Zutectra

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Active ingredient:

human hepatitis B immunoglobulin

Available from:

Biotest Pharma GmbH

ATC code:

J06BB04

INN (International Name):

human hepatitis B immunoglobulin

Therapeutic group:

Imuni serumi i homologna,

Therapeutic area:

Immunization, Passive; Hepatitis B; Liver Transplantation

Therapeutic indications:

Prevencija ponovne infekcije virusom hepatitisa B (HBV) u negativnim bolesnicima odraslih osoba HBsAg i HBV-DNA najmanje jedan tjedan nakon transplantacije jetre zbog hepatitisa B induciranog zatajivanja jetre. Negativni status HBV-DNA trebao bi se potvrditi u posljednja 3 mjeseca prije OLT-a. Bolesnici trebaju biti HBsAg negativni prije početka liječenja. Uz primjenu odgovarajućih agenata виростатического treba promatrati kao standard hepatitisa ponovno zaraze prevencija.

Product summary:

Revision: 16

Authorization status:

odobren

Authorization date:

2009-11-30

Patient Information leaflet

                                20
B. UPUTA O LIJEKU
21
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
ZUTECTRA 500 IU OTOPINA ZA INJEKCIJU U NAPUNJENOJ ŠTRCALJKI
ljudski imunoglobulin protiv hepatitisa B
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se svom liječniku ili
ljekarniku.
-
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 ili ljekarnika. To uključuje i
svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Zutectra i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati lijek Zutectra
3.
Kako primjenjivati lijek Zutectra
4.
Moguće nuspojave
5.
Kako čuvati lijek Zutectra
6.
Sadržaj pakiranja i druge informacije
7.
Kako samostalno injicirati lijek Zutectra ili kako će Vam ga
injicirati njegovatelj
1.
ŠTO JE ZUTECTRA I ZA ŠTO SE KORISTI
ŠTO JE ZUTECTRA
Zutectra sadrži antitijela protiv virusa hepatitisa B, a to su
vlastite obrambene tvari tijela koje štite od
hepatitisa B. Hepatitis B upala je jetre koju izaziva virus hepatitisa
B.
ZA ŠTO SE ZUTECTRA KORISTI
Zutectra se koristi za sprečavanje ponovne infekcije hepatitisom B u
odraslih bolesnika najranije tjedan
dana nakon transplantacije jetre zbog zatajenja jetre uzrokovanog
hepatitisom B.
2.
ŠTO MORATE ZNATI PRIJE NEGO ŠTO POČNETE PRIMJENJIVATI LIJEK
ZUTECTRA
NEMOJTE PRIMJENJIVATI LIJEK
ZUTECTRA
-
ako ste
alergični na ljudski imunoglobulin ili bilo koji drugi sastojak
lijeka
Zutectra (naveden u
dijelu 6). Osobito, u vrlo rijetkim slučajevima nedostatka
imunoglobulina A (IgA) kada u krvi imate
protutijela na IgA. To može dovesti do teške alergijske reakcije
(anafilaksije).
Alergijska reakcija može uključivati iznenadno piskanje, otežano
disanje, brz puls, oti
                                
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Summary of Product characteristics

                                1
DODATAK I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Zutectra 500 IU otopina za injekciju u napunjenoj štrcaljki
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Ljudski imunoglobulin protiv hepatitisa B
Jedan ml sadrži:
500 IU ljudskog imunoglobulina protiv hepatitisa B (čistoće
najamanje 96 % IgG)
Jedna napunjena štrcaljka s 1 ml otopine sadrži: 150 mg ljudskog
proteina, sa sadržajem antitijela na
površinski antigen virusa hepatitisa B (HBs) od 500 IU.
Distribucija IgG podklasa (približne vrijednosti):
IgG1:
59 %
IgG2:
35 %
IgG3:
3 %
IgG4:
3 %
Maksimalni sadržaj IgA je 6 000 mikrograma/ml.
Proizvedeno iz plazme ljudskih donora.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za injekciju
Otopina je bistrado opalescentna i bezbojna do blijedožuta, pH
vrijednosti 5,0-5,6 i osmolarnosti 300-
400 mOsm/kg.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Prevencija ponovne infekcije virusom hepatitisa B (HBV) u HBsAg i
HBV-DNA negativnih odraslih
bolesnika najranije tjedan dana nakon transplantacije jetre zbog
zatajenja jetre uzrokovanog hepatitisom
B. Potrebno je potvrditi HBV-DNA negativan status unutar zadnja tri
mjeseca prije ortotopne
transplantacije jetre. Bolesnici moraju biti HBsAg negativni prije
početka liječenja.
Potrebno je razmotriti istodobnu primjenu odgovarajućih virostatika
kao standardne profilakse ponovne
infekcije hepatitisom B.
4.2
DOZIRANJE I NAČIN PRIMJENE
Doziranje
3
U HBV-DNA negativnih odraslih bolesnika najranije tjedan dana nakon
transplantacije jetre, supkutane
injekcije lijeka Zutectra daju se, u skladu s najnižim razinama
anti-HBs-a u serumu, jednom tjedno ili
jednom u dva tjedna.
Prije početka supkutanog liječenja lijekom Zutectra, odgovarajuće
razine anti-HBs-a u serumu moraju se
stabilizirati intravenskim imunoglobulinom protiv hepatitisa B na
razine jednake ili više od 300 do
500 IU/l kako bi se osigurala odgovarajuća razina anti-HBs-a tijekom
prelaska s intravenskog na
supkutano doziranje. U HBsAg i HBV-DNA negativnih bolesnika mo
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-02-2024
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-02-2024
Public Assessment Report Public Assessment Report Bulgarian 23-02-2016
Patient Information leaflet Patient Information leaflet Spanish 13-02-2024
Public Assessment Report Public Assessment Report Spanish 23-02-2016
Patient Information leaflet Patient Information leaflet Czech 13-02-2024
Public Assessment Report Public Assessment Report Czech 23-02-2016
Patient Information leaflet Patient Information leaflet Danish 13-02-2024
Public Assessment Report Public Assessment Report Danish 23-02-2016
Patient Information leaflet Patient Information leaflet German 13-02-2024
Public Assessment Report Public Assessment Report German 23-02-2016
Patient Information leaflet Patient Information leaflet Estonian 13-02-2024
Public Assessment Report Public Assessment Report Estonian 23-02-2016
Patient Information leaflet Patient Information leaflet Greek 13-02-2024
Public Assessment Report Public Assessment Report Greek 23-02-2016
Patient Information leaflet Patient Information leaflet English 13-02-2024
Public Assessment Report Public Assessment Report English 23-02-2016
Patient Information leaflet Patient Information leaflet French 13-02-2024
Public Assessment Report Public Assessment Report French 23-02-2016
Patient Information leaflet Patient Information leaflet Italian 13-02-2024
Public Assessment Report Public Assessment Report Italian 23-02-2016
Patient Information leaflet Patient Information leaflet Latvian 13-02-2024
Public Assessment Report Public Assessment Report Latvian 23-02-2016
Patient Information leaflet Patient Information leaflet Lithuanian 13-02-2024
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-02-2024
Public Assessment Report Public Assessment Report Lithuanian 23-02-2016
Patient Information leaflet Patient Information leaflet Hungarian 13-02-2024
Summary of Product characteristics Summary of Product characteristics Hungarian 13-02-2024
Public Assessment Report Public Assessment Report Hungarian 23-02-2016
Patient Information leaflet Patient Information leaflet Maltese 13-02-2024
Public Assessment Report Public Assessment Report Maltese 23-02-2016
Patient Information leaflet Patient Information leaflet Dutch 13-02-2024
Public Assessment Report Public Assessment Report Dutch 23-02-2016
Patient Information leaflet Patient Information leaflet Polish 13-02-2024
Public Assessment Report Public Assessment Report Polish 23-02-2016
Patient Information leaflet Patient Information leaflet Portuguese 13-02-2024
Summary of Product characteristics Summary of Product characteristics Portuguese 13-02-2024
Public Assessment Report Public Assessment Report Portuguese 23-02-2016
Patient Information leaflet Patient Information leaflet Romanian 13-02-2024
Public Assessment Report Public Assessment Report Romanian 23-02-2016
Patient Information leaflet Patient Information leaflet Slovak 13-02-2024
Public Assessment Report Public Assessment Report Slovak 23-02-2016
Patient Information leaflet Patient Information leaflet Slovenian 13-02-2024
Summary of Product characteristics Summary of Product characteristics Slovenian 13-02-2024
Public Assessment Report Public Assessment Report Slovenian 23-02-2016
Patient Information leaflet Patient Information leaflet Finnish 13-02-2024
Public Assessment Report Public Assessment Report Finnish 23-02-2016
Patient Information leaflet Patient Information leaflet Swedish 13-02-2024
Public Assessment Report Public Assessment Report Swedish 23-02-2016
Patient Information leaflet Patient Information leaflet Norwegian 13-02-2024
Summary of Product characteristics Summary of Product characteristics Norwegian 13-02-2024
Patient Information leaflet Patient Information leaflet Icelandic 13-02-2024
Summary of Product characteristics Summary of Product characteristics Icelandic 13-02-2024

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