natgillin/translations-raw huggingface dataset:
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolniki na kraku TPF so prejemali antibiotično profilakso s ciprofloksacinom v odmerku 500 mg peroralno 68 dvakrat na dan 10 dni z začetkom 5. dne vsakega cikla, ali enakovredno profilakso.
n = 181
+ 5- FU
Median progression free survival (months) (95% CI) Adjusted Hazard ratio
Mediano preživetje brez napredovanja bolezni
11.4 (10.1-14.0)
n = 177 11, 4
0.70
= 181 8, 3
8.3 (7.4-9.1)
(meseci) (95% IZ) Popravljeno razmerje tveganja (95% IZ) * p- vrednost
(95% CI) *p-value
(10, 1- 14, 0) 0, 70 (0, 55- 0, 89) 0, 0042
(95% CI) Hazard ratio
(95% IZ) Razmerje tveganja
(95% CI) **p-value
(95% IZ) ** p- vrednost
(95% CI) ***p-value Best overall response to study treatment
(95% IZ) *** p- vrednost Najboljši celotni odziv na proučevano
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
zdravljenje [kemofarmacija + / - radioterapija] (%) (95% IZ)
72.3 (65.1-78.8)
58, 6 (51, 0- 65, 8)
58.6 (51.0-65.8)
Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci)
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI) Hazard ratio
(95% IZ) Razmerje tveganja
A Hazard ratio of less than 1 favors docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumor site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
(0, 52- 0, 99) (95% IZ) 0, 0457 ** p- vrednost Razmerje tveganj manj kot 1 je v prid kombinaciji DocetaKSel + cisplatin + 5- FU * Model po Cox- u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) ** Logrank test *** Hi - kvadrat test
67 Quality of life parameters Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Parametri kvalitete življenja Pri bolnikih, zdravljenih s TPF, se je lestvica globalnega zdravja signifikantno manj poslabšala kot pri tistih, ki so bili zdravljeni s PF (p = 0, 01, uporabljena je bila lestvica EORTC QLQ- C30).
Clinical benefit parameters The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favor of TPF as compared to PF.
Parametri klinične koristnosti Lestvica stanja zmogljivosti s podlestvicama za glavo in vrat (PSS- HN), namenjenima merjenju razumljivosti govora, sposobnosti uživanja hrane na javnem mestu in normalnosti hrane, je signifikantno govorila v korist TPF v primerjavi s PF.
• 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, trial (TAX324).
69 • Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
68 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
70 Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza znamenomzdravljenja)
Docetaxel clearance was not
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1, 5- kratna
69 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
70 6.3 Shelf life
72 6. 3 Rok uporabnosti
• 3 years. • Premix solution:
• 3 leta. • Osnovna raztopina:
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C). • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25 °C).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C). • Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi (do 25°C) treba uporabiti v 4 urah.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
En pretisni omot vsebuje: • eno vialo z enim odmerkom koncentrata in • eno vialo z enim odmerkom vehikla.
Docetaxel Winthrop 80 mg concentrate for solution for infusion vial
Viala Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje:
15 ml clear glass Type I vial with a red flip-off cap.
15- ml viala iz prozornega stekla tipa I z rdečo dvižno zaporko.
This vial contains 2 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
Viala vsebuje 2 ml raztopine docetaksela (v koncentraciji 40 mg/ ml) v polisorbatu 80 (polnilni volumen:
This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel Winthrop vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 80 mg per vial.
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za Docetaxel Winthrop to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 8 ml osnovne raztopine z 10 mg/ ml docetaksela, kar ustreza označeni količini 80 mg na vialo.
15 ml clear glass Type I vial with a transparent colourless flip-off cap.
15- ml viala iz prozornega stekla tipa I s prosojno, brezbarvno dvižno zaporko.
Solvent vial contains 6 ml of a 13% w/ w solution of ethanol 95% in water for injections (fill volume:
Viala z vehiklom vsebuje 6 ml 13% (m/ m) raztopine 95% etanola v vodi za injekcije (polnilni volumen:
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 80 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dodatek celotne vsebine viale z vehiklom vsebini viale Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ ml.
71 Preparation for the intravenous administration
73 Priprava za intravensko aplikacijo
a) Preparation of the Docetaxel Winthrop premix solution (10 mg docetaxel/ ml)
a) Priprava osnovne raztopine Docetaxel Winthrop (10 mg docetaksela/ ml)
If the vials are stored under refrigeration, allow the required number of Docetaxel Winthrop boxes to stand at room temperature (below 25 °C) for 5 minutes.
Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaxel Winthrop 5 minut stati na sobni temperaturi (do 25°C).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25°C).
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine, ki vsebuje 10 mg docetaksela/ ml, iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
The Docetaxel Winthrop infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
Aplicirati jo je treba aseptično v 1- urni infuziji, pri sobni temperaturi (do 25°C) in v pogojih običajne svetlobe.
73 ANNEX II
75 DODATEK II
• CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OBSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to restricted medical prescription (see Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
• CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The PSUR cycle of Docetaxel Winthrop is aligned with the cross-referred product, TAXOTERE, until otherwise specified.
PSUR periodika za zdravilo Docetaxel Winthrop je usklajena z referenčnim zdravilom TAXOTERE, razen če ni drugače navedeno.
75 ANNEX III
77 DODATEK III
77 PARTICULARS TO APPEAR ON OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ Docetaxel Winthrop 20 mg
79 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ Docetaxel Winthrop 20 mg
1 vial of Docetaxel Winthrop 20 mg concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ ml) Fill:
1 viala Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje 20 mg docetaksela v 0, 5 ml polisorbata 80 (40 mg/ ml) Polnitev:
24.4 mg/ 0.61 ml 1 vial of solvent for Docetaxel Winthrop 13% (w/ w) ethanol 95% in water for injections Fill:
24, 4 mg/ 0, 61 ml 1 viala vehikla za Docetaxel Winthrop 13% (m/ m) 95% etanol v vodi za injekcije Polnitev:
Docetaxel Winthrop vial: polysorbate 80.
Viala zdravila Docetaxel Winthrop: polisorbat 80.
Solvent vial: ethanol 95%, water for injections.
95% etanol voda za injekcije.
Each blister pack of Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
Ena škatla Docetaxel Winthrop 20 mg koncentrat in vehikel za raztopino za infundiranje vsebuje: • eno vialo z enim odmerkom koncentrata in • eno vialo z enim odmerkom vehikla.
Dilution required with the entire contents of the solvent vial.
Razredčite s celotno vsebino viale z vehiklom.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Zdravilo je potrebno aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
78 8.
80 8.
Single-use vials - discard unused contents appropriately
Viale za enkratno uporabo – neporabljeno vsebino ustrezno zavrzite.
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ Docetaxel Winthrop 20 mg
81 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU KONCENTRAT IN VEHIKEL Docetaxel Winthrop 20 mg
Aventis Pharma S. A
A.
Docetaxel Winthrop concentrate
Docetaxel Winthrop koncentrat
SOLVENT for Docetaxel Winthrop
VEHIKEL za Docetaxel Winthrop
80 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ Docetaxel Winthrop 20 mg
VIALA / Docetaxel Winthrop 20 mg
Docetaxel Winthrop 20 mg concentrate for solution for infusion docetaxel intravenous use
Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje docetaksel
0.5 ml (Fill 0.61 ml)
0, 5 ml (polnitev 0, 61 ml)
81 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
83 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ SOLVENT FOR Docetaxel Winthrop 20 mg
VIALA/ VEHIKEL ZA Docetaxel Winthrop 20 mg}
SOLVENT for Docetaxel Winthrop 20 mg
VEHIKEL za Docetaxel Winthrop 20 mg
13% (w/ w) ethanol 95% in water for injections 1.5 ml (Fill 1.98 ml)
13% (m/ m) etanol, 95 odstotni, v vodi za injekcije 1, 5 ml (polnjenje 1, 98 ml)
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ Docetaxel Winthrop 80 mg
84 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ Docetaxel Winthrop 80 mg
Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion
Docetaxel Winthrop 80 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
1 vial of Docetaxel Winthrop 80 mg concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ ml) Fill:
1 viala Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje 80 mg docetaksela v 2 ml polisorbata 80 (40 mg/ ml) Polnitev:
94.4 mg/ 2.36 ml 1 vial of solvent for Docetaxel Winthrop 13% (w/ w) ethanol 95% in water for injections Fill:
94, 4 mg/ 2, 36 ml 1 viala vehikla za Docetaxel Winthrop 13% (m/ m) 95% etanol v vodi za injekcije Polnitev:
Solvent vial: ethanol 95%, water for injections.
Viala vehikla: 95% etanol v vodi za injekcije.
Each blister pack of Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
Enpretisni omot Docetaxel Winthrop 80 mg koncentrat in vehikel za raztopino za infundiranje vsebuje: • eno vialo z enim odmerkom koncentrata in • eno vialo z enim odmerkom vehikla.
83 8.
85 8.
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ Docetaxel Winthrop 80 mg
86 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU KONCENTRAT IN VEHIKEL Docetaxel Winthrop 80 mg
85 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
87 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ Docetaxel Winthrop 80 mg
VIALA / Docetaxel Winthrop 80 mg
Docetaxel Winthrop 80 mg concentrate for solution for infusion docetaxel intravenous use
Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje
2 ml (Fill 2.36 ml)
2, 0 ml (polnitev 2, 36 ml)
86 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
88 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ SOLVENT FOR Docetaxel Winthrop 80 mg
VIALA/ VEHIKEL ZA Docetaxel Winthrop 80 mg
SOLVENT for Docetaxel Winthrop 80 mg
VEHIKEL za Docetaxel Winthrop 80 mg
13% (w/ w) ethanol 95% in water for injections 6 ml (Fill 7.33 ml)
13% (m/ m) etanol, 95 odstotni, v vodi za injekcije 6, 0 ml (polnjenje 7, 33 ml)
INFORMATION FOR THE USER Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion docetaxel
90 NAVODILO ZA UPORABO Docetaxel Winthrop 20 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
- If you have any further questions, ask your doctor or your hospital pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali z bolnišničnim farmacevtom.
- If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
please tell your doctor or hospital pharmacist.
omenjen v tem navodilu, obvestite svojega zdravnika ali bolnišničnega farmacevta.
What Docetaxel Winthrop is and what it is used for 2.
Kaj je zdravilo Docetaxel Winthrop in za kaj ga uporabljamo 2.
Before you use Docetaxel Winthrop 3.
Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Winthrop 3.
How to use Docetaxel Winthrop 4.
Kako uporabljati zdravilo Docetaxel Winthrop 4.
Possible side-effects 5.
Možni neželeni učinki 5.
How to store Docetaxel Winthrop 6.
Shranjevanje zdravila Docetaxel Winthrop 6.
WHAT Docetaxel Winthrop IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO DOCETAXEL WINTHROP IN ZA KAJ GA UPORABLJAMO
Its common name is docetaxel.
Njegovo običajno ime je docetaksel.
Docetaxel Winthrop has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
Zdravnik vam je Docetaxel Winthrop predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu:
- For the treatment of advanced breast cancer, Docetaxel Winthrop could be administered either alone
- Za zdravljenje napredovalega raka dojke se lahko Docetaxel Winthrop uporablja sam ali v
or in combination with doxorubicin, or trastuzumab, or capecitabine.
kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
- For the treatment of early breast cancer with lymph node involvement, Docetaxel Winthrop could be
- Za zdravljenje zgodnjega raka dojke s prizadetostjo bezgavk se Docetaxel Winthrop lahko aplicira v
administered in combination with doxorubicin and cyclophosphamide.
kombinaciji z doksorubicinom in ciklofosfamidom.
- For the treatment of lung cancer, Docetaxel Winthrop could be administered either alone or in
- Za zdravljenje pljučnega raka se Docetaxel Winthrop lahko uporablja sam ali v kombinaciji s
combination with cisplatin.
cisplatinom.
- For the treatment of prostate cancer, Docetaxel Winthrop is administered in combination with
- Za zdravljenje raka prostate se Docetaxel Winthrop lahko uporablja v kombinaciji s prednizonom ali
prednisone or prednisolone.
prednizolonom.
- For the treatment of metastatic gastric cancer, Docetaxel Winthrop is administered in combination
- Za zdravljenje metastatskega raka želodca se Docetaxel Winthrop uporablja v kombinaciji s
with cisplatin and 5-fluorouracil.
cisplatinom in 5- fluorouracilom.
- For the treatment of head and neck cancer, Docetaxel Winthrop is administered in combination with
- Za zdravljenje raka glave in vratu se zdravilo Docetaxel Winthrop uporablja v kombinaciji s
cisplatin and 5-fluorouracil.
cisplatinom in 5- fluorouracilom.
BEFORE YOU USE Docetaxel Winthrop
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO DOCETAXEL WINTHROP
You must not be given Docetaxel Winthrop if
Zdravila Docetaxel Winthrop ne smete dobiti, če:
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Winthrop. • the number of white blood cells is too low. • you have a severe liver disease. • you are pregnant or breast feeding.
• ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Docetaksel Winthrop. • imate premajhno število belih krvnih celic. • imate hudo bolezen jeter. • ste noseči ali dojite.
89 Take special care with Docetaxel Winthrop
91 Bodite posebno pozorni pri uporabi zdravila Docetaxel Winthrop
Before each treatment with Docetaxel Winthrop, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Winthrop.
Pred vsako uporabo zdravila Docetaxel Winthrop boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobiteDocetaxel Winthrop.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Winthrop administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Winthrop 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 Docetaxel Winthrop, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
During treatment, you may be given medication to maintain the number of your blood cells.
Med zdravljenjem boste morda prejemali zdravila za ohranjanje števila krvnih celic.
Docetaxel Winthrop must NOT be administered if you are pregnant or if you are planning to become pregnant.
Zdravila Docetaxel Winthrop NE smete dobiti, če ste noseči ali nameravate zanositi.
You must take adequate contraceptive precautions during therapy and for at least three months after Docetaxel Winthrop is no longer administered to you.
Med zdravljenjem z zdravilom Docetaxel Winthrop in vsaj tri mesece po koncu zdravljenja morate uporabljati ustrezno kontracepcijsko zaščito.
You must NOT breast-feed while you are treated with Docetaxel Winthrop.
Med zdravljenjem z zdravilom Docetaxel Winthrop NE smete dojiti.
If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.
Če razmišljate, da bi zanosili ali dojili, se prej posvetujte s svojim zdravnikom.
There is no reason why you cannot drive between courses of Docetaxel Winthrop except if you feel dizzy or are unsure of yourself.
Ni zadržkov, da med enim in drugim ciklusom prejemanja zdravila Docetaxel Winthrop ne bi vozili, razen če ste omotični ali se počutite negotovi.
HOW TO USE Docetaxel Winthrop
KAKO UPORABLJATI ZDRAVILO DOCETAXEL WINTHROP
Docetaxel Winthrop will be given by infusion into one of your veins.
Docetaxel Winthrop boste dobili v infuziji v eno od ven.
90 Frequency of administration
Pogostnost uporabe
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Winthrop.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi,
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 results of your blood tests.
Zdravniku izročite tudi izvide preiskav krvi.
Such information will allow her/ him to decide whether a dose reduction is needed.
Te informacije bodo zdravniku pomagale pri odločitvi, ali je odmerek treba zmanjšati.
If you have any further questions on the use of this product, ask your doctor, or hospital pharmacist.
Če imate glede uporabe tega zdravila še kakšna vprašanja, vprašajte zdravnika ali bolnišničnega farmacevta.
Like all other anticancer medicines, Docetaxel Winthrop can cause side effects, although not everybody gets them.
Tako kot vsa druga zdravila proti raku, ima lahko tudi zdravilo Docetaxel Winthrop neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most commonly reported adverse reactions of Docetaxel Winthrop alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea and tiredness.
Najpogosteje poročani neželeni učinki zdravila Docetaxel Winthrop samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
The severity of adverse events of Docetaxel Winthrop may be increased when Docetaxel Winthrop is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila Docetaxel Winthrop se lahko poveča, če dobivate Docetaxel Winthrop v kombinaciji z drugimi kemoterapevtiki.
During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur: • flushing, skin reactions, itching • chest tightness; difficulty in breathing • fever or chills • back pain • low blood pressure.
Med infundiranjem v bolnišnici se lahko pojavijo naslednje alergijske reakcije (pojavijo se pri več kot 1 od 10 oseb): • zardevanje, kožne reakcije, srbenje • tiščanje v prsih, težko dihanje • zvišana telesna temperatura ali mrzlica • bolečine v hrbtu • nizek krvni tlak.
Between infusions of Docetaxel Winthrop the following may occur, and the frequency may vary with the combinations of drugs that are received:
Med infuzijami zdravila Docetaxel Winthrop se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena: