natgillin/translations-raw huggingface dataset:
For 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
Pri zdravljenju 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).
A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
*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
1-year Survival (%)
mediana preživetja (meseci) 1-letno preživetje (%)
Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Mialgija (S3/4: 2 %), artralgija (S3/4: 1 %)
Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Dispneja (S3/4: 1 %), kašelj (S3/4: < 1 %), epistaksa (S3/4: < 1 %)
Solvent for Docefrez 80 mg, Powder for Solution for Infusion
Raztopilo za docefrez 80 mg, prašek za raztopino za infuzijo
• 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.
• Indukcijska kemoterapija in nato radioterapija (TAX323) 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 obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m2, infundiran 1 uro dolgo, prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m2 na dan pet dni.
• muscle aches and pains; back pain or bone pain*
• obarvanost nohtov*, ki se lahko začnejo cepiti; • bolečine v mišicah; bolečine hrbta ali bolečine v kosteh*;
Somnolence (G3/4: 0%)
somnolenca (S3/4; 0 %)
Based on pharmacokinetic data with docetaxel at 100 mg/ m2 as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
Oral candidiasis (G3/4: <1%)
Oralna kandidoza (S3/4: < 1 %)
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Docefrez v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
4.8 Undesirable effects
Možni neželeni učinki
• Each vial of Docefrez 80 mg contains 80 mg docetaxel (anhydrous) (plus 18% overfill: 94.4 mg
• Vsaka viala Docefrez 80 mg vsebuje 80 mg docetaxela (brez vode) (plus 18% prenapolnjenosti: 94,4 mg docetaxela).
Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Docefrez je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
• Each solvent vial of Docefrez 80 mg contains 4 ml of 35.4% w/w ethanol in Polysorbate 80.
• Vsaka viala topila docefreza 80 mg vsebuje 1 ml 35,4% etanola v polisorbatu 80
Infection (G3/4: 5.7%)
Okužba (S3/4: 5,7 %)
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Artralgija (S3/4: 0,3 %), mialgija (S3/4: 0,3 %)
Docetaxel 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.
Docefrez je indiciran 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.
- if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docefrez - if your number of white blood cells is too low - if you have severe liver disease
če ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Docefrez.
Alopecia (G3/4: 4.0%)
Alopecija (S3/4: 4,0 %)
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express HER2, and who previously had not received chemotherapy for metastatic disease.
Docetaksel so v kombinaciji s trastuzumabom raziskali za zdravljenje bolnic z metastatskim rakom dojke, ki so imele na tumorju hiperekspresijo HER2 in prej še niso dobivale kemoterapije za metastatsko bolezen.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 80 mg
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Embalaža 80 mg
Take special care with Docefrez
Z Docefrez-om bodite izredno previdni
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and
• 174 in 251 bolnikov z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
Peripheral sensory neuropathy (G3/4: 1.2%)
periferna senzorična nevropatija (S3/4: 1,2 %)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 20 mg
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Embalaža 20 mg
Solvent vial: 4 ml clear, colourless solution supplied in a glass vial with a grey non-latex rubber stopper and a brown aluminium seal.
Viala z vehiklom: 4 ml čistega, brezbarvnega vehikla v stekleni viali s sivim gumijastim pokrovom brez lateksa in rjavim aluminijastim zamaškom.
Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Nevtropenija (S3/4: 63 %), anemija (S3/4: 10 %)
Store in a refrigerator
POSEBNA NAVODILA ZA SHRANJEVANJE Hranite v hladilniku.
HOW TO STORE DOCEFREZ
Sestavine Docefrez
Discontinue treatment if these toxicities persist (see section
Če ti toksični učinki trajajo, zdravljenje prekinite (glejte poglavje 4.4).
Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil for head and neck cancer
Docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
• one single-dose powder vial with 20 mg docetaxel (plus 22% overfill: 24.4 mg), and
• viala z enim odmerkom praška, to je 20 mg docetaksela (plus 22% dodatka celotni vsebini: 24,4 mg)
Nausea; Diarrhoea;
Letargija, bolečine
G3/4 Blood bilirubin increased (2.1%);
Zvečanje bilirubina v krvi S3/4 (2,1 %),
Solvent vial: 1 ml clear, colourless solution supplied in a glass vial with a grey non-latex rubber stopper and a blue aluminium seal.
Viala z vehiklom: 1 ml čistega, brezbarvnega vehikla v stekleni viali s sivim gumijastim pokrovom brez lateksa in modrim aluminijastim zamaškom.
Peripheral sensory neuropathy (G3: 4.1%);
Periferna senzorična nevropatija (S3: 4,1 %),
Anorexia (G3/4:0.6%)
Anoreksija (S3/4: 0,6 %)
(95% CI) ***p-value Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil *Nekorigirani log-rang test **Nekorigirani log-rang test, nekorigiran za multiple primerjave ***Test hi-kvadrat, nekorigiran za multiple primerjave NP - ni podatka
Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Mialgija (S3/4: 0,7 %), artralgija (S3/4: 0,2 %)
• Each vial of Docefrez 20 mg contains 20 mg docetaxel (anhydrous) (plus 22% overfill: 24.4 mg
• Vsaka viala Docefrez 20 mg vsebuje 20 mg docetaksela (brez vode) (plus 22% prenapolnjenosti: 24,4 mg docetaksela).
First episode: reduce docetaxel and 5-FU doses by 20%.
Driska 4. stopnje Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
Anaemia (G3/4: 3%); Neutropenia (G3/4:
Anemija (S3/4: 3 %), nevtropenija (S3/4:
Preclinical data
Končna točka
• inflammation of the colon, small intestine; intestinal perforation
• vnetje debelega črevesa, tankega črevesa; črevesna perforacija;
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m in ciklofosfamidu 500 mg/m
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
• 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
2.2 Docefrez 20 mg solvent vials
2.2 Docefrez 20 mg viala z vehiklom
Docetaxel 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.
Docefrez 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.
Each single-dose vial of powder contains 20 mg docetaxel (anhydrous).
Vsaka viala s praškom vsebuje 20 mg docetaksela (brez vode).
The solvent for Docefrez is 35.4% w/w Ethanol in Polysorbate 80.
Vehikel za docefrez je 35,4 % etanola v polisorbatu 80.
Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
Mialgija, artralgija, bolečine v udih, bolečine v kosteh, bolečine v hrbtu
Best overall response (CR + PR) to chemotherapy
Najboljši celotni odziv (CR + PR) na kemoterapijo (%) (95 % IZ)
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
Asthenia (severe 12.4%); Fluid retention (severe 0.8%); Pain
Astenija (huda 12,4 %), zastajanje tekočine (hudo: 0,8
Solvent for Docefrez 20 mg, Powder for Solution for Infusion
Vehikel za docefrez 20 mg, prašek za raztopino za infuzijo
Other very common side effects:
Drugi zelo pogosti neželeni učinki:
After reconstitution, 1 ml of concentrate contains 24 mg docetaxel.
Po pripravi vsebuje 1 ml koncentrata 24 mg docetaxela.
Dyspepsia (G3/4:
Dispepsija (S3/4:
Hypotension (G3/4: 0%); Phlebitis (G3/4: 0%)
Hipotenzija (S3/4: 0 %), Flebitis (S3/4: 0 %)
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 12 %, p < 0,0001), podaljšal čas do napredovanja (19 tednov v prim.
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.
Anorexia (G3/4: 1.5%)
Anoreksija (S3/4: 1,5%)
Any unused product or waste material should be disposed of in accordance with local requirements
Neuporabljene izdelke ali odpadni material odstranite skladno z lokalnimi zahtevami
All materials that have been utilised for dilution and administration and any unused product should be disposed of in accordance with local requirements.
Vse materiale, uporabljene pri razredčevanju in aplikaciji, je treba odstraniti skladno z lokalnimi predpisi..
disorders
dispepsija
The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxelcontaining 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 shemi z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95 % interval zaupanja (IZ) = 0,54-0,90); celotni mediani čas spremljanja je bil 41,9 meseca.
• 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. dne, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Navzea (S3/4: 9,6 %), bruhanje (S3/4: 7,6 %), driska (S3/4: 6,4 %), stomatitis (S3/4: 2 %)
Thrombocytopenia (G4:
Trombocitopenija (S4:
Alopecia (G3/4: 4.0%).
Alopecija (S3/4: 4,0 %),
NAME OF THE MEDICINAL PRODUCT Docefrez 20 mg powder and solvent for concentrate for solution for infusion
IME ZDRAVILA Docefrez, 20 mg, prašek in vehikel za pripravo koncentrata za raztopino za infundiranje
Number of patients PSA** response rate (%)
Število bolnikov Odzivnost na PSA**(%) 95 % IZ p-vrednost*
Median survival (months)
Mediani ČDN (meseci)
95% CI p-value†*
Razmerje tveganja 95 % IZ p-vrednost†*
Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%).
Zaprtje, ezofagitis/disfagija/odin ofagija (S3/4: 0,6 %),
Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), diareja (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Primarna profilaksa z G-CSF pride v poštev pri bolnicah, ki prejemajo adjuvantno zdravljenje s TAC za raka dojke, za zmanjšanje tveganja zapletene nevtropenije
Peripheral sensory neuropathy (G3: 0.4%)
Periferna senzorična nevropatija (S3: 0,4 %)
Dilute before use
Pred uporabo razredčite
Dysgeusia/Parosmia (G3/4: 0.4%);
Disgevzija/parozmija (S3/4: 0,4 %),
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.
Med 300 bolniki (221 bolnikov v III. fazi študije in 79 bolnikov v II.
Peripheral motor neuropathy (G3/4: 0%)
Periferna motorična nevropatija (S3/4: 0 %)
Nervous system disorders
Periferna senzorična nevropatija
Cardiac left ventricular function decrease (G3/4: 0.3%)
Zmanjšanje funkcije levega srčnega prekata (S3/4: 0,3 %)
Peripheral motor neuropathy (G3/4: 0.4%)
Periferna motorična nevropatija (S3/4: 0,4 %)
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or below 25°C and for the final solution for infusion for 4 hours below 25°C .
Vendar je dokazano, da je pripravljena rekonstituirana raztopina fizično in kemično stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pod 25 °C, končna raztopina pa 4 ure, če je shranjena pri temperaturi do 25 °C .
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2in all subsequent cycles
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
Pri bolnikih z nedrobnoceličnim pljučnim rakom, ki še niso bili zdravljeni s kemoterapijo, je priporočena shema odmerjanja docetaksel v odmerku 75 mg/m2, ki mu takoj sledi cisplatin v odmerku
Arrhythmia (G3/4: 1.0%).
Aritmija (S3/4: 1,0 %)
Peripheral sensory neuropathy (G3/4: 0.8%)
Periferna senzorična nevropatija (S3/4: 0,8 %)
Vomiting (G3/4: 3%)
Trombocitopenija (S3/4: 3 %)
Myalgia (G3/4: 0.6%)
Mialgija (S3/4: 0,6 %)
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja ter zvišanje telesne temperature ali mrzlica.
• nausea, vomiting, indigestion*, bellyache* • diarrhoea, constipation*
• slabost, bruhanje, slaba prebava*, bolečine v trebuhu*;
Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%);
Bolečine v udih (S3/4: < 1 %), bolečine v hrbtu (S3/4: 1 %)
Docetaxel 100 mg/m² single agent MedDRA system organ classes
Docetaksel 100 mg/m2 v monoterapiji Organski sistemi po MedDRA
Neutropenic infection (Grade 3-4)
Nevtropenična okužba Nevtropenična okužba (3.-4.
Docetaxel 100 mg/m² in combination with trastuzumab: MedDRA system organ classes
Docetaksel 100 mg/m2 v kombinaciji s trastuzumabom
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljene izdelke ali odpadni material odstranite skladno z lokalnimi zahtevami.
• The solvent vial for Docefrez 80 mg is a 5 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm brown flip-off aluminium seal.
• Viala vehikla za Docefrez 80 mg je brezbarvnega cevastega stekla tipa 1 z 20 mm omniflex plus sivim brombutilnim gumijasto zaporko, zastesnjenim z 20 mm temnomodrim dvižnim aluminijastim tesnilom.
Conjunctivitis (G3/4:
Konjunktivitis (S3/4:
G3/4 Blood bilirubin increased (< 5%);
Zvečanje bilirubina v krvi S3/4 (< 5 %),
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]
Docetaxel should be administered with caution in patients concomitantly receiving potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, azole antifungals like ketoconazole or itraconazole).
(npr. zaviralce proteaze kot je ritonavir, antimikotike derivate azola kot je ketokonazol ali itrakonazol).
4.1.5 Allow the reconstituted vial to stand for 5 minutes at room temperature (below 25ºC) and then check that the solution is homogenous and clear.
4.1.5 Pripravljena viala naj stoji 5 minut na sobni temperaturi (manj kot 25ºC).
Cough (G3/4: 0%)
Kašelj (S3/4: 0 %)
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis;
Epistaksa, faringo-laringealna bolečina, nazofaringitis, dispneja,
• The solvent vial for Docefrez 20 mg is a 1 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm dark blue flip-off aluminium seal.
• Viala vehikla za Docefrez 20 mg je brezbarvnega cevastega stekla tipa 1 z 20 mm omniflex plus sivim brombutilnim gumijasto zaporko, zastesnjenim z 20 mm temnomodrim dvižnim aluminijastim tesnilom
Inter individual variation in total body clearance was approximately 50%.
V kombinaciji z docetakselom je bil očistek karboplatina približno 50
Stomatitis (G3/4: 7.8%); Diarrhoea (G3/4: 6.2%); Vomiting (G3/4: 5%); Constipation
Navzea (S3/4: 5 %), stomatitis (S3/4: 7,8 %), driska (S3/4: 6,2 %), bruhanje (S3/4: 5 %), zaprtje
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncentracije docetaksela 0,74 mg /ml.
After reconstitution, 1 ml of concentrate contains 24 mg docetaxel (anhydrous).
Po pripravi 1 ml koncentrata vsebuje 24 mg docetaxela (brez vode).
Hypersensitivity (G3/4:
Preobčutljivost (S3/4:
Age category 2 <35 years
≥50 let Starostna kategorija 2
Docetaxel in combination with trastuzumab
Docefrez v kombinaciji s trastuzumabom
Hypersensitivity (G3/4: 1.7%)
Preobčutljivost (S3/4: 1,7)
Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%).
23,7 %), bruhanje (S3/4: 14,3 %)
Lethargy; Pain
kašelj, rinoreja
2 BEFORE YOU USE DOCEFREZ
Pred uporabo zdravila Docefrez 3.
95% CI p-value*
95 % IZ p-vrednost3
Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Za zmanjšanje tveganja za hematološke toksične učinke je treba profilaktično uporabiti G-CSF (glejte
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
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
(FISH).
filgrastim).
Median TTP (months) (95%CI)
Mediano PBN (meseci) (95 % IZ)
Hypersensitivity (G3/4: 0.6%)
Preobčutljivost (S3/4: 0,6 %)
Docetaxel 75 mg/m² in combination with doxorubicin: MedDRA system organ classes
Docetaksel 75 mg/m2 v kombinaciji z doksorubicinom Organski sistemi po
Powder and solvent for concentrate for solution for infusion 1 vial of powder
Prašek in raztopilo za koncentrat infuzijske tekočine
Arrhythmia (G3/4:0.7%) Cardiac failure Hypotension;
Aritmija (S3/4: 0,7 %) Srčno popuščanje
G3/4 Blood bilirubin increased (<2.5%);
Zvečanje bilirubina v krvi S3/4 (< 2,5 %),
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ritonavir and other protease inhibitors, used to treat HIV infection/AIDS - ketoconazole and itraconazole, used to treat fungal infections - ciclosporin, used to suppress your immune system (e.g. after transplants) - erythromycin, antibiotic used for bacterial infections
- ciklosporin, za zaviranje imunskega sistema (npr. po presaditvi); - eritromicin, antibiotik, ki se uporablja za zdravljenje bakterijskih infekcij.
Lymphoedema
Docetaksel
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Stomatitis (S3/4: 18 %), driska (S3/4: 14 %), navzea (S3/4: 6 %), bruhanje (S3/4: 4 %), zaprtje (S3/4: 1 %),
4.2.4 The Docefrez infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Aplicirati jo je treba aseptično v 1-urni infuziji, pri sobni temperaturi (do 25°C) in v pogojih običajne svetlobe.
Pain
bolečine
Disposal
Zaprtje