Hizentra

Country: European Union

Language: Norwegian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
13-01-2022
Download Summary of Product characteristics (SPC)
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 immunglobuliner,

Therapeutic area:

Immunologiske mangelsyndrom

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:

autorisert

Authorization date:

2011-04-14

Patient Information leaflet

                                30
B. PAKNINGSVEDLEGG
31
PAKNINGSVEDLEGG: INFORMASJON TIL BRUKEREN
HIZENTRA 200 MG/ML INJEKSJONSVÆSKE TIL SUBKUTAN BRUK, OPPLØSNING
immunglobulin, normalt (humant) (immunoglobulinum humanum normale)
(SCIg =
S
ub
C
utaneous
I
mmuno
G
lobulin)
LES NØYE GJENNOM DETTE PAKNINGSVEDLEGGET FØR DU BEGYNNER Å BRUKE
LEGEMIDLET. DET INNEHOLDER
INFORMASJON SOM ER VIKTIG FOR DEG.
-
Ta vare på dette pakningsvedlegget. Du kan få behov for å lese det
igjen.
-
Spør lege eller helsepersonell hvis du har flere spørsmål eller
trenger mer informasjon.
-
Dette legemidlet er skrevet ut kun til deg. Ikke gi det videre til
andre. Det kan skade dem, selv
om de har symptomer på sykdom som ligner dine.
-
Kontakt helsepersonell dersom du opplever bivirkninger, inkludert
mulige bivirkninger som
ikke er nevnt i dette pakningsvedlegget. Se avsnitt 4.
I DETTE PAKNINGSVEDLEGGET FINNER DU INFORMASJON OM:
1.
Hva Hizentra er og hva det brukes mot
2.
Hva du må vite før du bruker Hizentra
3.
Hvordan du bruker Hizentra
4.
Mulige bivirkninger
5.
Hvordan du oppbevarer Hizentra
6.
Innholdet i pakningen samt ytterligere informasjon
1.
HVA HIZENTRA ER, OG HVA DET BRUKES MOT
HVA HIZENTRA ER
Hizentra tilhører legemiddelgruppen som kalles humane normale
immunglobuliner.
Immunglobuliner er også kjent som antistoffer og er blodproteiner som
hjelper kroppen med å
bekjempe infeksjoner.
HVORDAN HIZENTRA VIRKER
Hizentra inneholder immunglobuliner som er fremstilt av blod fra
friske personer. Immunglobuliner
produseres av menneskekroppens immunsystem. De hjelper kroppen med å
motkjempe infeksjoner
forårsaket av bakterier og virus eller vedlikeholde balansen i
immunsystemet (kjent som
immunmodulering). Legemidlet virker på akkurat samme måte som
immunglobuliner som finnes
naturlig i blodet.
HVA HIZENTRA BRUKES MOT
_Substitusjonsterapi _
Hizentra brukes for å heve unormalt lave immunglobulinnivåer i
blodet til normale nivåer
(substitusjonsbehandling). Legemidlet brukes hos voksne og barn (0-18
år) i følgende situasjoner:
1.
Behandling av pasien
                                
                                Read the complete document

Summary of Product characteristics

                                1
VEDLEGG I
PREPARATOMTALE
2
1.
LEGEMIDLETS NAVN
Hizentra 200 mg/ml injeksjonsvæske til subkutan bruk, oppløsning
Hizentra 200 mg/ml injeksjonsvæske til subkutan bruk, oppløsning i
ferdigfylt sprøyte
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Immunglobulin, normalt (humant) (immunoglobulinum humanum normale)
(SCIg).
Én ml inneholder:
Humant normalt immunglobulin
...................................................................................................
200 mg
(renhet: minst 98 % er immunoglobulin type G (IgG))
Hetteglass
Hvert hetteglass med 5 ml oppløsning inneholder: 1 g humant normalt
immunglobulin
Hvert hetteglass med 10 ml oppløsning inneholder: 2 g humant normalt
immunglobulin
Hvert hetteglass med 20 ml oppløsning inneholder: 4 g humant normalt
immunglobulin
Hvert hetteglass med 50 ml oppløsning inneholder: 10 g humant normalt
immunglobulin
Ferdigfylte sprøyter
Hver ferdigfylte sprøyte med 5 ml oppløsning inneholder: 1 g humant
normalt immunglobulin
Hver ferdigfylte sprøyte med 10 ml oppløsning inneholder: 2 g humant
normalt immunglobulin
Hver ferdigfylte sprøyte med 20 ml oppløsning inneholder: 4 g humant
normalt immunglobulin
Fordeling på IgG-subklasser (omtrentlige verdier):
IgG1 ............ 69 %
IgG2 ............ 26 %
IgG3 ............ 3 %
IgG4 ............ 2 %
Maks. IgA-innhold er 50 mikrogram/ml.
Produsert av plasma fra humane donorer.
Hjelpestoffer med kjent effekt
Hizentra inneholder ca. 250 mmol/l (område: 210 til 290) L-prolin.
For fullstendig liste over hjelpestoffer, se pkt. 6.1.
3.
LEGEMIDDELFORM
Injeksjonsvæske til subkutan bruk, oppløsning.
Løsningen er klar og svakt gul eller lysebrun.
Hizentra har en omtrentlig osmolalitet på 380 mOsmol/kg.
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJONER
Substitusjonsterapi for voksne, barn og ungdom (0–18 år) ved:
-
Primær immunsviktsyndrom med nedsatt antistoffproduksjon (se pkt.
4.4).
3
-
Sekundær immunsvikt (SID) hos pasienter som lider av alvorlige og
tilbakevendende
infeksjoner, ineffektiv antimikrobiell behandling og en
                                
                                Read the complete document

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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
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Public Assessment Report Public Assessment Report Spanish 13-01-2022
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