Vistide

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
19-01-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
19-01-2015
Public Assessment Report Public Assessment Report (PAR)
19-01-2015

Active ingredient:

cidofovir

Available from:

Gilead Sciences International Limited

ATC code:

J05AB12

INN (International Name):

cidofovir

Therapeutic group:

Antivirusi za sistemsko uporabo

Therapeutic area:

Citomegalovirusni retinitis

Therapeutic indications:

Zdravilo Vistide je indicirano za zdravljenje citomegalovirusnega retinitisa pri bolnikih s sindromom pridobljene imunske pomanjkljivosti (AIDS) in brez ledvične disfunkcije. Zdravilo Vistide je treba uporabljati le, če se druga zdravila štejejo za neprimerna.

Product summary:

Revision: 21

Authorization status:

Umaknjeno

Authorization date:

1997-04-23

Patient Information leaflet

                                17
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte pri temperaturi do 30°C. Ne shranjujte v hladilniku ali
zamrzujte.
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
Gilead Sciences Intl Ltd
Cambridge
CB21 6GT
Velika Britanija
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/97/037/001
13.
ŠTEVILKA SERIJE
Lot
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
18
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
VIALA
1.
IME ZDRAVILA IN POT(I) UPORABE
Vistide 75 mg/ml koncentrat za raztopino za infundiranje
cidofovir
Samo za intravensko uporabo.
2.
POSTOPEK UPORABE
Pred uporabo raztopite.
Ne sme se uporabljati za intraokularno injiciranje.
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
375 mg/5 ml
6.
DRUGI PODATKI
EU/1/97/037/001
Zdravilo nima veā dovoljenja za promet
19
B. NAVODILO ZA UPORABO
Zdravilo nima veā dovoljenja za promet
20
NAVODILO ZA UPORABO
VISTIDE 75 MG/ML KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
cidofovir
PRED UPORABO NATANČNO PREBERITE NAVODILO!
-
Navodilo shranite. Morda ga boste želeli ponovno prebrati.
-
Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s
farmacevtom.
-
Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Njim bi lahko celo
škodovalo, čeprav imajo znake bolezni, podobne vašim.
-
Če katerikoli neželeni učinek postane resen ali če opazite
katerikoli neželeni učinek, ki ni
omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
NAVODILO VSEBUJE:
1.
Kaj je zdravilo Vistide in za kaj ga uporabljamo
2.
Kaj morate vedeti, preden boste uporabili zdravilo Vistide
3.
Kako uporabljati zdravilo Vistide
4.
Možni ne
                                
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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
Vistide 75 mg/ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En ml vsebuje 75 mg brezvodnega cidofovira. Ena viala kot zdravilno
učinkovino vsebuje
375 mg/5 ml brezvodnega cidofovira.
Pomožne snovi:
Ena viala vsebuje približno 2,5 mmol (ali 57 mg) natrija na vialo (5
ml) kot sestavino pomožnih snovi.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
Koncentrat za raztopino za infundiranje.
Bistra raztopina.
pH pripravka je uravnan na 7,4.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Vistide je indicirano za zdravljenje citomegalovirusnega
(CMV) retinitisa pri odraslih s
sindromom pridobljene imunske pomanjkljivosti (AIDS-om), ki nimajo
motenega delovanja ledvic.
Zdravilo Vistide naj bi uporabljali le, če druga zdravila niso
primerna.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravljenje mora predpisati zdravnik, ki ima izkušnje z vodenjem
okužbe s HIV.
Pred vsako aplikacijo zdravila Vistide je treba izmeriti kreatinin v
serumu in koncentracijo beljakovin
v urinu. Z vsako infuzijo zdravila Vistide je treba uporabiti
peroralni probenecid in intravensko
fiziološko raztopino (za ustrezna priporočila glejte poglavje 4.4,
za informacije, kako dobiti
probenecid, pa poglavje 6.6).
Odmerjanje
_Odrasli: _
Začetno zdravljenje.
Priporočeni odmerek cidofovira je 5 mg/kg telesne teže (v enourni
intravenski
infuziji s stalno hitrostjo) enkrat na teden, dva tedna zapored.
Vzdrževalno zdravljenje. Vzdrževalno zdravljenje se začne dva tedna
po koncu začetnega. Priporočeni
vzdrževalni odmerek cidofovira je 5 mg/kg telesne teže (v enourni
intravenski infuziji s stalno
hitrostjo) enkrat na dva tedna.
Prenehanje vzdrževalnega zdravljenja s cidofovirom mora biti
usklajeno z lokalnimi priporočili za
vodenje bolnikov, okuženih s HIV.
_Starejši: _
Varnost in učinkovitost zdravljenja citomegalovirusne bolezni z
zdravilom Vistide pri bolnikih,
sta
                                
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Active ingredient cidofovir

cidofovir

ATC code J05AB12

J05AB12

Marketed by Gilead Sciences International Limited

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INN (International Name) cidofovir

cidofovir

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