natgillin/translations-raw huggingface dataset:
• The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
• Viala zdravila TAXOTERE 80 mg/2 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Koncentrat je opremljen v 15-ml prozorni brezbarvni viali iz stekla tipa I z modro aluminijasto zaporko in z modro dvižno zaporko.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
• operable node-negative breast cancer .
• operabilnim rakom dojke z negativnimi bezgavkami.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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 TAXOTERE, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
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 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.
Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
biokemičnega neuspeha (opredeljenega kot zvišanje PSA za 50 % nad 24-tedensko obdobje znotraj najnižje vrednosti in nad 4 ng/ml ter potrjenega s ponovnim testiranjem ali z zdravljenjem); napredovanja bodisi lokalno, v bezgavkah ali oddaljenih metastaz; skeletnega dogodka; smrti zaradi raka prostate.
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
VIAL/TAXOTERE 20 mg/0.5 ml
VIALA/TAXOTERE 20 mg/0,5 ml
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 33 ml wine.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 3,16 g brezvodnega etanola na vialo; kar ustreza 80 ml piva ali 33 ml vina.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.
- Pomožni snovi sta polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina.
VIAL LABEL / TAXOTERE 20 mg/1 ml
NALEPKA NA VIALI/TAXOTERE 20 mg/1 ml
• oral candidiasis
• oralna kandidoza
The concentrate is supplied in a 7 ml clear colourless glass vial with a green aluminium seal and a green plastic flip-off cap.
Koncentrat je opremljen v 7-ml prozorni brezbarvni viali iz stekla tipa I z zeleno aluminijasto zaporko in z zeleno dvižno zaporko.
SOLVENT for TAXOTERE
Shranjevanje zdravila TAXOTERE
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
En ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela.
• Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml).
• Ena viala zdravila TAXOTERE 80 mg/2 ml vsebuje 2,0 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 94,4 mg/2,36 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 to 8°C.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
• The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.
• Viala zdravila TAXOTERE 80 mg/2 ml je 15-ml viala iz prozornega stekla z rdečo dvižno zaporko.
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Splošne težave in spremembe na mestu aplikacije astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Zdravilo TAXOTERE je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
FAC patients (17.0%).
in pri 5 bolnicah (1,0 %) v kraku FAC.
• Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml).
• Ena viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje 0,5 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,61 ml).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
• The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap.
• Viala zdravila TAXOTERE 20 mg/0,5 ml je 7-ml viala iz prozornega stekla z zeleno dvižno zaporko.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Bolezni živčevja periferna senzorična nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
Zdravilo TAXOTERE v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
• The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
• Viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
- If you get any side effects talk to your doctor, hospital pharmacist or nurse.
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test ***Hi - kvadrat test
Peripheral sensory neuropathy (≥G3: 2%)
Bolezni živčevja periferna senzorična nevropatija (≥ 3. st.: 2 %)a glavobol omotica
If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
• Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
• Potem jo vbrizgajte preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
VIAL/TAXOTERE 80 mg/2 ml
VIALA/TAXOTERE 80 mg/2 ml
Vomiting (G3/4: 3%)
trombocitopenija (S3/4: 3 %)
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid
For metastatic castration-resistant prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Pri zdravljenju metastatskega, proti kastraciji odpornega raka prostate, v primeru sočasne uporabe prednizona ali prednizolona, je priporočena premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (prosimo, glejte poglavje 4.4).
TAXOTERE 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 TAXOTERE v kombinaciji z doksorubicinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
Following the administration of a 100 mg/m 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.
3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Adjusted hazard ratio 95% CI p-valuea
Prilagojeno razmerje ogroženosti 95 % IZ
TAXOTERE 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.
Zdravilo TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
• S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za injiciranje.
• haemorrhage
• vnetje požiralnika
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2.
Priporočeno odmerjanje docetaksela je 75 mg/m2.
In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
V zdravilu TAXOTERE 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
Myalgia (severe: 1.4%) Arthralgia
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (huda: 1,4 %) artralgija
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.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 1,58 g brezvodnega etanola na vialo; kar ustreza 40 ml piva ali 17 ml vina.
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
VIAL LABEL / TAXOTERE 80 mg/4 ml
NALEPKA NA VIALI/TAXOTERE 80 mg/4 ml
Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Najboljši celotni odziv (CR + PR) na raziskovano terapijo [kemoterapija +/kemoradioterapija] (%) (95 % IZ) ***Vrednost p
Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila TAXOTERE (10 mg docetaksela/ml)
Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
En pretisni omot zdravila TAXOTERE 20 mg/0,5 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
• 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/m as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m 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.
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila
2 ml (Fill 2.36 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 ml (polnitev 2,36 ml)
• operable node-positive breast cancer
• operabilnim rakom dojke s pozitivnimi bezgavkami
Anorexia (G3/4: 1%); Decreased appetite
Presnovne in prehranske motnje anoreksija (S3/4: 1 %), zmanjšan apetit dehidracija (S3/4: 2 %),
95% CI p-valuea
95 % IZ p =
• 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).
• Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
Cautions for use in gastric adenocarcinoma cancer Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
fazi študije), ki so jih zdravili z docetakselom v kombinaciji s cisplatinom in 5-fluorouracilom v študiji raka želodca, je bilo 74 bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
En pretisni omot zdravila TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
• blood clots
• krvni strdki
Venous disorder (G3/4:
Žilne bolezni venske motnje (S3/4:
Infection (G3/4: 3.6%) Neutropenic infection
Infekcijske in parazitske bolezni okužba (S3/4: 3,6 %) nevtropenična okužba
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.5 ml per vial.
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za zdravilo TAXOTERE to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 20 mg/0,5 ml na vialo.
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm
Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
Thrombocytopenia (G4:
trombocitopenija (S4:
13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 1.5 ml (Fill 1.98 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 13 % (m/m) 95 % etanol v vodi za injekcije (za dodatne informacije glejte navodilo za uporabo) 1,5 ml (polnjenje 1,98 ml)
TAXOTERE 80 mg/2 ml concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Lacrimation increased (G3/4: <0.1%)
motnja solzenja (S3/4: <0,1 %)
Discontinue treatment if these toxicities persist (see section 4.4).
zdravljenje prekinite (glejte poglavje 4.4).
Constipation (severe:
vnetje požiralnika (hud:
Neutropenia (G3/4:
Preobčutljivost (S3/4:
TAXOTERE 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Zdravilo Taxotere 20 mg/1 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
Myocardial ischemia (G3/4:1.7%)
Srčne bolezni miokardna ishemija (S3/4: 1,7 %)
TAXOTERE 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Zdravilo Taxotere 80 mg/4 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2 ml per vial.
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za zdravilo TAXOTERE to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 8 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 80 mg/2 ml na vialo.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 359 mg brezvodnega etanola na vialo; kar ustreza 10 ml piva ali 4 ml vina.
Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri metastatskem, proti kastraciji odpornim rakom prostate v kombinaciji s prednizonom ali prednizolonom
TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Bolezni prebavil navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
Somnolence (G3/4: 0%)
limfedem (S3/4: 0 %)
Patients on the comparator arm received cisplatin (P) 100 mg/m followed by 5-fluorouracil (F)
Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m2 v
Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
z 11 tedni, p = 0,0004) in podaljšal celotno preživetje (11 mesecev v prim.
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali 9 mg/ml (0,9 %) raztopina natrijevega klorida za infundiranje.
Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je, bledorumena do rjavkastorumena raztopina.
TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Rak dojke Zdravilo TAXOTERE v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
Dysgeusia (G3/4: < 1%); Pareaesthesia (G3/4: < 1%)
Bolezni živčevja disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)
If signs and symptoms suggestive of these reactions appear discontinuation of docetaxel should be considered.
Če se pojavijo hudi kožni neželeni učinki, je treba razmisliti o prekinitvi zdravljenja.
Aseptically withdraw the required amount of TAXOTERE concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila TAXOTERE.
7 ml clear glass Type I vial with a transparent colourless flip-off cap.
7-ml viala iz prozornega stekla tipa I s prosojno, brezbarvno dvižno zaporko.
TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel
TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Opis izbranih neželenih učinkov zdravljenja z zdravilom TAXOTERE 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 6 ml (Fill 7.33 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 13 % (m/m) 95 % etanol v vodi za injekcije (za dodatne informacije glejte navodilo za uporabo) 6 ml (polnjenje 7,33 ml)
Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m every 3 weeks for 6 cycles.
Priporočeni odmerek docetaksela je 75 mg/m2 na 3 tedne 6 ciklusov.
What TAXOTERE looks like and contents of the pack TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Zdravilo TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje je bistra viskozna, rumena do rjavo-rumena raztopina.
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor PR = progesterone receptor a
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
pruritični izpuščaj (S3/4: 0,7 %), spremembe nohtov (S3/4: eksfoliacija kože (S3/4: 0 %)
Tabulated list of adverse reactions in head and neck cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Navodilo za uporabo TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
OUTER CARTON / TAXOTERE 160 mg/8 ml
PODATKI NA ZUNANJI OVOJNINI ŠKATLA / TAXOTERE 160 mg/8 ml