natgillin/translations-raw huggingface dataset:
Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Pri bolnikih, zdravljenih s TPF, se je lestvica globalnega zdravja signifikantno manj poslabšala kot pri tistih, ki so bili zdravljeni s PF (p = 0,01, uporabljena je bila lestvica EORTC QLQ-C30).
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
• V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4.stopnje, odmerek docetaksela prekinite.
Hazard Ratio: 1.032 [95% CI: 0.876; 1.216]
razmerje tveganj: 1,032 [95 % IZ: 0,876, 1,216]
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Neželeni učinki na moda, opisani v študijah toksičnosti na glodalcih, nakazujejo, da lahko docetaksel prizadene moško plodnost.
Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Pri bolnikih, ki so kdaj imeli preobčutljivostno reakcijo na paklitaksel, lahko obstaja tveganje za pojav preobčutljivostne reakcije na docetaksel, vključno s hujšo preobčutljivostno reakcijo.
2 year Survival (%)
2-letno preživetje (%)
One hundred eighty six patients were randomised to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Stošestinosemdeset (186) bolnic je bilo randomiziranih na prejemanje docetaksela (100 mg/m2) s trastuzumabom ali brez njega; 60 % bolnic je prej dobilo adjuvantno kemoterapijo na osnovi antraciklinov.
You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines (see section 4 Possible side effects).
To zdravilo vam lahko povzroči neželene učinke, ki lahko poslabšajo sposobnost upravljanja vozil, uporabe orodij ali upravljanja strojev (glejte poglavje 4 Možni neželeni učinki).
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Podatki o reverzibilnosti so na voljo za 35,3 % bolnikov, pri katerih so se po zdravljenju z docetakselom kot monoterapijo v odmerku 100 mg/m2 pojavili nevrotoksični učinki.
DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Podatki o preživetju brez bolezni niso bili statistično značilni, a so kljub temu kazali pozitiven trend v korist TAC.
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
• intersticijska bolezen pljuč (vnetje pljuč, ki povzroča kašljanje in težave z dihanjem.
Grade 3
3. stopnja
In combination with cisplatin and 5-fluorouracil
V kombinaciji s cisplatinom in 5-fluorouracilom
The pharmacokinetic profile of cisplatin administered shortly after docetaxel infusion is similar to that observed with cisplatin alone.
Farmakokinetični profil cisplatina, uporabljenega kmalu po infuziji docetaksela, je podoben kot po uporabi samega cisplatina.
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Celotna objektivna deleža odziva v vsej randomizirani populaciji (ocena raziskovalca) sta bila 41,6 % (docetaksel + kapecitabin) in 29,7 % (samo docetaksel), p = 0,0058.
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Učinek prednizona na farmakokinetiko docetaksela, ki so ga aplicirali s standardno premedikacijo z deksametazonom so študirali pri 42 bolnikih.
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 študiji III faze pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (glejte povzetek glavnih značilnosti kapecitabina).
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF Velika Britanija
The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive or use machines (see sections 4.4 and 4.8).
Količina alkohola v tem zdravilu in neželeni učinki zdravila lahko poslabšajo sposobnost vožnje in upravljanja strojev (glejte poglavji 4.4 in 4.8).
What DOCETAXEL KABI is and what it is used for
Kaj je zdravilo DOCETAKSEL KABI in za kaj ga uporabljamo
In cases of overdose, exacerbation of adverse events may be expected.
Pri prevelikih odmerkih je mogoče pričakovati eksacerbacijo neželenih učinkov.
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Nevtropenični zapleti pri bolnicah, ki so prejemale TAC z ali brez primarne profilakse z G-CSF (GEICAM 9805)
• fever: if this happens you must tell your doctor immediately
• povišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku,
There is no relevant use of DOCETAXEL KABI 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 KABI 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.
Docetaxel plus trastuzumab1 n = 92
parameter docetaksel in trastuzumab1 n = 92
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 shemo so uporabljali 4 cikle vsake 3 tedne, če so po 2 ciklih opazili vsaj majhen odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Preživetje brez bolezni (DFS) je bilo primarni, celokupno preživetje (OS) pa sekundarni opazovani dogodek učinkovitosti.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental anti-tumour activity against advanced murine and human grafted tumours.
In vivo docetaksel ni odvisen od sheme in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Bolezni krvi in limfatičnega sistema: Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
Head and neck cancer
Rak glave in vratu
• Induction chemotherapy followed by radiotherapy (TAX 323)
• Indukcijska kemoterapija in nato radioterapija (TAX 323)
DOCETAXEL KABI 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 KABI could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Zdravnik vam je zdravilo DOCETAKSEL KABI 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 DOCETAKSEL KABI uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
Docetaksel se sme uporabljati le v enotah, specializiranih za citotoksično kemoterapijo in samo pod nadzorom zdravnika, izkušenega na področju onkološke kemoterapije (glejte poglavje 6.6).
The updated analysis was performed when all patients had reached their 10-year (median follow up time of 10 years and 5 months) follow-up visit (unless they had a DFS event or were lost to follow-up previously).
Posodobljena analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10-letnem (mediani čas spremljanja: 10 let in 5 mesecev) spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se predhodno izgubile spremljanju).
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.
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
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).
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 cikli priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
• pneumonia (infection of the lungs)
• pljučnica (okužba pljuč),
The recommended dose of docetaxel is 75 mg/m2.
Priporočeno odmerjanje docetaksela je 75 mg/m2.
Docetaxel did not influence the binding of digitoxin.
Docetaksel ni vplival na vezavo digitoksina.
The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Glavni pričakovani zapleti prevelikega odmerjanja so supresija kostnega mozga, periferni nevrotoksični učinki in mukozitis.
Second primary malignancies (including acute myeloid leukemia, 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.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci) (95 % IZ)
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly.
V kombinaciji s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
Following chemotherapy, patients should receive radiotherapy.
Po kemoterapiji morajo bolniki prejeti radioterapijo.
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 konvecionalno 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).
Fluid retention is cumulative in incidence and severity (see section 4.4).
Zastajanje tekočine je kumulativno po incidenci in izrazitosti (glejte poglavje 4.4).
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Na koncu kemoterapije, z minimalnim intervalom 4 tednov in maksimalnim intervalom 7 tednov, so bolniki, katerih bolezen ni napredovala, 7 tednov prejemali radioterapijo (RT) v skladu s smernicami ustanove (PF/RT).
Rare cases of myocardial infarction have been reported.
Poročali so o redkih primerih miokardnega infarkta.
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili kemotradioterapijo (KRT) po protokolu (TPF/KRT).
Overall response rate (%):
celotni delež odziva (%)
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Tri bolnice (2 %), ki so prejemale docetaksel, so zdravljenje prekinile zaradi zastajanja tekočine, 15 prejemnic (9 %) doksorubicina pa ga je prekinilo zaradi kardiotoksičnih učinkov (trije primeri usodnega kongestivnega srčnega popuščanja).
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Zelo pogosti: Hematoloških toksičnih učinkov je bilo več pri bolnikih, ki so dobivali trastuzumab in docetaksel kot pri tistih, ki so dobivali samo docetaksel (32 % nevtropenije stopnje 3/4 v primerjavi z 22 % po merilih NCI-CTC).
All patients who did not have progressive disease were to receive CRT as per protocol (PF/CRT).
Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili KRT po protokolu (PF/KRT).
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Med študijama III. faze se je varnostni profil docetaksela skladal z varnostnim profilom, ugotovljenim v študijah II.
To be taken into account in pregnant or breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.
Vsebnost etanola je treba upoštevati tudi pri nosečnicah, doječih ženskah, otrocih in skupinah z velikim tveganjem, npr. pri bolnikih z boleznijo jeter ali epilepsijo.
Additional cautions for use in adjuvant treatment of breast cancer
Dodatna opozorila pri uporabi adjuvantne terapije raka dojke
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.
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat na dan (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70-72 Gy).
Therefore, men being treated with docetaxel 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.
Zato je priporočljivo, da moški, ki se zdravijo z docetakselom, ne zaplodijo otroka med zdravljenjem in v obdobju šestih mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščejo nasvet glede ohranitve sperme.
These patients should be closely monitored during initiation of docetaxel therapy.
Takšne bolnike je treba med uvedbo zdravljenja z docetakselom natančno spremljati.
DOCETAXEL KABI contains alcohol.
Zdravilo DOCETAKSEL KABI vsebuje alkohol.
DOCETAXEL KABI was administered as a 1-hour infusion, all other medicinal product were given intraveinously on day 1 every three weeks.
Zdravilo DOCETAKSEL KABI je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Dokazano je, da je docetaksel mutagen v mikronukleusnem in kromosomskem aberacijskem testu na celicah CHO-K1 in vitro ter v mikronukleusnem testu pri miših in vivo.
Congestive heart failure (CHF)
Kongestivno srčno popuščanje (KSP)
With primary G-CSF prophylaxis (n = 421) n (%)
S primarno profilakso z G-CSF (n = 421) n (%)
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Če se sočasni uporabi močnega zaviralca CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
Some cases of anaphylactic shock, sometimes fatal, have been reported.
Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
V primeru hudih reakcij, npr. hude hipotenzije, bronhospazma ali generaliziranega izpuščaja oz. eritema, pa je treba zdravljenje z docetakselom takoj prekiniti in uporabiti ustrezno terapijo.
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
Efficacy results are presented in the table below:
Rezultati učinkovitosti so predstavljeni v spodnji tabeli:
Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Opisani so bili primeri hiponatriemije, večinoma povezani z dehidracijo, bruhanjem in pljučnico.
Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Analize podskupine - adjuvantno zdravljenje bolnic v študiji raka dojke z negativnimi bezgavkami (analiza z-namenom-zdravljenja)
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Možna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, a medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatomin vitro ni vplivalo na vezavo docetaksela na beljakovine.
Acute leukaemia / Myelodysplastic syndrome
Akutna levkemija/mielodisplastični sindrom:
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1.000 mg/m2 in mediani čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek: 818,9 mg/m2), kot pri tistih, ki je ne (mediani kumulativni odmerek: 489,7 mg/m2); vendar je pri nekaterih bolnikih opisan med zgodnjimi cikli zdravljenja.
Previous chemotherapy should have included an anthracycline or an alkylating agent.
Predhodna kemoterapija bi morala vključevati antraciklin ali alkilirajočo učinkovino.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
V primeru blažjih preobčutljivostnih reakcij, npr. pordevanja ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
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 (eg, day 6-15) in all subsequent cycles.
V ključnih študijah SCCHN pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, febrilno 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.
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 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, ß 36 minut in γ 11,1 ure.
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
• zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem),
• feeling of numbness or pins and needles or pain in the joints or muscles
• občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah,
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Zaradi možnih neželenih učinkov na dojenčke je treba dojenje med zdravljenjem z docetakselom prekiniti.
Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Na mestu prejšnje ekstravazacije so opažali reakcijo pomnjenja na mestu injiciranja (ponovitev kožne reakcije na mestu predhodne ekstravazacije med dajanjem docetaksela na druge mestu) (pogostnost ni znana).
If you are a man being treated with DOCETAXEL KABI 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 DOCETAKSEL KABI 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.
Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Bolnice z operabilnim rakom dojke z negativnimi bezgavkami, primerne za prejemanje kemoterapije (GEICAM 9805)
Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Opisani so bili zelo redki primeri prehodnih motenj vida (bliskanje, bliskajoča svetloba, skotomi), ki so se praviloma pojavili med infundiranjem zdravila in v povezavi s preobčutljivostnimi reakcijami.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Za uporabo pri starejših bolnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.