Privigen solution for infusion

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

human normal immunoglobulin

Доступна с:

CSL Behring AG

код АТС:

J06BA02

ИНН (Международная Имя):

human normal immunoglobulin

дозировка:

100mg/ml

Фармацевтическая форма:

solution for infusion

Штук в упаковке:

200ml glass vial

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-11-11

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIVIGEN 100 MG/ML (10%) SOLUTION FOR INFUSION
human normal immunoglobulin (IVIg)
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.
-
If you get any side effects, talk to your doctor or healthcare
professional. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Privigen is and what it is used for
2.
What you need to know before you are given Privigen
3.
How to use Privigen
4.
Possible side effects
5.
How to store Privigen
6.
Contents of the pack and other information
1.
WHAT PRIVIGEN IS AND WHAT IT IS USED FOR
WHAT PRIVIGEN IS
Privigen 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 PRIVIGEN WORKS
Privigen contains immunoglobulins that have been prepared from the
blood of healthy people. The
medicine works in exactly the same way as the immunoglobulins
naturally present in human blood of
healthy people.
2
WHAT PRIVIGEN IS USED FOR
Privigen is used for the treatment of adults and children (0-18 years)
in the following situations:
A)
To increase abnormally low immunoglobulin levels in your blood to
normal levels (replacement
therapy):
1.
Patients who are born with a reduced ability or inability to produce
immunoglobulins
(primary immunodeficiencies (PID)).
2.
Patients with an acquired immunodeficiency (SID) who suffer from
severe or recurrent
infections, ineffective antimicrobial treatment and either proven
specific antibody failure
or serum IgG level of <4 g/l.
B)
To treat certain inflammatory disorders (immunomodulation). There are
5 groups:
1.
Patients who do not have enough blood platelets (primary immune
thrombocytopenia
(ITP) and who are at high risk of bleeding or will have surger

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Privigen 100 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)*
One ml contains:
Human normal immunoglobulin
100 mg
(purity of at least 98% IgG)
Each vial of 25 ml solution contains: 2.5 g human normal
immunoglobulin
Each vial of 50 ml solution contains: 5 g human normal immunoglobulin
Each vial of 100 ml solution contains: 10 g human normal
immunoglobulin
Each vial of 200 ml solution contains: 20 g human normal
immunoglobulin
Each vial of 400 ml solution contains: 40 g human normal
immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG
1
....................... 69 %
IgG
2
....................... 26 %
IgG
3
......................... 3 %
IgG
4
......................... 2 %
The maximum IgA content is 25 micrograms/ml.
*Produced from the plasma of human donors.
Excipients with known effects:
Privigen 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 infusion.
The solution is clear or slightly opalescent and colourless to pale
yellow.
Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:
–
Primary immunodeficiency syndromes (PID) 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 <4 g/l.
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide
and polypeptide antigen vaccines.
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
–
Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery
to correct the platelet coun