natgillin/translations-raw huggingface dataset:
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) - kumulativni podatki
- For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
- Za zdravljenje raka prostate se docetaksel lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC(92,3 %), in pri 645 od 736 bolnic, ki so prejemale FAC (87,6 %).
- 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 5fluorouracilom.
• operable node-negative breast cancer .
• z operabilnim rakom dojke z negativnimi bezgavkami.
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m2 v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m2, infundiran 1 uro dolgo prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m2 na dan pet dni.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m2 compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
- 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 docetaksel uporablja v kombinaciji s cisplatinom in 5fluorouracilom.
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 (0.64-1.08), p=0.1646).
Po medianem spremljanju 10 let in 5 mesecev so imele prejemnice TAC 16,5 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti = 0,84, 95 % IZ 0,65-1,08, p = 0,1646).
Each box contains one vial of 1 ml concentrate.
Ena škatla vsebuje 1 vialo z 1 ml koncentrata.
Patients with operable node-positive breast cancer (TAX 316) Data from a multicentre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Podatki multicentriče, odprte randomiziranege študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem  80 %.
If you have any further questions, ask your doctor, hospital pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, s farmacevtom ali z medecinsko sestro.
Each box contains one vial of 8 ml concentrate.
Ena škatla vsebuje 1 vialo z 8 ml koncentrata.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 0.07%)
Bolezni živčevja periferna senzorična nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), dizgevzija (huda: 0,07
More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje Docetaksel Accord.
Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%)
sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4: somnolenca (S3/4; 0 %)
Vascular disorders Venous thromboembolic events have rarely been reported.
Žilne bolezni Opisani so bili redki primeri venskih trombembolij.
Each box contains one vial of 4 ml concentrate.
Ena škatla vsebuje 1 vialo s 4 ml koncentrata.
(33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
z 11 tedni, p = 0,0004) in podaljšal celotno preživetje (11 mesecev v prim.
• Mix the infusion bag manually using a rocking motion.
• Infuzijsko vrečko ročno premešajte z nagibanjem sem in tja.
If Docetaxel Accord 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 Docetaksel Accord v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel.
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg docetaksela.
In Docetaxel Accord 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
V Docetaksel Accord 20 mg/1 ml vialah je koncentracija docetaksela 20 mg/ml.
The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL ACCORD CONCENTRATE FOR SOLUTION FOR INFUSION
NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE DOCETAKSEL ACCORD
Docetaxel + Cis + 5-FU n = 177
Končna točka docetaksel+ Cis+5-FU n = 177
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks,
Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
Docetaxel infusion solution is supersaturated, therefore may crystallise over time.
Raztopina docetaksela je prenasičena raztopina, ki lahko čez čas kristalizira.
1060 patients were randomised 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 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
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
Docetaxel in combination with capecitabine
Docetaksel v kombinaciji s kapecitabinom
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m2 every 3 weeks.
Z docetakselom sta bili v priporočenem odmerku in shemi 100 mg/m2 na 3 tedne opravljeni dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Starostniki podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
• flushing, skin reactions, itching
• vročinski oblivi, kožne reakcije, srbenje
Docetaxel Accord 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 Docetaksel Accord v kombinaciji s cisplatinom je indicirano za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
If Docetaxel Accord concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat ali raztopina za infundiranje Docetaksel Accord v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
Docetaxel + Cis + 5-FU n = 255
Končna točka docetaksel + Cis + 5-FU n = 255
Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period,
Limfedem, ki se je začel med obdobjem zdravljenja, se je med obdobjem spremljanja nadaljeval pri 5 bolnicah (0,9 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serij Accord Healthcare Ltd.
For patients with serum bilirubin levels > ULN and/or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Zdravilo Docetaksel Accord v kombinaciji s kapecitabinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Opisani so redki primeri enterokolitisa, vključno s kolitisom, ishemičnim kolitisom in nevtropeničnim enterokolitisom, s potencialnim smrtnim izidom (pogostnost neznana).
50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
50 vol % brezvodnega etanola (alkohola), kar ustreza 3,16 g brezvodnega etanola na vialo in je ekvivalentno 80 ml piva ali 33 ml vina.
3 weeks for 4 cycles.
CF pa 4 tedne.
50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
50 vol % brezvodnega etanola (alkohola), kar ustreza 1,58 g brezvodnega etanola na vialo in je ekvivalentno 40 ml piva ali 17 ml vina.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Ena viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
What Docetaxel Accord contains - The active substance is docetaxel.
Kaj vsebuje zdravilo Docetaksel Accord Učinkovina je docetaksel.
Hazard ratio (TAC/FAC) (95% CI)
Razmerje ogroženosti (TAC/FAC)
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]*
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
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%).
After 10 years of follow-up in GEICAM 9805 study acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm No cases were reported in patients in FAC arm No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 2 ml brezvodnega etanola (1,58 g).
Docetaxel Accord 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 Docetaksel Accord 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.
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 160 mg/8 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 160 mg/8 ml sterilni koncentrat docetaksel i.v.
Cardiac left ventricular function decrease (G3/4: 0.3%)
Srčne bolezni zmanjšanje funkcije levega srčnega prekata (S 3/4: 0,3 %)
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel), s tem zdravilom (Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give any results of your blood tests to your doctor.
Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
Mix the infusion bag manually using a rocking motion.
Infuzijsko vrečko ročno premešajte z nagibanjem sem in tja.
You must not be given Docetaxel Accord
Zdravila Docetaksel Accord ne smete dobiti:
Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
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
Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Zdravilo Docetaksel Accord je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 20 mg/1 ml sterilni koncentrat docetaksel i.v.
lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Na koncu spremljanja so limfedem še vedno opažali pri 4 bolnicah (0,8 %) v kraku TAC in pri 1 bolnici (0,2 %) v kraku FAC.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 359 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina.
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
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m 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).
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 tej ključni študiji je bila imunohistokemija (IHK).
In Docetaxel Accord vial the concentration of docetaxel is 20 mg/ml.
V viali, ki vsebuje zdravilo Docetaksel Accord, je koncentracija docetaksela 20 mg/ml.
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
s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
Docetaxel Accord 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 Docetaksel Accord 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.
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel), s tem zdravilom (Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel), s tem zdravilom (Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
1 ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela.
severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m2.
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Če imate težave z vidom, morate to povedati zdravniku, bolnišničnemu farmacevtu ali medicinski sestri.V primeru težav z vidom, zlasti zamegljenega vida, morate takoj opraviti pregled oči in vida.
Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Docetaksel Accord 160 mg/8 ml je na voljo v 10 ml viali iz prozornega stekla s fluorotek plus gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 80 mg/4 ml sterilni koncentrat docetaksel i.v.
You must not breast-feed while you are treated with docetaxel.
Med zdravljenjem z zdravilom Docetaksel Accord ne smete dojiti.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate.
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in oranžno zaporko, ki vsebuje 1 ml koncentrata.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 8 ml of concentrate.
Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko, ki vsebuje 8 ml koncentrata.