FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 10 ml of concentrate.
Slovenian: Ena viala vsebuje 10 ml koncentrata
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Slovenian: Infekcijske in parazitske bolezni Benigne in maligne neoplazme (vključno s cistami in polipi)
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Slovenian: okužba, povezana z nevtropenijo S4 (S3/4:4,6 %)
English: There are limited available data in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
English: Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
Slovenian: sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4: somnolenca (S3/4;
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala s 4 ml
English: p=0.1646).
Slovenian: z 9 meseci, p = 0,01).
English: Each vial contains 1 ml of concentrate.
Slovenian: Ena viala vsebuje 1 ml koncentrata
English: One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Slovenian: Ena viala z 10 ml koncentrata vsebuje 200 mg docetaksela.
English: 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).
Slovenian: 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).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 1 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala z 1 ml
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: BATCH NUMBER Lot:
Slovenian: †Stratificiran log-rang test
English: 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:
Slovenian: Povečanje v preživetju opazovano pri kraku tedenskega docetaksela ni bilo statistično značilno v primerjavi z mitoksantronovo kontrolno roko zdravljenja.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively.
Slovenian: 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 %.
English: Frequency unknown:
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela v obliki brezvodnega docetaksela.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: One vial contains 200 mg of docetaxel.
Slovenian: Ena viala vsebuje 200 mg docetaksela
English: One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
Slovenian: Ena viala z 1 ml koncentrata vsebuje 395 mg brezvodnega etanola.
English: What Docetaxel Mylan 80 mg/4 ml is and what it is used for
Slovenian: Kaj je zdravilo Docetaxel Mylan 80 mg/4 ml in za kaj ga uporabljamo
English: 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.
Slovenian: 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.
English: 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.
Slovenian: s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m² značilno daljša kot z najboljšo podporno oskrbo.
English: 1Full analysis set (intent-to-treat)
Slovenian: 1celotna množica za analizo (z-namenom-zdravljenja) ocenjeno mediano preživetje
English: Each vial contains 4 ml of concentrate.
Slovenian: Ena viala vsebuje 4 ml koncentrata
English: What Docetaxel Mylan 20 mg/1 ml is and what it is used for
Slovenian: Kaj je zdravilo Docetaxel Mylan 20 mg/1 ml in za kaj ga uporabljamo
English: Docetaxel Mylan contains ethanol
Slovenian: Zdravilo Docetaxel Mylan vsebuje etanol (alkohol)
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
Slovenian: Vsak ml koncentrata za infundirane vsebuje 20 mg docetaksela (brezvodnega).
English: Nail disorders (severe: Skin reaction (no severe)
Slovenian: Bolezni kože in podkožja alopecija, spremembe nohtov (hude kožna reakcija (nobene hude)
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je bledorumena do rjavkasto rumena raztopina.
English: • 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.
Slovenian: • 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.
English: What you need to know before you use Docetaxel Mylan 200 mg/10 ml
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 200 mg/10 ml
English: • operable node-negative breast cancer
Slovenian: • z operabilnim rakom dojke z negativnimi bezgavkami
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 2,4 %), nevtropenična okužba (S3/4:2,6 %)
English: How to store Docetaxel Mylan 200 mg/10 ml Contents of the pack and other information
Slovenian: Shranjevanje zdravila Docetaxel Mylan 200 mg/10 ml Vsebina pakiranja in ostale informacije
English: If Docetaxel Mylan concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje Docetaxel Mylan v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: 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
Slovenian: 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)
English: 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.
Slovenian: 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.
English: Discuss with your doctor if you suffer from alcohol dependency or liver impairment.
Slovenian: Če trpite zaradi alkoholizma ali obolenja jeter, se posvetujte s svojim zdravnikom.
English: 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.
Slovenian: 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.
English: One vial contains 80 mg of docetaxel.
Slovenian: Ena viala vsebuje 80 mg docetaksela
English: 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.
Slovenian: 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:
English: How to store Docetaxel Mylan 80 mg/4 ml Contents of the pack and other information
Slovenian: Shranjevanje zdravila Docetaxel Mylan 80 mg/4 ml Vsebina pakiranja in ostale informacije
English: What you need to know before you use Docetaxel Mylan 80 mg/4 ml
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 80 mg/4 ml
English: Arrhythmia (G3/4: 0.7%) Cardiac failure
Slovenian: Srčne bolezni aritmija (S3/4:0,7 %) srčno popuščanje
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje metastatskega raka želodca se docetaksel uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: 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).
Slovenian: 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).
English: What you need to know before you use Docetaxel Mylan 20 mg/1 ml
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Mylan 20 mg/1 ml
English: Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku prostate v kombinaciji s prednizonom ali prednizolonom
English: How to store Docetaxel Mylan 20 mg/1 ml Contents of the pack and other information
Slovenian: Shranjevanje zdravila Docetaxel Mylan 20 mg/1 ml Vsebina pakiranja in ostale informacije
English: Headache (G3/4: < 1%); Neuropathy peripheral
Slovenian: Bolezni živčevja omotica, glavobol (S3/4: < 1 %), periferna nevropatija
English: If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje zdravilo Docetaxel Mylan v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
English: How to use Docetaxel Mylan 200 mg/10 ml
Slovenian: Kako uporabljati zdravilo Docetaxel Mylan 200 mg/10 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/001 - 1 viala
English: 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.
Slovenian: Zdravilo Docetaxel Mylan v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/003 - 1 viala
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/005 - 1 vial
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/748/005 - 1 viala
English: Oral candidiasis (G3/4: < 1%)
Slovenian: Infekcijske in parazitske bolezni oralna kandidoza (S3/4): < 1 %)
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje
English: EU/1/11/748/006 - 5 vials
Slovenian: EU/1/11/748/006 - 5 vial
English: Dry skin ; Desquamation
Slovenian: Bolezni kože in podkožja suha koža, luščenje
English: Metabolism and nutrition disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje Bolezni živčevja vrtoglavica
English: Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo Docetaxel Mylan je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: Diarrhoea grade 4
Slovenian: driska 4. stopnje
English: Epistaxis (G3/4: < 1%)
Slovenian: S3/4 zvišanje ALT (< 1 %)
English: One vial contains 20 mg of docetaxel.
Slovenian: Ena viala vsebuje 20 mg docetaksela
English: - For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje raka glave in vratu se zdravilo docetaksel uporablja v kombinaciji s cisplatinom in 5-fluorouracilom
English: 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.
Slovenian: 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.
English: Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion Docetaxel
Slovenian: Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje docetaksel
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
English: Disease Free Survival
Slovenian: Preživetje brez bolezni Razmerje ogroženosti
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: EU/1/11/748/002 - 5 vials
Slovenian: EU/1/11/748/002 - 5 vial
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje
English: 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).
Slovenian: 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.
English: EU/1/11/748/004 - 5 vials
Slovenian: EU/1/11/748/004 - 5 vial
English: How to use Docetaxel Mylan 80 mg/4 ml
Slovenian: Kako uporabljati zdravilo Docetaxel Mylan 80 mg/4 ml
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje
English: How to use Docetaxel Mylan 20 mg/1 ml
Slovenian: Kako uporabljati zdravilo Docetaxel Mylan 20 mg/1 ml
English: Venous disorder (G3/4: 0.6%)
Slovenian: Žilne bolezni venske motnje (S3/4: 0,6 %)
English: Hypersensitivity (G3/4:0.6%)
Slovenian: Preobčutljivost (S3/4: 0,6 %)
English: Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion Docetaxel
Slovenian: Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
English: G3/4 ALT increased
Slovenian: S3/4 zvišanje ALT
English: Hypersensitivity (G3/4: 1.2%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S3/4: 1,2 %
English: 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.
Slovenian: Še prisotno amenorejo so pri spremljanju zabeležili pri 140 od 251 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
English: G3/4 Blood bilirubin increased (< 2.5%);
Slovenian: S 3/4 zvišanje bilirubina v krvi (< 2,5 %) S3/4 zvišanje alkalne fosfataze v krvi (< 2,5 %)
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Slovenian: omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4:
English: Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion Docetaxel
Slovenian: Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: How to store Docetaxel Mylan 200 mg/10 ml
Slovenian: Shranjevanje zdravila Docetaxel Mylan 200 mg/10 ml
English: Median survival (months) (95% CI)
Slovenian: mediano preživetje (meseci) (95 % IZ)
English: 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.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je 1,58 g na vialo, kar ustreza 40 ml piva ali 17 ml vina na vialo.
English: Single-use vial.
Slovenian: NALEPKA NA VIALI
English: Dyspnoea; Cough; Rhinorrhoea
Slovenian: • vnetje debelega črevesa, tankega črevesa, predrtje črevesa
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Slovenian: Presnovne in prehranske motnje Bolezni živčevja nevropatija (S3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
English: How to store Docetaxel Mylan 20 mg/1 ml
Slovenian: Shranjevanje zdravila Docetaxel Mylan 20 mg/1 ml
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m² pri raku dojke v kombinaciji s trastuzumabom
English: How to store Docetaxel Mylan 80 mg/4 ml
Slovenian: Shranjevanje zdravila Docetaxel Mylan 80 mg/4 ml
English: What Docetaxel Mylan 80 mg/4 ml looks like and contents of the pack
Slovenian: Izgled zdravila Docetaxel Mylan 80 mg/4 ml in vsebina pakiranja
English: What Docetaxel Mylan 200 mg/10 ml looks like and contents of the pack
Slovenian: Izgled zdravila Docetaxel Mylan 200 mg/10 ml in vsebina pakiranja