HIZENTRA

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

IMMUNOGLOBULINS, NORMAL HUMAN

Saatavilla:

CSL BEHRING LTD., ISRAEL

ATC-koodi:

J06BA01

Lääkemuoto:

SOLUTION FOR INFUSION

Koostumus:

IMMUNOGLOBULINS, NORMAL HUMAN 200 MG / 1 ML

Antoreitti:

S.C

Prescription tyyppi:

Required

Valmistaja:

CSL BEHRING AG, SWITZERLAND

Terapeuttinen alue:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.

Käyttöaiheet:

Replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency and Wiskott-Aldrich syndrome - IgG subclass deficiencies with recurrent infectionsReplacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Valtuutus päivämäärä:

2020-05-04

Pakkausseloste

PATIENT LEAFLET IN ACCORDANCE WITH
PHARMACIST’S REGULATIONS (PREPARATIONS)
1986
The medicine is marketed according to
doctor’s
prescription only.
HIZENTRA, 200 MG/ML SOLUTION FOR SUBCUTANEOUS INFUSION IN VIAL
HIZENTRA, 200 MG/ML SOLUTION FOR SUBCUTANEOUS INFUSION IN PRE-FILLED
SYRINGE
Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin)
COMPOSITION
The ACTIVE SUBSTANCE is human normal immunoglobulin. One ml contains
200 mg of
human normal immunoglobulin, of which at least 98% is immunoglobulin
type G
(IgG).
The approximate percentage of IgG subclasses is as follows:
IgG1 69 %
IgG2 26 %
IgG3 3 %
IgG4 2 %
This medicine contains trace amounts of IgA (not more than 50
micrograms /ml).
Hizentra is essentially sodium free.
OTHER INGREDIENTS (EXCIPIENTS)
See section 6.
- READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or the pharmacist.
- This medicine was prescribed for you. Do not pass it on to others.
It may harm
them even if their medical condition seems similar to yours.
1.
WHAT HIZENTRA IS USED FOR?
Hizentra is used in the treatment of adults and children:
1.
Who are born with a reduced ability or inability to produce
immunoglobulins
(primary immunodeficiencies). This includes conditions such as:
•
low immunoglobulin levels (hypogammaglobulinaemia) or absence of
immunoglobulins (agammaglobulinaemia) in the blood
•
combination of low immunoglobulin levels, frequent infections and
inability
to produce adequate amounts of antibodies after vaccination (common
variable immunodeficiency)
•
combination of low level or absence of immunoglobulins and absence or
non-functional immune cells (severe combined immunodeficiency and
Wiskott- Aldrich syndrome)
•
lack of certain immunoglobulin G subclasses causing recurrent
infections.
2.
Treatment of low immunoglobulin levels (Hypogammaglobulinaemia ) and
recurrent infections in patients with chronic lymphocytic leukaemia
(CLL

Valmisteyhteenveto

1.
NAME OF THE MEDICINAL PRODUCT
Hizentra
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Immunoglobulin normal Human (SCIg)
One ml contains:
Human normal immunoglobulin
....................................................................................................200
mg
(purity: at least 98% is immunoglobulin type G (IgG))
Vials
Each vial of 5 ml solution contains: 1 g of human normal
immunoglobulin
Each vial of 10 ml solution contains: 2 g of human normal
immunoglobulin
Each vial of 20 ml solution contains: 4 g of human normal
immunoglobulin
Each vial of 50 ml solution contains: 10 g of human normal
immunoglobulin
Pre-filled syringes
Each pre-filled syringe of 5 ml solution contains: 1 g human normal
immunoglobulin
Each pre-filled syringe of 10 ml solution contains: 2 g human normal
immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG1 ............ 69 %
IgG2 ............ 26 %
IgG3 ............ 3 %
IgG4 2 %
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipients with known effects
Hizentra contains approximately 250 mmol/L of L-proline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous infusion.
The solution is clear and pale-yellow or light-brown.
Hizentra has an approximate osmolality of 380 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults and children in primary immunodeficiency
syndromes such as:
−
congenital agammaglobulinaemia and hypogammaglobulinaemia
−
common variable immunodeficiency
−
severe combined immunodeficiency and Wiskott-Aldrich syndrome
−
IgG subclass deficiencies with recurrent infections
Replacement therapy in myeloma or chronic lymphocytic leukaemia with
severe secondary
hypogammaglobulinaemia and recurrent infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology for adults and children
The dose may need to be individualised for each patient dependent on
the pharmacokinetic and clinical
response and serum IgG trough levels.