natgillin/translations-raw huggingface dataset:
Taxotere/ Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be ‘ expressing’ large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.
Zdravilo Taxotere/ Docetaxel Winthrop naj bi se uporabljalo za zdravljenje raka dojke, ki ga je mogoèe zdraviti z operativnim posegom, èe se ugotovi, da rak „ izraža “ velike kolièine HER2: to je vrsta raka, ki na površini rakavih celic v velikih kolièinah tvori (izraža) doloèeno beljakovino, imenovano HER2.
Taxotere/ Docetaxel Winthrop was expected to be used in addition to surgery to remove the tumour in the following treatment combinations: • together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide; • together with trastuzumab and carboplatin (another anticancer medicine).
Zdravilo Taxotere/ Docetaxel Winthrop naj bi se uporabljalo kot dodatek operativnemu posegu za odstranitev tumorja v naslednjih kombinacijah zdravljenja: • skupaj s trastuzumabom (drugim zdravilom proti raku) po zdravljenju z doksorubicinom in ciklofosfamidom; • skupaj s trastuzumabom in karboplatinom (drugim zdravilom proti raku).
How is Taxotere/ Docetaxel Winthrop expected to work?
Kako naj bi zdravilo Taxotere/ Docetaxel Winthrop delovalo?
The active substance in Taxotere/ Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the ‘ taxanes’.
Zdravilna učinkovina zdravila Taxotere/ Docetaxel Winthrop, docetaksel, spada v skupino zdravil proti raku, ki jim pravimo „ taksani “.
Docetaxel blocks the ability of cells to destroy the internal ‘ skeleton ’ that allows them to divide and multiply.
Docetaksel blokira sposobnost celic za uničevanje notranjega „ skeleta “, ki jim omogoča deljenje in razmnoževanje.
The study compared the effectiveness of the following treatment combinations, which were used in addition to surgery:
Zdravilo Taxotere/ Docetaxel Winthrop je bilo prouèeno v eni glavni študiji, v katero je bilo vkljuèenih veè kot 3 000 žensk z rakom dojke, ki je izražal HER2 in ga je bilo možno zdraviti z operativnim
Reproduction is authorised provided the source is acknowledged. • the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by Taxotere/ Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab; • the combination of Taxotere/ Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.
V študiji so primerjali uèinkovitost naslednjih kombinacij zdravil, ki so se uporabila poleg operativnega posega: • 12- tedenska kombinacija doksorubicina in ciklofosfamida, čemur je sledila 12- tedenska uporaba zdravila Taxotere/ Docetaxel Winthrop s trastuzumabom ali brez njega; • 18- tedenska kombinacija zdravila Taxotere/ Docetaxel Winthrop s trastuzumabom in karboplatinom.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/ Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Taxotere/ Docetaxel Winthrop, namenjenim zdravljenju bolnikov z rakom dojke, ki ga je možno zdraviti z operativnim posegom in katerega tumorji čezmerno izražajo HER2, v kombinaciji s trastuzumabom in s karboplatinom ali brez njega.
The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/ Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed.
CHMP je menil, da ni bilo mogoèe ugotoviti koristi kombinacij zdravljenja, vkljuèno z zdravilom Taxotere/ Docetaxel Winthrop, kot dodatkov po operativnem posegu zaradi naèina zasnove edine glavne študije.
The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/ Docetaxel Winthrop, carboplatin and trastuzumab.
Odbor je menil tudi, da družba ni predložila zadostnih kliniènih dokazov za utemeljitev uporabe kombinacije zdravila Taxotere/ Docetaxel Winthrop, karboplatina in trastuzumaba.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Taxotere/ Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je v času umika menil, da koristi zdravila Taxotere/ Docetaxel Winthrop niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
What are the consequences of the withdrawal for patients undergoing clinical trials with Taxotere/ Docetaxel Winthrop?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Taxotere/ Docetaxel Winthrop?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/ Docetaxel Winthrop.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Taxotere/ Docetaxel Winthrop.
What is happening for Taxotere/ Docetaxel Winthrop for the treatment of other types of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer?
Kakšne so posledice za zdravilo Taxotere/ Docetaxel Winthrop, indicirano za zdravljenje drugih vrst raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, adenokarcinoma želodca ter raka glave in vratu.
There are no consequences on the use of Taxotere/ Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila Taxotere/ Docetaxel Winthrop za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
TAXOTERE 20 mg concentrate and solvent for solution for infusion
TAXOTERE 20 mg koncentrat in vehikel za raztopino za infundiranje
Each single-dose vial of TAXOTERE 20 mg concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous).
Vsaka viala z enim odmerkom zdravila TAXOTERE 20 mg koncentrat vsebuje docetaksel v obliki trihidrata, ki ustreza 20 mg brezvodnega docetaksela.
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
TAXOTERE je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic z operabilnim rakom dojke s pozitivnimi bezgavkami.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
TAXOTERE v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
TAXOTERE 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.
TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
TAXOTERE v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
TAXOTERE je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
TAXOTERE je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
TAXOTERE je v kombinaciji s cisplatinom in 5- fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.
Profilaktični G- CSF (granulocyte- colony stimulating factor, granulocitne kolonije stimulirajoči faktor) se lahko uporabi za ublažitev tveganja hematološke toksičnosti.
Breast cancer In the adjuvant treatment of operable node-positive breast cancer, the recommended dose of docetaxel is 75 mg/ m2 administered 1-hour after doxorubicin 50 mg/ m2 and cyclophosphamide 500 mg/ m2 every 3 weeks for 6 cycles (see also Dose adjustments during treatment).
Rak dojke Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/ m2, apliciran eno uro po doksorubicinu 50 mg/ m2 in ciklofosfamidu 500 mg/ m2 vsake tri tedne v 6 ciklih (glejte tudi Prilagajanje odmerka med zdravljenjem).
Adjuvant therapy for breast cancer In the pivotal trial in patients who received adjuvant therapy for breast cancer and who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 4 to 11) in all subsequent cycles.
Adjuvantna terapija raka dojke V raziskavi osrednjega pomena pri bolnicah z rakom dojke, pri katerih se je med dopolnilnim zdravljenjem razvila nevtropenija z zapleti (dalj časa trajajoča nevtropenija, febrilna nevtropenija ali okužba), so priporočali profilaktično uporabo G- CSF (npr. od 4. do 11. dne) v vseh naslednjih ciklusih zdravljenja.
5 Special populations:
5 Posebne skupine bolnikov:
Children and adolescents The experience in children is limited.
Izkušnje pri otrocih so omejene.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical trial excluded patients with ALT and/ or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; 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 želodca so izključili bolnike z ALT in/ ali AST > 1, 5 × ULN ter hkrati alkalno fosfatazo > 2, 5 × ULN in bilirubinom > 1 × ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
8 4.5 Interaction with other medicinal products and other forms of interaction
8 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri: • 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/ m² docetaksela, 121 pa jih je prejemalo 75 mg/ m². • 258 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom. • 406 bolnikih, ki so prejemali docetaksel v kombinaciji s cisplatinom. • 92 bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom.
9 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
9 • 255 bolnikih, ki so prejemali docetaksel v kombinaciji s kapecitabinom. • 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 744 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II. fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5- fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki). • 174 in 251 bolnikov z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5- fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
10 extremities and may become generalised with a weight gain of 3 kg or more.
Periferni edemi se ponavadi začnejo na nogah in lahko 10 postanejo generalizirani; telesna masa se lahko poveča za 3 kg ali več.
TAXOTERE 100 mg/ m² single agent
TAXOTERE 100 mg/ m2 v monoterapiji:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients G3/ 4 Blood bilirubin increased (< 5%); G3/ 4 Blood alkaline phosphatase increased (< 4%); G3/ 4 AST increased (< 3%); G3/ 4 ALT increased (< 2%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
Thrombocytopenia (G4:
limfatičnega sistema
Nervous system disorders
Bolezni živčevja Bolezni dihal, prsnega koša in mediastinalnega prostora
0.07%)
4%), disgevzija (huda 0, 07%) dispneja (huda 2, 7%)
Respiratory, thoracic and mediastinal disorders
zaprtje (hudo 0, 2%),
2.7%)
vnetje požiralnika
5.3%); 0.2%); Diarrhoea (G3/ 4:
5, 3%), driska (S3/ 4:
4%); Abdominal pain Nausea (G3/ 4:
4%), navzea (S3/ 4:
4%); (severe:
4%), bruhanje (S3/ 4:
1%); Vomiting (G3/ 4:
3%)
0.3%)
bolečine v trebuhu (hude 1%), gastrointestinalna krvavitev (huda 0, 3%)
Oesophagitis (severe:
(hud:
2.6%)
5, 9%), spremembe nohtov (hude 2, 6%)
11
11 Organski sistemi po MedDRA
Infections and infestations
pljučnico, s smrtnim izidom v 1, 7%)
Fluid retention (severe:
zastajanje tekočine (hudo:
Infusion site reaction; 6.5%); Non-cardiac chest pain Asthenia (severe:
6, 5%), astenija (huda:
(severe:
11, 2%), bolečine preobčutljivost (S3/ 4:
Hypersensitivity (G3/ 4:
reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude:
12 TAXOTERE 75 mg/ m² single agent
12 TAXOTERE 75 mg/ m2 v monoterapiji:
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Bolezni kože in podkožja Bolezni mišično- skeletnega sistema in vezivnega tkiva
0.8%) Myalgia
0, 8%) mialgija
Infections (G3/ 4:
anoreksija okužbe (S3/ 4:
13 TAXOTERE 75 mg/ m² in combination with doxorubicin
13 TAXOTERE 75 mg/ m2 v kombinaciji z doksorubicinom:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov zvečanje AST S3/ 4
Peripheral sensory Peripheral motor neuropathy (G3:
periferna senzorična
0.4%) neuropathy (G3/ 4:
nevropatija (S3:
0.4%)
0, 4%) nevropatija (S3/ 4:
Gastrointestinal disorders
0, 4%) Bolezni prebavil
0.4%); Skin reaction (no severe)
alopecija, spremembe nohtov (hude 0, 4%), kožna reakcija (nobene hude)
14 TAXOTERE 75 mg/ m² in combination with cisplatin
14 TAXOTERE 75 mg/ m2 v kombinaciji s cisplatinom:
G3/ 4 Blood bilirubin increased (2.1%); G3/ 4 ALT increased (1.3%)
zvečanje bilirubina v krvi S3/ 4 (2, 1%), zvečanje ALT S3/ 4 (1, 3%)
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
(0, 5%), zvečanje alkalne fosfataze v krvi S3/ 4 (0, 3%)
0.2%)
0, 7%), kožna reakcija (S3/ 4:
Myalgia (severe:
0, 2%) mialgija (huda:
5.7%)
5, 7%) bolezni Žilne bolezni
Hypersensitivity (G3/ 4:
Preobčutljivost (S3/ 4:
2.5%)
2, 5%),
15 TAXOTERE 100 mg/ m² in combination with trastuzumab
15 TAXOTERE 100 mg/ m2 v kombinaciji s trastuzumabom:
16 TAXOTERE 75 mg/ m² in combination with capecitabine
16 TAXOTERE 75 mg/ m2 v kombinaciji s kapecitabinom:
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zmanjšanje telesne mase, zvečanje bilirubina v krvi S3/ 4 (9%)
Asthenia (G3/ 4:
oralna kandidoza (S3/ 4: < 1%) letargija,
17 TAXOTERE 75 mg/ m² in combination with prednisone or prednisolone
17 TAXOTERE 75 mg/ m2 v kombinaciji s prednizonom ali prednizolonom:
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zmanjšanje funkcije levega srčnega prekata (S3/ 4:
0.6%)
alopecija, spremembe nohtov (nobenih hudih)
0.3%) Arthralgia (G3/ 4:
eksfoliacijski izpuščaj (S3/ 4:
Infections and infestations General disorders and administration site conditions Immune system disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Presnovne in prehranske motnje Infekcijske in parazitske bolezni Splošne težave in spremembe na mestu aplikacije Bolezni imunskega sistema
Infection (G3/ 4:
0, 6%) okužba (S3/ 4:
3.3%) Fatigue (G3/ 4:
3, 3%) utrujenost (S3/ 4:
3.9%); Fluid retention (severe:
3, 9%), zastajanje tekočine (hudo 0, 6%)
0.6%)
0, 3%), mialgija (S3/ 4:
Hypersensitivity (G3/ 4:
0, 3%) preobčutljivost (S3/ 4:
18 TAXOTERE 75 mg/ m² in combination with doxorubicin and cyclophosphamide
18 TAXOTERE 75 mg/ m2 v kombinaciji z doksorubicinom in ciklofosfamidom:
0.3%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
65.5%); Thrombocytopenia (G3/ 4:
65, 5%), trombocitopenija (S3/ 4:
2.0%); Febrile neutropenia
2, 0%), febrilna nevtropenija
Nervous system disorders
periferna motorična
Dysgeusia (G3/ 4:
sinkopa (S3/ 4:
0.1%)
disgevzija (S3/ 4:
Syncope (G3/ 4:
0, 3%), nevropatija (S3/ 4:
0%)
0%) nevrocerebelarni (S3/ 4:
Eye disorders
0, 1%) Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
0.3%)
0, 3%) kašelj (S3/ 4:
5.1%); Abdominal pain (G3/ 4:
5, 1%),
0.5%) 7.1%); Vomiting (G3/ 4:
7, 1%), bruhanje (S3/ 4:
4.3%); Diarrhoea (G3/ 4:
4, 3%), driska (S3/ 4:
0.8%); Arthralgia (G3/ 4:
0, 8%), artralgija (S3/ 4:
3.2%); Neutropenic infection.
3, 2%), nevtropenična okužba.
1.2%); Oedema peripheral (G3/ 4:
1, 2%), periferni edemi (S3/ 4:
20 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
20 TAXOTERE 75 mg/ m2 v kombinaciji s cisplatinom in 5- fluorouracilom za adenokarcinom želodca:
Metabolism and nutrition disorders
Presnovne in prehranske motnje Infekcijske in parazitske bolezni
11.7%)
anoreksija (S3/ 4:
Neutropenic infection; Infection (G3/ 4:
11, 7%) nevtropenična okužba, okužba (S3/ 4:
19.0%); Fever (G3/ 4:
19, 0%), zvišana telesna temperatura (S3/ 4:
21 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
21 TAXOTERE 75 mg/ m² v kombinaciji s cisplatinom in 5- fluorouracilom (za rak glave in vratu):
MedDRA System Organ classes Investigations
MedDRA Preiskave
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased
učinki ≥ 10% bolnikov
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
≥ 1 do < 10% bolnikov povečanje telesne mase
Cardiac disorders Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema
Myocardial ischemia (G3/ 4:1.7%) Neutropenia (G3/ 4:
nevtropenija (S3/ 4:
Febrile neutropenia 76.3%); Anemia (G3/ 4:
76, 3%), anemija (S3/ 4:
9.2%); Thrombocytopenia (G3/ 4:
9, 2%), trombocitopenija (S3/ 4:
5.2%)
5, 2%)
0.6%)
febrilna nevtropenija
Nervous system disorders
vrtoglavost Bolezni živčevja
Dysgeusia/ Parosmia; Dizziness Peripheral sensory neuropathy (G3/ 4:
disgevzija/ parozmija, periferna senzorična nevropatija (S3/ 4:
0.6%); Constipation; Stomatitis (G3/ 4:
stomatitis (S3/ 4:
Esophagitis/ dysphagia/ 4.0%); odynophagia (G3/ 4:
4, 0%), ezofagitis/ disfagija/ odin
Diarrhea (G3/ 4:
diareja (S3/ 4:
0.6%) Abdominal pain; Dyspepsia; Gastrointestinal haemorrhage (G3/ 4:
0, 6%), bolečine v trebuhu, dispepsija, krvavitev v prebavilih (S3/ 4:
Myalgia (G3/ 4:
srbeč izpuščaj, suha koža, luščenje kože (S3/ 4: 0, 6%) mialgija (S3/ 4:
6.3%); Neutropenic infection Cancer pain (G3/ 4:
6, 3%), nevtropenična okužba
3.4%); Pyrexia (G3/ 4:
3, 4%), pireksija (S3/ 4:
0.6%); Fluid retention; Oedema
0, 6%), retenca tekočine, edem
22
22 • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324)
12.4%); Thrombocytopenia (G3/ 4:
12, 4%), trombocitopenija (S3/ 4:
4.0%); Febrile neutropenia
4, 0%), febrilna nevtropenija
2.0%); Peripheral motor neuropathy (G3/ 4:
periferna motorična nevropatija (S3/ 4:
12.0%); Constipation (G3/ 4:
12, 0%), zaprtje (S3/ 4:
0.8%); Gastrointestinal pain (G3/ 4:
0, 8%), bolečine v prebavilih (S3/ 4:
1.2%); Gastrointestinal haemorrhage (G3/ 4:
1, 2%), gastrointestinalna krvavitev (S3/ 4:
Infections and infestations
Infekcijske in parazitske bolezni Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi)
Neutropenic infection
nevtropenična okužba bolečina zaradi raka (S3/ 4:
23
23 Pomarketinške izkušnje
L01CD 02
L01CD02
TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
TAXOTERE v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Obe shemi so aplicirali enkrat na 3 tedne, in sicer 6 ciklov. docetaksel so aplicirali v 1- urni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan.
25 An interim analysis was performed with a median follow up of 55 months.
Narejena je bila vmesna analiza z mediano 55- mesečnim spremljanjem.