Crixivan

Country: European Union

Language: Croatian

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:

индинавира sulfat ethanolate

Available from:

Merck Sharp & Dohme B.V.

ATC code:

J05AE02

INN (International Name):

indinavir

Therapeutic group:

Antivirusni lijekovi za sustavnu uporabu

Therapeutic area:

HIV infekcije

Therapeutic indications:

Crixivan je indiciran u kombinaciji s antiretrovirusnim nukleozidnim analogom za liječenje HIV-1 inficiranih odraslih osoba.

Product summary:

Revision: 39

Authorization status:

povučen

Authorization date:

1996-10-04

Patient Information leaflet

                                64
B. UPUTA O LIJEKU
Lijek koji više nije odobren
65
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
CRIXIVAN 200 MG TVRDE KAPSULE
indinavir
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku
ili medicinskoj sestri.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je CRIXIVAN i za što se koristi
2.
Što morate znati prije nego počnete uzimati CRIXIVAN
3.
Kako uzimati CRIXIVAN
4.
Moguće nuspojave
5.
Kako čuvati CRIXIVAN
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE CRIXIVAN I ZA ŠTO SE KORISTI
ŠTO JE CRIXIVAN
CRIXIVAN sadrži tvar koja se zove indinavir. Pripada skupini lijekova
koji se zovu ‘inhibitori
proteaze’.
ZA ŠTO SE KORISTI CRIXIVAN
CRIXIVAN se koristi za liječenje infekcije virusom humane
imunodeficijencije (HIV) u odraslih.
CRIXIVAN se primjenjuje istodobno s drugim lijekovima za HIV
(antiretrovirusnim lijekovima). To
se naziva kombiniranim antiretrovirusnim liječenjem.

Primjer drugog lijeka koji biste mogli dobivati istodobno s lijekom
CRIXIVAN je ritonavir.
KAKO DJELUJE CRIXIVAN
CRIXIVAN liječi HIV infekciju i pomaže smanjiti broj HIV čestica u
krvi.
CRIXIVAN pomaže:

smanjiti rizik da dobijete bolesti povezane s HIV-om

smanjiti količinu HIV-a u tijelu (‘virusno opterećenje’)

povećati broj CD4 (T) stanica. CD4 stanice su važan dio Vašeg
imunološkog sustava. Glavna
uloga imunološkog sustava je da Vas zaštiti od infekcija.
CRIXIVAN to možda neće učiniti u svih bolesnika. Liječnik će
pratiti kako ovaj lijek djeluje na Vas.
2.
ŠTO MORATE
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
Lijek koji više nije odobren
2
1.
NAZIV LIJEKA
CRIXIVAN 200 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedna tvrda kapsula sadrži 200 mg indinavira u obliku
indinavirsulfata.
Pomoćna tvar s poznatim učinkom
Jedna kapsula od 200 mg sadrži 74,8 mg laktoze.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula.
Kapsule su poluprozirne bijele s oznakom ‘CRIXIVAN ™ 200 mg’
plave boje.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
CRIXIVAN je u kombinaciji s antiretrovirusnim nukleozidnim analozima
indiciran za liječenje
odraslih bolesnika zaraženih virusom HIV-1.
4.2
DOZIRANJE I NAČIN PRIMJENE
CRIXIVAN mora primijeniti liječnik s iskustvom u liječenju HIV
infekcije. Prema postojećim
farmakodinamičkim podacima, indinavir se mora primjenjivati u
kombinaciji s drugim
antiretrovirusnim lijekovima. Kada se indinavir primjenjuje kao
monoterapija, brzo se razvijaju
rezistentni virusi (vidjeti dio 5.1).
Doziranje
Preporučena doza indinavira je 800 mg peroralno svakih 8 sati.
Podaci iz objavljenih ispitivanja pokazuju da kombinacija lijeka
CRIXIVAN u dozi od 400 mg i
ritonavira u dozi od 100 mg, primijenjena peroralno dvaput na dan,
može poslužiti kao alternativni
režim doziranja. Taj se prijedlog temelji na ograničenom broju
objavljenih podataka (vidjeti dio 5.2).
Pri istodobnoj primjeni itrakonazola ili ketokonazola treba razmotriti
smanjenje doze indinavira na
600 mg svakih 8 sati (vidjeti dio 4.5).
Posebne populacije
_Oštećenje funkcije jetre_
U bolesnika s blagim do umjerenim oštećenjem funkcije jetre koje je
posljedica ciroze, dozu
indinavira treba smanjiti na 600 mg svakih 8 sati. Ova se preporuka
temelji na malobrojnim
farmakokinetičkim podacima (vidjeti dio 5.2). Bolesnici s teškim
oštećenjem funkcije jetre nisu
ispitivani, stoga se ne može dati preporuka za doziranje (vidjeti dio
4.4).
_Oštećenje funkcije bubrega_
Nije ispitivana sigurnost primjene u bolesnika s oštećenom funkcijom
bubrega, m
                                
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Similar products

Active ingredient индинавира sulfat ethanolate

индинавира 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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