natgillin/translations-raw huggingface dataset:
Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Podatki multicentrične, odprte randomiziranege študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80 %.
The ORR was 59.3% (95% CI: 52.8-65.9) in AT arm versus 46.5% (95% CI: 39.8-53.2) in AC arm.
V kraku AT je bil celotni delež odziva 59,3 % (95 % IZ: 52,8-65,9) in v kraku AC 46,5 % (95 % IZ: 39,8-53,2).
Patients with baseline neutrophil count of < 1,500 cells/mm
Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution for infusion.
Na primer: za odmerek 140 mg docetaksela bi potrebovali 7 ml koncentrata za raztopino docetaksela.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² (TAC arm), or doxorubicin 50 mg/m² followed by fluorouracil 500 mg/m² and cyclosphosphamide 500 mg/m² (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m², apliciranega 1 uro po doksorubicinu 50 mg/m² in ciklofosfamidu 500 mg/m² (krak TAC), ali na prejemanje doksorubicina 50 mg/m², ki sta mu sledila fluorouracil 500 mg/m² in ciklofosfamid 500 mg/m² (krak FAC).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy
Benigne in maligne neoplazme (vključno s cistami in polipi) Poročali so primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/m² v monoterapiji.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice, doječe matere, otroci in skupine z velikim tveganjem, npr. pri bolnikih z jetrnimi obolenji ali epilepsijo.
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m² v 1-urni infuziji bodisi na paklitaksel 175 mg/m² v 3-urni infuziji.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Pri bolnicah z neuspelim alkilirajočim zdravljenjem so docetaksel primerjali z doksorubicinom (75 mg/m² na 3 tedne).
• Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
• Ko je zdravilo enkrat dodano v infuzijsko vrečko, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25°C.
Use immediately the medicine once added into the non-PVC infusion bag.
Ko je zdravilo dodano infuzijski vrečki, ki ne vsebuje PVC, ga je potrebno takoj uporabiti.
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m² as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m² twice daily for 2 weeks followed by 1-week rest period).
V tem preskušanju so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m² v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m² dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
Docetaxel Mylan contains alcohol.
Zdravilo Docetaxel Mylan vsebuje etanol (alkohol).
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
S3/4 zvišanje AST S3/4 zvišanje alkalne fosfataze v krvi
Esophagitis/dysphagia/ odynophagia (G3/4:
zaprtost, ezofagitis/disfagija/ odinofagija (S3/4:
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
V študiji GEICAM 9805 so nadaljnjo prisotnost limfedema na koncu kemoterapije opazili pri 4 od 5 bolnic v kraku TAC in pri 1 od 2 bolnic v kraku FAC; limfedem med obdobjem spremljanja ni izginil (mediano obdobje spremljanja 10 let in 5 mesecev).
What Docetaxel Mylan 200 mg/10 ml is and what it is used for What you need to know before you use Docetaxel Mylan 200 mg/10 ml How to use Docetaxel Mylan 200 mg/10 ml Possible side effects
Kaj je zdravilo Docetaxel Mylan 200 mg/10 ml in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 200 mg/10 ml Kako uporabljati zdravilo Docetaxel Mylan 200 mg/10 ml Možni neželeni učinki
95% CI p-value*
95 % IZ p-vrednost*
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 zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
• Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 mg/10 ml
Docetaxel Mylan in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Zdravilo Docetaxel Mylan je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Zdravilo Docetaxel Mylan je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic:
In Docetaxel Mylan, the concentration of docetaxel is 20 mg/ml.
V viali, ki vsebuje zdravilo Docetaxel Mylan, je koncentracija docetaksela 20 mg/ml.
5 vials of 4 ml
5 vial s 4 ml
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m² and LFTs should be measured at baseline and before each cycle (see section 4.2).
Zato je pri bolnikih z zvišanimi vrednostmi testov jetrne funkcije priporočeni odmerek docetaksela 75 mg/m², teste jetrne funkcije pa je treba opraviti na začetku in pred vsakim ciklusom zdravljenja (glejte poglavje 4.2).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 80 mg/4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/1 ml
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m² on day 1) in combination with cisplatin (C) (75 mg/m² on day 1) and 5-fluorouracil (F) (750 mg/m² per day for 5 days) or cisplatin (100 mg/m² on day 1) and 5-fluorouracil (1000 mg/m² per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/m² 1. dan) v kombinaciji s cisplatinom (C) (75 mg/m² 1. dan) in 5-fluorouracilom (F) (750 mg/m² na dan, 5 dni), bodisi cisplatin (100 mg/m² 1. dan) in 5-fluorouracil (1000 mg/m² na dan, 5 dni).
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m², so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
In GEICAM 9805 study, amenorrhoea persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm.
V študiji GEICAM 9805 je amenoreja trajala v obdobje spremljanja (mediano obdobje spremljanja 10 let in 5 mesecev); njeno nadaljnjo prisotnost so zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah (1,0 %) v kraku FAC.
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Splošne težave in spremembe na mestu aplikacije reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude: 0,4 %)
Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.
Tudi celotno preživetje pri 10 letih je bilo značilno povečano pri TAC v primerjavi z FAC (76 % proti 69 %) t.j.
What Docetaxel Mylan 80 mg/4 ml is and what it is used for What you need to know before you use Docetaxel Mylan 80 mg/4 ml How to use Docetaxel Mylan 80 mg/4 ml Possible side effects
Kaj je zdravilo Docetaxel Mylan 80 mg/4 ml in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 80 mg/4 ml Kako uporabljati zdravilo Docetaxel Mylan 80 mg/4 ml Možni neželeni učinki
- For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.
Za zdravljenje pljučnega raka se docetaksel lahko uporablja sam ali v kombinaciji s cisplatinom.
(39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
zmanjšanje absolutnega tveganja za 6 % (p = 0.0043).
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m² every three weeks, combined with capecitabine at 1250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m² na tri tedne, kombiniran s kapecitabinom 1.250 mg/m² dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 minutes.
Pri bolnikih z nedrobnoceličnim pljučnim rakom, ki še niso bili zdravljeni s kemoterapijo, je priporočena shema odmerjanja docetaksel v odmerku 75 mg/m², ki mu takoj sledi cisplatin v odmerku 75 mg/m², apliciran 30-60 minut.
The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Priporočeni odmerek docetaksela je 75 mg/m² v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m² v 1- do 3-urni infuziji (oboje samo 1. dan); temu sledi 5-fluorouracil 750 mg/m² na dan v 24-urni stalni infuziji 5 dni, z začetkom ob koncu infuzije cisplatina.
Docetaxel + Cis + 5-FU n = 177
Docetaksel + Cis + 5 FU n = 177
Dehydration (G3/4: 2%)
dehidracija (S3/4: 2 %),
As with all parenteral products, Docetaxel Mylan concentrate for solution or diluted solution for infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Tako kot vsa zdravila za parenteralno uporabo je treba raztopino za infundiranje Docetaxel Mylan pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
MedDRA system organ Classes
Organski sistemi po MedDRA
General disorders and administration site conditions Investigations
Splošne težave in spremembe na mestu aplikacije Preiskave
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour infusion followed by cisplatin 75 mg/m² over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for five days.
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN-squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m² v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m², infundiran 1 uro dolgo prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m² na dan pet dni.
Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Zdravilo Docetaxel Mylan koncentrat raztopine za infundiranje je bledorumena do rjavkasto rumena raztopina.
Data from a multicenter open label randomized trial support the use of docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podatki multicentričnega, odprtega, randomiziranega preskušanja podpirajo uporabo zdravila docetaksel za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benigne in maligne neoplazme (vključno s cistami in polipi)
One vial of 4 ml of concentrate contains 1.58 g of ethanol anhydrous.
Ena viala s 4 ml koncentrata vsebuje 1,58 g brezvodnega etanola.
Each ml of concentrate for solution for infusion contains 395 mg of ethanol anhydrous.
Vsak ml koncentrata za raztopino za infundiranje vsebuje 395 mg brezvodnega etanola.
Progressive Disease as Best Overall Response (%) *Unstratified logrank test
celotni delež odziva (popolni odziv +delni odziv) (%) *vrednost p napredujoča bolezen kot najboljši celotni odziv (%) *nestratificirani log-rang test
Vascular disorders Venous thromboembolic events have rarely been reported.
Žilne bolezni Opisani so bili redki primeri venskih tromboembolij.
G3/4 AST increased
S3/4 zvišanje AST
What Docetaxel Mylan 20 mg/1 ml is and what it is used for What you need to know before you use Docetaxel Mylan 20 mg/1 ml How to use Docetaxel Mylan 20 mg/1 ml Possible side effects
Kaj je zdravilo Docetaxel Mylan 20 mg/1 ml in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 20 mg/1 ml Kako uporabljati zdravilo Docetaxel Mylan 20 mg/1 ml Možni neželeni učinki
Infections and infestations Blood and lymphatic system disorders
Infekcijske in parazitske bolezni Bolezni krvi in limfatičnega sistema
Docetaxel Mylan in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Zdravilo Docetaxel Mylan je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
Pain response rate (%)
število bolnikov odzivnost tumorja (%)
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
• Indukcijska kemoterapija in nato radioterapija (TAX323) Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji III. faze (TAX323).
G3/4 AST increased G3/4 ALT increased
S3/4 zvišanje AST S3/4 zvišanje ALT
Amenorrhoea (G3/4: NA)
febrilna nevtropenija (S3/4: NA)
One vial of 10 ml of concentrate contains 3,95 g of ethanol anhydrous.
Ena viala z 10 ml koncentrata vsebuje 3,95 g brezvodnega etanola.
Patients on the comparator arm received cisplatin (P) 100 mg/m² followed by 5-fluorouracil (F) 1000 mg/m² per day for 5 days.
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m², ki mu je sledil 5-fluorouracil (F) 1000 mg/m² na dan 5 dni.
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema) • decrease of the sodium in your blood.
• zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem)
- For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
Za zdravljenje raka prostate se docetaksel lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
Each vial contains 10 ml of concentrate.
Ena viala vsebuje 10 ml koncentrata
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² followed by cisplatin (P) 75 mg/m² followed by 5-fluorouracil (F) 750 mg/m² per day as a continuous infusion for 5 days.
Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m², ki mu je sledil cisplatin (P) 75 mg/m², temu pa 5-fluorouracil (F) 750 mg/m² na dan v obliki neprekinjene infuzije 5 dni.
6 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flip-off cap containing 1 ml of concentrate for solution for infusion.
6 ml viala iz prozornega stekla tipa I z bromobutilno gumijasto zaporko in aluminijastim pečatom in plastično dvižno zaporko z 1 ml koncentrata za raztopino za infundiranje.
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infekcijske in parazitske bolezni Benigne in maligne neoplazme (vključno s cistami in polipi)
Infection associated with G4 neutropenia (G3/4: 4.6%)
okužba, povezana z nevtropenijo S4 (S3/4:4,6 %)
There are limited available data in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4: somnolenca (S3/4;
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala s 4 ml
p=0.1646).
z 9 meseci, p = 0,01).
Each vial contains 1 ml of concentrate.
Ena viala vsebuje 1 ml koncentrata
One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Ena viala z 10 ml koncentrata vsebuje 200 mg docetaksela.
At the median follow up time of 10 years and 5 months, TAC treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Po medianem spremljanju 10 let in 5 mesecev so imele prejemnice TAC 16,5 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti = 0,84, 95 % IZ 0,65-1,08, p = 0,1646).
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 1 ml
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala z 1 ml
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 sta bili v priporočenem odmerku in shemi 100 mg/m² na 3 tedne opravljeni 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.
10 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 4 ml of concentrate for solution for infusion.
10 ml viala iz prozornega stekla tipa I z bromobutilno gumijasto zaporko in aluminijevo aluminijastim pečatom ter plastično dvižno zaporko s 4 ml koncentrata za raztopino za infundiranje.
BATCH NUMBER Lot:
†Stratificiran log-rang test
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Povečanje v preživetju opazovano pri kraku tedenskega docetaksela ni bilo statistično značilno v primerjavi z mitoksantronovo kontrolno roko zdravljenja.
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively.
Povprečni celotni telesni očistek je bil 21 l/h/m², volumen porazdelitve v stanju dinamičnega ravnovesja pa 113 l. Interindividualno variiranje celotnega telesnega očistka je bilo približno 50 %.
Frequency unknown:
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela v obliki brezvodnega docetaksela.
15 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 10 ml of concentrate for solution for infusion.
15 ml viala iz prozornega stekla tipa I z bromobutilno gumijasto zaporko in aluminijastim pečatom ter plastično dvižno zaporko z 10 ml koncentrata za raztopino za infundiranje.
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m² v 30-minutni do 3-urni intravenski infuziji 1. dan in nato stalno intravensko infuzijo 5-fluorouracila (F) 1000 mg/m²/dan od 1. do 5. dneva.
One vial contains 200 mg of docetaxel.
Ena viala vsebuje 200 mg docetaksela
One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
Ena viala z 1 ml koncentrata vsebuje 395 mg brezvodnega etanola.
What Docetaxel Mylan 80 mg/4 ml is and what it is used for
Kaj je zdravilo Docetaxel Mylan 80 mg/4 ml in za kaj ga uporabljamo
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m² v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m² v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5-fluorouracila (F) 1000 mg/m²/dan od 1. do 4. dneva.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m² značilno daljša kot z najboljšo podporno oskrbo.
1Full analysis set (intent-to-treat)
1celotna množica za analizo (z-namenom-zdravljenja) ocenjeno mediano preživetje
Each vial contains 4 ml of concentrate.
Ena viala vsebuje 4 ml koncentrata
What Docetaxel Mylan 20 mg/1 ml is and what it is used for
Kaj je zdravilo Docetaxel Mylan 20 mg/1 ml in za kaj ga uporabljamo