natgillin/translations-raw huggingface dataset:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Asthenia (G3/ 4:
Zelo pogosti neželeni učinki ≥ 10% bolnikov
0.4%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
57 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
56 TAXOTERE 75 mg/ m2 v kombinaciji s cisplatinom in 5- fluorouracilom za adenokarcinom želodca
Infections and infestations
Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S3/ 4:
58 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
57 TAXOTERE 75 mg/ m² v kombinaciji s cisplatinom in 5- fluorouracilom za rak glave in vratu
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov povečanje telesne mase
Cardiac disorders Blood and lymphatic system disorders
Srčne bolezni
9.2%); Thrombocytopenia (G3/ 4:
miokardna ishemija (S3/ 4:
Nervous system disorders
Bolezni krvi in limfatičnega sistema
Dysgeusia/ Parosmia; Dizziness Peripheral sensory neuropathy (G3/ 4:
9, 2%), trombocitopenija (S3/ 4:
Hearing impaired
okvara sluha zaprtje,
Esophagitis/ dysphagia/ 4.0%); odynophagia (G3/ 4:
4, 0%), ofagija (S3/ 4:
Diarrhea (G3/ 4:
0, 6%), diareja (S3/ 4:
2.9%); 0.6%); Vomiting (G3/ 4:
2, 9%), bolečine v trebuhu, bruhanje (S3/ 4:
0.6%)
0, 6%) dispepsija, krvavitev v prebavilih (S3/ 4:
Skin and subcutaneous tissue disorders
0, 6%) Bolezni kože in podkožja
10.9%) Rash pruritic; Dry skin; Skin exfoliative (G3/ 4:
srbeč izpuščaj, suha koža, luščenje kože (S3/ 4:
0.6%)
6, 3%), nevtropenična okužba
Venous disorder (G3/ 4:
bolečina zaradi raka (S3/ 4:
3.4%); Pyrexia (G3/ 4:
3, 4%) pireksija (S3/ 4:
• Induction chemotherapy followed by chemoradiotherapy (TAX 324)
58 • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324)
Post-marketing experience
59 Pomarketinške izkušnje
Nervous system disorders Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Bolezni živčevja Ob uporabi docetaksela so opažali redke primere konvulzij ali prehodne izgube zavesti.
Eye disorders Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Očesne bolezni Opisani so bili zelo redki primeri prehodnih motenj vida (bliskanje, bliskajoča svetloba, skotomi), ki so se praviloma pojavili med infundiranjem zdravila in v povezavi s preobčutljivostnimi reakcijami.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/ or hearing loss have been reported.
Ušesne bolezni, vključno z motnjami labirintaOpisani so bili redki primeri ototoksičnosti, okvar sluha in/ ali poslabšanja sluha.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Bolezni dihal, prsnega koša in mediastinalnega prostora V redkih primerih so bili opisani akutni respiracijski distres sindrom, intersticijska pljučnica in pljučna fibroza.
Gastrointestinal disorders Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Bolezni prebavil Opisani so redki primeri dehidracije zaradi prebavnih motenj, gastrointestinalne perforacije, ishemični kolitis, kolitis in nevtropenični enterokolitis.
Skin and subcutaneous tissue disorders Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Bolezni kože in podkožja Zelo redko so pri zdravljenju z docetakselom poročali o kožnem eritematoznem lupusu in o buloznih erupcijah, npr. o multiformnem eritemu, Stevens- Johnsonovem sindromu, toksični nekrolizi epidermisa.
In some cases concomitant factors may have contributed to the development of these effects. Sclerodermal-like changes usually proceded by peripheral lymphedema have been reported with docetaxel.
Pred nastankom teh sprememb je ponavadi prisoten periferni limfedem.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/ or radiotherapy.
Benigne in maligne neoplazme (vključno s cistami in polipi) Poročali so o zelo redkih primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ ali radioterapijo.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Splošne težave in spremembe na mestu aplikacije Redko so poročali o pojavu pomnjenja obsevanja.
61 Hepatobiliary disorders Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Bolezni jeter, žolčnika in žolčevodov Opisani so zelo redki primeri hepatitisa, včasih s smrtnim izidom, pri bolnikih z že prej obstoječo boleznijo jeter.
4.9 Overdose
60 4. 9 Preveliko odmerjanje
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
61 preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i. e. an absolute risk reduction by 7% (p = 0.001).
Pogostost recidiva pri 5 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (25% proti 32%) t. j. zmanjšanje absolutnega tveganja za 7% (p = 0. 001).
0.59-0.88
0, 59– 0, 88
0.70 0.53-0.91
0, 70 0, 53– 0, 91
1-3 4+
1– 3 4+
0.46-0.82 0.63-1.08
0, 46– 0, 82 0, 63– 1, 08
0.29-0.70 0.66-1.33
0, 29– 0, 70 0, 66– 1, 33
63 TAXOTERE in combination with doxorubicin
62 TAXOTERE v kombinaciji z doksorubicinom
Docetaxel
docetaksel1
TAXOTERE in combination with capecitabine
63 TAXOTERE v kombinaciji s kapecitabinom
65 Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti življenja z EuroQoL- 5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
Docetaxel every Docetaxel every 3 weeks week
docetaksel
Mitoxantrone every 3 weeks
docetaksel vsak
No statistical differences were observed between treatment groups for Global Quality of Life.
65 Med skupinami zdravljenja niso opazovali statističnih razlik po oceni globalnega vprašalnika o kvaliteti življenja (» Global Quality of Life «).
66 Gastric adenocarcinoma
Adenokarcinom želodca
• 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 trial (TAX323).
• Indukcijska kemoterapija in nato radioterapija (TAX323) Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentričnem odprtem randomiziranemu
Patients on the docetaxel arm received docetaxel (T) 75 mg/ m2 followed by cisplatin (P) 75 mg/ m2 followed by 67 5-fluorouracil (F) 750 mg/ m2 per day as a continuous infusion for 5 days.
Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/ m2, ki mu je sledil cisplatin (P) 75 mg/ m2, temu pa 5- fluorouracil (F) 750 mg/ m2 na dan v obliki neprekinjene infuzije 5 dni.
Patients on the comparator arm received cisplatin (P) 100 mg/ m2 followed by 5-fluorouracil (F) 1000 mg/ m2 per day for 5 days.
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/ m2, ki mu je sledil 5- fluorouracil 1000 mg/ m2 (F) na dan 5 dni.
Docetaxel + Cis + 5-FU
Končna točka
n = 177
Docetaksel + Cis+5- FU n = 177
n = 181
Cis+5- FU n = 181
Median progression free survival (months) (95% CI) Adjusted Hazard ratio
Mediano preživetje brez napredovanja bolezni (meseci) (95% IZ)
11.4 (10.1-14.0)
11, 4 (10, 1- 14, 0)
(95% CI) ***p-value Best overall response to study treatment
(95% IZ) *** p- vrednost Najboljši celotni odziv na proučevano zdravljenje [kemoterapija + / - radioterapija] (%) (95% IZ)
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
*** p- vrednost Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci) (95% IZ)
n = 128 15.7 (13.4-24.6)
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
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5- FU 67 * Model po Cox- u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) ** Log- rank test *** Hi - kvadrat test
68 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).
• 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).
• 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).
69 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
68 Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z- namenom- zdravljenja)
70 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.
71 6.3 Shelf life
70 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 treba uporabiti v 4 urah (do 25 °C).
TAXOTERE 80 mg concentrate for solution for infusion vial
Viala TAXOTERE 80 mg koncentrat za raztopino za infundiranje:
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE 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 TAXOTERE 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.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 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 TAXOTERE 80 mg koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ ml.
72 Preparation for the intravenous administration
71 Priprava za intravensko aplikacijo
73 8.
72 8.
74 ANNEX II
73 DODATEK II
Not applicable.
75 DODATEK III
78 PARTICULARS TO APPEAR ON OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ TAXOTERE 20 mg
77 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ TAXOTERE 20 mg
1 vial of TAXOTERE 20 mg concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ ml) Fill:
1 viala TAXOTERE 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 TAXOTERE 13% (w/ w) ethanol 95% in water for injections Fill:
24, 4 mg/ 0, 61 ml 1 viala vehikla za TAXOTERE 13% (m/ m) 95% etanol v vodi za injekcije Polnitev:
TAXOTERE vial: polysorbate 80.
Viala TAXOTERA: polisorbat 80.
Solvent vial: ethanol 95%, water for injections.
95% etanol, voda za injekcije.
Each blister pack of TAXOTERE 20 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
En pretisni omot TAXOTERE 20 mg koncentrat in vehikel za raztopino za infundiranje vsebuje: • eno vialo z enim odmerkom koncentrata • eno vialo z enim odmerkom vehikla.
79 8.
78 8.
Do not store above 25 °C or below 2 °C.
Ne shranjujte pri temperaturi nad 25 °C ali pod 2 °C..
80 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ TAXOTERE 20 mg
79 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU KONCENTRAT IN VEHIKEL TAXOTERE 20 mg
TAXOTERE concentrate
TAXOTERE koncentrat
SOLVENT for TAXOTERE
VEHIKEL za TAXOTERE
81 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
80 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ TAXOTERE 20 mg
VIALA/ TAXOTERE 20 mg
TAXOTERE 20 mg concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 20 mg koncentrat za raztopino za infundiranje
82 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
81 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ SOLVENT FOR TAXOTERE 20 mg
VIALA/ VEHIKEL ZA TAXOTERE 20 mg
SOLVENT for TAXOTERE 20 mg
VEHIKEL za TAXOTERE 20 mg
13% (w/ w) ethanol 95% in water for injections 1.5 ml (Fill 1.98 ml)
13% (m/ m) 95% etanol v vodi za injekcije 1, 5 ml (polnjenje 1, 98 ml)
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ TAXOTERE 80 mg
82 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA/ TAXOTERE 80 mg
TAXOTERE 80 mg concentrate and solvent for solution for infusion
TAXOTERE 80 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
1 vial of TAXOTERE 80 mg concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ ml) Fill:
1 viala TAXOTERE 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 TAXOTERE 13% (w/ w) ethanol 95% in water for injections Fill:
94, 4 mg/ 2, 36 ml 1 viala vehikla za TAXOTERE 13% (m/ m) 95% etanol v vodi za injekcije Polnitev:
Solvent vial: ethanol 95%, water for injections.
95% etanol v vodi za injekcije.
Each blister pack of TAXOTERE 80 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
En pretisni omot TAXOTERE 80 mg koncentrat in vehikel za raztopino za infundiranje vsebuje: • eno vialo z enim odmerkom koncentrata • eno vialo z enim odmerkom vehikla.
84 8.
83 8.
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ TAXOTERE 80 mg
84 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU KONCENTRAT IN VEHIKEL TAXOTERE 80 mg
86 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
85 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ TAXOTERE 80 mg
VIALA/ TAXOTERE 80 mg
TAXOTERE 80 mg concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 80 mg koncentrat za raztopino za infundiranje
2 ml (Fill 2.36 ml)
2 ml (polnitev 2, 36 ml)
87 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
86 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL/ SOLVENT FOR TAXOTERE 80 mg
VIALA/ VEHIKEL ZA TAXOTERE 80 mg
SOLVENT for TAXOTERE 80 mg
VEHIKEL za TAXOTERE 80 mg
13% (w/ w) ethanol 95% in water for injections 6 ml (Fill 7.33 ml)
13% (m/ m) 95% etanol v vodi za injekcije 6 ml (polnjenje 7, 33 ml)
INFORMATION FOR THE USER TAXOTERE 20 mg concentrate and solvent for solution for infusion docetaxel
88 NAVODILO ZA UPORABO TAXOTERE 20 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
What TAXOTERE is and what it is used for 2.
Kaj je zdravilo TAXOTERE in za kaj ga uporabljamo 2.
Before you use TAXOTERE 3.
Kaj morate vedeti, preden boste uporabili zdravilo TAXOTERE 3.
How to use TAXOTERE 4.
Kako uporabljati zdravilo TAXOTERE 4.
How to store TAXOTERE 6.
Shranjevanje zdravila TAXOTERE 6.
WHAT TAXOTERE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TAXOTERE IN ZA KAJ GA UPORABLJAMO
TAXOTERE 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 TAXOTERE 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, TAXOTERE could be administered either alone or in
- Za zdravljenje napredovalega raka dojke se lahko TAXOTERE uporablja sam ali v kombinaciji z
combination with doxorubicin, or trastuzumab, or capecitabine.
doksorubicinom ali trastuzumabom ali kapecitabinom.
- For the treatment of early breast cancer with lymph node involvement, TAXOTERE could be
- Za zdravljenje zgodnjega raka dojke s prizadetostjo bezgavk se TAXOTERE lahko aplicira v
- For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination
- Za zdravljenje pljučnega raka se TAXOTERE lahko uporablja sam ali v kombinaciji s cisplatinom.
- For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or
- Za zdravljenje raka prostate se TAXOTERE lahko uporablja v kombinaciji s prednizonom ali
prednisolone.
prednizolonom.
- For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with
- Za zdravljenje metastatskega raka želodca se TAXOTERE uporablja v kombinaciji s cisplatinom in
cisplatin and 5-fluorouracil.
5- fluorouracilom.
- For the treatment of head and neck cancer, TAXOTERE is administered in combination with
- Za zdravljenje raka glave in vratu se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in
BEFORE YOU USE TAXOTERE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO TAXOTERE
You must not be given TAXOTERE if
TAXOTERA ne smete dobiti, če:
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE. • the number of white blood cells is too low. • you have a severe liver disease. • you are pregnant or breast feeding.
• če ste alergični na (preobčutljivi za) docetaxel ali katerokoli sestavino zdravila TAXOTERE. • imate premajhno število belih krvnih celic. • imate hudo bolezen jeter. • ste noseči ali dojite.
Take special care with TAXOTERE
Bodite posebno pozorni pri uporabi zdravila TAXOTERE
Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Pred vsako uporabo TAXOTERA boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite TAXOTERE.
90 You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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 TAXOTERA, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
TAXOTERE must NOT be administered if you are pregnant or if you are planning to become pregnant.
TAXOTERA NE smete dobiti, če ste noseči ali nameravate zanositi.
You must take adequate contraceptive precautions during therapy and for at least three months after TAXOTERE is no longer administered to you.
Med zdravljenjem s TAXOTEROM in vsaj tri mesece po koncu zdravljenja morate uporabljati ustrezno kontracepcijsko zaščito.
You must NOT breast-feed while you are treated with TAXOTERE.
Med zdravljenjem s TAXOTEROM NE smete dojiti.
There is no reason why you cannot drive between courses of TAXOTERE except if you feel dizzy or are unsure of yourself.
Ni zadržkov, da med enim in drugim ciklusom prejemanja TAXOTERA ne bi vozili, razen če ste omotični ali se počutite negotovi.
HOW TO USE TAXOTERE
KAKO UPORABLJATI ZDRAVILO TAXOTERE
TAXOTERE will be administered to you by a healthcare professional.
TAXOTERE vam bo dal pristojni zdravstveni delavec.
TAXOTERE will be given by infusion into one of your veins.
TAXOTERE boste dobili v infuziji v eno od ven.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na TAXOTERE.
91 4.
90 4.
Like all other anticancer medicines, TAXOTERE can cause side effects, although not everybody gets them.
Tako kot vsa druga zdravila proti raku, ima lahko tudi zdravilo TAXOTERE neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most commonly reported adverse reactions of TAXOTERE 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 TAXOTERA samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila TAXOTERE se lahko poveča, če dobivate TAXOTERE v kombinaciji z drugimi kemoterapevtiki.
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of drugs that are received:
Med infuzijami TAXOTERA se lahko pojavi naslednje in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena: