Hizentra

Country: European Union

Language: French

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:

immunoglobuline humaine normale (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Des sérums et immunoglobulines,

Therapeutic area:

Syndromes de déficience immunologique

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:

Autorisé

Authorization date:

2011-04-14

Patient Information leaflet

                                30
B. NOTICE
31
NOTICE : INFORMATION DE L’UTILISATEUR
HIZENTRA 200 MG/ML, SOLUTION INJECTABLE SOUS-CUTANÉE
Immunoglobuline humaine normale (IgSC =
I
mmuno
G
lobuline
S
ous-
C
utanée)
VEUILLEZ LIRE ATTENTIVEMENT CETTE NOTICE AVANT D’UTILISER CE
MÉDICAMENT CAR ELLE CONTIENT DES
INFORMATIONS IMPORTANTES POUR VOUS.
-
Gardez cette notice. Vous pourriez avoir besoin de la relire.
-
Si vous avez d’autres questions, interrogez votre médecin ou votre
pharmacien.
-
Ce médicament vous a été personnellement prescrit. Ne le donnez pas
à d’autres personnes. Il
pourrait leur être nocif, même si leurs symptômes sont identiques
aux vôtres.
-
Si vous ressentez un quelconque effet indésirable, parlez-en à votre
médecin ou votre
pharmacien. Ceci s’applique aussi à tout effet indésirable qui ne
serait pas mentionné dans cette
notice. Voir rubrique 4.
QUE CONTIENT CETTE NOTICE ?
1.
Qu’est-ce que Hizentra et dans quel cas est-il utilisé ?
2.
Quelles sont les informations à connaître avant d’utiliser
Hizentra ?
3.
Comment utiliser Hizentra ?
4.
Effets indésirables éventuels
5.
Comment conserver Hizentra ?
6.
Contenu de l'emballage et autres informations
1.
QU’EST-CE QUE HIZENTRA ET DANS QUEL CAS EST-IL UTILISÉ ?
QU’EST-CE QUE HIZENTRA ?
Hizentra appartient à la classe de médicaments appelée
immunoglobulines normales humaines. Les
immunoglobulines sont également connues sous le nom d’anticorps et
sont des protéines du sang qui
aident votre organisme à combattre les infections.
QUEL EST LE MÉCANISME D’ACTION DE HIZENTRA ?
Hizentra contient des immunoglobulines qui ont été fabriquées dans
le sang d’individus sains. Les
immunoglobulines sont produites par le système immunitaire du corps
humain. Elles aident votre
corps à combattre les infections causées par les bactéries et les
virus ou à maintenir l'équilibre de votre
système immunitaire (immunomodulation). Le médicament agit
exactement de la même manière que
les immunoglobulines naturellement présentes dans votre sang.
D
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNEXE I
RESUME DES CARACTERISTIQUES DU PRODUIT
2
1.
DENOMINATION DU MEDICAMENT
Hizentra 200 mg/ml, solution injectable sous-cutanée
Hizentra 200 mg/ml, solution injectable sous-cutanée en seringue
préremplie
2.
COMPOSITION QUALITATIVE ET QUANTITATIVE
Immunoglobuline humaine normale (IgSC)
Un ml contient :
Immunoglobuline humaine normale
.............................................................................................
200 mg
(pureté : au moins 98 % d’immunoglobulines de type G (IgG))
Flacons
Chaque flacon de 5 ml de solution contient : 1 g d’immunoglobuline
humaine normale
Chaque flacon de 10 ml de solution contient : 2 g d’immunoglobuline
humaine normale
Chaque flacon de 20 ml de solution contient : 4 g d’immunoglobuline
humaine normale
Chaque flacon de 50 ml de solution contient : 10 g d’immunoglobuline
humaine normale
Seringues préremplies
Chaque seringue préremplie de 5 ml de solution contient : 1 g
d’immunoglobuline humaine normale
Chaque seringue préremplie de 10 ml de solution contient : 2 g
d’immunoglobuline humaine normale
Chaque seringue préremplie de 20 ml de solution contient : 4 g
d’immunoglobuline humaine normale
Distribution des sous-classes d’IgG (valeurs approximatives) :
IgG1 ............ 69 %
IgG2 ............ 26 %
IgG3 ............ 3 %
IgG4 ............ 2 %
La teneur maximale en IgA est de 50 microgrammes/ml.
Fabriqué à partir du plasma de donneurs humains.
Excipients à effet notoire
Hizentra contient approximativement 250 mmol/l (limites : 210 à 290)
de L-proline.
Pour la liste complète des excipients, voir rubrique 6.1.
3.
FORME PHARMACEUTIQUE
Solution injectable sous-cutanée.
La solution est claire et jaune pâle ou brun clair.
Hizentra a une osmolalité approximative de 380 mOsmol/kg.
4.
DONNEES CLINIQUES
4.1
INDICATIONS THÉRAPEUTIQUES
Traitement de substitution chez les adultes, les enfants et les
adolescents (0 à 18 ans) atteints de :
−
Déficits immunitaires primitifs avec déficit de production
d’anticorps (voir rubrique 4.4).
3
−
D
                                
                                Read the complete document

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Active ingredient immunoglobuline humaine normale (SCIg)

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ATC code J06BA01

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Marketed by CSL Behring GmbH

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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
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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Summary of Product characteristics Summary of Product characteristics Spanish 13-01-2022
Public Assessment Report Public Assessment Report Spanish 13-01-2022
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Public Assessment Report Public Assessment Report German 13-01-2022
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