natgillin/translations-raw huggingface dataset:
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) 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 (2,6 %), v kraku FAC pa 4 bolnice (0,5
Skin reaction (G3/4: 5.9%); Nail disorders (severe: 2.6%)
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4: 5,9 %), spremembe nohtov (hude: 2,6 %)
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) 1000 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 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 4. dneva.
Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Bolezni živčevja parestezije, glavobol, disgevzija, hipestezija
- If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
- For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
- Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo DOCETAKSEL KABI lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
• 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 1000 mg/m2/dan od 1. do 4. dneva.
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).
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 (11,7 %).
Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Pojavljale so se reverzibilne, praviloma blage do zmerne kožne reakcije.
TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg brezvodnega docetaksela.
DOCETAXEL KABI in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Zdravilo DOCETAKSEL KABI je v kombinaciji s trastuzumabom indiciran za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 3od 744 bolnic, ki so prejemale TAC (0,4 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1%).
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 3 od 744 bolnic, ki so prejemale TAC (0,4 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1 %).
DOCETAXEL KABI in combination with capecitabine
DOCETAKSEL KABI v kombinaciji s kapecitabinom
Reproductive system and breast disorders
Motnje reprodukcije in bolezni dojk:
Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Infekcijske in parazitske bolezni okužba (S3/4: 2,4 %), nevtropenična okužba (S3/4: 2,6 %)
The pharmacokinetics of docetaxel were not altered by the age or sex of the patient.
Starost in spol bolnika nista spremenila farmakokinetike docetaksela.
Arrhythmia (no severe)
Srčne bolezni aritmija (nobene hude)
Arrhythmia (G3/4: 1.0%)
Srčne bolezni aritmija (S3/4: 1,0 %)
G3/4 ALT increased
zvečanje ALT S3/4
In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up 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 %).
One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Ena viala z 9 ml koncentrata vsebuje 180 mg docetaksela.
Neutropenia (G4: 51.5%); Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%)
Bolezni krvi in limfatičnega sistema nevtropenija (S4: 51,5 %), anemija (S3/4: 6,9 %), trombocitopenija (S4: 0,5 %)
Alopecia; Skin reaction (G3/4: 0.8%)
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4: 0,8 %)
• weight gain or loss.
• povečanje ali zmanjšanje telesne mase.
DOCETAXEL KABI in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Zdravilo DOCETAKSEL KABI je v kombinaciji s kapecitabinom indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Docetaksel, doksorubicin in ciklofosfamid pri sočasni aplikaciji ne vplivajo na farmakokinetiko drug drugega.
Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Bolezni živčevja disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Pri bolnicah, ki prejemajo adjuvantno zdravljenje raka dojke z docetakselom, doksorubicimom in ciklofosfamidom (TAC), pride v poštev profilaksa z G-CSF.
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Če opazite katerega koli izmed neželeni učinek, se posvetujte s svojim zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
Nail disorders (severe: 0.4%); Skin reaction (no severe)
Bolezni kože in podkožja alopecija, spremembe nohtov (hude: 0,4 %), kožna reakcija (nobene hude)
Median survival (months) (95% CI)
Mediano preživetje (meseci) (95 % IZ)
Third episode: reduce docetaxel dose by 20%.
Tretji pojav: zmanjšajte odmerek docetaksela za 20 %.
DOCETAXEL KABI will be administered to you by a healthcare professional.
Kako uporabljati zdravilo DOCETAKSEL KABI Zdravilo DOCETAKSEL KABI vam bo dal pristojni zdravstveni delavec.
Dehydration and pulmonary oedema have rarely been reported.
V redkih primerih so poročali o dehidraciji in pljučnem edemu.
Peripheral motor neuropathy (G3/4: 0%)
periferna motorična nevropatija (S3/4: 0 %)
Anorexia (G3/4: 1%); Decreased appetite
Presnovne in prehranske motnje anoreksija (S3/4: 1 %), zmanjšan apetit dehidracija (S3/4: 2 %)
Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Najboljši celotni odziv (CR + PR) na kemoterapijo (%) (95 % IZ) ***vrednost p
• shortness of breath
• težko dihanje,
Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Pri bolnikih zdravljenih z docetakselom so bili opisani primeri cistoidnega makularnega edema (CMO).
Myocardial ischemia (G3/4: 1.7%)
Srčne bolezni miokardna ishemija (S3/4: 1,7 %)
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.
3.-4. stopnja = S3/4; 4. stopnja = S4) in z izrazi COSTART in MedDRA.
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
Second episode: reduce docetaxel dose by 20%.
Drugi pojav: zmanjšajte odmerek docetaksela za 20 %.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi polisorbat 80 brezvodni etanol brezvodna citronska kislina (za uravnavanje pH)
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).
Best overall response to chemotherapy (%) (95% CI) ***p-value
Najboljši celotni odziv na kemoterapijo (%) (95 % IZ) ***p-vrednost
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]* razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0] razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
Median overall survival (months) (95% CI)
Mediano celotno preživetje (meseci) (95 % IZ)
Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
trombocitopenija (S3/4: 0,6 %), febrilna nevtropenija
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 180 mg/9 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
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 povišana telesna temperatura.
Peripheral motor neuropathy (G3/4: 0.4%)
periferna motorična nevropatija (S3/4: 0,4 %)
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Za prilagajanje odmerka trastuzumaba prosimo, glejte povzetek glavnih značilnosti trastuzumaba.
Toxicity
Hematologija
Median TTP (months) (95% CI)
Mediano PBN (meseci) (95 % IZ)
DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Zdravilo DOCETAKSEL KABI je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
Psychiatric disorders Insomnia Nervous system disorders
Presnovne in prehranske motnje anoreksija Psihiatrične motnje nespečnost
Arrhythmia (G3/4: 0.6%)
aritmija (S3/4: 0,6 %)
Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Opis izbranih neželenih učinkov zdravila DOCETAKSEL KABI 100 mg/m2 v kombinaciji s trastuzumabom pri raku dojke
You must not breast-feed while you are treated with DOCETAXEL KABI.
Med zdravljenjem z zdravilo DOCETAKSEL KABI ne smete dojiti.
Cardiac left ventricular function decrease (G3/4: 0.3%)
Srčne bolezni zmanjšanje funkcije levega srčnega prekata (S3/4: 0,3 %)
At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Na koncu obdobja spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajočo alopecijo zabeležili pri 29 bolnicah (3,9 %), ki so prejemale TAC, in pri 16 bolnicah (2,2 %), ki so prejemale FAC.
Constipation
vrtoglavica
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Ena viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Ena škatla vsebuje 1 vialo z 9 ml koncentrata (180 mg docetaksela).
Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Splošne težave in spremembe na mestu aplikacije astenija (huda: 12,4 %), zastajanje tekočine (hudo: 0,8 %), bolečine
Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Ena škatla vsebuje 1 vialo s 6 ml koncentrata (120 mg docetaksela).
Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
bolečine v udih (S3/4: < 1 %), bolečine v hrbtu (S3/4: 1 %)
Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Bolezni prebavil navzea (S3/4: 5,0 %), stomatitis (S3/4: 6,0 %), bruhanje (S3/4: 4,2 %), driska (S3/4: 3,4 %), zaprtje (S3/4: 0,5 %)
Peripheral sensory neuropathy (G3: 0.4%)
Bolezni živčevja periferna senzorična nevropatija (S3: 0,4 %)
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 ciklu kemoterapije do 5 let prejemale tamoksifen 20 mg enkrat na dan. Adjuvantna radioterapija je bila uporabljena v skladu z veljavnimi smernicami v sodelujočih ustanovah.
• muscle aches and pains; back pain or bone pain
• bolečine v mišicah, bolečine v hrbtu ali kosteh,
Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Pri bolnikih zdravljenih z docetakselom je bil opisan cistoidni makularni edem (CMO).
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
sinkopa (S3/4: 0 %), nevrotoksičnost (S3/4: 0 %), somnolenca (S3/4: 0 %)
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
IME ZDRAVILA DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje
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/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 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/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60 minutah, tretja pa na 4 tedne (VCis) vinorelbin (V) 25 mg/m2 v 6-10 minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklov sledil cisplatin 100 mg/m2.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 160 mg/8 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Splošne težave in spremembe na mestu aplikacije astenija (huda: 8,1 %), zastajanje tekočine (hudo: 1,2 %), bolečine reakcija na mestu infundiranja
One vial of 6 ml of concentrate contains 120 mg of docetaxel.
Ena viala s 6 ml koncentrata vsebuje 120 mg docetaksela.
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
• operable node-positive breast cancer
• z operabilnim rakom dojke s pozitivnimi bezgavkami,
Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Opis izbranih neželenih učinkov zdravila DOCETAKSEL KABI 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
Vascular disorders Lymphoedema Respiratory, thoracic and mediastinal disorders
Očesne bolezni zvečano solzenje, konjunktivitis
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
95% CI p-value*
95 % IZ p =
Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Ena škatla vsebuje 1 vialo s 4 ml koncentrata (80 mg docetaksela).
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%).
V študiji TAX316 so astenijo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 236 od 744 bolnicah v kraku TAC (31,7 %) in pri 180 od 736 bolnicah v kraku FAC (24,5 %).
Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Ena škatla vsebuje 1 vialo z 8 ml koncentrata (160 mg docetaksela).
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
*Razmerje ogroženosti vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
IME ZDRAVILA DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje
Phlebitis (G3/4: 0%)
limfedem (S3/4: 0 %)
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
IME ZDRAVILA DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje
Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), febrilna nevtropenija (vključuje nevtropenijo, povezano s povišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Kombinacija docetaksela in trastuzumaba je bila pri bolnicah učinkovita ne glede na to, ali so prej dobile adjuvantne antracikline ali ne. Glavni test za ugotavljanje HER2-pozitivnosti v tej odločilni študiji je bila imunohistokemija (IHK).
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
IME ZDRAVILA DOCETAKSEL KABI 180 mg/9 ml koncentrat za raztopino za infundiranje
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 120 mg/6 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Ena škatla vsebuje 1 vialo z 1 ml koncentrata (20 mg docetaksela).
DOCETAXEL KABI in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Zdravilo DOCETAKSEL KABI je v kombinaciji z doksorubicinom indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
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
DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
IME ZDRAVILA DOCETAKSEL KABI 80 mg/4 ml koncentrat za raztopino za infundiranje
There are no data available in patients with severely impaired renal function treated with docetaxel.
O zdravljenju z docetakselom pri bolnikih s hudo okvaro ledvic ni podatkov.
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
V študiji GEICAM 9805 so nadaljnjo prisotnost amenoreje, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah (1,0 %) v kraku FAC.
For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
Za odmerjanje in dajanje trastuzumaba prosimo, glejte povzetek glavnih značilnosti zdravila trastuzumaba.
Thrombocytopenia (G3/4: 3%)
trombocitopenija (S3/4: 3 %)
10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
10 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in oranžno snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 9 ml koncentrata.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
IME ZDRAVILA IN POT(I) UPORABE DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml OTHER Cytotoxic
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 80 mg/4 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
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.
Single-use vial.
Viala za enkratno uporabo.
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%).
V študiji TAX316 so limfedem, ki se je pojavil med obdobjem zdravljenja in je trajal še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 11 od 744 bolnic v kraku TAC (1,5 %) in pri 1 od 736 bolnic v kraku FAC (0,1 %).
Rare cases of ileus and intestinal obstruction have been reported.
Opisani so redki primeri ileusa in zapore črevesa.
As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women.
Pri nosečnicah uporabljeni docetaksel lahko škoduje plodu, tako kot druga citotoksična zdravila.
Amenorrhoea (G3/4: NA)
Motnje reprodukcije in dojk amenoreja (S3/4: NA)