Octagam

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

immunoglobulin human normal

Доступна с:

Octapharma Pharmazeutica Produktionsges. m.b.H. Oberlaaer Strasse 235

ИНН (Международная Имя):

immunoglobulin human normal

дозировка:

50mg/ml

Фармацевтическая форма:

solution for infusion

Тип рецепта:

Prescription

Характеристики продукта

_20130415_spc_840_AM_01.00_en.doc _
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SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM
50 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE INGREDIENTS
Human normal immunoglobulin (IVIg)
2.2
QUANTITATIVE COMPOSITION
1 ml solution contains:
Protein, of which > 95% is
human normal immunoglobulin G
50 mg
IgA
<0.2 mg
Distribution of IgG subclasses:
IgG
1
ca. 60%
IgG2
ca. 32%
IgG3
ca. 7%
IgG4
ca. 1%
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_4.1.1_
_ _
_REPLACEMENT THERAPY IN: _
•
Primary immunodeficiency syndromes such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
_20130415_spc_840_AM_01.00_en.doc _
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- common variable immunodeficiency
- severe combined immunodeficiencies
-
Wiskott Aldrich syndrome.
•
Myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.
•
Children with congenital AIDS who have repeated bacterial infections.
_4.1.2_
_ _
_IMMUNOMODULATION _
•
Idiopathic
thrombocytopenic
purpura
(ITP)
in
children
or
adults
at
high
risk
of
bleeding or prior to surgery to correct the platelet count.
•
Guillain Barré syndrome
•
Kawasaki disease.
_4.1.3_
_ _
_ALLOGENEIC BONE MARROW TRANSPLANTATION _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_4.2.1_
_ _
_POSOLOGY _
The dose and dosage regimen is dependant on the indication.
_ _
In
replacement
therapy
the
dosage
may
need
to
be
individualised
for
each
patient
dependant on the pharmacokinetic and clinical response.
The following dosage regimens are given as a guideline.
•
The dosage regimen should achieve a trough level of IgG (measured
before the next
infusion) of at least 4.0 - 6.0 g/l. Three to six months are required
after the initiation of
therapy for equilibration to occur. The recommended starting dose is
0.4 - 0.8 g/kg
followed by at least 0.2 g/kg every three weeks.
Replacement therapy in primary immunodefic