natgillin/translations-raw huggingface dataset:
Docetaxel Mylan in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docetaxel Mylan u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² (TAC arm), or doxorubicin 50 mg/m² followed by fluorouracil 500 mg/m² and cyclosphosphamide 500 mg/m² (FAC arm).
Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (TAC skupina) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
Each vial contains 10 ml of concentrate.
Jedna bočica sadržava 10 ml koncentrata.
Inject the required volume of concentrate for solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Potrebni volumen koncentrata za otopinu za infuziju treba injicirati u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida.
The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Preporučena doza docetaksela je 75 mg/m2 u obliku jednosatne infuzije, nakon čega slijedi infuzija 75 mg/m cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5
(G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
(G3/4: 0,6%) poremećaji noktiju (G3/4: 0,4%)
- For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje uznapredovalog karcinoma želuca docetaxel se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
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).
Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda =0 ,84, 95% CI (0,65-1,08), p=0,1646).
How to store Docetaxel Mylan 200 mg/10 ml Contents of the pack and other information
Kako čuvati Docetaxel Mylan 200 mg/10 ml Sadržaj pakiranja i druge informacije
One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Jedna bočica s 10 ml koncentrata sadržava 200 mg docetaksela.
Use immediately the medicine once added into the non-PVC infusion bag.
Nakon dodavanja lijeka u infuzijsku vrećicu koja nije izrađena od polivinilklorida (PVC), pripremljenu otopinu upotrijebite odmah.
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.
Ovaj lijek sadrži 50 vol% etanola (alkohol), odnosno do 1,58 g po bočici, što odgovara količini od 40 ml piva ili 17 ml vina po bočici.
One vial contains 200 mg of docetaxel.
Jedna bočica sadržava 200 mg docetaksela.
How to store Docetaxel Mylan 80 mg/4 ml Contents of the pack and other information
Kako čuvati Docetaxel Mylan 80 mg/4 ml Sadržaj pakiranja i druge informacije
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 4 ml
OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica od 4 ml
What Docetaxel Mylan 20 mg/1 ml is and what it is used for
Što je Docetaxel Mylan 20 mg/1 ml i za što se koristi
One vial of 10 ml of concentrate contains 3,95 g of ethanol anhydrous.
Jedna bočica od 10 ml koncentrata sadržava 3,95 g etanola, bezvodnog.
More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Ponekad je potrebno više od jedne bočice Docetaxel Mylan koncentrata za otopinu za infuziju kako bi se dobila doza potrebna za bolesnika.
Data from a multicenter open label randomized trial support the use of docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu lijeka docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
What Docetaxel Mylan 80 mg/4 ml is and what it is used for
Što je Docetaxel Mylan 80 mg/4 ml i za što se koristi
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Omjer hazarda: 1,122 [97,2% CI: 0,937; 1,342]*
What Docetaxel Mylan 200 mg/10 ml contains
Što Docetaxel Mylan 200 mg/10 ml sadrži
How to store Docetaxel Mylan 20 mg/1 ml Contents of the pack and other information
Kako čuvati Docetaxel Mylan 20 mg/1 ml Sadržaj pakiranja i druge informacije
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
• Indukcijska kemoterapija praćena radioterapijom (TAX 323) Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m
1060 bolesnika randomizirano je u skupine koje su primale ili docetaksela 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
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.
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P) 75 mg/m2 te 5-fluorouracil (F) 750 mg/m2 dnevno u obliku kontinuirane infuzije tijekom 5 dana.
Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Opis odabranih nuspojava za adjuvantno liječenje za docetakselom 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
The infusion bag solution should be used within 6 hours below 25 °C and normal lighting conditions including the one hour infusion to the patient.
Pripremljenu infuzijsku otopinu treba upotrijebiti unutar 6 sati nakon priprave, uključujući u to vrijeme i primjenu jednosatnom intravenskom infuzijom, uz čuvanje na temperaturi ispod 25°C te pri normalnoj svjetlosti.
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.
Nakon 10 godina praćenja u GEICAM 9805 studiji, akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 1 ml
OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica od 1 ml
Menopausal status
Menopauzalni status Premenopauza Postmenopauza
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/005 - 1 vial
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/748/005 - 1 vial
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.
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m kao 30-minutnu do trosatnu intravensku infuziju na dan 1, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m2 dnevno od dana 1 do dana 5.
One vial contains 80 mg of docetaxel.
Jedna bočica sadržava 80 mg docetaksela.
What Docetaxel Mylan 20 mg/1 ml contains
Što Docetaxel Mylan 20 mg/1 ml sadrži
If Docetaxel Mylan concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Ako Docetaxel Mylan koncentrat ili infuzijska otopina dođu u dodir s kožom, to mjesto odmah treba dobro i temeljito isprati sapunom i vodom.
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.
U GEICAM 9805 studiji, alopecija je i dalje bila prisutna tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
How to store Docetaxel Mylan 200 mg/10 ml
Kako čuvati Docetaxel Mylan 200 mg/10 ml
Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
Jedan ml koncentrata za otopinu za infuziju sadržava 20 mg docetaksela (bezvodnog).
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.
Docetaxel Mylan u kombinaciji s trastuzumabom indiciran je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.
Ovaj lijek sadrži 50 vol% etanola (alkohol), odnosno do 0,395 g po bočici, što odgovara količini od 10 ml piva ili 4 ml vina po bočici.
Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Docetaxel Mylan je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Opći poremećaji i reakcije na mjestu primjene umor/slabost (G3/4: 5%); periferni edem (G3/4: 1%)
This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.95 g per vial, equivalent to 100 ml of beer or 40 ml wine per vial.
Ovaj lijek sadrži 50 vol% etanola (alkohol), odnosno do 3,95 g po bočici, što odgovara količini od 100 ml piva ili 40 ml vina po bočici.
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.
Prozirna staklena bočica od 6 ml (staklo tip I) s 1 ml koncentrata za otopinu za infuziju, s bromobutilnim gumenim čepom i aluminijskim prstenom te plastičnim "flip off" zatvaračem.
Patients on the comparator arm received cisplatin (P) 100 mg/m² followed by 5-fluorouracil (F) 1000 mg/m² per day for 5 days.
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
Lacrimation increased (G3/4: <0.1%)
Poremećaji oka pojačano suzenje (G3/4: <0,1%);
What Docetaxel Mylan 80 mg/4 ml contains
Što Docetaxel Mylan 80 mg/4 ml sadrži
Infections and infestations Blood and lymphatic system disorders
Infekcije i infestacije Poremećaji krvi i limfnog sustava neutropenija (G4:
Nausea (G3/4: 0.6%); Stomatitis (G3/4: 4.0%);
Poremećaji probavnog sustava mučnina (G 3/4: 0,6%); stomatitis (G3/4: 4,0%);
Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 200 mg/10 ml koncentrat za otopinu za infuziju docetaksel
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.
Tablični popis nuspojava za adjuvantno liječenje docetakselom 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
If Docetaxel Mylan concentrate or solution for infusion should come into contact with skin, wash immediately and thoroughly with soap and water.
Ako Docetaxel Mylan koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
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).
Bolesnici su randomizirani tako da su primali ili docetaksel (T) 75 mg/m u obliku jednosatne infuzije, nakon čega je odmah uslijedila terapija cisplatinom (Cis) 75mg/m tijekom 30-60 minuta svaka 3 tjedna (TCis), ili docetaksel 75 mg/m2 u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m primijenjen tijekom 6 do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m2 na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
- For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje karcinoma glave i vrata docetaxel se primjenjuje u kombinaciji s cisplatinom i 5
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 200 mg/10 ml sterilni koncentrat docetaksel
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Opis odabranih nuspojava kod karcinoma dojke za docetaksel 100 mg/m² u kombinaciji s trastuzumabom
Peripheral sensory neuropathy (G3/4:
periferna motorna neuropatija (G3/4:
One vial contains 20 mg of docetaxel.
Jedna bočica sadržava 20 mg docetaksela.
For patients who are dosed initially at docetaxel 75 mg/m² in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m².
Kombinacija s cisplatinom Bolesnicima koji početnu dozu docetaksela od 75 mg/m primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25.000 stanica/mm
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
NAZIV LIJEKA Docetaxel Mylan 200 mg/10 ml koncentrat za otopinu za infuziju
How to store Docetaxel Mylan 80 mg/4 ml
Kako čuvati Docetaxel Mylan 80 mg/4 ml
• inflammation of the colon, small intestine; intestinal perforation
• upala debelog crijeva, tankog crijeva; probušenje crijeva
Alopecia; Erythema, Rash; Nail disorders
Poremećaji kože i potkožnog tkiva alopecija;eritem; osip; poremećaji noktiju
How to store Docetaxel Mylan 20 mg/1 ml
Kako čuvati Docetaxel Mylan 20 mg/1 ml
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.
Docetaxel Mylan u kombinaciji s cisplatinom indiciran je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
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.
Prozirna staklena bočica od 10 ml (staklo tip I) s 4 ml koncentrata za otopinu za infuziju, bromobutilnim gumenim čepom i aluminijskim prstenom te plastičnim "flip-off" zatvaračem.
Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Krvožilni poremećaji hipotenzija (G3/4: flebitis (G3/4: 0%)
(539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
(539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m nakon kojeg slijedi fluorouracil
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous.
Jedna bočica od 1 ml koncentrata sadržava 395 mg etanola, bezvodnog.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion
NAZIV LIJEKA Docetaxel Mylan 80 mg/4 ml koncentrat za otopinu za infuziju
G3/4 Blood alkaline phosphatase increased
G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 80 mg/4 ml sterilni koncentrat docetaksel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 20 mg/1 ml sterilni koncentrat docetaksel
Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
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.
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 intravenskom. infuzijom na dan 1 nakon čega je slijedio cisplatin (P) 100 mg/m2 primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5-fluorouracila (F) 1000 mg/m dnevno od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion
NAZIV LIJEKA Docetaxel Mylan 20 mg/1 ml koncentrat za otopinu za infuziju
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion Docetaxel
Docetaxel Mylan 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
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.
Prozirna staklena bočica od 15 ml (staklo tip I) s 10 ml koncentrata, za otopinu za infuziju, s bromobutilnim gumenim čepom i aluminijskim prstenom te plastičnim "flip off" zatvaračem.
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Tablični popis nuspojava kod karcinoma dojke za docetaksel 75 mg/m² u kombinaciji s kapecitabinom
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.
Docetaxel Mylan u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako Docetaxel Mylan koncentrat ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
1060 patients were randomized to receive either docetaxel 75 mg/m administered 1-hour after doxorubicin 50 mg/m
1060 bolesnika randomizirano je u skupine koje su primale ili docetaksel 75 mg/m primijenjen jedan sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m
Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Poremećaji imunološkog sustava preosjetljivost (G3/4: 1,7%) Poremećaji metabolizma i prehrane anoreksija (G3/4: 11,7%) Poremećaji živčanog sustava periferna senzorna neuropatija omaglica (G3/4: 2,3%); periferna motorna neuropatija (G3/4: 1,3%)
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.
Docetaxel Mylan u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent
Opis odabranih nuspojava kod karcinoma dojke za docetaksel 100 mg/m2 u monoterapiji
Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel Mylan kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
Anorexia (G3/4:
aritmija (G3/4:
There are limited available data in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
Excipients
Prednizon
Data from a multicenter open label randomized 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.
Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Tablični popis nuspojava kod karcinoma prostate za docetaksel 75 mg/m² u kombinaciji s prednizonom ili prednizolonom MedDRA klasifikacija organskih sustava