natgillin/translations-raw huggingface dataset:
In a cross-study analysis using data from four Phase I studies, the pharmacokinetics of nelarabine and ara-G were characterized in patients aged less than 18 years and adult patients with refractory leukaemia or lymphoma.
Farmakokinetiko nelarabina in ara-G pri bolnikih, mlajših od 18 let, in odraslih bolnikih z neodzivno levkemijo ali limfomom, so ovrednotili z analizo presečne študije, kjer so uporabili podatke iz štirih študij I. faze.
What Atriance contains
Kaj vsebuje zdravilo Atriance
Because the timecourse of intracellular ara-GTP was prolonged, its elimination half-life could not be accurately estimated.
(151 %), povprečni ledvični očistek ara-G pa 2,6 l/h/m Ker so bile vrednosti znotrajceličnega ara-GTP določene v daljšem časovnem okviru, njegovega razpolovnega časa izločanja ni bilo možno zanesljivo določiti.
• The other ingredients are sodium chloride, water for injections, hydrochloric acid, sodium hydroxide (see section 2 “Atriance contains sodium”).
• Pomožne snovi so natrijev klorid, voda za injekcije, klorovodikova kislina, natrijev hidroksid
The pharmacokinetics of nelarabine and ara-G have not been specifically studied in renally impaired or haemodialysed patients.
Pri bolnikih z ledvično okvaro ali bolnikih na hemodializi farmakokinetike nelarabina in ara-G niso posebej proučevali.
Duration of response in both classifications of response ranged between 4.7 and 36.4 weeks and median overall survival was 13.1 weeks [95 % CI: 8.7-17.4] and survival at one year was 14 % [95 % CI: 3 %-26 %].
Srednja celotna doba preživetja je bila 13,1 tednov [95 % interval zaupanja: 8,7-17,4].
Plasma ara-G Cmax values generally occurred at the end of the nelarabine infusion and were generally higher than nelarabine Cmax values, suggesting rapid and extensive conversion of nelarabine to ara-G. After infusion of 1,500 mg/m nelarabine over two hours in adult patients, mean (%CV) plasma nelarabine Cmax and AUCinf values were 13.9 µM (81 %) and 13.5 µM.h (56 %) respectively.
Po dvourni infuziji nelarabina v odmerku 1.500 mg/m je bila pri odraslih bolnikih srednja plazemska koncentracija Cmax (% KV) nelarabina 13,9 µM (81 %), srednja vrednost AUCinf nelarabina (% KV) pa 13,5 µM.h (56 %).
Twenty-eight of the 39 adults had relapsed or were refractory to at least two prior induction regimens and aged between 16 to 65 years of age (mean 34 years).
Pri osemindvajsetih od 39 bolnikov je prišlo do ponovite bolezni ali pa se najmanj na dva od predhodnih indukcijskih režimov zdravljenja niso odzvali.
Nelarabine and ara-G are extensively distributed throughout the body based on combined Phase I pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m2.
Na osnovi kombiniranih farmakokinetičnih podatkov iz študij I. faze z odmerki nelarabina od 104 do 2.900 mg/m je porazdelitev nelarabina in ara-G v telesu obsežna.
Each vial contains 50 ml of solution.
1 viala vsebuje 50 ml raztopine.
There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Pri bolnikih, ki so se zdravili z nelarabinom, so poročali o pojavu oportunističnih okužb, ki so bile v posameznih primerih usodne.
No data are available to provide a dose advice for patients with Clcr less than 50 ml/min.
Pri bolnikih s Clcr manjšim od 50 ml/min zaradi pomanjkanja podatkov priporočil za prilagoditev odmerka ne moremo podati.
Breast-feeding must be discontinued while you are taking Atriance.
Med zdravljenjem z zdravilom Atriance morate z dojenjem prekiniti.
Nelarabine has not been studied in patients with hepatic impairment.
Pri bolnikih z okvaro jeter uporabe nelarabina niso proučevali.
Hepatobiliary disorders Hyperbilirubinaemia
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija zvišana aktivnost transaminaz
Intracellular ara-GTP accumulated with repeated administration of nelarabine.
Pri ponavljajočih se aplikacijah se je ara-GTP kopičil v celicah.
Rhabdomyolysis and increased blood creatine phosphokinase have been identified during postapproval use of nelarabine.
Med uporabo nelarabina po pridobitvi dovoljenja za promet so opažali rabdomiolizo in zvišanje koncentracij kreatin fosfokinaze v krvi.
Wheezing
piskanje
Eye disorders Blurred vision
Očesne bolezni zamegljen vid
Maternal body weight gain and foetal body weights were reduced in rabbits given a dose approximately 2-fold the adult human dose.
Pri odmerku, ki je bil približno 2-krat večji od odmerka za odrasle bolnike, so pri kuncih opazili počasnejše povečevanje telesne mase pri materah ter manjšo telesno maso plodov.
Sodium chloride
glavobol paragevzija
Severe nervous system side effects have been reported with the use of Atriance.
Pri zdravljenju z zdravilom Atriance so poročali o pojavu resnih neželenih učinkov na živčevje.
Your doctor will check for these symptoms regularly during treatment (see also section 4, "Possible side effects").
(glejte tudi poglavje 4 “Možni neželeni učinki”).
Hepatic impairment
tremor omotica
• Feeling of an upset stomach (nausea); being sick/throwing up (vomiting); diarrhoea; constipation
• Siljenje na bruhanje (navzea), bruhanje, driska in zaprtost.
Patients treated with nelarabine are potentially at risk of suffering from somnolence during and for several days after treatment.
Med zdravljenjem in še več dni po zdravljenju z nelarabinom se pri bolniku lahko pojavi somnolenca.
Balance disorder
raztopina za infundiranje
Asthenia
Bolezni živčevja
Tumour size ≤ 2 cm >2 cm
Velikost tumorja  2 cm > 2 cm
Consideration should be given to possible effects on the central nervous system.
Razmisliti je treba o možnih učinkih na centralni živčni sistem.
Date of latest renewal: 23rd February 2017
Datum zadnjega podaljšanja: 23. februar 2017
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2012
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. maj 2012
Accord (listed in section 6).
Accord (navedeno v poglavju 6),
Such information will allow your doctor to decide whether a dose reduction is needed.
Te informacije bodo zdravniku pomagale pri odločitvi, ali je odmerek treba zmanjšati.
Use the medicine immediately after it is added into the infusion bag.
Zdravilo uporabite takoj potem, ko je dodano v infuzijsko vrečko.
An effective method of contraception should be used during treatment.
Med zdravljenjem se mora uporabljati učinkovita metodo kontracepcije.
• raised liver enzymes (hence the need for regular blood tests)
• zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi).
• if the number of white blood cells is too low.
• če imate premajhno število belih krvnih celic,
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Vsebnost alkohola v tem zdravilu lahko vpliva na centralni živčni sistem (del živčnega sistema, ki vključuje možgane in hrbtenjačo).
If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Če bolnik tudi pri odmerku 60 mg/m2 še doživlja te reakcije, je treba zdravljenje prekiniti.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Opredelitev pogostnosti je: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10); občasno (≥ 1/1.000 do < 1/100); redko (≥ 1/10.000 do < 1/1.000); zelo redko (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
EXP: Shelf life in infusion bag: see the leaflet.
EXP: Rok uporabnosti v infuzijski vrečki: glejte navodilo.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
• decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
• znižanje natrija, kalija, magnezija in/ali kalcija v krvi (motnje ravnotežja elektrolitov)
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Accord.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Docetaksel Accord.
Overall Age category 1 <50 years ≥50 years Age category 2 <35 years ≥35 years
Starostna kategorija 2 < 35 let ≥ 35 let
Cases of permanent alopecia (frequency not known) have been reported.
Opisani so bili primeri trajne alopecije (neznana pogostnost).
Recommendations for the safe handling
Priporočila za varno ravnanje:
Before each treatment with Docetaxel Accord, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Accord.
Pred vsako uporabo zdravila Docetaksel Accord boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Docetaksel Accord.
Elderly treated with TCF should be closely monitored.
Starostnike, ki dobivajo TCF, je treba natančno nadzirati.
This is because Docetaxel Accord or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Bodisi zdravilo Docetaksel Accord 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.
Docetaxel Accord will be given by infusion into one of your veins (intravenous use).
Zdravilo Docetaksel Accord boste dobili v infuziji v eno od ven (intravenska uporaba).
The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila docetaksel za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
If this happens, you must tell your doctor immediately
Če se to zgodi, morate nemudoma obvestiti zdravnika
Docetaxel Accord contains alcohol.
Zdravilo Docetaksel Accord vsebuje alkohol.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaksel spada v skupino zdravil proti raku, imenovanih taksani.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Prepare the infusion solution as recommended.
Pripravite raztopino za infundiranje po navodilih.
What you need to know before you use Docetaxel Accord
Kaj morate vedeti, preden boste uporabili zdravilo Docetaksel Accord
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because docetaxel may be harmful for the unborn baby.
Med zdravljenjem z zdravilom Docetaksel Accord ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker docetaksel lahko škoduje vašemu nerojenemu otroku.
Other medicines and Docetaxel Accord
Druga zdravila in zdravilo Docetaksel Accord
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Docetaksel Accord neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Between infusions of docetaxel the following may occur, and the frequency may vary with the combinations of medicines that are received
Med infuzijami zdravila Docetaksel Accord se lahko pojavi naslednji neželeni učinki in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
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 follow-up 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 are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
• če ste alergični na (preobčutljivi za) docetaksel ali katero koli sestavino zdravila Docetaksel
The name of this medicine is Docetaxel Accord.
To zdravilo se imenuje Docetaksel Accord.
The incidence of serious adverse events was higher in elderly compared to younger patients.
Incidenca resnih neželenih učinkov je bila pri starostnikih večja kot pri mlajših.
What Docetaxel Accord is and what it is used for
Kaj je zdravilo Docetaksel Accord in za kaj ga uporabljamo
Metabolism and nutrition disorders Cases of electrolyte imbalance have been reported.
Poročali so o primerih neravnovesja elektrolitov.
If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel Accord concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Če so viale shranjene v hladilniku, pustite potrebno število škatel koncentrata za raztopino za infundiranje Docetaksel Accord pred uporabo 5 minut stati na temperaturi do 25°C.
Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, Taxanes, ATC Code: L01CD02
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), rastlinski alkaloidi in druge naravne učinkovine (zaviralci mitoze), taksani, oznaka ATC: L01CD02 Mehanizem delovanja
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.
See also section “Docetaxel Accord contains ethanol (alcohol)” below.
Glejte tudi poglavje »Zdravilo Docetaksel Accord vsebuje etanol (alkohol)«.
Summary of the safety profile for all indications
4.8 Neželeni učinki Povzetek varnostnih značilnosti za vse indikacije
Docetaxel was administered as a 1-hour infusion, all other medicinal products 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.
Infections and infestations Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Infekcijske in parazitske bolezni okužba (S3/4): 5,7 %; vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
Docetaxel Accord 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 could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Zdravnik vam je zdravilo Docetaksel Accord 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 docetaksel uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
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).
From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
Z mikrobiološkega stališča mora biti redčenje opravljeno v nadzarovanih in preverjenih aseptičnih pogojih.
Docetaxel Accord will be administered to you by a healthcare professional.
Zdravilo Docetaksel Accord vam bo dal zdravstveni delavec.
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).
Splošne težave in spremembe na mestu aplikacije 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).
If you are a man being treated with Docetaxel Accord 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 Accord 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.
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
V kombinaciji s kapecitabinom je priporočljivo začetni odmerek kapecitabina pri bolnikih, starejših od 60 let, zmanjšati na 75 % (glejte povzetek glavnih značilnosti zdravila za kapecitabin).
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multicentre phase III study.
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III.
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, ketoconazole, erythromycin.
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, ketokonazol in eritromicin.
• From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
• Z mikrobiološkega stališča mora biti redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in raztopino za infundiranje je treba uporabiti takoj.
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9,805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
• 1.276 bolnikih (744 v TAX 316 in 532 GEICAM 9.805), ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Benigne in maligne neoplazme (vključno s cistami in polipi) O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
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.
The European Medicines Agency has waived the obligation to submit the results of studies with Docetaxel Accord in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij z zdravilom Docetaksel za vse skupine pediatrične populacije za raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, karcinom želodca in raka glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Z mikrobiološkega stališča mora biti redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in zdravilo je potrebno uporabiti takoj.
Docetaxel Accord must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila Docetaksel Accord NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
• Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
• mitoksantron 12 mg/m2 vsake 3 tedne, 10 ciklov.
How to use Docetaxel Accord
Kako uporabljati zdravilo Docetaksel Accord
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Mediana časa do napredovanja je bila v kraku AT 37,3 tedna (95 % IZ: 33,4-42,1) in v kraku AC 31,9 tedna (95 % IZ: 27,4-36,0).
Docetaxel Accord 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.
Zdravilo Docetaksel Accord je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m2 every 6 weeks and 6 mg/m2 every 3 weeks).
Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/m2 na 6 tednov in 6 mg/m2 na 3 tedne).
Docetaxel Accord concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Docetaksel Accord koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje k raztopini za infundiranje.
• hair loss: in most cases normal hair growth should return.
• izguba las in dlak: večinoma se obnovi njihova normalna rast; v nekaterih primerih (neznana pogostnost) so bili opisani primeri trajne izgube las in dlak
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 nima 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.