Hizentra

Country: European Union

Language: Slovenian

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:

humani normalni imunoglobulin (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Imunski sera in imunoglobulini,

Therapeutic area:

Sindromi imunološke pomanjkljivosti

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:

Pooblaščeni

Authorization date:

2011-04-14

Patient Information leaflet

                                24
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Hizentra
1 g
2 g
4 g
10 g
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
PC
SN
NN
25
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA (NAPOLNJENA INJEKCIJSKA BRIZGA)
1.
IME ZDRAVILA
Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni
injekcijski brizgi
humani polispecifični imunoglobulin (s.c.Ig)
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
1 ml vsebuje:
humani polispecifični imunoglobulin ............ 200 mg
IgG .................................................................
≥ 98 %
IgA .................................................................
≤ 50 mikrogramov
1 g/5 ml
2 g/10 ml
4 g/20 ml
3.
SEZNAM POMOŽNIH SNOVI
Pomožne snovi: L-prolin, polisorbat 80, voda za injekcije
Za nadaljnje informacije glejte navodilo za uporabo.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
raztopina za injiciranje
1 x 5 ml
1 x 10 ml
1 x 20 ml
10 x 5 ml
10 x 10 ml
10 x 20 ml
Napolnjena(e) injekcijska(e) brizga(e)
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
samo za subkutano uporabo
Pred uporabo preberite priloženo navodilo!
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
26
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
Ne injicirajte intravaskularno.
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Zdravilo shranjujte pri temperaturi do 25 ºC.
Ne zamrzujte.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za
zagotovitev zaščite pred svetlobo.
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
CSL Behring GmbH
D-35041 Marburg
Nemčija
12.
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/11/687/015 1 x 5 ml napolnjena injekcijska brizga
EU/1/11/687/016 10 x 5 ml napolnjenih injekcijskih bri
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Hizentra 200 mg/ml raztopina za subkutano injiciranje
Hizentra 200 mg/ml raztopina za subkutano injiciranje v napolnjeni
injekcijski brizgi
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Humani polispecifični imunoglobulin (s.c.Ig).
En ml vsebuje:
humani polispecifični imunoglobulin
............................................................................................
200 mg
(čistost: vsaj 98 % je imunoglobulina tipa G (IgG))
Viale
Ena viala s 5 ml raztopine vsebuje: 1 g humanega polispecifičnega
imunoglobulina.
Ena viala z 10 ml raztopine vsebuje: 2 g humanega polispecifičnega
imunoglobulina.
Ena viala z 20 ml raztopine vsebuje: 4 g humanega polispecifičnega
imunoglobulina.
Ena viala z 50 ml raztopine vsebuje: 10 g humanega polispecifičnega
imunoglobulina.
Napolnjene injekcijske brizge
Ena napolnjena injekcijska brizga s 5 ml raztopine vsebuje: 1 g
humanega polispecifičnega
imunoglobulina.
Ena napolnjena injekcijska brizga z 10 ml raztopine vsebuje: 2 g
humanega polispecifičnega
imunoglobulina.
Ena napolnjena injekcijska brizga z 20 ml raztopine vsebuje: 4 g
humanega polispecifičnega
imunoglobulina.
Porazdelitev podrazredov IgG (približne vrednosti):
IgG
1
............ 69 %
IgG
2
............ 26 %
IgG
3
............ 3 %
IgG
4
............ 2 %
Največja vsebnost IgA je 50 mikrogramov/ml.
Narejeno iz plazme človeških darovalcev.
Pomožne snovi z znanim učinkom:
Zdravilo Hizentra vsebuje približno 250 mmol/l (razpon: 210 do 290)
L-prolina.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
raztopina za subkutano injiciranje
Raztopina je prozorna in je bledo rumene ali svetlo rjave barve.
Približna osmolalnost zdravila Hizentra je 380 mOsmol/kg.
3
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Nadomestno zdravljenje pri odraslih, otrocih in mladostnikih (0–18
let) pri:
-
sindromih primarne imunske pomanjkljivosti (PID
_ - primary imunodeficiency_
) z zmanjšano
tvorbo protiteles (glejte poglavje 4.4).
-
sek
                                
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Active ingredient humani normalni imunoglobulin (SCIg)

humani 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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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2022
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