Hizentra
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
13-01-2022
Vara einkenni
(SPC)
13-01-2022
Opinber matsskýrsla
(PAR)
13-01-2022
Virkt innihaldsefni:
human normal immunoglobulin (SCIg)
Fáanlegur frá:
CSL Behring GmbH
ATC númer:
J06BA01
INN (Alþjóðlegt nafn):
human normal immunoglobulin (SCIg)
Meðferðarhópur:
Immune sera and immunoglobulins,
Lækningarsvæði:
Immunologic Deficiency Syndromes
Ábendingar:
Replacement therapy in adults, children and adolescents (0-18 years) in:- Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).- 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
Vörulýsing:
Revision: 21
Leyfisstaða:
Authorised
Leyfisdagur:
2011-04-14
Upplýsingar fylgiseðill
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIZENTRA 200 MG/ML SOLUTION FOR SUBCUTANEOUS INJECTION
Human normal immunoglobulin (SCIg =
S
ub
C
utaneous
I
mmuno
G
lobulin)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or healthcare
professional.
−
This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.
−
If you get any side effects talk to your healthcare professional. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hizentra is and what it is used for
2.
What you need to know before you use Hizentra
3.
How to use Hizentra
4.
Possible side effects
5.
How to store Hizentra
6.
Contents of the pack and other information
1.
WHAT HIZENTRA IS AND WHAT IT IS USED FOR
WHAT HIZENTRA IS
Hizentra belongs to the class of medicines called human normal
immunoglobulins. Immunoglobulins
are also known as antibodies and are blood proteins that help your
body to fight infections.
HOW HIZENTRA WORKS
Hizentra contains immunoglobulins that have been prepared from the
blood of healthy people.
Immunoglobulins are produced by human body’s immune system. They
help your body to fight
infections caused by bacteria and viruses or maintain the balance in
your immune system (referred to
as immunomodulation). The medicine works in exactly the same way as
the immunoglobulins
naturally present in your blood.
WHAT HIZENTRA IS USED FOR
_Replacement therapy _
Hizentra is used to raise abnormally low immunoglobulin levels in your
blood to normal levels
(replacement therapy). The medicine is used in adults and children
(0-18 years) in the following
situations:
1.
Treatment of patients who are born with a reduced ability or inability
to produce
immunoglobulins (primary immunodeficienci
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hizentra 200 mg/ml solution for subcutaneous injection
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (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
Each pre-filled syringe of 20 ml solution contains: 4 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 (range: 210 to 290) of
L-proline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection.
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, children and adolescents (0-18 years)
in:
−
Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4).
3
−
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
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