natgillin/translations-raw huggingface dataset:
Figure 1: Kaplan Meier overall survival curves (EFC6193)
Slika 1: Kaplan-Meierjevi krivulji preživetja (EFC6193)
Step 2: Second (final) dilution for infusion
Korak 2: Drugo (končno) redčenje za infuzijo
Follow the preparation instructions provided below.
Upoštevajte spodnja navodila za pripravo.
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines.
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Unopened vials 3 years.
Neodprte viale 3 leta
Physicians should assess for the presence or worsening of neuropathy before each treatment.
Zdravniki morajo pred vsakim zdravljenjem oceniti prisotnost ali poslabšanje nevropatije.
Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.
Med celotnim zdravljenjem je treba zagotoviti ustrezno hidracijo bolnika, da bi preprečili zaplete, kakršen je odpoved ledvic.
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
Priporočljiva je profilaksa z antiemetiki; profilakso je mogoče dajati peroralno ali intravensko, kot je potrebno.
Inject the entire contents into the corresponding concentrate vial.
Injicirajte celotno vsebino v ustrezno vialo s koncentratom.
Patients should be advised not to drive or use machines if they experience these adverse reactions during treatment.
Bolnikom je treba naročiti, naj ne vozijo in ne upravljajo s stroji, če se jim med zdravljenjem pojavijo ti neželeni učinki.
Appropriate measures should be taken to re-hydrate patients.
Potrebni so ustrezni ukrepi za rehidracijo bolnikov.
From a microbiological point of view, the two-step dilution process must take place in controlled and aseptic conditions (see below “Preparation and administration precautions”).
Z mikrobiološkega stališča je treba dvostopenjski postopek redčenja opraviti v nadzorovanih in aseptičnih pogojih (glejte "Previdnostni ukrepi za pripravo in uporabo", spodaj).
Pregnant staff should not handle it.
Noseče članice osebja ne smejo ravnati z njim.
Anti-allergic medicines will be given to you before you have JEVTANA to reduce the risk of allergic reactions.
Preden boste dobili zdravilo JEVTANA, boste dobili zdravila proti alergiji za zmanjšanje tveganja alergijskih reakcij.
• high blood sugar
• visok sladkor v krvi
Preparation steps
Koraka za pripravo
This leads to the stabilisation of microtubules, which results in the inhibition of mitotic and interphase cellular functions.
To povzroči stabilizacijo mikrotubulov s posledičnim zavrtjem celičnih funkcij v mitozi in interfazi.
• lack of white blood cells associated with fever and infection
• pomanjkanje belih krvnih celic, povezano z zvišano telesno temperaturo in okužbo
Cabazitaxel did not induce mutations in the bacterial reverse mutation (Ames) test.
Kabazitaksel ni povzročil mutacij v bakterijskem testu reverzne mutacije (Amesovem testu).
There are no data from the use of cabazitaxel in pregnant women.
Podatkov o uporabi kabazitaksela pri nosečnicah ni.
Neutropenia, and associated clinical events
Nevtropenija in povezani klinični dogodki
• decrease in the number of platelets (which results in increased risk of bleeding)
• zmanjšano število krvnih ploščic (kar se odraža kot povečano tveganje krvavitev)
• Neutrophil counts less than 1,500/mm3.
• Število nevtrofilcev manj kot 1.500/mm3.
Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness.
Kabazitaksel lahko vpliva na sposobnost vožnje in upravljanja s stroji, ker lahko povzroči utrujenost in omotico.
In case of overdose, the patient should be kept in a specialised unit and closely monitored.
V primeru prevelikega odmerjanja je treba bolnika namestiti v posebno enoto in ga natančno kontrolirati.
What you need to know before you are given JEVTANA
Kaj morate vedeti, preden boste prejeli zdravilo JEVTANA
None were considered related by the investigator.
Po raziskovalčevi oceni noben dogodek ni bil povezan.
If any of the above applies to you, tell your doctor immediately.
Če kaj od naštetega velja za vas, morate o tem nemudoma obvestiti svojega zdravnika.
The in vitro blood-to-plasma concentration ratios in human blood ranged from 0.90 to 0.99 indicating that cabazitaxel was equally distributed between blood and plasma.
In vitro je bilo razmerje koncentracije v krvi in v plazmi za človeško kri od 0,90 do 0,99, kar kaže, da se je kabazitaksel enako porazdelil med krvjo in plazmo.
Carcinogenicity studies have not been conducted with cabazitaxel.
Študij kancerogenosti s kabazitakselom niso izvedli.
Appropriate measures should be taken to rehydrate patients and to monitor and correct serum electrolyte levels, particularly potassium.
Potrebni so ustrezni ukrepi za rehidracijo bolnikov ter kontrolo in korekcijo koncentracije elektrolitov v serumu, zlasti kalija.
The benefit of resuming cabazitaxel treatment must be carefully evaluated.
Koristi nadaljevanja zdravljenja s kabazitakselom je treba skrbno ovrednotiti.
Demographics, including age, race, and ECOG performance status (0 to 2), were balanced between the treatment arms.
Osnovne značilnosti, vključno s starostjo, raso in stanjem zmogljivosti po ECOG (0 do 2), so bile med terapevtskima krakoma uravnotežene.
During treatment with JEVTANA, it is more likely that your white blood cell count may be reduced.
Med zdravljenjem z zdravilom JEVTANA je verjetneje, da se vam število belih krvnih celic zmanjša.
The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away.
Najzgodnejši znak okužbe je lahko zvišana telesna temperatura; če se vam pojavi, morate o tem takoj obvestiti zdravnika.
Frequency not known (cannot be estimated from the available data): • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing).
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): • intersticijska bolezen pljuč (vnetje pljuč, ki povzroča kašljanje in težave z dihanjem).
Number of patients with dose reduction n (%)
Število bolnikov z zmanjšanjem odmerka n (%)
• mental confusion
• duševna zmedenost
If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
Če se pojavijo novi simptomi ali pride do poslabšanja pljučne funkcije, je treba bolnike skrbno spremljati, nemudoma ugotoviti vzrok in ga ustrezno zdraviti.
Overall survival (OS) was the primary efficacy endpoint of the study.
Celokupno preživetje (CP) je bilo primarni opazovani dogodek učinkovitosti v študiji.
• JEVTANA will be given to you by a doctor or a nurse.
• Zdravilo JEVTANA vam bo dal zdravnik ali medicinska sestra.
Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of cabazitaxel, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available.
Preobčutljivostne reakcije se lahko pojavijo v nekaj minutah po začetku infundiranja kabazitaksela, zato morajo biti na voljo prostor in oprema za zdravljenje hipotenzije in bronhospazma.
This medicine may be harmful for those suffering from alcoholism.
Zdravilo lahko škoduje osebam z alkoholizmom.
• JEVTANA will be given by a drip (infusion) into one of your veins (intravenous use) in hospital for about an hour.
• Zdravilo JEVTANA boste dobili v kapalni (infuziji) v eno od ven (intravensko); dobili ga boste v bolnišnici, infuzija pa bo trajala približno eno uro.
Grade ≥3 diarrhoea or persisting diarrhoea despite appropriate treatment, including fluid and electrolytes replacement
Driska ≥ 3. stopnje ali trdovratna driska kljub ustreznemu zdravljenju, vključno z nadomeščanjem tekočine in elektrolitov
The name of your medicine is JEVTANA.
Vaše zdravilo se imenuje JEVTANA.
This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation).
To se lahko pojavi, če imate predrtje v želodcu, požiralniku ali črevesu (gastrointestinalna perforacija).
However, in-use storage time can be longer under specific conditions mentioned in section Shelf life and special precautions for storage above.
Vendar pa je lahko čas shranjevanja med uporabo daljši v specifičnih pogojih, omenjenih v poglavju Rok uporabnosti in posebna navodila za shranjevanje, zgoraj.
Neutropenia was the most common adverse reaction leading to medicinal product discontinuation
Nevtropenija je bila najpogostejši neželeni učinek, ki je povzročil prenehanje uporabe zdravila
The use of G-CSF has been shown to limit the incidence and severity of neutropenia.
Ugotovljeno je, da uporaba G-CSF zmanjša incidenco in izrazitost nevtropenije.
SANOFI BULGARIA EOOD Тел.
SANOFI BULGARIA Тел.
It is important that you read the entire content of this procedure prior to the preparation of the infusion solution.
Pomembno je, da pred pripravo raztopine za infundiranje preberete celotni opis tega postopka.
Contains an overfill.
Vsebuje prepolnitev.
However these genotoxicity findings are inherent to the pharmacological activity of the compound (inhibition of tubulin depolymerization) and have been observed with medicinal products exhibiting the same pharmacological activity.
Toda ti genotoksični izsledki so inherentni farmakološkemu delovanju spojine (zavrtje depolimerizacije tubulina) in so jih opazili pri zdravilih, ki imajo enako farmakološko delovanje.
Concomitant medicinal products use
Sočasna uporaba drugih zdravil
For intravenous use (infusion) AFTER final dilution.
Za intravensko uporabo (infundiranje) PO dokončnem redčenju.
• loss of appetite (anorexia)
• izguba apetita (neješčnost)
The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.
Koncentracija raztopine za infundiranje mora biti med 0,10 mg/ml in 0,26 mg/ml.
JEVTANA contains ethanol (alcohol)
Zdravilo JEVTANA vsebuje etanol (alkohol)
Cabazitaxel is the main circulating compound in human plasma.
Kabazitaksel je glavna spojina, ki kroži v človeški plazmi.
It belongs to a group of medicines called “taxanes” used to treat cancers.
Zdravilo JEVTANA spada v skupino zdravil, imenovanih "taksani", ki se uporabljajo za zdravljenje raka.
The European Medicines Agency has waived the obligation to submit the results of studies with JEVTANA in all subsets of the paediatric population in the indication of prostate cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom JEVTANA za vse podskupine pediatrične populacije, za indikacijo raka na prostati (glejte poglavje 4.2 za informacije o pediatrični uporabi).
There is no potential risk of inhibition of medicinal products that are substrates of other CYP enzymes (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6) as well as no potential risk of induction by cabazitaxel on medicinal products that are substrates of CYP1A, CYP2C9, and CYP3A.
Ni pa možnega tveganja zavrtja zdravil, ki so substrati drugih encimov CYP (1A2, 2B6, 2C9, 2C8, 2C19, 2E1 in 2D6), in tudi ne možnega tveganja, da bi kabazitaksel povzročil indukcijo pri zdravilih, ki so substrati CYP1A, CYP2C9 in CYP3A.
• blood in the urine
• kri v urinu
• Concomitant vaccination with yellow fever vaccine (see section 4.5).
• Sočasno cepljenje s cepivom proti rumeni mrzlici (glejte poglavje 4.5).
As the infusion solution is supersaturated, it may crystallize over time.
Ker je raztopina za infundiranje prenasičena, lahko sčasoma kristalizira.
Discontinuation of treatment due to adverse reactions occurred in 68 patients (18.3%) receiving cabazitaxel.
Zaradi neželenih učinkov so zdravljenje prekinili pri 68 bolnikih (18,3 %), ki so prejemali kabazitaksel.
The median number of cycles was 6 in the JEVTANA group and 4 in the mitoxantrone group.
Mediano število ciklusov v skupini z zdravilom JEVTANA je bilo 6 in v skupini z mitoksantronom 4.
In vitro, the binding of cabazitaxel to human serum proteins was 89-92% and was not saturable up to 50,000 ng/ml, which covers the maximum concentration observed in clinical studies.
In vitro je bila vezava kabazitaksela na beljakovine v človeškem serumu 82-92 % in ni bila saturabilna do 50.000 ng/ml; to vključuje največjo koncentracijo, ugotovljeno v kliničnih študijah.
Therefore the risk of interaction with substrates of MRP, OCT1, PgP, BCRP and OATP1B3 is unlikely in vivo at the dose of 25 mg/m2.
Zato tveganje medsebojnega delovanja s substrati MRP, OCT1, PgP, BCRP in OATP1B3 in vivo pri odmerku 25 mg/m2 ni verjetno.
Severe reactions can occur and may include generalised rash/erythema, hypotension and bronchospasm.
Pojavijo se lahko hude reakcije, med njimi generaliziran izpuščaj/eritem, hipotenzija in bronhospazem.
Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections.
Uporaba živih ali živih oslabljenih cepiv pri bolnikih, ki so imunsko oslabeli zaradi kemoterapije, lahko povzroči resne okužbe ali okužbe s smrtnim izidom.
Due to potential effects on male gametes and to potential exposure via seminal liquid, men treated with cabazitaxel should use effective contraception throughout treatment and are recommended to continue this for up to 6 months after the last dose of cabazitaxel.
Zaradi možnih učinkov na moške gamete in možno izpostavljenost preko semenske tekočine morajo moški, zdravljeni s kabazitakselom, uporabljati učinkovito kontracepcijo med celotnim zdravljenjem; priporočljivo je, da jo uporabljajo tudi še 6 mesecev po zadnjem odmerku kabazitaksela.
INFORMATION IN BRAILLE Justification for not including Braille accepted.
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, zakaj niso vključeni podatki v Braillovi pisavi.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hour at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2°C do 8°C, razen če je redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
It was not clastogenic in an in vitro test in human lymphocytes (no induction of structural chromosomal aberration but it increased number of polyploid cells) and induced an increase of micronuclei in the in vivo test in rats.
V testu na človeških limfocitih in vitro ni bil klastogen (ni induciral strukturnih kromosomskih aberacij, povečal pa je število poliploidnih celic) ter je izzval povečanje mikrojeder v testih in vivo na podganah.
It works by stopping cells from growing and multiplying.
Deluje tako, da prepreči rast in razmnoževanje celic.
As with other cytotoxic medicinal products, cabazitaxel may cause foetal harm in exposed pregnant women.
Tako kot druga citotoksična zdravila lahko tudi kabazitaksel škoduje plodu izpostavljene nosečnice.
Caution is recommended in patients with haemoglobin <10 g/dl and appropriate measures should be taken as clinically indicated.
Pri bolnikih, ki imajo hemoglobin < 10 g/dl, je potrebna previdnost in treba je ustrezno ukrepati, kot je klinično indicirano.
One pack of JEVTANA contains:
Eno pakiranje zdravila JEVTANA vsebuje:
The safety and the efficacy of JEVTANA in children and adolescents below 18 years of age have not been established (see section 5.1).
Varnost in učinkovitost zdravila JEVTANA pri otrocih in mladostnikih do 18 let nista bili dokazani (glejte poglavje 5.1).
These patients received cabazitaxel at doses of 10 to 30 mg/m2 weekly or every 3 weeks.
Ti bolniki so prejemali kabazitaksel v odmerkih od 10 do 30 mg/m2 na teden ali na 3 tedne.
Serum creatinine should be measured at baseline, with each blood count and whenever the patient reports a change in urinary output.
Kreatinin v serumu je treba izmeriti na začetku, pri vsaki določitvi krvne slike in kadarkoli bolnik navede spremembo v količini izločenega urina.
Information about storage and the time to use JEVTANA, once it has been diluted and is ready to use, are described in the section “PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA“.
Informacije o shranjevanju in času za uporabo zdravila JEVTANA, ko je že redčeno in pripravljeno za uporabo, so navedene v poglavju "PRAKTIČNE INFORMACIJE ZA ZDRAVSTVENO OSEBJE O PRIPRAVI, UPORABI IN RAVNANJU Z ZDRAVILOM JEVTANA ".
Renal failure including cases with fatal outcome has been observed.
Zabeležena je bila odpoved ledvic, tudi s smrtnim izidom.
Since foam may persist on the wall of the vial of this solution, following its preparation described in Step 1, it is preferable to place the needle of the syringe in the middle when extracting.
Ker je lahko po pripravi, opisani v koraku 1, na steni viale z raztopino prisotna pena, je bolje, da pri izvleku namestite iglo brizge na sredino.
In this case, the solution must not be used and should be discarded.
V takšnem primeru raztopine ne smete uporabiti, ampak jo morate zavreči.
Cabazitaxel treatment delay or discontinuation may be necessary.
Potrebna je lahko odložitev ali prekinitev zdravljenja s kabazitakselom.
Concentrate vial (60 mg - 1.5 ml)
Viala s koncentratom (60 mg - 1.5 ml)
• corticosteroid (dexamethasone 8 mg or equivalent), and
• kortikosteroid (8 mg deksametazona ali enakovredno zdravilo) in
JEVTANA is used to treat prostate cancer that has progressed after having had other chemotherapy.
Zdravilo JEVTANA se uporablja za zdravljenje raka prostate, ki je napredoval po zdravljenju z drugo kemoterapijo.
• fever (high temperature).
• zvišano telesno temperaturo (vročino).
To limit foaming as much as possible when injecting the solvent, direct the needle onto the inside wall of the vial of concentrate solution and inject slowly.
Da bo med brizganjem vehikla čim manj penjenja, usmerite iglo v notranjo steno viale z raztopino koncentrata in injicirajte počasi.
Appropriate measures should be taken to identify the cause and intensively treat the patients if this occurs.
Če se to zgodi, so potrebni ustrezni ukrepi za ugotovitev vzroka in intenzivno zdravljenje bolnikov.
• H2 antagonist (ranitidine or equivalent) (see section 4.4).
• antagonist H2 (ranitidin ali enakovredno zdravilo) (glejte poglavje 4.4).
1.5 ml 10 mg/ml after first dilution.
1,5 ml 10 mg/ml po prvem redčenju.
After a 1-hour intravenous infusion [14C]-cabazitaxel at 25 mg/m2 in patients, approximately 80% of the administered dose was eliminated within 2 weeks.
Po 1-urni intravenski infuziji [14C]-kabazitaksela v odmerku 25 mg/m2 pri bolnikih se je približno 80 % uporabljenega odmerka odstranilo v 2 tednih.
Before each treatment with JEVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive JEVTANA.
Pred vsakim zdravljenjem z zdravilom JEVTANA boste morali opraviti preiskave krvi, s katerimi bo zdravnik preveril, ali imate dovolj krvnih celic ter zadostno delovanje jeter in ledvic, da lahko dobite zdravilo JEVTANA.
One patient in the cabazitaxel group died from cardiac failure.
En bolnik v skupini s kabazitakselom je umrl zaradi srčnega popuščanja.
Fatal ventricular fibrillation was reported in 1 patient (0.3%), and cardiac arrest in 2 patients (0.5%).
Fibrilacija prekatov s smrtnim izidom je bila opisana pri 1 bolniku (0,3 %) in zastoj srca pri 2 bolnikih (0,5 %).
If the treatment is envisaged in patients with moderate hepatic impairment the dose of cabazitaxel should not exceed 15 mg/m2.
Če je predvideno zdravljenje pri bolnikih z zmerno okvaro jeter, odmerek kabazitaksela ne sme preseči 15 mg/m2.
• severe stomach pain or stomach pain that doesn't go away.
• hude bolečine v trebuhu ali bolečine v trebuhu, ki ne minejo.
The risk of interaction with OATP1B1 transporter is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion (see section 4.5).
Tveganje medsebojnega delovanja s prenašalcem OATP1B1 je možno, predvsem v času trajanja infuzije (1 uro) in do 20 minut po koncu infuzije (glejte poglavje 4.5).
One pack contains one vial of concentrate and one vial of solvent:
Eno pakiranje vsebuje eno vialo koncentrata in eno vialo vehikla:
Concomitant medicinal products that are strong inducers or strong inhibitors of CYP3A should be avoided.
Potrebno se je izogibati sočasni uporabi drugih zdravil, ki so močni induktorji ali močni zaviralci CYP3A.
SPECIAL STORAGE CONDITIONS Do not store above 30°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 30°C.
The incidence of atrial fibrillation was 1.1% in the cabazitaxel group.
Incidenca atrijske fibrilacije je bila v skupini s kabazitakselom 1,1 %.
The most common adverse reactions leading to cabazitaxel discontinuation was neutropenia.
Najpogostejši neželeni učinek, ki je povzročil prenehanje uporabe kabazitaksela, je bila nevtropenija.
If you are not sure, talk to your doctor before having JEVTANA.
Če ste negotovi, se posvetujte z zdravnikom, preden dobite zdravilo JEVTANA.
• As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
• Kot del zdravljenja boste vsak dan zaužili tudi kortikosteroidno zdravilo (prednizon ali prednizolon).
Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Simptomi, kot so bolečine v trebuhu ali občutljivost trebuha, zvišana telesna temperatura, dolgotrajna zaprtost, driska, z nevtropenijo ali brez nje, so lahko zgodnji znaki resnih toksičnih učinkov na prebavilih in jih je treba takoj ovrednotiti in zdraviti.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
A. IZDELOVALCI , ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
Cabazitaxel did not inhibit in vitro the major biotransformation pathway of warfarin into 7-hydroxywarfarin, which is mediated by CYP2C9.
Kabazitaksel in vitro ni zavrl glavne poti biotransformacije varfarina v 7-hidroksivarfarin, ki poteka preko CYP2C9.
Among the 371 patients treated with cabazitaxel in the prostate cancer study, 240 patients were 65 years or over including 70 patients older than 75 years.
Med 371 bolniki, ki so prejemali kabazitaksel v študiji raka prostate, je bilo 240 bolnikov starih 65 let ali več, med njimi 70 bolnikov, starejših od 75 let.
To be taken into account if you are in a high-risk group such as patients with liver disease, or epilepsy.
To je treba upoštevati, če spadate v skupino z velikim tveganjem, kakršna so bolniki z boleznijo jeter ali z epilepsijo.
If patients experience nausea or vomiting, they may be treated with commonly used anti-emetics.
Če se bolnikom pojavita navzea ali bruhanje, ju je mogoče zdraviti z običajno uporabljanimi antiemetiki.
Table 3 - Efficacy of JEVTANA in EFC6193 study in the treatment of patients with metastatic castration resistant prostate cancer
Preglednica 3 - Učinkovitost zdravila JEVTANA v študiji EFC6193 pri zdravljenju bolnikov z metastatskim, na kastracijo odpornim rakom prostate
• urinary incontinence
• inkontinenca urina
Seven metabolites were detected in plasma (including 3 active metabolites issued form O-demethylations), with the main one accounting for 5% of parent exposure.
V plazmi so ugotovili sedem presnovkov (vključno s 3 aktivnimi presnovki O-demetilacije); glavni od njih doseže 5 % izpostavljenosti matičnemu zdravilu.
Cabazitaxel is mainly bound to human serum albumin (82.0%) and lipoproteins (87.9% for HDL, 69.8% for LDL, and 55.8% for VLDL).
Kabazitaksel je v glavnem vezan na človeški serumski albumin (82,0 %) in na lipoproteine (87,9 % pri HDL, 69,8 % pri LDL in 55,8 % pri VLDL).
What JEVTANA is and what it is used for
Kaj je zdravilo JEVTANA in za kaj ga uporabljamo
Intensity of the adverse reactions is graded according to CTCAE 4.0 (grade ≥3 = G≥3).
Izrazitost neželenih učinkov je ocenjena po skupnih merilih toksičnosti CTCAE 4.0 (stopnja ≥ 3 = S ≥ 3).