Paxene

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
22-03-2010
Summary of Product characteristics Summary of Product characteristics (SPC)
22-03-2010
Public Assessment Report Public Assessment Report (PAR)
22-03-2010

Active ingredient:

paklitaksel

Available from:

Norton Healthcare Ltd.

ATC code:

L01CD01

INN (International Name):

paclitaxel

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Sarcoma, Kaposi; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Breast Neoplasms

Therapeutic indications:

Paxene je indiciran za zdravljenje bolnikov z:• napredno za AIDSOM Kaposi ' s sarkom (AIDS-CS), ki je ni pred liposomal anthracycline terapije;• metastatskim karcinom dojk (MBC), ki je ni, ali pa niso kandidati za standardne anthracycline-ki vsebujejo terapije;• napredno karcinom iz jajčnikov (AOC) ali z preostale bolezni (> 1 cm) po začetnem laparotomija, v kombinaciji z cisplatin kot prvo linijo zdravljenja;• metastatskim karcinom iz jajčnikov (MOC) po izpadu platinum, ki vsebujejo kombinacijo terapija brez taxanes kot drugi liniji zdravljenja;• non-small cell karcinom pljuč (NSCLC), ki niso kandidati za potencialno kurativno operacijo in/ali obsevanjem, v kombinaciji z cisplatin. Omejeni podatki o učinkovitosti podpirajo to indikacijo (glejte poglavje 5).

Product summary:

Revision: 14

Authorization status:

Umaknjeno

Authorization date:

1999-07-19

Patient Information leaflet

                                Iz mikrobiološkega vidika je treba razredčeno zdravilo porabiti
takoj.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 25
°
C.
Vialo shranjujte v zunanji ovojnini.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Neporabljeno zdravilo zavrzite v skladu s standardnimi postopki za
citotoksične snovi.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
EU/1/99/113/001
13.
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
Serija:
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
Prosimo, preberite priloženo navodilo za uporabo.
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
22
Zdravilo nima veā dovoljenja za promet
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
BESEDILO NA VIALI ZA PAXENE 30 MG/5 ML
1.
IME ZDRAVILA IN POT(I) UPORABE
Paxene 6 mg/ml koncentrat za raztopino za infundiranje
paklitaksel
intravenska uporaba
2.
POSTOPEK UPORABE
Pred uporabo preberite navodilo za uporabo.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do:
4.
ŠTEVILKA SERIJE
Serija:
5.
DRUGI PODATKI
30 mg/5 ml
OPOZORILO: potrebno redčiti.
23
Zdravilo nima veā dovoljenja za promet
PODATKI NA ZUNANJI OVOJNINI
BESEDILO NA ŠKATLI ZA PAXENE 100 MG/16,7 ML
1.
IME ZDRAVILA
Paxene 6 mg/ml koncentrat za raztopino za infundiranje
paklitaksel
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena viala vsebuje 6 mg/ml paklitaksela (100 mg paklitaksela v 16,7
ml).
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje tudi: makrogolglicerol ricinolat, citronsko kislino
(brezvodno) in 49,7 % (v/v) etanola. Glejte
navodilo za uporabo za več informacij.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
Koncentrat za raztopino za infundiranje
100 mg/16,7 ml
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Intravenska uporaba.
Pred uporabo preberite priloženo nav
                                
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Summary of Product characteristics

                                DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
1
Zdravilo nima veā dovoljenja za promet
1.
IME ZDRAVILA
Paxene 6 mg/ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena viala vsebuje 6 mg/ml paklitaksela (30 mg paklitaksela na 5 ml,
100 mg paklitaksela na 16,7 ml,
150 mg paklitaksela na 25 ml ali 300 mg paklitaksela na 50 ml).
_ _
Pomožne snovi
Ena viala vsebuje 527 mg/ml makrogolglicerol ricinolata
in 49,7-odstotni v/v brezvodni etanol
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Koncentrat za raztopino za infundiranje.
Bistra, brezbarvna do rahlo rumena viskozna tekočina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Paxene
je indicirano za zdravljenje bolnikov z:
–
napredovalim Kaposijevim sarkomom, povezanim z AIDS (AIDS-KS), pri
katerih je bilo
predhodno zdravljenje z antraciklini v obliki liposomov neuspešno,
–
metastatskim karcinomom dojke (metastatic breast cancer - MBC), pri
katerih je bilo standardno
zdravljenje z antraciklini neuspešno ali pa tovrstno zdravljenje za
njih ni primerno,
–
napredovalim karcinomom jajčnikov (advanced carcinoma of the ovary -
AOC) ali z rezidualno
boleznijo (> 1 cm) po prvotni lapratomiji, v kombinaciji s cisplatinom
kot zdravljenje prvega
izbora,
–
metastatskim karcinomom jajčnika (metastatic ovarian cancer - MOC) po
neuspešnem
kombiniranem zdravljenju s platino, ki ne vključuje taksanov
zdravljenje drugega izbora,
–
nedrobnoceličnim karcinomom pljuč (non-small cell lung carcinoma -
NSCLC), ki niso
kandidati za potencialno zdravilni operacijski poseg in/ali
zdravljenje z obsevanjem, v
kombinaciji s cisplatinom. Omejeni podatki o učinkovitosti podpirajo
to indikacijo (glejte
poglavje 5.1).
4.2
ODMERJANJE IN NAČIN UPORABE
Odmerjanje in uporaba
Zdravilo Paxene se lahko uporablja samo pod nadzorom usposobljenega
onkologa na oddelkih, ki so
specializirani za aplikacijo citotoksičnih snovi (glejte poglavje
6.6).
Pred uporabo zdravila Paxene je treba vse bolnike predhodno zdraviti 
                                
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Similar products

Active ingredient paklitaksel

paklitaksel

ATC code L01CD01

L01CD01

Marketed by Norton Healthcare Ltd.

Norton Healthcare Ltd.

INN (International Name) paclitaxel

paclitaxel

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Patient Information leaflet Patient Information leaflet Bulgarian 22-03-2010
Summary of Product characteristics Summary of Product characteristics Bulgarian 22-03-2010
Public Assessment Report Public Assessment Report Bulgarian 22-03-2010
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Paxene