natgillin/translations-raw huggingface dataset:
95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
95-% IZ vrednost p†* število bolnikov delež odziva PSA** (%) 95-% IZ vrednost p* število bolnikov delež odziva bolečine (%) 95-% IZ vrednost p* število bolnikov delež odziva tumorja (%) 95-% IZ vrednost p* † stratificirani test log-rank * prag statistične značilnosti = 0,0175 ** PSA: prostatični specifični antigen
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Med monoterapijo z docetakselom so opazili več neţelenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
V študiji TAX 316 se je kongestivno srčno popuščanje pojavilo 26 bolnicam (3.5 %) v kraku s TAC in 17 bolnicam (2.3 %) v kraku s FAC.
Other medicines and Docetaxel Teva Pharma
Druga zdravila in zdravilo Docetaxel Teva Pharma
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION 4.1 Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml) 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila Docetaxel Teva Pharma (10 mg docetaksela/ml) Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaxel Teva Pharma 5 minut stati na sobni temperaturi (do 25°C).
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
V kraku z docetakselom in trastuzumabom je 64 % bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta deleţ 55 %.
This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem docetaksela za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine zaradi penjenja, adhezije na stene viale in »mrtvega volumna«.
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Pri zdravljenju raka prostate je premedikacija peroralni deksametazon v odmerku 8 mg 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (glejte poglavje 4.2).
The name of this medicine is Docetaxel Teva Pharma.
To zdravilo se imenuje Docetaxel Teva Pharma.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Redkeje so poročali o hudih simptomih, npr. izpuščajih s poznejšim luščenjem, zaradi katerih je bilo treba v redkih primerih zdravljenje z docetakselom prekiniti (glejte poglavji 4.2 in 4.4).
Solvent vial: water for injections.
Vehikel: voda za injekcije.
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Pri zdravljenju raka dojke in nedrobnoceličnega pljučnega raka lahko tridnevna premedikacija s peroralnim kortikosteroidom, npr. deksametazonom 16 mg dnevno (npr. 8 mg dvakrat dnevno), ki se začne en dan pred aplikacijo docetaksela, zmanjša pogostost in izrazitost zastajanja tekočine ter izrazitost preobčutljivostnih reakcij, če ni kontraindicirana.
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Med bolniki, ki so docetaksel dobivali v kombinaciji s cisplatinom in 5-fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okuţba redkeje pojavili pri bolnikih, ki so profilaktično dobivali G-CSF.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom ţelodca so izključili bolnike z ALT in/ali AST > 1,5 × ZMRO ter hkrati alkalno fosfatazo > 2,5 × ZMRO in bilirubinom > 1 × ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni izrecno indiciran.
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 Srednji kumulativni odmerek do prekinitve zdravljenja je bil več kot 1000 mg/m in srednji čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Zdravilo Docetaxel Teva Pharma v kombinaciji s prednizonom ali prednizolonom je indicirano za zdravljenje bolnikov z metastatskim, hormonsko neodzivnim rakom prostate.
Ischemia myocardial
miokardna ishemija
CYTOTOXIC.
C-docetakselom.
Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Vsem bolnikom, ki dobivajo docetaksel, je treba pogosto pregledovati celotno krvno sliko.
See leaflet for further information.
Dodatne informacije preberite v navodilu za uporabo.
What Docetaxel Teva Pharma looks like and contents of the pack: Docetaxel Teva Pharma concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Izgled zdravila Docetaxel Teva Pharma in vsebina pakiranja Zdravilo Docetaxel Teva Pharma koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Prednizon Opazili niso nobenih učinkov prednizona na farmakokinetiko docetaksela.
MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Imetnik dovoljenja za promet z zdravilom Teva Pharma B.V.
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.
Pomoţne snovi z znanim učinkom: Ena viala koncentrata vsebuje 25,1 % (m/m) brezvodnega etanola.
Neutropenic infection Neutropenic infection (Grade 3-4)
Nevtropenična okuţba Nevtropenična okuţba (stopnje 3-4)
Preparation for the intravenous administration a) Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml)
PRIPRAVA ZA INTRAVENSKO UPORABO 4.1 Priprava osnovne raztopine zdravila Docetaxel Teva Pharma (10 mg docetaksela/ml)
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Ţenskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women.
Kakor druga citotoksična zdravila ima lahko tudi docetaksel škodljive učinke na plod, če se uporablja med nosečnostjo.
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p=0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p=0.54), docetaxel increased response rate (52% vs. 37%, p=0.01) and shortened time to response (12 weeks vs. 23 weeks, p=0.007).
Docetaksel ni vplival na celotni čas preţivetja (docetaksel 15 mesecev, doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja bolezni (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa povečal deleţ odziva (52 % v prim.
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Zato ga nosečnice ne smejo uporabljati, razen če je to nujno potrebno.
b) Preparation of the infusion solution
b) Priprava raztopine za infundiranje
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Med bolnicami, ki so docetaksel prejemale v kombinaciji z doksorubicinom in ciklofosfamidom (TAC), sta se febrilna nevtropenija in/ali nevtropenična okuţba redkeje pojavili pri bolnicah, ki so prejemale primarno profilakso z G-CSF.
Docetaxel Teva Pharma must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila Docetaxel Teva Pharma NE smete dobiti, če ste noseči, razen če je to nuno potrebno.
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).
3, ki traja sedem dni ali dlje), se med naslednjimi cikli priporoča zmanjšanje odmerka ali uporaba ustreznih simptomatskih ukrepov (glejte poglavje 4.2).
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Opisali so redke primere dehidracije zaradi prebavnih motenj, gastrointestinalnih perforacij, ishemičnega kolitisa, kolitisa in nevtropeničnega enterokolitisa.
• Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
docetaksel 75 mg/m vsake 3 tedne, 10 ciklov;
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Opisali so hude simptome, npr. izpuščaje s poznejšim luščenjem, zaradi katerih je bilo treba zdravljenje z docetakselom prekiniti ali opustiti (glejte poglavje 4.2).
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
In vitro so ugotovili, da docetaksel v klonogenih preskusih deluje citotoksično proti različnim linijam mišjih in človeških tumorskih celic in proti sveţe odstranjenim človeškim tumorskim celicam.
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeleţili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT water for injections
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Treatment difference: 6.2% [95% CI: 0.2; 12.3]
razlika zdravljenj: 6,2 % [95-% IZ: 0,2; 12,3]
4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250 ml infuzijsko vrečko (ne iz PVC-ja), v kateri je 5 % raztopina glukoze ali 9 mg/ml (0,9 %) raztopina natrijevega klorida za infundiranje.
- If you have any further questions, ask your doctor, hospital pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali z medicinsko sestro.
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
V kombinacijskem kraku s trastuzumabom je prišlo do povečane incidence resnih neţelenih učinkov (40 % proti 31 %) in neţelenih učinkov stopnje 4 (34 % proti 23 %) v primerjavi z monoterapijo z docetakselom.
The severity of adverse events of Docetaxel Teva Pharma may be increased when Docetaxel Teva Pharma is given in combination with other chemotherapeutic agents.
Izrazitost neţelenih učinkov na zdravilo Docetaxel Teva Pharma se lahko poveča, če se zdravilo daje v kombinaciji z drugimi kemoterapevtiki.
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, ki so se zdravili z docetakselom v odmerku 75 mg/m2, so potrebovali manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in obsevanja (p < 0,01) kot tisti, ki so bili deleţni najboljše podporne oskrbe.
Elimination
ODSTRANJEVANJE
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
povišanje ravni AST S3/4 (0,5 %), povišanje ravni alkalne fosfataze v krvi S3/4
The infusion solution should be used within 4 hours at room temperature (below 25°C).
Raztopino za infundiranje je pri sobni temperaturi (do 25°C) treba uporabiti v 4 urah.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Ušesne bolezni, vključno z motnjami labirinta Opisali so redke primere ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
The recommended dose of docetaxel is 75 mg/m2.
Priporočeni odmerek docetaksela je 75 mg/m².
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Za bolnike z okvaro jeter, ki se zdravijo z docetakselom v kombinaciji pri drugih indikacijah, ni podatkov.
Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Pojavljale so se reverzibilne, praviloma blage do zmerne koţne reakcije.
Inject the required premix volume into a non-PVC 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Potrebno količino osnovne raztopine vbrizgajte v 250 ml infuzijsko vrečko (ne iz PVC-ja), v kateri je 5 % raztopina glukoze ali 0,9 % (9 mg/ml) raztopina natrijevega klorida za infundiranje.
More than one premix vial may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, bo morda potrebna več kot ena viala z osnovno raztopino.
How to use Docetaxel Teva Pharma
Kako uporabljati zdravilo Docetaxel Teva Pharma
Cases of lacrimation with or without conjunctivitis, as cases of lachrymal duct obstruction resulting in excessive tearing have been rarely reported.
Redko je bilo opisano solzenje s konjunktivitisom ali brez njega ter obstrukcija solzovoda s posledičnim čezmernim solzenjem.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1500 celic/mm Pri bolnikih, ki so med zdravljenjem z docetakselom doţiveli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm za več kot en teden, hude ali kumulativne koţne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m na 75 mg/m oziroma s
Headache (G3/4: <1%); Neuropathy peripheral
omotica, glavobol (S3/4: < 1 %), periferna nevropatija
Bone marrow suppression and other haematologic adverse reactions have been reported.
Poročali so o supresiji kostnega mozga in drugih neţelenih hematoloških učinkih.
(ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Pri bolnikih, ki se zdravijo s 100 mg docetaksela/m v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ZMRO in hkrati zvišano serumsko alkalno fosfatazo nad 2,5-kratno ZMRO, obstaja večja nevarnost hudih neţelenih učinkov, kot so smrt zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilna nevtropenija, okuţbe, trombocitopenija, stomatitis in astenija.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Izrazitost neţelenih učinkov docetaksela se lahko poveča, če se zdravilo daje v kombinaciji z drugimi kemoterapevtiki.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Pri zdravljenju raka prostate, v primeru sočasne uporabe prednizona ali prednizolona, se priporoča premedikacija s peroralnim deksametazonom v odmerku 8 mg, in sicer 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (glejte poglavje 4.4).
Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning.
Za blage do zmerne senzorične motnje so značilne parestezije, disestezije ali bolečina s pekočim občutkom.
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Z docetakselom so v priporočenem odmerku in reţimu 100 mg/m na 3 tedne opravili dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
fazi študije), ki so se zdravili z docetakselom v kombinaciji s cisplatinom in 5-fluorouracilom v študiji raka ţelodca, je bilo 74 bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva Pharma premix solution or the Docetaxel Teva Pharma infusion solution
Pomembno je, da pred pripravo osnovne raztopine zdravila Docetaxel Teva Pharma ali raztopine za infundiranje Docetaxel Teva Pharma v celoti preberete ta navodila.
Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Zdravilo Docetaxel Teva Pharma v kombinaciji s cisplatinom je indicirano za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Bolniki z okvaro jeter Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m je priporočeni odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo referenčnega območja (ZMRO) in alkalno fosfatazo nad 2,5-kratno ZMRO, 75 mg/m
Manufacturer:
Serija:
Each box contains one Docetaxel Teva Pharma vial (20 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Vsaka škatla vsebuje eno vialo (20 mg) zdravila Docetaxel Teva Pharma in eno vialo ustreznega vehikla za zdravilo Docetaxel Teva Pharma v škatli.
Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Pri bolnikih, ki so se sočasno zdravili z obsevanjem, so poročali o redkih primerih radiacijskega pnevmonitisa.
Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Še prisotno amenorejo so med spremljanjem v študiji TAX316 zabeleţili pri 121 od 202 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
- If you get any side effects talk to your doctor, hospital pharmacist or nurse.
- Če opazite kateri koli neţeleni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Viala z vehiklom vsebuje 5,12 ml vode za injekcije (polnilni volumen: 6,29 ml).
Docetaxel Teva Pharma is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions.
Zdravilo Docetaxel Teva Pharma je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med ravnanjem in pripravo raztopin docetaksela potrebna previdnost.
Concentrate and solvent for solution for infusion.
Koncentrat in vehikel za raztopino za infundiranje.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neţeleni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm
MedDRA system organ classes Very common adverse reactions Common adverse reactions
Organski sistemi po MedDRA Zelo pogosti neželeni učinki
Each box contains one Docetaxel Teva Pharma vial (80 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Vsaka škatla vsebuje eno vialo (80 mg) zdravila Docetaxel Teva Pharma in eno vialo ustreznega vehikla za zdravilo Docetaxel Teva Pharma v škatli.
4.2.5 As with all parenteral products, Docetaxel Teva Pharma premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje zdravila Docetaxel Teva Pharma pred uporabo pregledati; če vsebuje oborino, jo je treba zavreči.
• Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Vsaka viala z vehiklom vsebuje 1,28 ml vode za injekcije (polnilni volumen: 1,71 ml).
Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Ena viala z vehiklom vsebuje 1,28 ml vode za injekcije (polnilni volumen: 1,71 ml).
Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Opisani so bili akutni respiracijski distres sindrom, intersticijska pljučnica/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so lahko bili usodni.
There are no data available in patients with severely impaired renal function treated with docetaxel.
Za bolnike s hudo okvaro ledvic, ki se zdravijo z docetakselom, ni podatkov.