natgillin/translations-raw huggingface dataset:
If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
The primary efficacy endpoint in this study, OS was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6
CP je bilo značilno daljše (log-rang test, p = 0,0058) pri shemi z docetakselom kot s PF (mediano CP: shema z docetakselom 70,6, PF 30,1 meseca).
Toxicity Diarrhoea grade 3
stomatitis/mukozitis 3. stopnje
Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje Taxespira 80 mg/4 ml koncentrat za raztopino za infundiranje Taxespira 120 mg/6 ml koncentrat za raztopino za infundiranje Taxespira 140 mg/7 ml koncentrat za raztopino za infundiranje Taxespira 160 mg/8 ml koncentrat za raztopino za infundiranje
Taxespira 140 mg/7 ml concentrate for solution for infusion.
Taxespira 140 mg/7 ml koncentrat za raztopino za infundiranje docetaksel
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC
80mg/4 ml contains 4 ml of concentrate
80 mg/4 ml vsebuje 4 ml koncentrata.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxespira 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 Taxespira in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Namen tega je minimaliziranje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Taxespira , zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
Taxespira 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 Taxespira je indicirano 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.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him the results of your blood tests.
Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Zdravilo Taxespira je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Pomožne snovi z znanim učinkom20 mg/1 ml Ena 1 ml viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
• operable node-negative breast cancer.
• z operabilnimrakom dojke z negativnimi bezgavkami.
In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
V študiji TAX316 so amenorejo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 202 od 744 bolnic v kraku TAC (27,2 %) in pri 125 od 736 bolnic v kraku FAC (17,0 %).
Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide (see section 4.8).
Pri bolnikih, zdravljenih z docetakselom v kombiniranih shemah, ki so vključevale doksorubicin, 5fluorouracil in/ali ciklofosfamid, so poročali o prekatnih motnjah srčnega ritma, vključno s prekatno tahikardijo (včasih s smrtnim izidom) (glejte poglavje 4.8).
Full analysis set (intent-to-treat)
celotna množica za analizo (z-namenom-zdravljenja) ocenjeno mediano preživetje
Ethanol (anhydrous) Citric acid monohydrate
6.1 Seznam pomožnih snovi polisorbat 80 etanol (brezvodni) citronska kislina monohidrat
Myalgia (G3/4: 0.6%)
aritmija (S3/4: 0,6 %)
Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4:
• operable node-positive breast cancer
• z operabilnimrakom dojke s pozitivnimi bezgavkami
Taxespira 160 mg/8 ml concentrate for solution for infusion.
Taxespira 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
Docetaxel
C-docetakselom.
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 uporabljenav skladu z veljavnimi smernicami v sodelujočih ustanovah.
Taxespira in combination with platinum agents in chemotherapy-naïve patients 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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
V študiji III. faze so 1.218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, randomizirali v tri skupine.
Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%);
Splošne težave in spremembe na mestu aplikacije astenija (huda: 8,1 %), zastajanje tekočine (hudo: 1,2 %), bolečine reakcija na mestu infundiranja
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.
Zdravilo Taxespira v monoterapiji 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.
Peripheral motor neuropathy (G3/4:
Bolezni živčevja periferna motorična nevropatija (S3/4:
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine.
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 3160 mg brezvodnega etanola na 8 ml vialo, kar ustreza 80 ml piva oziroma 33 ml vina.
Taxespira 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 Taxespira v kombinaciji z doksorubicinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
Metabolism and nutrition disorders Nervous system disorders
Presnovne in prehranske motnje Bolezni živčevja
Taxespira 120 mg/6 ml concentrate for solution for infusion.
Taxespira 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
Docetaxel increased response rate (33% vs. 12%, p <0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged OS (11 months vs. 9 months, p = 0.01).
z 12 %, p < 0,0001), podaljšal čas do napredovanja (19 tednov v prim.
140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel.
140 mg/7 ml Ena viala s 7 ml koncentrata vsebuje 140 mg docetaksela.
Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%)
Infekcijskein parazitske bolezni okužbe (S3/4: 5 %) Bolezni krvi in limfatičnega sistema nevtropenija (S4: 54,2 %), anemija (S3/4: 10,8 %), trombocitopenija (S4: 1,7 %)
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Za prilagajanje odmerka trastuzumaba glejte povzetek glavnih značilnosti trastuzumaba.
Uncommon (may affect up to 1 in 100 people):
Občasno (pojavijo se lahko pri največ 1 od 100 bolnikov):
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).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).
Prejemnice TAC so imele 32 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti 0,68, 95 % IZ (0,49-0,93), p = 0,01).
Preparation of the infusion solution
Priprava infuzijske raztopine
160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel.
160 mg/8 ml Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
Statistical analysis
FARMACEVTSKI PODATKI
20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
20 mg/1 ml 1 viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
Reproductive system and breast disorders
Motnje reprodukcije in bolezni dojk
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab
Opis izbranih neželenih učinkov zdravljenja z zdravilom Taxespira 100 mg/m 2 pri raku dojke v kombinaciji s trastuzumabom
Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 pri raku prostate v kombinaciji s prednizonom ali prednizolonom
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine.
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 2765 mg brezvodnega etanola na 7 ml vialo, kar ustreza 70 ml piva oziroma 29 ml vina.
Taxespira 80 mg/4 ml concentrate for solution for infusion.
Taxespira 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4:
hipotenzija (S3/4: 0 %) flebitis (S 3/4: 0 %)
Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin
Adenokarcinom želodca Priporočeni odmerek docetaksela je 75 mg/m 2 v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m 2 v 1- do 3
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine.
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 395 mg brezvodnega etanola na 1 ml vialo, kar ustreza 10 ml piva ali 4 ml vina.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine.
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 1580 mg brezvodnega etanola na 4 ml vialo, kar ustreza 40 ml piva oziroma 17 ml vina.
(G3/4: 0%)
(S3/4: 14,3 %)
In study TAX316, peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
V študiji TAX316 se je pri 84 bolnicah (11,3 %) v kraku TAC in pri 15 bolnicah (2 %) v kraku FAC med zdravljenjem pojavila periferna senzorična nevropatija, ki je trajala še med obdobjem spremljanja.
Lacrimation increased Conjunctivitis
Očesne bolezni močnejše solzenje konjunktivitis
Taxespira 20 mg/1 ml concentrate for solution for infusion
Taxespira 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
• heart failure
• srčno popuščanje
At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajočo astenijo opažali pri 29 bolnicah v kraku TAC (3,9 %) in pri 16 bolnicah v kraku FAC
Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
Opis izbranih neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 v kombinaciji s cisplatinom in 5-fluorouracilom pri adenokarcinomu želodca
Common (may affect up to 1 in 10 people):
Pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov):
The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Kombinacija docetaksela in trastuzumaba je bila pri bolnicah učinkovita ne glede na to, ali so prej dobile adjuvantne antracikline ali ne. Glavni test za ugotavljanje HER2-pozitivnosti v tem odločilnem preskušanju je bila imunohistokemija (IHK).
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza do 2370 mg brezvodnega etanola na 6 ml vialo.
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
V študiji GEICAM 9805 so nadaljnjo prisotnost amenoreje, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah (1,0 %) v kraku FAC.
80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
80 mg/ 4 ml Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
Lacrimation increased (G3/4:
močnejše solzenje (S3/4:
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
To zdravilo vsebuje 50 vol. % brezvodnega etanola (alkohola), to je do 2370 mg brezvodnega etanola na 6 ml vialo, kar ustreza 60 ml piva oziroma 25 ml vina.
Cough (G3/4: 0%)
limfedem (S3/4: 0 %)
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza do 2765 mg brezvodnega etanola na 7 ml vialo.
(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).
in 5-fluorouracilom (F) (750 mg/m 2 na dan, 5 dni), bodisi cisplatin (100 mg/m 2 1. dan) in 5- fluorouracil
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza do 395 mg brezvodnega etanola na 1 ml vialo.
Rash pruritic; Dry skin; Skin exfoliative (G3/4:
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4:
Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: 1,0 %), ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
Disease free survival
Žilne bolezni bolezen ven
Rare (may affect up to 1 in 1,000 people): inflammation of the colon, small intestine, which could be fatal (frequency not known);
• vnetje debelega črevesa, tankega črevesa, ki je lahko smrtno (pogostnost ni znana) predrtje črevesa.
Weight decreased; G3/4 Blood bilirubin increased
Preiskave zmanjšanje telesne mase, zvečanje bilirubina v krvi S3/4
Fever (G3/4: 1.2%)
bolečina zaradi raka (S3/4: 1,2 %)
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
bolečine v prebavilih (S3/4: 1,2 %), gastrointestinalna krvavitev (S3/4: 0,4 %)
Stomatitis (G3/4: 5.3%); Diarrhoea
Bolezni prebavil navzea (S3/4: 2,4 %), driska
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m ki mu je sledil 5-fluorouracil (F) 1000 mg/m2 na dan 5 dni.
In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
V študiji GEICAM 9805 se je med zdravljenjem nastala periferna senzorična nevropatija nadaljevala še med obdobjem spremljanja pri 10 bolnicah (1,9 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
• 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/m administered as a 30-minute to
• 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 5fluorouracila 1000 mg/m2/dan od 1. do 4. dneva.
Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Najboljši celotni odziv (CR + PR) na raziskovano terapijo [kemoterapija +/kemoradioterapija] (%) (95 % IZ)
120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
120 mg/6 ml 1 viala s 6 ml koncentrata vsebuje 120 mg docetaksela.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza do 3160 mg brezvodnega etanola na 8 ml vialo.
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4:
Progressive disease as best overall response (%) *Unstratified logrank test
2-letna ocena (%) razmerje tveganja (95 % IZ) *vrednost p celotni delež odziva (popolni odziv +delni odziv) (%) vrednost p napredujoča bolezen kot najboljši celotni odziv (%) *nestratificirani log-rang test
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 100 mg/m 2 pri raku dojke v kombinaciji s trastuzumabom
120mg/6 ml One vial of 6 ml concentration contains 120 mg docetaxel.
120 mg/6 ml Ena viala s 6 ml koncentrata vsebuje 120 mg docetaksela.
This is equivalent to 40 ml of beer or17 ml of wine.
To ustreza 40 ml piva ali 17 ml vina.
Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzea (S3/4: 4 %), bruhanje (S3/4: 3 %)
Disease free survival Hazard ratio*
Preživetje brez bolezni Razmerje ogroženosti*
G3/4 Blood bilirubin increased (2.1%);
Preiskave zvečanje bilirubina v krvi S3/4 (2,1 %), zvečanje ALT S3/4
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anhydrous per 4 ml vial.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza do 1580 mg brezvodnega etanola na 4 ml vialo.
General disorders and administration site conditions In study TAX316, peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
V študiji TAX316 so periferne edeme, ki so se pojavili med obdobjem zdravljenja in so trajali še med obdobjem spremljanja po koncu kemoterapije, opažali pri 119 od 744 bolnic v kraku TAC (16,0 %) in pri 23 od 736 bolnic v kraku FAC (3,1 %).
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with doxorubicin
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Taxespira 75 mg/m 2 pri raku dojke v kombinaciji z doksorubicinom
• weight gain or loss.
• zvečanje ali zmanjšanje telesne mase.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).
NE uporabljajte drugih zdravil, ki vsebujejo docetaksel in so sestavljena iz dveh vial (koncentrata in vehikla), skupaj s tem zdravilom (Taxespira 140 mg/7 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Nausea (G3/4: 5%); Stomatitis (G3/4:
Bolezni prebavil navzea (S3/4: 13,9 %), stomatitis (S3/4:
MedDRA system organ classes Very common adverse reactions Common adverse reactions Infections and infestations
Organski sistemi po MedDRA Zelo pogosti neželeni učinki
Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v udih (S3/4: < 1 %), bolečine v hrbtu (S3/4: 1 %)
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
NE uporabljajte drugih zdravil, ki vsebujejo docetaksel in so sestavljena iz dveh vial (koncentrata in vehikla), skupaj s tem zdravilom (Taxespira 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Pri bolnicah, zdravljenih z docetakselom v kombiniranih shemah, ki so vključevale doksorubicin, 5fluorouracil in/ali ciklofosfamid, so poročali o prekatnih motnjah srčnega ritma, vključno s prekatno tahikardijo (pogostnost ni znana), včasih s smrtnim izidom.
• For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
• Za zdravljenjeraka prostate se zdravilo Taxespira lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
• For the treatment of lung cancer, Taxespira could be administered either alone or in
• Za zdravljenjepljučnega raka se zdravilo Taxespira lahko uporablja sam ali v kombinaciji s cisplatinom.