Docetaxel Teva Pharma

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
29-01-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
29-01-2014
Public Assessment Report Public Assessment Report (PAR)
29-01-2014

Active ingredient:

docetaksel

Available from:

Teva Pharma B.V.

ATC code:

L01CD02

INN (International Name):

docetaxel

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms

Therapeutic indications:

Prsi cancerDocetaxel Teva Pharma monotherapy je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskega raka dojke po okvari citotoksična terapija. Predhodna kemoterapija je morala vključevati antraciklin ali sredstvo za alkiliranje. Non-small-cell lung cancerDocetaxel Teva Pharma je indiciran za zdravljenje bolnikov z lokalno napredno ali metastatskim non-small-cell lung cancer po izpadu pred kemoterapijo. Docetaxel Teva Pharma v kombinaciji z cisplatin je indiciran za zdravljenje bolnikov z unresectable, lokalno napredno ali metastatskim non-small-celice pljučnega raka, pri bolnikih, ki pred tem še niso prejele kemoterapijo za to stanje. Prostate cancerDocetaxel Teva Pharma v kombinaciji z prednizon ali prednizolon je indiciran za zdravljenje bolnikov z hormon ognjevzdržni metastatskega raka prostate.

Product summary:

Revision: 6

Authorization status:

Umaknjeno

Authorization date:

2011-01-21

Patient Information leaflet

                                63
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
_ _
Uporabno do:
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25°C.
Ne zamrzujte.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Viale za enkratno uporabo.
Neporabljeno vsebino ustrezno zavrzite.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/10/662/001
13.
ŠTEVILKA SERIJE
Serija:
14.
NAČIN IZDAJANJA ZDRAVILA
Predpisovanje in izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Zdravilo nima veā dovoljenja za promet
64
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA NA VIALI – KONCENTRAT 20 MG
1.
IME ZDRAVILA IN POT(I) UPORABE
Docetaxel Teva Pharma 20 mg koncentrat za raztopino za infundiranje
docetaksel
2.
POSTOPEK UPORABE
intravenska uporaba
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
4.
ŠTEVILKA SERIJE
Serija:
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
0,72 ml (napolnjena: 0,88 ml)
6.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
65
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA NA VIALI – VEHIKEL ZA 20 MG
1.
IME ZDRAVILA IN POT(I) UPORABE
Vehikel za Docetaxel Teva Pharma 20 mg
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
4.
ŠTEVILKA SERIJE
Serija:
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
voda za injekcije
1,28 ml (napolnjena: 1,71 ml)
6.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
66
PODATKI NA ZUNANJI OVOJNINI
KARTONSKA ŠKATLA – 80 MG
1.
IME ZDRAVILA
Docetaxel Teva Pharma 80 mg koncentrat in vehikel za raztopino za
infundiranje
docetaksel
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Vsaka enoodmerna viala k
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Docetaxel Teva Pharma 20 mg koncentrat in vehikel za raztopino za
infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena enoodmerna viala koncentrata Docetaxel Teva Pharma vsebuje 20 mg
docetaksela (brezvodnega).
En ml koncentrata vsebuje 27,73 mg docetaksela.
Pomoţne snovi z znanim učinkom:
Ena viala koncentrata vsebuje 25,1 % (m/m) brezvodnega etanola.
Za celoten seznam pomoţnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Koncentrat in vehikel za raztopino za infundiranje.
Koncentrat je bistra, viskozna, rumena do rjavorumena raztopina.
Vehikel je brezbarvna raztopina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Rak dojke
Zdravilo Docetaxel Teva Pharma v monoterapiji je indicirano za
zdravljenje bolnic z lokalno
napredovalim ali metastatskim rakom dojke, pri katerih predhodna
citotoksična terapija ni bila
uspešna. Predhodna kemoterapija bi morala vključevati antraciklin
ali alkilirajočo učinkovino.
Nedrobnocelični pljučni rak
Zdravilo Docetaxel Teva Pharma je indicirano za zdravljenje bolnikov z
lokalno napredovalim ali
metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna
kemoterapija ni bila uspešna.
Zdravilo Docetaxel Teva Pharma 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.
Rak prostate
Zdravilo Docetaxel Teva Pharma v kombinaciji s prednizonom ali
prednizolonom je indicirano za
zdravljenje bolnikov z metastatskim, hormonsko neodzivnim rakom
prostate.
4.2
ODMERJANJE IN NAČIN UPORABE
Docetaksel se sme uporabljati samo v enotah, specializiranih za
citotoksično kemoterapijo in samo
pod nadzorom zdravnika, izkušenega v uporabi onkološke kemoterapije
(glejte poglavje 6.6).
Priporočeno odmerjanje
Pri zdravljenju raka dojke in nedrobnoceličnega pljučnega raka se
lahko kot premedikacija uporabijo
p
                                
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Similar products

Active ingredient docetaksel

docetaksel

ATC code L01CD02

L01CD02

Marketed by Teva Pharma B.V.

Teva Pharma B.V.

INN (International Name) docetaxel

docetaxel

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