natgillin/translations-raw huggingface dataset:
No events were reported in patients randomized to warfarin.
Pri bolnikih, randomiziranih na varfarin, niso poročali o nobenem dogodku.
Modafinil is suspected to cause birth defects if taken during pregnancy.
Obstaja sum, da modafinil povzroča prirojene nepravilnosti, če se jemlje med nosečnostjo.
In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
V randomizirani, odprti multicentrični študiji s slepo presojo opazovanega dogodka, ki so jo sponzorirali raziskovalci, so rivaroksaban primerjali z varfarinom pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ter z visokim tveganjem za trombembolične dogodke (pozitivnih pri vseh treh antifosfolipidnih preiskavah: za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I).
What you need to know before you take [Product name] Other medicines and [Product name]
Kaj morate vedeti, preden boste vzeli zdravilo [ime zdravila]
Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke).
Cimetidin, lansoprazol in omeprazol (ki se uporabljajo za zdravljenje želodčnih razjed), flukonazol (ki se uporablja za zdravljenje glivičnih okužb), fluvoksamin (antidepresiv) in tiklopidin (ki se uporablja za zmanjševanje tveganja za možgansko kap).
Major bleeding occurred in 4 patients (7%) of the rivaroxaban group and 2 patients (3%) of the warfarin group.
V skupini, ki je prejemala rivaroksaban, se je večja krvavitev pojavila pri 4 bolnikih (7 %), v skupini, ki je prejemala varfarin, pa pri 2 bolnikih (3 %).
In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Zlasti pri trojno pozitivnih bolnikih (za lupusni antikoagulant, protitelesa proti kardiolipinu in protitelesa proti beta 2-glikoproteinu I) je zdravljenje s peroralnimi antikoagulanti z neposrednim delovanjem v primerjavi z zdravljenjem z antagonisti vitamina K lahko povezano s povečano pogostnostjo ponavljajočih se trombotičnih dogodkov.
Selective serotonin reuptake inhibitors: citalopram; escitalopram - Drug interaction with fluconazole (EPITT no
Selektivni zaviralci ponovnega privzema serotonina: citalopram; escitalopram - medsebojno delovanje s flukonazolom (št. EPITT 19327)
4.5 Interaction with other medicinal products and other forms of interaction Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluconazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine.
Zato je potrebna previdnost, kadar se uporablja sočasno z zaviralci CYP2C19 (npr. omeprazolom, esomeprazolom, flukonazolom, fluvoksaminom, lansoprazolom, tiklopidinom) ali cimetidinom.
Direct-acting oral anticoagulants (DOACs): apixaban; dabigatran etexilate; edoxaban; rivaroxaban - Recurrent thrombosis in patients with antiphospholipid syndrome (EPITT no 19320)
Peroralni antikoagulanti z neposrednim delovanjem: apiksaban, dabigatran eteksilat, edoksaban, rivaroksabanponavljajoča se tromboza pri bolnikih z antifosfolipidnim sindromom (št. EPITT 19320)
Direct acting Oral Anticoagulants (DOACs) including rivaroxaban/apixaban/edoxaban/dabigatran etexilate are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome.
Uporaba peroralnih antikoagulantov z neposrednim delovanjem, vključno z rivaroksabanom/apiksabanom/edoksabanom/dabigatran eteksilatom, pri bolnikih z anamnezo tromboze in diagnozo antifosfolipidnega sindroma ni priporočljiva.
There is limited data on the use of modafinil in pregnant women.
Plodnost, nosečnost in dojenje Podatkov o uporabi modafinila pri nosečnicah je malo.
If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Bodite posebno pozorni pri jemanju zdravila Eliquis/Lixiana/Roteas Če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
Take special care with Eliquis/Lixiana/Roteas
Apiksaban/edoksaban
An updated RMP shall be submitted by 31 October 2019.
Posodobljen RMP je treba predložiti do 31. oktobra 2019.
Tumour size 2 cm >2 cm
Velikost tumorja  2 cm > 2 cm
75008 Paris
75008 Pariz
(Harbor Park) 1, Campona utca Budapest 1225
(Harbor Park) 1, Campona utca Budimpešta 1225
Harmful for those suffering from alcoholism.
Škodljivo je za osebe, ki trpijo za alkoholizmom.
• change or absence of menstrual period
• spremembe ali izostanek menstruacije
a From the GETUG AFU15 study
a Iz študije GETUG AFU15.
(listed in section 6).
(navedeno v poglavju 6).
None of these increases in frequency reached 10% difference with the control arm.
Nobeno od teh povečanj pogostnosti ni doseglo 10-odstotne razlike v primerjavi s kontrolno skupino.
Each box contains one vial.
Vsaka škatla vsebuje eno vialo.
(26.8-ne) TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
ČDN = čas do napredovanja; “no” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
• if the number of white blood cells is too low.
• če imate premajhno število belih krvnih celic.
Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored.
Bolnike je treba seznaniti z znaki in simptomi resnih kožnih manifestacij in jih skrbno spremljati.
• 2 years.
• 2 leti.
Alopecia (persisting:
Alopecija (persistentna:
STAMPEDE study
ŠTUDIJA STAMPEDE
The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom PSUR za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portal o zdravilih.
Other medicines and TAXOTERE
Druga zdravila in zdravilo TAXOTERE
The safety and efficacy of TAXOTERE in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila TAXOTERE za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
You must not be given TAXOTERE:
Zdravila TAXOTERE ne smete dobiti:
Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Pred vsako uporabo zdravila TAXOTERE boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo TAXOTERE.
TAXOTERE will be given by infusion into one of your veins (intravenous use).
Zdravilo TAXOTERE boste dobili v infuziji v eno od ven (intravenska uporaba).
What you need to know before you use TAXOTERE
Kaj morate vedeti, preden boste uporabili zdravilo TAXOTERE
See accompanying preparation guide.
Glejte priložena navodila za pripravo.
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
G-CSF so uporabili za sekundarno profilakso pri 19,3 % bolnikov (10,7 % ciklusov).
TAXOTERE contains alcohol.
Zdravilo TAXOTERE vsebuje alkohol.
• decrease of the potassium, calcium and/or phosphate in your blood.
• znižanje kalija, kalcija in/ali fosfata v krvi.
Frequency not known (cannot be estimated from the available data):
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
CHAARTED study
ŠTUDIJA CHAARTED
• raised liver enzymes (hence the need for regular blood tests)
• zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi)
However, the distribution of OS was not significantly different between the 2 groups.
Toda porazdelitev celotnega preživetja se med obema skupinama ni značilno razlikovala
Ask your doctor for advice before being given any medicine.
Posvetujte se z zdravnikom preden vzamete katerokoli zdravilo.
a Time to event variables: Stratified log-rank test.
a Spremenljivke časa do dogodka: stratificirani log-rang test.
Histological grade Grade1 (includes grade not assessed) Grade 2
Histološka stopnja 1. stopnja (vključuje primere z neocenjeno stopnjo)
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received:
Med infuzijami zdravila TAXOTERE se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
RECOMMENDATIONS FOR THE SAFE HANDLING
PRIPOROČILA ZA VARNO RAVNANJE
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo TAXOTERE.
Sanofi - Produtos Farmacêuticos, Lda.
Portugal Sanofi - Produtos Farmacêuticos, Lda
Meeting relative indication for chemotherapy a
Izpolnjena relativna indikacija za kemoterapijo a
The name of this medicine is TAXOTERE.
To zdravilo se imenuje TAXOTERE.
This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Bodisi zdravilo TAXOTERE bodisi drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
Response rate variables: Fisher's Exact test * p-value for descriptive purpose.
Spremenljivke deleža odziva: Fisherjev eksaktni test. *Vrednost p za opisen namen.
TAXOTERE will be administered to you by a healthcare professional.
Zdravilo TAXOTERE vam bo dal pristojni zdravstveni delavec.
Time to clinical progressionc
Čas do kliničnega napredovanjac
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Farmakoterapevtska skupina: Taksani, oznaka ATC: L01CD02
TAXOTERE vials should be stored between 2°C and 25°C and protected from light.
Viale zdravila TAXOTERE morajo biti shranjene pri temperaturi med 2°C in 25°C in zaščitene pred svetlobo.
• infection of the upper respiratory tract.
• okužba zgornjih dihal.
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised.
Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
Use immediately the medicine once added into the infusion bag.
Zdravilo uporabite takoj potem, ko je dodano v infuzijsko vrečko.
Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005
Datum prve pridobitve dovoljenja za promet z zdravilom: 27 November 1995 Datum zadnjega podaljšanja: 27 November 2005
What TAXOTERE is and what it is used for
Kaj je zdravilo TAXOTERE in za kaj ga uporabljamo
A total of 790 male patients were allocated to the 2 treatment groups.
Skupno 790 moških je bilo vključenih v 2 terapevtski skupini:
• infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
• okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov
The premix solution should be used immediately after preparation.
Osnovno raztopino je treba uporabiti takoj po pripravi.
• ADT alone
• ADT samo.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/m2 povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Simptomi kot so: abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
• swelling caused by faulty lymphatic drainage
• otekanje zaradi nepravilne limfatične drenaže
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če ni uporabljena takoj, so čas in pogoji shranjevanja odgovornost uporabnika.
Do not store above 25°C or below 2°C.
Ne shranjujte pri temperaturi nad 25°C ali pod 2°C.
Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone.
Od 1776 randomiziranih bolnikov jih je 1086 (61 %) imelo metastatsko bolezen, 362 je bilo randomiziranih na docetaksel v kombinaciji s standardno oskrbo, 724 pa jih je prejemalo samo standardno oskrbo.
Once added to the infusion bag
Potem, ko je zdravilo dodano v infuzijsko vrečko
Shelf life in infusion bag: see the leaflet.
Rok uporabnosti v infuzijski vrečki: glejte navodilo.
Ready to add to infusion solution.
Pripravljeno za dodatek raztopini za infundiranje.
Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Docetaksela se ne sme uporabljati pri bolnikih s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
• rises in blood sugar levels (diabetes)
• zvišanje koncentracije krvnega sladkorja (sladkorna bolezen)
Do not store above 25°C.
Ne shranjujte pri temperaturi nad 25°C.
• decrease of the sodium and/or magnesium in your blood (electrolyte balance disorders)
• znižanje natrija in /ali magnezija v krvi (motnje ravnotežja elektrolitov)
TAXOTERE must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila TAXOTERE NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
4.1.3 Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to followup before).
Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10-letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional.
Če se vam pojavi huda kožna reakcija ali kateri koli od zgoraj navedenih učinkov, se nemudoma posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE
• če ste alergični na (preobčutljivi za) docetaksel ali katero koli sestavino zdravila TAXOTERE
** PSA response: Prostate-Specific Antigen response: PSA level <0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart.
**Odziv PSA: Odziv za prostato specifičnega antigena: koncentracija PSA < 0,2 ng/ml na dveh zaporednih meritvah v presledku vsaj 4 tednov.
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Nemčija
TAXOTERE contains ethanol (alcohol)
Zdravilo TAXOTERE vsebuje etanol (alkohol)
Stomatitis/mucositis grade 3
Stomatitis/mukoziti s 3. stopnje
Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
CAUTION: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
OPOZORILO: Odvzemite potrebno količino tega koncentrata docetaksela (20 mg/ml) iz viale in ga dodajte neposredno v raztopino za infundiranje.
Each blister pack contains:
En pretisni omot vsebuje:
Menopausal status Pre-Menopausal Post-Menopausal
Menopavzalno stanje Pred menopavzo Po menopavzi
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because TAXOTERE may be harmful for the unborn baby.
Med zdravljenjem z zdravilom TAXOTERE ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo TAXOTERE lahko škoduje vašemu nerojenemu otroku.
The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
How to use TAXOTERE
Kako uporabljati zdravilo TAXOTERE
Docetaxel + standard of care Standard of care alone
Docetaksel + standardna oskrba
Second primary malignancies (including acute myeloid leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Drugi primarni malignomi (vključno z akutno mieloično levkemijo, mielodisplastičnim sindromom in ne-Hodgkinovim limfomom) se lahko pojavijo več mesecev ali let po zdravljenju, ki vključuje docetaksel.
If you are a man being treated with TAXOTERE 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 zdravilom TAXOTERE je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
Full analysis set (intent-to-treat) Estimated median survival
1celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
1000 mg/m per day for 5 days.
1000 mg/m2/dan od 1. do 4. dneva.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
To terapevtsko shemo so uporabljali vsake tri tedne za 4 cikle, če so po 2 ciklih opazili vsaj manjši odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
Median duration of response to chemotherapy  radiotherapy (months) (95% CI)
Mediano trajanje odziva na kemoterapijo  radioterapijo (meseci) (95 % IZ)
TAXOTERE was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Zdravilo TAXOTERE je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
2-year estimate (%)
2-letna ocena (%)
In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
V ključni študiji so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tako kot vsa druga zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Method of administration For instructions on preparation and administration of the product, see section 6.6.
Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days.
fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
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.
The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Najpogosteje poročani neželeni učinki zdravila TAXOTERE samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.
• 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone and ADT.
• 545 bolnikov (študija STAMPEDE), ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom in ADT.
In the case of severe neutropenia (< 500 cells/mm 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).
Acute leukaemia / Myelodysplastic syndrome.
Akutna levkemija / mielodisplastični sindrom
TAXOTERE 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, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Zdravnik vam je zdravilo TAXOTERE predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu: - Za zdravljenje napredovalega raka dojke se lahko zdravilo TAXOTERE uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine (glejte poglavje 4) zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
Discard unused contents appropriately in accordance with local requirements.
Neporabljeno vsebino ustrezno zavrzite v skladu z lokalnimi zahtevami.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively.
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11,1 ure.
• feeling of numbness or pins and needles or pain in the joints or muscles
• občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaksel spada v skupino zdravil proti raku, imenovanih taksoidi.
• Standard of care alone
• standardna oskrba sama.