natgillin/translations-raw huggingface dataset:
Docetaxel Mylan contains ethanol
Zdravilo Docetaxel Mylan vsebuje etanol (alkohol)
Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
Vsak ml koncentrata za infundirane vsebuje 20 mg docetaksela (brezvodnega).
Nail disorders (severe: Skin reaction (no severe)
Bolezni kože in podkožja alopecija, spremembe nohtov (hude kožna reakcija (nobene hude)
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je bledorumena do rjavkasto rumena raztopina.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m² administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4.
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m² v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m² v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila 1000 mg/m²/dan od 1. do 4. dneva.
What you need to know before you use Docetaxel Mylan 200 mg/10 ml
Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 200 mg/10 ml
• operable node-negative breast cancer
• z operabilnim rakom dojke z negativnimi bezgavkami
Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Infekcijske in parazitske bolezni okužba (S3/4: 2,4 %), nevtropenična okužba (S3/4:2,6 %)
How to store Docetaxel Mylan 200 mg/10 ml Contents of the pack and other information
Shranjevanje zdravila Docetaxel Mylan 200 mg/10 ml Vsebina pakiranja in ostale informacije
If Docetaxel Mylan concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat ali raztopina za infundiranje Docetaxel Mylan v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Opis izbranih neželenih učinkov adjuvantnega zdravljenja z zdravilom Docetaksel 75 mg/m² v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
Docetaxel Mylan 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 Mylan v kombinaciji s cisplatinom je indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Discuss with your doctor if you suffer from alcohol dependency or liver impairment.
Če trpite zaradi alkoholizma ali obolenja jeter, se posvetujte s svojim zdravnikom.
Docetaxel Mylan in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Zdravilo Docetaxel Mylan je indiciran v kombinaciji s trastuzumabom za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
One vial contains 80 mg of docetaxel.
Ena viala vsebuje 80 mg docetaksela
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data.
Tabelarični prikaz neželenih učinkov adjuvantnega zdravljenja z zdravilom Docetaksel 75 mg/m² v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativnimi podatki:
How to store Docetaxel Mylan 80 mg/4 ml Contents of the pack and other information
Shranjevanje zdravila Docetaxel Mylan 80 mg/4 ml Vsebina pakiranja in ostale informacije
What you need to know before you use Docetaxel Mylan 80 mg/4 ml
Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 80 mg/4 ml
Arrhythmia (G3/4: 0.7%) Cardiac failure
Srčne bolezni aritmija (S3/4:0,7 %) srčno popuščanje
- For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje metastatskega raka želodca se docetaksel uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Mylan administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Namen tega je zmanjšanje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Docetaxel Mylan, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
What you need to know before you use Docetaxel Mylan 20 mg/1 ml
Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 20 mg/1 ml
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku prostate v kombinaciji s prednizonom ali prednizolonom
How to store Docetaxel Mylan 20 mg/1 ml Contents of the pack and other information
Shranjevanje zdravila Docetaxel Mylan 20 mg/1 ml Vsebina pakiranja in ostale informacije
Headache (G3/4: < 1%); Neuropathy peripheral
Bolezni živčevja omotica, glavobol (S3/4: < 1 %), periferna nevropatija
If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat ali raztopina za infundiranje zdravilo Docetaxel Mylan v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
How to use Docetaxel Mylan 200 mg/10 ml
Kako uporabljati zdravilo Docetaxel Mylan 200 mg/10 ml
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/001 - 1 viala
Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Zdravilo Docetaxel Mylan v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/003 - 1 viala
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/005 - 1 vial
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/005 - 1 viala
Oral candidiasis (G3/4: < 1%)
Infekcijske in parazitske bolezni oralna kandidoza (S3/4): < 1 %)
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
V obeh krakih so bolnice s tumorji, ki so imeli pozitivne ER in/ali PgR, po zadnjem ciklusu kemoterapije do 5 let prejemale tamoksifen 20 mg enkrat na dan. Adjuvantna radioterapija je bila uporabljena v skladu z veljavnimi smernicami v sodelujočih ustanovah.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
IME ZDRAVILA Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje
EU/1/11/748/006 - 5 vials
EU/1/11/748/006 - 5 vial
Dry skin ; Desquamation
Bolezni kože in podkožja suha koža, luščenje
Metabolism and nutrition disorders Nervous system disorders
Presnovne in prehranske motnje Bolezni živčevja vrtoglavica
Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Zdravilo Docetaxel Mylan je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
Diarrhoea grade 4
driska 4. stopnje
Epistaxis (G3/4: < 1%)
S3/4 zvišanje ALT (< 1 %)
One vial contains 20 mg of docetaxel.
Ena viala vsebuje 20 mg docetaksela
- For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje raka glave in vratu se zdravilo docetaksel uporablja v kombinaciji s cisplatinom in 5-fluorouracilom
In GEICAM 9805 study, alopecia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm.
V študiji GEICAM 9805 je alopecija trajala v obdobje spremljanja (mediano obdobje spremljanja 10 let in 5 mesecev); njeno nadaljnjo prisotnost so zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje docetaksel
Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
Disease Free Survival
Preživetje brez bolezni Razmerje ogroženosti
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
EU/1/11/748/002 - 5 vials
EU/1/11/748/002 - 5 vial
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion
IME ZDRAVILA Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje
In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m² as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m² over 30-60 minutes every 3 weeks, docetaxel 75 mg/m² as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m² administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m² administered on day 1 of cycles repeated every 4 weeks (VCis).
Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m² v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60minutah, tretja pa na 4 tedne (Vcis) vinorelbin (V) 25 mg/m² v 6-10minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklusov sledil cisplatin 100 mg/m².
EU/1/11/748/004 - 5 vials
EU/1/11/748/004 - 5 vial
How to use Docetaxel Mylan 80 mg/4 ml
Kako uporabljati zdravilo Docetaxel Mylan 80 mg/4 ml
Docetaxel Mylan in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Zdravilo Docetaxel Mylan v kombinaciji z doksorubicinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
IME ZDRAVILA Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje
How to use Docetaxel Mylan 20 mg/1 ml
Kako uporabljati zdravilo Docetaxel Mylan 20 mg/1 ml
Venous disorder (G3/4: 0.6%)
Žilne bolezni venske motnje (S3/4: 0,6 %)
Hypersensitivity (G3/4:0.6%)
Preobčutljivost (S3/4: 0,6 %)
Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
G3/4 ALT increased
S3/4 zvišanje ALT
Hypersensitivity (G3/4: 1.2%)
Bolezni imunskega sistema preobčutljivost (S3/4: 1,2 %
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 pri spremljanju zabeležili pri 140 od 251 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
G3/4 Blood bilirubin increased (< 2.5%);
S 3/4 zvišanje bilirubina v krvi (< 2,5 %) S3/4 zvišanje alkalne fosfataze v krvi (< 2,5 %)
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4:
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
How to store Docetaxel Mylan 200 mg/10 ml
Shranjevanje zdravila Docetaxel Mylan 200 mg/10 ml
Median survival (months) (95% CI)
mediano preživetje (meseci) (95 % IZ)
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 1.58 g per vial, equivalent to 40 ml of beer or 17 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je 1,58 g na vialo, kar ustreza 40 ml piva ali 17 ml vina na vialo.
Single-use vial.
NALEPKA NA VIALI
Dyspnoea; Cough; Rhinorrhoea
• vnetje debelega črevesa, tankega črevesa, predrtje črevesa
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Presnovne in prehranske motnje Bolezni živčevja nevropatija (S3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
How to store Docetaxel Mylan 20 mg/1 ml
Shranjevanje zdravila Docetaxel Mylan 20 mg/1 ml
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m² pri raku dojke v kombinaciji s trastuzumabom
How to store Docetaxel Mylan 80 mg/4 ml
Shranjevanje zdravila Docetaxel Mylan 80 mg/4 ml
What Docetaxel Mylan 80 mg/4 ml looks like and contents of the pack
Izgled zdravila Docetaxel Mylan 80 mg/4 ml in vsebina pakiranja
What Docetaxel Mylan 200 mg/10 ml looks like and contents of the pack
Izgled zdravila Docetaxel Mylan 200 mg/10 ml in vsebina pakiranja
Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Presnovne in prehranske motnje Bolezni živčevja periferna senzorična nevropatija (S3: periferna motorična nevropatija (S3/4: 2 %)
Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Pri bolnikih zdravljenih z docetakselom, je bil opisan cistoidni makularni edem (CMO).
Peripheral motor neuropathy (G3/4: 0%)
Bolezni živčevja periferna motorična nevropatija (S3/4: 0 %)
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
2 Estimated median survival
celotna množica za analizo (z-namenom-zdravljenja) 2ocenjeno mediano preživetje
What Docetaxel Mylan 20 mg/1 ml looks like and contents of the pack
Izgled zdravila Docetaxel Mylan 20 mg/1 ml in vsebina pakiranja
Peripheral sensory neuropathy (G3/4:
periferna motorična nevropatija (S3/4:
If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Navadno naj se ne shranjuje dlje kot šest ur pod 25°C, vklučno z eno uro infindiranja.
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 1.58g per vial equivalent to 40 ml of beer or 17 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 158 mg na vialo, kar ustreza 40 ml piva ali 17 ml vina na vialo.
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
Asthenia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm.
V študiji GEICAM 9805 je astenija trajala v obdobje spremljanja (mediano obdobje spremljanja 10 let in 5 mesecev); njeno nadaljnjo prisotnost so zabeležili pri 12 bolnicah (2,3 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku dojke v kombinaciji s kapecitabinom
Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Žilne bolezni hipotenzija (S3/4: 0 %) vnetje žile (S 3/4: 0 %)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Arrhythmia (G3/4: 0.7%)
Srčne bolezni aritmija (S3/4:0,7 %)
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
What Docetaxel Mylan 200 mg/10 ml contains
Kaj vsebuje zdravilo Docetaxel Mylan 200 mg/10 ml
Nail disorders (severe: 0.7%); Skin reaction (G3/4:< 0.2%)
Bolezni kože in podkožja alopecija, spremembe nohtov (hude: 0,7 %), kožna reakcija (S3/4:
Hearing impaired (G3/4: 1.2%)
bolečina zaradi raka (S3/4: 1,2 %)
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.95 g per vial, equivalent to 100 ml of beer or 40 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 3,95 g na vialo, kar ustreza 100 ml piva ali 40 ml vina na vialo.
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku dojke v kombinaciji z doksorubicinom Organski sistemi po MedDRA
5-fluorouracil (clinically important treatment related adverse events are presented).
fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Zdravilo Docetaxel Mylan v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
Nervous system disorders
Bolezni živčevja vrtoglavica
Arrhythmia (G3/4:
Srčne bolezni aritmija (S3/4:
Lacrimation increased (G3/4: <0.1%)
Očesne bolezni motnja solzenja (S3/4: < 0,1 %),
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
Nausea (G3/4: 0.6%); Stomatitis (G3/4: 4.0%);
Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
What Docetaxel Mylan 20 mg/1 ml contains
Kaj vsebuje zdravilo Docetaxel Mylan 20 mg/1 ml
PSA** response rate (%) 95% CI p-value*
število bolnikov odzivnost na bolečino (%) 95 % IZ p-vrednost*
Arrhythmia (G3/4: 0.2%)
Srčne bolezni aritmija (S3/4: 0,2 %),
Infusion site reaction
Splošne težave in spremembe na mestu aplikacije reakcija na mestu infundiranja
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 3.95g per vial equivalent to 100 ml of beer or 40 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 395 mg na vialo, kar ustreza 100 ml piva ali 40 ml vina na vialo.
What Docetaxel Mylan 80 mg/4 ml contains
Kaj vsebuje zdravilo Docetaxel Mylan 80 mg/4 ml
Diarrhoea (G3/4:
eksfoliacijski izpuščaj (S3/4:
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
bruhanje (S3/4: 8,4 %), driska (S3/4: 6,8 %), ezofagitis/disfagija/
The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR SOLUTION FOR INFUSION
NAVODILA ZA PRIPRAVO DOCETAXEL MYLAN KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE
Vascular disorders Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora bolečina, nazofaringitis, dispneja, kašelj, rinoreja
Overall survival (Primary end-point):
statistična analiza celotno preživetje (primarni opazovani dogodek) mediana preživetja (meseci)
Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
driska (S3/4: 6,2 %), bruhanje (S3/4: 5 %), zaprtje
Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Presnovne in prehranske motnje anoreksija Psihiatrične motnje
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 395 mg na vialo, kar ustreza 10 ml piva ali 4 ml vina na vialo.
Disease Free Survival Hazard ratio*
celotno preživetje podskupina bolnic razmerje tveganj*
Thrombocytopenia
C-docetakselom.
Citric acid (pH adjustment)
6.1 Seznam pomožnih snovi brezvodni etanol polisorbat 80 citronska kislina (uravnavanje pH)
Anaemia (G3/4: 3%); Neutropenia (G3/4:
Bolezni prebavil navzea (S3/4: 5 %), stomatitis (S3/4:
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Splošne težave in spremembe na mestu aplikacije astenija (huda: 9,9 %), zastajanje tekočine (hudo: 0,7 %),
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila docetaksel 75 mg/m² 1 uro po doksorubicinu 50 mg/m² in ciklofosfamidu 500 mg/m² (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m², ki sta mu sledila fluorouracil 500 mg/m² in ciklofosfamid 500 mg/m² (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.-Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial, equivalent to 10 ml of beer or 4 ml wine per vial.
Zdravilo vsebuje 50 vol % etanola (alkohola), to je 395 mg na vialo, kar ustreza 10 ml piva ali 4 ml vina na vialo.