natgillin/translations-raw huggingface dataset:
The benefit/risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Pri bolnicah s 4+ bezgavkami razmerje korist/tveganje za TAC v vmesnih analizah ni bilo docela definirano (glejte poglavje 5.1).
Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu.
Podrobne informacije o zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMA): ://www.ema.europa.eu.
4.2 Preparation of the infusion solution
4.2 Priprava infuzijske raztopine
The required number of Docefrez powder vials should be allowed to reach room temperature (between 15°C - 25°C) for 5 minutes.
Ustrezno število vial s praškom Docefrez pustite stati na sobni temperaturi (od 15°C do 25°C) 5 minut.
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih:
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor
If you are a man being treated with Docefrez you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Če ste moški, ki se zdravi z Docefrezom, se vam svetuje, da med zdravljenjem in vsaj 6 mesecev po njem ne oplodite svoje partnerice ter, da poiščete nasvet glede konzervacije sperme, kajti Docetaksel lahko vpliva na plodnost moškega.
Women of childbearing potential /contraception:
Ženske v rodni dobi/kontracepcija
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
Overall response rate (%)
Celotni delež odziva (%)
See leaflet for further information.
Za dodatne informacije glejte brošuro.
• inflammation of the eye or increased watering of the eyes
• vnetje oči ali povečano solzenje;
The most frequent side effects of Docefrez, when given alone, are decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness (all very common).
Najpogostejši neželeni učinek zdravila Docefrez ob samostojni uporabi, je zmanjšanje število rdečih krvnih celic ali belih krvnih celic, plešavost, slabost, bruhanje, vnetja v ustni votlini, diareja in utrujenost (vsi zelo pogosti).
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Za hudo prizadetost nohtov so značilni hipo ali hiperpigmentacija in včasih bolečine in oniholiza.
A drug interaction study performed in patients receiving ketoconazole and docetaxel showed that the clearance of docetaxel was reduced by half by ketoconazole, probably because the metabolism of docetaxel involves CYP3A4 as a major (single) metabolic pathway.
Študija interakcije, ki so jo izvajali pri bolnikih, ki so jemali ketokonazol in docetaksel, je pokazala, da je ketokonazol za polovico zmanjšal očistek docetaksela, verjetno zato ker metabolizem docetaksela vključuje CYP3A4 kot glavno (edino) metabolično pot.
4.2.1 More than one vial of reconstituted solution may be necessary to obtain the required dose for the patient.
4.2.1 Za pripravo potrebnega odmerka za pacienta boste morda morali uporabiti več kot eno vialo.
The solvent is a viscous, clear and colourless solution.
Vehikel je viskozna, bistra in brezbarvna raztopina.
4.2.5 As with all parenteral products, Docefrez reconstituted solution and solution for infusion should be visually inspected prior to use, solutions containing a precipitate should be discarded.
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docefrez pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Razmerje tveganj: 1,032 [95 % IZ: 0,876, 1,216]
The reconstituted solution contains ~ 24 mg/ml docetaxel, corresponding with an extractable volume of approximately 20 mg/0.84 ml and 80 mg/3.36 ml.
Pripravljena raztopina vsebuje približno ~ 24 mg/ml docetaksela, kar ustreza izločeni količini od približno 20 mg/0,84 ml in 80 mg/3,36 ml.
In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
Uncommon side effects:
Neobičajni stranski učinki:
Treatment difference: 7.1% [95% CI: 0.7; 13.5]
Razlika zdravljenj: 7,1 % [95 % IZ: 0,7, 13,5]
95% CI p=
95 % IZ p =
• fungal infection of the mouth (oral candidiasis)
• glivične infekcije ust (oralna kandidoza);
The benefit/risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage.
Na tej stopnji analize razmerje med koristjo in tveganjem ni bilo povsem definirano pri bolnicah s 4 ali več pozitivnimi bezgavkami.
Fluid retention (severe/lifethreatening: 1%).
zastajanje tekočine (hudo/smrtno nevarno: 1 %)
Docetaxel was administered as a 1-hour infusion, all other drugs were given intravenously on day 1 every three weeks.
Zdravilo Docetaksel je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy-2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Lokoregionalno terapijo z obsevanjem so aplicirali bodisi s konvencionalno frakcijo (1,8 Gy - 2,0 Gy enkrat na dan, 5 dni na teden v celotnem odmerku 66 do 70 Gy), ali s pospešenimi/ hiperfrakcioniranimi shemami obsevalnega zdravljenja (dvakrat na dan, z minimalnim intervalom med frakcijama 6 ur, 5 dni na teden).
Side effects may occur with certain frequencies, which are defined as follows: - very common: affects more than 1 user in 10 - common: affects 1 to 10 users in 100 - uncommon: affects 1 to 10 users in 1,000 - rare: affects 1 to 10 users in 10,000 - very rare: affects less than 1 user in 10,000 - not known: frequency cannot be estimated from the available data.
Stranski učinki se lahko pojavijo različno pogosto, kar je določeno kot sledi: - zelo pogosti se pojavijo pri več kot 1 uporabniku na 10 uporabnikov - pogosti: učinek pri 1 do 10 uporabnikov na 100 uporabnikov - občasni: učinek pri 1 do 10 uporabnikov na 1.000 uporabnikov - redki: učinek pri 1 do 10 uporabnikov na 10.000 uporabnikov - zelo redki: učinek pri manj kot 1 uporabniku na 10.000 uporabnikov
In the pivotal SCCHN studies, patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g. day 6-15) in all subsequent cycles.
V ključni SCCHN študiji pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
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.
Po menopavzi *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
Tell your doctor or nurse immediately during or shortly after the infusion, you notice any of the following symptoms of allergic reactions (very common): - flushing, skin reactions, itching - chest tightness, difficulty in breathing - fever or chills - back pain - low blood pressure.
Zdravnika ali medicinsko sestro nemudoma med ali po infuziji obvestite, če opazite katerega izmed naslednjih simptomov alergijske reakcije (zelo običajno): - rdečica, kožne reakcije, srbenje; - občutek utesnjenosti v prsih, težave z dihanjem; - vročica ali mrzlica; - bolečine v hrbtu;
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Incidenca naslednjih neželenih učinkov (vse stopnje)letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več, > 10 % večja kot pri mlajših bolnikih.
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 12 patients out of the 83 patients with peripheral sensory neuropathy at the end of the chemotherapy.
Še prisotno periferno senzorično nevropatijo so pri spremljanju zabeležili pri 12 od 83 bolnicah, ki so imeli periferno senzorično nevropatijo ob koncu kemoterapije.
Hazard ratio*
Razmerje tveganj*
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hrs at 2 to 8°C, unless reconstitution and further dilution has taken place in controlled and validated aseptic conditions.
Če raztopine ne uporabimo takoj, moramo zagotoviti ustrezen čas roka uporabe in pogoje shranjevanja pred uporabo, po navadi je to do 24 ur pri temperaturi od 2 do 8 °C, razen če je bila v nadzorovanih in ustreznih aseptičnih pogojih raztopina znova pripravljena in razredčena.
Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Bolnike, ki prejemajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala > 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo), kot so ciklosporin, terfenadin, ketokonazol, eritromicin in troleandomicin.
Important information about some of the ingredients of Docefrez
Pomembne informacije o sestavinah v Docefrez
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection
Nevtropenija (4. stopnje) Febrilna nevtropenija
Neutropenic infection
nevtropenična okužba
In the node positive study (TAX316) one patient in each treatment arm died because of cardiac failure.
V študijah pri bolnicah s pozitivnimi bezgavkami (TAX 316), je zaradi srčnega popuščanja umrla po ena bolnica v vsakem kraku.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
(G3/4 2.7%).
(S3/4 2.7%).
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Docetaksel se metabolizira s CYP3A4, za prednizon pa je znano, da inducira
Age category 1 <50 years
Starostna kategorija 1 < 50 let ≥ 50 let
• decreased number of white blood cells (may make you more prone to infections)
• znižano število belih krvnih celic (dovzetnost za infekcije);
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Starostniki Za uporabo pri starostnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
There is no relevant use of docetaxel in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Zdravilo docetaksel ni primerno za uporabo pri pediatrični populaciji za indikacije rak dojke, nedrobnocelični pljučni rak, rak prostate, karcinom želodca in rak glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART terms and the MedDRA terms.
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.- 4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
Solvent: Polysorbate 80 and ethanol, anhydrous
Polisorbat 80 in etanol, brez vode
Additional cautions for use in adjuvant treatment of breast cancer For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Dodatna opozorila pri uporabi adjuvantne terapije raka dojke Pri bolnicah, ki doživijo komplicirano nevtropenijo (podaljšano nevtropenijo, febrilno nevtropenijo ali okužbo) je potrebno razmisliti o G-CSF in zmanjšanju odmerka (glejte poglavje 4.2).
WHAT DOCEFREZ IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO DOCEFREZ IN ZA KAJ GA UPORABLJAMO
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomized to one of two treatment arms.
V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126).
Preživetje je bilo boljše v kraku s kombinacijo docetaksel + kapecitabin (p = 0,0126).
• pain in the joints or muscles
• bolečine v mišičnih sklepih;
Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Docefrez je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
Alopecia was observed to be ongoing during follow-up in 25 patients out of the 736 patients with alopecia at the end of the chemotherapy.
Še prisotno alopecijo so pri spremljanju zabeležili pri 25 od 736 bolnicah, ki so imeli alopecijo ob koncu kemoterapije.
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF, (see section 4.2).
Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z G-CSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed (see table below):
Podskupine bolnic, zdravljenih s TAC,so analizirali po prospektivno opredeljenih prognostičnih dejavnikih (glejte spodnjo preglednico):
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Zato se docetaksela med nosečnostjo ne sme uporabljati, razen če se jasno ne indicira.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
primeru blažjih preobčutljivostnih reakcij, npr. pordevanja ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
METHOD OF ADMINISTRATION Read the package leaflet before use EXPIRY DATE
POSTOPEK UPORABE Pred uporabo preberite brošuro v embalaži DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
Intravenous use
Docetaksel Intravenska uporaba
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
Myalgia (severe: 1.4%) Arthralgia
Mialgija (huda: 1,4 %) Artralgija
Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
V redkih primerih so bili opisani akutni respiracijski distres sindrom, intersticijska pljučnica in pljučna fibroza.
Ethanol This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Ta medicinski izdelek vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
of patients
bolnikov
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO
The Netherlands tel: +31-23-5685501 fax: +31-23-5685505
Nizozemska tel: +31-23-5685501 faks: +31-23-5685505
Peripheral oedema was observed to be ongoing during follow-up time in 18 patients out of the 112 patients with peripheral oedema at the end of the chemotherapy in study TAX 316, whereas lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy in the study GEICAM 9805.
Še prisotne periferne edeme so pri spremljanju zabeležili pri 18 od 112 bolnicah, ki so imeli periferne edeme ob koncu kemoterapije v študiji TAX 316, limfedem pa je še trajal pri 4 od 5 bolnicah z limfedemom na koncu kemoterapije v študiji GEICAM 9805.
Median duration of response to chemotherapy ± radiotherapy (months) (95%CI)
Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci) (95 % IZ)
Using a syringe with a needle, the entire contents of the correct vial of solvent for Docefrez is to be withdrawn and injected into the respective Docefrez powder vials.
Z injekcijsko brizgo z nameščeno iglo izvlecite celotno vsebino ustrezne viale z vehiklom za Docefrez in jo vbrizgajte v ustrezne viale s praškom Docefrez.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138.
• Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Prejemnice TAC so imele 32 % manjše tveganje recidiva kot prejemnice FAC (razmerje ogroženosti = 0,68, 95 % IZ (0,49-0,93), p = 0,01).
Docetaxel every week Mitoxantrone every 3 weeks
Mitoksantron vsake 3 tedne
Any solution containing a precipitate should be discarded.
Če raztopina vsebuje precipitat, jo je treba zavreči.
This volume of concentrate should be injected into a 250 ml infusion bag or bottle containing either glucose 50 mg/ml (5%) solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
To količino koncentrata je treba injicirati v 250-mililitrsko infuzijsko vrečko ali steklenico, v kateri je bodisi 5-odstotna raztopina glukoze (50 mg/ml) ali 0,9-odstotna raztopina natrijevega klorida (9 mg/ml) za infundiranje.
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
(TAX 316)
III (TAX323).
You must not use Docefrez if you are pregnant unless clearly indicated by your doctor.
Docefrez NE smete dobiti, če ste noseči, razen čav vam zdravnik tako izrecno naloži.
No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Nobenih sprememb niso zabeležili pri bolnicah, ki so prejemale fluorouracil, doksorubicin in ciklofosfamid.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze a 4 minute, P 36 minut in y 11,1 ure.
Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemoterapy agents and/or radiotherapy.
Poročali so o zelo redkih primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
Powder vial:
Viala z vehiklom:
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (> 5 %), o katerih so poročali v fazi III klinične študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs.
Na primer, za odmerek od 140 mg docetaksela bo potreben en 80 miligramskoi pakiranje in tri 20 miligramska pakiranja.
Keep out of the reach and sight of children.
Hranite izven dosega otrok.
Infusion site reaction
Reakcija na mestu infundiranja
• For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel / capecitabine treatment, delay treatment until resolved to Grade 0- 1, and resume at 100% of the original dose.
• Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 ter znova uporabite 100 % izvirnega odmerka.
Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes.
Docetaksel se pridobiva iz iz iglic tise in spada v skupino zdravil proti raku, imenovanih taksoidi.
Pain response rate (%)
Odzivnost na bolečino (%)
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
• Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0,009.
Keep the vial in the outer carton in order to protect from light
Vialo hranite v zunanji embalaži, da jo zaščitite pred svetlobo
Overall
celotno
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docefrez vial by partially inverting the vial.
4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docefrez iz viale tako, da vialo delno obrnete.
Abdominal pain upper; Dry mouth
Bolečine v zgornjem delu trebuha, suha usta
The docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1 hour infusion under room temperature and normal lighting conditions.
Infuzijsko raztopino docetaksela je treba uporabiti v 4 urah, odmeriti pa jo je treba aseptično v 1 uri pri sobni temperaturi in pri normalni osvetlitvi.
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Opisani so redki primeri dehidracije zaradi prebavnih motenj, gastrointestinalne perforacije, ishemični kolitis, kolitis in nevtropenični enterokolitis.