. 
Taxespira 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%. 
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
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). 
z 12 %, p < 0,0001), podaljšal čas do napredovanja (19 tednov v prim.
140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel. 
140 mg/7 ml Ena viala s 7 ml koncentrata vsebuje 140 mg docetaksela.
Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%) 
Infekcijskein parazitske bolezni okužbe (S3/4: 5 %) Bolezni krvi in limfatičnega sistema nevtropenija (S4: 54,2 %), anemija (S3/4: 10,8 %), trombocitopenija (S4: 1,7 %)
For trastuzumab dose modifications, see trastuzumab summary of product characteristics. 
Za prilagajanje odmerka trastuzumaba glejte povzetek glavnih značilnosti trastuzumaba.
Uncommon (may affect up to 1 in 100 people): 
Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov):
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). 
Prejemnice TAC so imele 32 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti 0,68, 95 % IZ (0,49-0,93), p = 0,01).
Preparation of the infusion solution 
Priprava infuzijske raztopine
160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel. 
160 mg/8 ml Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
Statistical analysis 
FARMACEVTSKI PODATKI
20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel. 
20 mg/1 ml 1 viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
Reproductive system and breast disorders 
Motnje reprodukcije in bolezni dojk
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab 
Opis izbranih neželenih učinkov zdravljenja z zdravilom Taxespira 100 mg/m 2 pri raku dojke v kombinaciji s trastuzumabom
Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 pri raku prostate v kombinaciji s prednizonom ali prednizolonom
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. 
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 2765 mg brezvodnega etanola na 7 ml vialo, kar ustreza 70 ml piva oziroma 29 ml vina.
Taxespira 80 mg/4 ml concentrate for solution for infusion. 
Taxespira 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4: 
hipotenzija (S3/4: 0 %) flebitis (S 3/4: 0 %)
Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 
Adenokarcinom želodca Priporočeni odmerek docetaksela je 75 mg/m 2 v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m 2 v 1- do 3
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. 
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 395 mg brezvodnega etanola na 1 ml vialo, kar ustreza 10 ml piva ali 4 ml vina.
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. 
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 1580 mg brezvodnega etanola na 4 ml vialo, kar ustreza 40 ml piva oziroma 17 ml vina.
(G3/4: 0%) 
(S3/4: 14,3 %)
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. 
V študiji TAX316 se je pri 84 bolnicah (11,3 %) v kraku TAC in pri 15 bolnicah (2 %) v kraku FAC med zdravljenjem pojavila periferna senzorična nevropatija, ki je trajala še med obdobjem spremljanja.
Lacrimation increased Conjunctivitis 
Očesne bolezni močnejše solzenje konjunktivitis
Taxespira 20 mg/1 ml concentrate for solution for infusion 
Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
• heart failure 
• srčno popuščanje
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%). 
Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajočo astenijo opažali pri 29 bolnicah v kraku TAC (3,9 %) in pri 16 bolnicah v kraku FAC