Crixivan

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
07-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
07-07-2022
Public Assessment Report Public Assessment Report (PAR)
07-07-2022

Active ingredient:

indinavir sulfat ethanolate

Available from:

Merck Sharp & Dohme B.V.

ATC code:

J05AE02

INN (International Name):

indinavir

Therapeutic group:

Antivirusi za sistemsko uporabo

Therapeutic area:

Okužbe z virusom HIV

Therapeutic indications:

Crixivan je indiciran v kombinaciji s protiretrovirusnimi analogi nukleozidov za zdravljenje odraslih, okuženih s HIV-1.

Product summary:

Revision: 39

Authorization status:

Umaknjeno

Authorization date:

1996-10-04

Patient Information leaflet

                                58
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalni plastenki. Plastenko shranjujte tesno zaprto
za zagotovitev zaščite pred vlago.
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
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/96/024/001 180 trdih kapsul
EU/1/96/024/002 270 trdih kapsul
EU/1/96/024/003 360 trdih kapsul
13.
ŠTEVILKA SERIJE
Serija
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
CRIXIVAN 200 mg
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
Zdravilo nima več dovoljenja za promet
59
PODATKI NA PRIMARNI OVOJNINI
CRIXIVAN 200 MG – PAKIRANJE PO 180, 270 IN 360 KAPSUL – NALEPKA NA
PLASTENKI
1.
IME ZDRAVILA
CRIXIVAN 200 mg trde kapsule
indinavir
2.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
Ena trda kapsula vsebuje indinavirjev sulfat, ki ustreza 200 mg
indinavirja.
3.
SEZNAM POMOŽNIH SNOVI
Brezvodna laktoza. Za nadaljnje informacije glejte navodilo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
180 trdih kapsul
270 trdih kapsul
360 trdih kapsul
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
peroralna uporaba
Trde kapsule je treba pogoltniti cele.
6.
POSEBNO
OPOZORILO
O
SHRANJEVANJU
ZDRAVILA
ZUNAJ
DOSEGA
IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Sušilnega sredstva ne smete odstraniti iz vsebnika.
Sušilnega sredstva ne smete pogoltniti.
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Uporabno do
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v originalni plastenki. Plastenko shranjujte tesno zaprto
za zagotovitev zaščite pred vlago.
Zdravilo nima več dovoljenja za promet
60
10.
POSEBNI
VARNOSTNI
UKREPI
ZA
ODSTRANJEVANJE
NEUPORABLJENIH
ZDRAVI
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Zdravilo nima več dovoljenja za promet
2
1.
IME ZDRAVILA
CRIXIVAN 200 mg trde kapsule
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Ena trda kapsula vsebuje indinavirjev sulfat, ki ustreza 200 mg
indinavirja.
Pomožna snov z znanim učinkom
Ena 200 mg kapsula vsebuje 74,8 mg laktoze.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
trda kapsula
Kapsule so polprosojne, bele, z oznako
‘
CRIXIVAN

200 mg
’
modre barve.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo CRIXIVAN je v kombinaciji s protiretrovirusnimi nukleozidnimi
analogi indicirano za
zdravljenje z virusom HIV-1 okuženih odraslih.
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo CRIXIVAN mora predpisati zdravnik, ki ima izkušnje z
zdravljenjem okužbe s HIV. Na
podlagi trenutnih farmakodinamskih podatkov moramo indinavir
uporabljati v kombinaciji z drugimi
protiretrovirusnimi zdravili. Če se indinavir uporablja kot
samostojno zdravilo, se hitro pojavijo
rezistentni virusi (glejte poglavje 5.1).
Odmerjanje
Priporočeni odmerek indinavirja je 800 mg peroralno vsakih 8 ur.
Podatki iz objavljenih študij kažejo, da je lahko alternativni
režim odmerjanja zdravila CRIXIVAN
400 mg peroralno dvakrat na dan v kombinaciji z ritonavirjem 100 mg
peroralno dvakrat na dan. To
temelji na omejenih objavljenih podatkih (glejte poglavje 5.2).
Pri sočasni uporabi itrakonazola ali ketokonazola je treba razmisliti
o zmanjšanju odmerka
indinavirja na 600 mg vsakih 8 ur (glejte poglavje 4.5).
Posebne populacije bolnikov
_Jetrna okvara_
Pri bolnikih z blago do zmerno jetrno okvaro zaradi ciroze je treba
odmerek indinavirja zmanjšati na
600 mg vsakih 8 ur. Priporočilo temelji na omejenih
farmakokinetičnih podatkih (glejte poglavje
5.2). Študij pri bolnikih s hudo jetrno okvaro niso opravili, zato
zanje posebnega odmerjanja ne
moremo priporočiti (glejte poglavje 4.4).
_Ledvična okvara_
Varnosti pri bolnikih z okvarjeno ledvično funkcijo niso preučevali,
vendar se z urinom izloči man
                                
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Similar products

Active ingredient indinavir sulfat ethanolate

indinavir sulfat ethanolate

ATC code J05AE02

J05AE02

Marketed by Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (International Name) indinavir

indinavir

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