natgillin/translations-raw huggingface dataset:
1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaksel Teva 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 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).
4.1 Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
PRIPRAVA ZA INTRAVENSKO UPORABO 4.1 Priprava osnovne raztopine zdravila Docetaksel Teva (10 mg docetaksela/ml)
Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Opis izbranih neželenih učinkov adjuvantnega zdravljenja z zdravilom Docetaksel Teva 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
Hazard ratio (95% CI) **p-value
razmerje tveganja (95-odstotni interval zaupanja) **vrednost p
• Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
• Osnovna raztopina: dokazano je, da je osnovna raztopina kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 in 8°C ali pri sobni temperaturi (do 25°C).
p= Hazard ratio*
95-% IZ p = razmerje tveganja*
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC) ali da bi docetaksel vplival na farmakokinetiko 5'-DFUR, pomembnega presnovka kapecitabina.
Myalgia (G3/4: 0.6%)
aritmija (S 3/4: 0,6 %)
Anorexia (G3/4: 1%); Decreased appetite
Presnovne in prehranske motnje anoreksija (S 3/4: 1 %), zmanjšan apetit dehidracija (S 3/4: 2 %)
• muscle aches and pains; back pain or bone pain
• bolečine v mišicah, bolečine v hrbtu ali kosteh;
75 to 60 mg/m².
20 mg/0,72 ml na vialo.
Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel.
Ena viala koncentrata Docetaksel Teva 20 mg/0,72 ml vsebuje 20 mg docetaksela.
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri raku prostate v kombinaciji s prednizonom ali prednizolonom
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
hipotenzija (S 3/4: flebitis (S 3/4: 0 %)
Number of patients PSA** response rate (%) 95% CI p-value*
95-% IZ razmerje tveganja 95-% IZ vrednost p†* število bolnikov delež odziva PSA** (%) 95-% IZ vrednost p* število bolnikov delež odziva bolečine (%)
• The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
• Viala zdravila Docetaksel Teva 20 mg/0,72 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 27,73 mg/ml.
Docetaxel Teva 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 Teva v kombinaciji z doksorubicinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki se zaradi te bolezni še niso zdravile s citotoksično terapijo.
G3/4 Blood bilirubin increased (< 5%);
Preiskave povišanje ravni bilirubina v krvi S 3/4 (< 2 %)
5-fluorouracil (clinically important treatment related adverse events are presented).
(predstavljeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki);
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Dokazali so, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
Oedema (G3/4: 1.2%)
edem (S 3/4: 1,2 %)
For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
Za odmerjanje in dajanje trastuzumaba glejte povzetek glavnih značilnosti trastuzumaba.
2.1 Docetaxel Teva 80 mg/2.88 ml vial:
2.1 Viala zdravila Docetaksel Teva 80 mg/2,88 ml:
Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, Docetaxel Teva could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
- za zdravljenje napredovalega raka dojke se lahko zdravilo Docetaksel Teva uporablja samo ali v kombinaciji z doksorubicinom, trastuzumabom ali kapecitabinom; - za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo Docetaksel Teva lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom;
Nausea (G3/4: 2.4%);
omotica (S 3/4: 2,3 %);
Dyspnoea (severe:
zastajanje tekočine (hudo:
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
stomatitis/mukozitis 4. stopnje prvi pojav: med vsemi naslednjimi cikli zdravljenja opustite samo 5-FU drugi pojav: zmanjšajte odmerek docetaksela za 20 %
Tabulated list of adverse reactions for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Tabelarični prikaz neželenih učinkov adjuvantnega zdravljenja z zdravilom Docetaksel 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativni podatki
Myalgia (severe: 1.4%) Arthralgia
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija (huda: 1,4 %) artralgija
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
periferna motorična nevropatija (S 3/4: 4 %), disgevzija (huda:
Vomiting (G3/4: 1.2%)
bruhanje (S 3/4: 1,2 %)
Concentrate vial:
Viala z vehiklom
• 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/m2 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.
Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck) je priporočeni odmerek docetaksela 75 mg/m2 v enourni infuziji, ki ji prvi dan sledi enourna infuzija cisplatina v odmerku 75 mg/m2, temu pa sledi neprekinjena infuzija 5-fluorouracila v odmerku 750 mg/m2 dnevno, ki traja 5 dni.
Vomiting (G3/4: 3%)
trombocitopenija (S 3/4: 3 %)
• 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).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Pred aplikacijo cisplatina in po njej morajo bolniki dobiti premedikacijo z antiemetiki in ustrezno hidracijo.
Alopecia; Skin reaction (G3/4:
Bolezni kože in podkožja alopecija, kožna reakcija (S 3/4:
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Rak dojke Zdravilo Docetaksel Teva v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
Nervous system disorders
Bolezni živčevja periferna senzorična nevropatija
Esophagitis/dysphagia/ odynophagia (G3/4:
zaprtost, ezofagitis / disfagija / odinofagija (S
You must not breast-feed while you are treated with Docetaxel Teva.
V obdobju zdravljenja z zdravilom Docetaksel Teva ne smete dojiti.
Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
diareja (S 3/4: 2,9 %), bruhanje (S 3/4: 0,6 %)
Docetaxel in combination with capecitabine
Zdravilo Docetaksel Teva v kombinaciji s kapecitabinom
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docetaksel Teva v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
Number of patients Pain response rate (%) 95% CI p-value*
95-% IZ vrednost p* število bolnikov delež odziva tumorja (%) 95-% IZ vrednost p* † stratificirani test log-rank
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
Docetaxel every week Mitoxantrone every 3 weeks
končna točka docetaksel vsake 3 tedne docetaksel vsak teden mitoksantron vsake 3 tedne število bolnikov srednji čas preživetja
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Bolezni prebavil navzeja, driska, bruhanje, zaprtost, stomatitis, dispepsija, bolečine v trebuhu
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
Nausea (G3/4: 0.6%); Stomatitis (G3/4:
Bolezni prebavil navzeja (S 3/4: 0,6 %), stomatitis (S 3/4:
administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m administered on day 1 of cycles repeated every 4 weeks (VCis).
15. in 22. dan, ki mu je 1. dan ciklov sledil cisplatin 100 mg/m2.
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolnikih, ki so dobivali docetaksel v kombinaciji s prednizonom ali prednizolonom
• Induction chemotherapy followed by radiotherapy (TAX323)
• Indukcijska kemoterapija in nato kemoradioterapija (TAX324)
Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
trombocitopenija, stomatitis in astenija.
NN: {number]
(tedni):
Anaemia (G3/4: 8.9%); Febrile neutropenia
trombocitopenija (S 3/4: 0,6 %), febrilna nevtropenija
Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel.
Ena viala koncentrata Docetaksel Teva 80 mg/2,88 ml vsebuje 80 mg docetaksela.
• one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
• eno 6 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 0,72 ml koncentrata in • eno 6 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 1,28 ml vehikla.
The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Ob tem so pri režimu z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95-% interval zaupanja = 0,54-0,90); celotni srednji čas spremljanja je bil 41,9 meseca.
Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Limfedem, ki se je začel med obdobjem zdravljenja, se je med obdobjem spremljanja nadaljeval pri 5 bolnicah (0,9 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
Peripheral motor neuropathy (G3/4: 2.5%)
periferna motorična nevropatija (S 3/4: 2 %)
2.2 Solvent for Docetaxel Teva 80 mg/2.88 ml vial:
2.2 Viala z vehiklom zdravila Docetaksel Teva 80 mg/2,88 ml:
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva 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 Docetaxel Teva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Namen tega je zmanjšanje nekaterih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Docetaksel Teva, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali povečanje telesne mase).
Dizziness;
ciklih;
Oral candidiasis (G3/4: <1%)
Infekcijske in parazitske bolezni oralna kandidoza (S 3/4: < 1 %)
Median duration of response (months) (95% CI)
delež odziva (95-odstotni interval zaupanja) srednje trajanje odziva (meseci) (95-odstotni interval zaupanja)
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri raku dojke v kombinaciji z doksorubicinom
Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
bolečine v okončinah (S 3/4: < bolečine v hrbtu (S 3/4: 1 %)
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Bolezni prebavil stomatitis (S 3/4: 18 %), driska (S 3/4: 14 %), navzeja (S 3/4: 6 %), bruhanje (S 3/4: 4 %), zaprtost (S 3/4: 1 %),
Alopecia; Nail disorders (no severe)
Bolezni kože in podkožja alopecija, spremembe nohtov (ne hude)
G3/4 Blood bilirubin increased
Preiskave povišanje ravni bilirubina v krvi S 3/4
Data from a multi-centre open-label randomised trial support the use of Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Docetaksel Teva za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Bolezni krvi in limfatičnega sistema nevtropenija (S 3/4: 32 %), anemija (S 3/4: 4,9 %)
Combination therapy
Kombinirano zdravljenje Doksorubicin
• The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Viala zdravila Docetaksel Teva 20 mg/0,72 ml je 6 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Navodilo za uporabo Docetaksel Teva 80 mg/2,88 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion docetaxel
Docetaksel Teva 80 mg/2,88 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Cough (G3/4: 0%)
limfedem (S 3/4: 0 %)
Infection (G3/4: 7.8%)
Infekcijske in parazitske bolezni okužba (S 3/4: 7,8 %)
• The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Viala zdravila Docetaksel Teva 80 mg/2,88 ml je 15 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
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.
V študiji GEICAM 9805 se je med zdravljenjem nastala periferna senzorična nevropatija nadaljevala še med obdobjem spremljanja pri 10 bolnicah (1,9 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku
Nausea (G3/4: 5%); Stomatitis (G3/4:
Bolezni prebavil navzeja (S 3/4: 5 %), stomatitis (S 3/4:
Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Zdravilo Docetaksel Teva v monoterapiji je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih citotoksična terapija ni bila uspešna.
2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial:
2.2 Viala z vehiklom za zdravilo Docetaksel Teva 20 mg/0,72 ml:
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Navodilo za uporabo Docetaksel Teva 20 mg/0,72 ml koncentrat in vehikel za raztopino za infundiranje docetaksel
Anorexia (G3/4: 11.7%)
okužba (S 3/4: 11,7 %)
Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/or cyclophosphamide.
Pri bolnicah, 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 (pogostnost ni znana), včasih s smrtnim izidom.
Median duration of response
srednji čas do napredovanja bolezni
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
Without primary G-CSF prophylaxis
Primarna profilaktična uporaba G-CSF je postala v kraku TAC
Statistical analysis
statistična analiza celotno preživetje
Alopecia (persisting Skin disorder (G3/4:
Bolezni kože in podkožja alopecija (persistentna < 3%), bolezni kože (S 3/4:
Overall survival
Tudi celotno preživetje po
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docetaksel Teva v stik s kožo, površino takoj in temeljito umijte z milom in vodo.
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion
• Viala zdravila Docetaksel Teva 80 mg/2,88 ml koncentrat in vehikel za raztopino za infundiranje
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion
• Viala zdravila Docetaksel Teva 20 mg/0,72 ml koncentrat in vehikel za raztopino za infundiranje
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Docetaksel Teva 20 mg/0,72 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Anaemia (G3/4: 3%); Neutropenia (G3/4:
Bolezni krvi in limfatičnega sistema anemija (S 3/4: 3 %), nevtropenija (S 3/4:
• The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Viala z vehiklom zdravila Docetaksel Teva 20 mg/0,72 ml vialo je 6 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
Myalgia (severe: 0.5%)
zaprtost (huda: 0,2 %),
Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija (S 3/4: 0,7 %), artralgija (S 3/4: 0,2 %)
Hepatobiliary disorders
ezofagitis / disfagija /
Vomiting (G3/4:
nevrotoksičnost (S3/4:
• The solvent for Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Viala z vehiklom zdravila Docetaksel Teva 80 mg/2,88 ml vialo je 15 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Docetaksel so aplicirali v enourni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan. Bolnice, ki so doživele zapleteno nevtropenijo (febrilna nevtropenija, dolgotrajna nevtropenija ali okužba), so kot sekundarno profilakso dobile G-CSF.
Blood and lymphatic Neutropenia (G3/4:
Bolezni krvi in nevtropenija (S 4:
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 dobivala docetaksel 75 mg/m2 v enourni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60 minutah, tretja pa na 4 tedne vinorelbin (VCis) 25 mg/m2 v 6-10 minutah 1., 8.,
Lymphoedema
OVOJNINAH
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Tabelarični prikaz neželenih učinkov monoterapije z zdravilom Docetaksel 100 mg/m2 pri raku dojke
Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Bolezni prebavil driska (S 3/4: 19,7 %), navzeja (S 3/4: 16 %), stomatitis (S 3/4: 23,7 %), bruhanje (S 3/4: 14,3 %)
Hypersensitivity (G3/4: 0.6%)
Bolezni imunskega sistema preobčutljivost (S 3/4: 0,6 %)
Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Zdravilo Docetaksel Teva v kombinaciji s platinskimi zdravili pri bolnikih, ki se še niso zdravili s kemoterapijo
• haemorrhage
Žilne bolezni
Dysgeusia/Parosmia (G3/4: 0.4%);
dispepsija (S 3/4: 0,8 %),
Infection (G3/4: 5.7%)
Infekcijske in parazitske bolezni okužba (S 3/4: 5,7 %)
Peripheral sensory neuropathy (G3/4: 1.2%);
Bolezni živčevja periferna senzorična nevropatija (S 3: 4,1 %),
Infections and infestations
Infekcijske in parazitske bolezni nevtropenična okužba,
Posology
PAKIRANJE
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
(S 3/4: 1,2 %) disgevzija (S 3/4: 0 %)
G3/4 ALT increased
povišanje ravni ALT S
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg/0.72 ml
NALEPKA NA VIALI - KONCENTRAT 20 mg/0,72 ml
What Docetaxel Teva looks like and contents of the pack: Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
koncentrat in vehikel za raztopino za infundiranje Koncentrat je bistra, viskozna, rumena do rjavorumena raztopina.
p=
***vrednost p
Epistaxis (G3/4: 0%);
(S 3/4: 0 %)
Gastrointestinal haemorrhage (severe:
zvečano solzenje (S