Hizentra

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
13-01-2022

Active ingredient:

ljudski normalni imunoglobulin (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Imuni serumi i homologna,

Therapeutic area:

Sindromi imunološke manjkavosti

Therapeutic indications:

Replacement therapy in adults, children and adolescents (0-18 years) in:- Primary immunodeficiency syndromes with impaired antibody production (see section 4. - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of.

Product summary:

Revision: 21

Authorization status:

odobren

Authorization date:

2011-04-14

Patient Information leaflet

                                29
B. UPUTA O LIJEKU
30
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
HIZENTRA 200 MG/ML OTOPINA ZA SUPKUTANU INJEKCIJU
ljudski normalni imunoglobulin (s.c.Ig = supkutani imunoglobulin)
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 liječniku ili zdravstvenom
radniku.
-
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
zdravstvenog radnika. To uključuje
i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte
dio 4.
_ _
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Hizentra i za što se koristi
2.
Što morate znati prije nego počnete primjenjivati Hizentru
3.
Kako primjenjivati Hizentru
4.
Moguće nuspojave
5.
Kako čuvati Hizentru
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE HIZENTRA I ZA ŠTO SE KORISTI
ŠTO JE HIZENTRA
Hizentra pripada skupini lijekova koji se nazivaju ljudskim normalnim
imunoglobulinima.
Imunoglobulini su također poznati kao protutijela, to su proteini
krvi koji pomažu Vašem organizmu u
borbi protiv infekcija.
KAKO HIZENTRA DJELUJE
Hizentra sadrži imunoglobuline koji su pripremljeni od krvi zdravih
ljudi. Imunoglobuline stvara
ljudski imunološki sustav. Oni pomažu Vašem tijelu u borbi s
infekcijama uzrokovanim bakterijama i
virusima ili održavaju ravnotežu u Vašem imunološkom sustavu (u
daljenjem tekstu
imunomodulacija). Lijek djeluje na isti način kao i imunoglobulini
prirodno prisutni u Vašoj krvi.
ZA ŠTO SE HIZENTRA KORISTI
_Nadomjesna terapija _
Hizentra se koristi za podizanje abnormalno niske razine
imunoglobulina u krvi na normalnu razinu
(nadomjesna terapija). Lijek se koristi u odraslih i djece (0-18
godina) u sljedećim situacijama:
1.
Liječenje bolesnika koji su rođeni sa smanjenom sposobnošću ili
nemogućnost stvaranja
imunoglobu
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Hizentra 200 mg/ml otopina za supkutanu injekciju
Hizentra 200 mg/ml otopina za supkutanu injekciju u napunjenoj
štrcaljki
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Ljudski normalni imunoglobulin (s.c.Ig)
Jedan ml sadrži:
Ljudski normalni
imunoglobulin………………………….................................200
mg
(čistoće: najmanje 98% imunoglobulina tipa G (IgG))
Bočice
Jedna bočica od 5 ml otopine sadrži: 1 g ljudskog normalnog
imunoglobulina
Jedna bočica od 10 ml otopine sadrži: 2 g ljudskog normalnog
imunoglobulina
Jedna bočica od 20 ml otopine sadrži: 4 g ljudskog normalnog
imunoglobulina
Jedna bočica od 50 ml otopine sadrži: 10 g ljudskog normalnog
imunoglobulina
Napunjene štrcaljke
Jedna napunjena štrcaljka s 5 ml otopine sadrži: 1 g ljudskog
normalnog imunoglobulina
Jedna napunjena štrcaljka s 10 ml otopine sadrži: 2 g ljudskog
normalnog imunoglobulina
Jedna napunjena štrcaljka s 20 ml otopine sadrži: 4 g ljudskog
normalnog imunoglobulina
Distribucija IgG podvrste (približne vrijednosti):
IgG1 .......... 69%
IgG2 .......... 26%
IgG3 .......... 3%
IgG4 .......... 2%
Maksimalna količina IgA je 50 mikrograma/ml.
Proizvedeno iz plazme ljudskih donora.
Pomoćne tvari s poznatim učinkom
Hizentra sadrži približno 250 mmol/l (raspon od: 210 do 290)
L-prolina.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za supkutanu injekciju.
Otopina je bistra, blijedo žute ili svijetlo smeđe boje.
Približna osmolalnost Hizentre iznosi 380 mOsmol/kg.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Nadomjesna terapija u odraslih, djece i adolescenata (0-18 godina)
kod:
−
Sindroma primarne imunodeficijencije s poremećajem stvaranja
protutijela (vidjeti dio 4.4).
3
−
Sekundarne imunodeficijencije (SID) u bolesnika s teškim ili
rekurentnim infekcijama, u kojih
antimikrobno liječenje nije bilo učinkovito te koji imaju ili
dokazanu nemogućnost stvaranja
specifičnih antitijela (PSAF)* ili razinu IgG
                                
                                Read the complete document

Similar products

Active ingredient ljudski normalni imunoglobulin (SCIg)

ljudski normalni imunoglobulin (SCIg)

ATC code J06BA01

J06BA01

Marketed by CSL Behring GmbH

CSL Behring GmbH

INN (International Name) human normal immunoglobulin (SCIg)

human normal immunoglobulin (SCIg)

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