Hizentra

Country: European Union

Language: Danish

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:

human normal immunoglobulin (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Immune sera og immunoglobuliner,

Therapeutic area:

Immunologiske mangelsyndromer

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:

autoriseret

Authorization date:

2011-04-14

Patient Information leaflet

                                28
B. INDLÆGSSEDDEL
29
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
HIZENTRA 200 MG/ML SUBKUTAN INJEKTIONSVÆSKE, OPLØSNING
Humant normalt immunglobulin (SCIg = subkutant immunglobulin)
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT BRUGE
MEDICINEN, DA DEN INDEHOLDER
VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
-
Lægen har ordineret Hizentra til dig personligt. Lad derfor være med
at give det til andre. Det
kan være skadeligt for andre, selvom de har de samme symptomer, som
du har.
-
Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver
værre, eller du får
bivirkninger, som ikke er nævnt her. Se pkt 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at bruge Hizentra
3.
Sådan skal du bruge Hizentra
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
HVAD ER HIZENTRA
Hizentra tilhører den medicinklasse, der kaldes humant normalt
immunglobulin. Immunglobuliner er
også kendt som antistoffer og er blodproteiner, som hjælper kroppen
med at bekæmpe infektioner.
HVORDAN VIRKER HIZENTRA
Hizentra indeholder immunglobuliner, som er fremstillet af blod fra
raske personer. Immunglobuliner
produceres af immunsystemet i menneskets krop. De hjælper din krop
med at bekæmpe infektioner
forårsaget af bakterier og virus og opretholder balancen i dit
immunsystem (kaldet immunmodulation).
Medicinen virker på nøjagtigt samme måde som de immunglobuliner,
der er naturligt til stede i blodet.
HVAD ANVENDES HIZENTRA TIL
_Substitutionsterapi _
Hizentra anvendes til at øge unormalt lave koncentrationer af
immunglobulin i blodet til normale
niveauer (erstatningsterapi). Medicinen anvendes til voksne og børn
(0-18 år) i følgende situationer:
1.
Behandling af patienter med medfødt nedsat eller manglende evne til
at danne immunglobuliner
(primære i
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
Hizentra 200 mg/ml injektionsvæske, opløsning, til subkutan
anvendelse
Hizentra 200 mg/ml injektionsvæske, opløsning, til subkutan
anvendelse i fyldt injektionssprøjte
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Humant normalt immunglobulin (immunoglobulinum humanum normale) (SCIg)
En ml indeholder:
Humant normalt immunglobulin
...................................................................................................
200 mg
(renhedsgrad: mindst 98 % er immunglobulin type G (IgG))
Hætteglas
Hvert hætteglas med 5 ml injektionsvæske indeholder: 1 g humant
normalt immunglobulin
Hvert hætteglas med 10 ml injektionsvæske indeholder: 2 g humant
normalt immunglobulin
Hvert hætteglas med 20 ml injektionsvæske indeholder: 4 g humant
normalt immunglobulin
Hvert hætteglas med 50 ml injektionsvæske indeholder: 10 g humant
normalt immunglobulin
Fyldte injektionssprøjter
Hver fyldt injektionssprøjte med 5 ml injektionsvæske indeholder: 1
g humant normalt immunglobulin
Hver fyldt injektionssprøjte med 10 ml injektionsvæske indeholder: 2
g humant normalt
immunglobulin
Hver fyldt injektionssprøjte med 20 ml injektionsvæske indeholder: 4
g humant normalt
immunglobulin
Fordeling af IgG-subklasser (cirkaværdier):
IgG1 ............ 69 %
IgG2 ............ 26 %
IgG3 ............ 3 %
IgG4 ............ 2 %
Det maksimale IgA-indhold er 50 mikrogram/ml.
Fremstillet af humant plasma fra donorer.
Hjælpestoffer, som behandleren skal være opmærksom på
Hizentra indeholder ca. 250 mmol (interval: 210-290) L-prolin/l.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Subkutan injektionsvæske, opløsning.
Injektionsvæsken er klar og bleggul eller lysebrun.
Hizentra har en anslået osmolalitet på 380 mOsmol/kg.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Substitutionsterapi til voksne, børn og unge (0-18 år) med:
-
Primært immundefektsyndrom med nedsat produktion af antistoffer (se
pkt. 4.4).
3
-
Sekundære immundefekter (SID) hos patie
                                
                                Read the complete document

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Active ingredient human normal immunoglobulin (SCIg)

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INN (International Name) human normal immunoglobulin (SCIg)

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Patient Information leaflet Patient Information leaflet Bulgarian 13-01-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-01-2022
Public Assessment Report Public Assessment Report Bulgarian 13-01-2022
Patient Information leaflet Patient Information leaflet Spanish 13-01-2022
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Public Assessment Report Public Assessment Report Spanish 13-01-2022
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