Hizentra

Country: European Union

Language: Italian

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:

immunoglobulina umana normale (SCIg)

Available from:

CSL Behring GmbH

ATC code:

J06BA01

INN (International Name):

human normal immunoglobulin (SCIg)

Therapeutic group:

Sieri immuni e immunoglobuline,

Therapeutic area:

Sindromi da immunodeficienza immunologica

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:

autorizzato

Authorization date:

2011-04-14

Patient Information leaflet

                                31
B. FOGLIO ILLUSTRATIVO
32
FOGLIO ILLUSTRATIVO: INFORMAZIONI PER L’UTILIZZATORE
HIZENTRA 200 MG/ML SOLUZIONE PER INIEZIONE SOTTOCUTANEA
Immunoglobulina umana normale (SCIg = immunoglobulina sottocutanea)
LEGGA ATTENTAMENTE QUESTO FOGLIO PRIMA DI USARE QUESTO MEDICINALE
PERCHÉ CONTIENE IMPORTANTI
INFORMAZIONI PER LEI.
-
Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.
-
Se ha qualsiasi dubbio, si rivolga al medico o all’operatore
sanitario.
-
Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad
altre persone, anche se i
sintomi della malattia sono uguali ai suoi, perché potrebbe essere
pericoloso.
-
Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non
elencati in questo foglio, si
rivolga all’operatore sanitario. Vedere paragrafo 4.
CONTENUTO DI QUESTO FOGLIO
1.
Cos’è Hizentra e a che cosa serve
2.
Cosa deve sapere prima di usare Hizentra
3.
Come usare Hizentra
4.
Possibili effetti indesiderati
5.
Come conservare Hizentra
6.
Contenuto della confezione e altre informazioni
1.
COS’È HIZENTRA E A CHE COSA SERVE
COS’È HIZENTRA
Hizentra appartiene alla classe di medicinali noti come
immunoglobuline umane normali. Le
immunoglobuline sono chiamate anche anticorpi e sono proteine ematiche
che aiutano l'organismo a
combattere le infezioni.
COME AGISCE HIZENTRA
Hizentra contiene immunoglobuline preparate dal sangue di persone
sane. Le immunoglobuline sono
prodotte dal sistema immunitario del corpo umano. Esse aiutano il suo
organismo a combattere le
infezioni causate da batteri e virus o a mantenere l'equilibrio del
suo sistema immunitario (azione
definita di immunomodulazione). Il medicinale agisce esattamente come
le immunoglobuline presenti
naturalmente nell'organismo.
A CHE COSA SERVE HIZENTRA
_Terapia sostitutiva _
Hizentra è usato per aumentare livelli patologicamente bassi di
immunoglobuline nel sangue
riportandoli a valori normali (terapia di sostituzione). Il medicinale
è usato negli adulti e nei bambini
(0 – 18 anni) nelle seguenti situaz
                                
                                Read the complete document

Summary of Product characteristics

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
2
1.
DENOMINAZIONE DEL MEDICINALE
Hizentra 200 mg/mL soluzione per iniezione sottocutanea
Hizentra 200 mg/mL soluzione per iniezione sottocutanea in siringa
pre-riempita
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
Immunoglobulina umana normale (SCIg).
1 mL contiene:
Immunoglobulina umana normale
200 mg
(purezza: almeno 98% è immunoglobulina di tipo G (IgG))
Flaconcino
Ogni flaconcino da 5 mL di soluzione contiene: 1 g di immunoglobulina
umana normale
Ogni flaconcino da 10 mL di soluzione contiene: 2 g di immunoglobulina
umana normale
Ogni flaconcino da 20 mL di soluzione contiene: 4 g di immunoglobulina
umana normale
Ogni flaconcino da 50 mL di soluzione contiene: 10 g di
immunoglobulina umana normale
Siringhe pre-riempite
Ogni siringa pre-riempita da 5 mL di soluzione contiene: 1 g di
immunoglobulina umana normale
Ogni siringa pre-riempita da 10 mL di soluzione contiene: 2 g di
immunoglobulina umana normale
Ogni siringa pre-riempita da 20 mL di soluzione contiene: 4 g di
immunoglobulina umana normale
Distribuzione delle sottoclassi di IgG (valori approssimativi):
IgG1
69%
IgG2
26%
IgG3
3%
IgG4
2%
Il contenuto massimo in IgA è 50 microgrammi/mL.
Prodotto dal plasma di donatori umani.
Eccipienti con effetti noti
Hizentra contiene approssimativamente 250 mmol/L (intervallo: 210
-290) di L-prolina.
Per l’elenco completo degli eccipienti, vedere paragrafo 6.1.
3.
FORMA FARMACEUTICA
Soluzione per iniezione sottocutanea.
La soluzione è limpida, di colore giallo pallido o marrone chiaro.
Hizentra possiede un’osmolalità di circa 380 mOsmol/kg.
4.
INFORMAZIONI CLINICHE
4.1
INDICAZIONI TERAPEUTICHE
Terapia sostitutiva in adulti, bambini e adolescenti (da 0 a 18 anni)
in caso di:
•
Sindromi da immunodeficienza primaria con alterata produzione di
anticorpi (vedere
paragrafo 4.4).
3
•
Sindromi da immunodeficienza secondaria (SID) in pazienti affetti da
infezioni severe o
ricorrenti, nei quali il trattamento antimicrobico è risultato
inefficace e con comprov
                                
                                Read the complete document

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Active ingredient immunoglobulina umana normale (SCIg)

immunoglobulina umana normale (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
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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Public Assessment Report Public Assessment Report Greek 13-01-2022
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