Docetaxel Mylan

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
12-03-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
12-03-2015
Public Assessment Report Public Assessment Report (PAR)
12-03-2015

Active ingredient:

docetaksel

Available from:

Mylan S.A.S.

ATC code:

L01CD02

INN (International Name):

docetaxel

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms

Therapeutic indications:

Zdravljenje raka na dojki, posebnih oblik pljučnega raka (nedrobnoceličnega pljučnega raka), raka prostate, raka želodca ali raka glave in vratu.

Product summary:

Revision: 6

Authorization status:

Umaknjeno

Authorization date:

2012-01-31

Patient Information leaflet

                                123
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
Za rok uporabnosti razredčenega zdravila preberite priloženo
navodilo.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Ne shranjujte pri temperaturi nad 25
o
C.
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
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Mylan S.A.S.
117 allée des parcs
69800 Saint Priest
Francija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/748/001 - 1 viala
EU/1/11/748/002 - 5 vial
13.
ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV>
Številka serije:
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
124
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA NA VIALI
1.
IME ZDRAVILA IN POT(I) UPORABE
Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje
docetaksel
intravenska uporaba
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
4.
ŠTEVILKA SERIJE<, ENOTNE OZNAKE DAROVANJA IN IZDELKOV>
Številka serije:
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
20 mg/1 ml
6.
DRUGI PODATKI
Zdravilo nima veā dovoljenja za promet
125
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
1.
IME ZDRAVILA
Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje
docetaksel
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
1 ml koncentrata vsebuje 20 mg docetaksela (brezvodnega).
Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
3.
SEZNAM POMOŽNIH SNOVI
Pomožne snovi: polisorbat 80, brezvodni etanol in citronska kislina.
Za dodatne informacije glejte navodilo za uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
koncentrat za raztopino za infundiranje
1 viala s 4 ml
5 vial s 4 ml
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo prebe
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima veā dovoljenja za promet
2
1.
IME ZDRAVILA
Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
_ _
1 ml koncentrata za raztopino za infundiranje vsebuje 20 mg
docetaksela v obliki brezvodnega
docetaksela.
Ena viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
Pomožna snov z znanim učinkom:
Vsak ml koncentrata za raztopino za infundiranje vsebuje 395 mg
brezvodnega etanola.
Ena viala z 1 ml koncentrata vsebuje 395 mg brezvodnega etanola.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
koncentrat za raztopino za infundiranje (sterilni koncentrat)
Koncentrat je bledorumena do rjavkasto rumena raztopina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Rak dojke
Zdravilo Docetaxel Mylan je v kombinaciji z doksorubicinom in
ciklofosfamidom indiciran za
adjuvantno zdravljenje bolnic:

z operabilnim rakom dojke s pozitivnimi bezgavkami

z operabilnim rakom dojke z negativnimi bezgavkami
Pri bolnicah z operabilnim rakom dojke z negativnimi bezgavkami mora
biti adjuvantno zdravljenje
omejeno na bolnice, primerne za prejemanje kemoterapije v skladu z
mednarodno sprejetimi merili za
primarno zdravljenje zgodnjega raka dojke (glejte poglavje 5.1).
Zdravilo Docetaxel Mylan v kombinaciji z doksorubicinom je indiciran
za zdravljenje bolnic z lokalno
napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še
niso prejemale citotoksične
terapije.
Zdravilo Docetaxel Mylan v monoterapiji je indiciran 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.
Zdravilo Docetaxel Mylan je indiciran 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.
Zdravilo D
                                
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Active ingredient docetaksel

docetaksel

ATC code L01CD02

L01CD02

Marketed by Mylan S.A.S.

Mylan S.A.S.

INN (International Name) docetaxel

docetaxel

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