Intratect solution for infusion 50gl

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin)

זמין מ:

GRIFOLS ASIA PACIFIC PTE. LTD.

קוד ATC:

J06BA02

כמות:

50 mg/ml

טופס פרצבטיות:

INFUSION, SOLUTION

הרכב:

Human normal immunoglobulin (human plasma protein containing at least 96% immunoglobulin) 50 mg/ml

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

Biotest AG

מצב אישור:

ACTIVE

תאריך אישור:

2012-06-26

עלון מידע

184566
001
ACTIVE SUBSTANCE
Human normal immunoglobulin for intravenous administration
COMPOSITION
1 ml solution contains
–   active substance(s):
  human plasma protein 50 mg
  thereof immunoglobulin G ≥ 96 %
–   excipient(s):
  glycine (300 μmol), water for injections.
The distribution of IgG subclasses is defined around 57 % IgG1, 37 % IgG2, 
3 % IgG3 and 3 % IgG4.
The IgA content is ≤ 2 mg/ml.
PHARMACEUTICAL FORM
Solution for infusion
PRESENTATIONS
Vial with 20 ml, 50 ml, 100 ml and 200 ml.
PHARMACOTHERAPEUTIC GROUP
Human normal immunoglobulin for intravenous administration
NAME AND ADDRESS OF MANUFACTURER
Biotest Pharma GmbH, Landsteinerstrasse 5,
63303 Dreieich, Germany
INDICATIONS
Replacement therapy in adults. and children and adolescents (0-18 years) 
in:
•   Primary immunodeficiency syndromes with impaired antibody produc-
tion.
•   Hypogammaglobulinaemia and recurrent bacterial infections in
patients
with  chronic  lymphocytic  leukaemia,  in  whom  prophylactic  antibiotics 
have failed.
•   Hypogammablobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma patients who have failed to respond to pneumo-
coccal immunization.
PACKAGE LEAFLET 
50 mg/ml; solution for infusion
184.566.001.indd   1
22.06.2012   8:56:15 Uhr
•   Hypogammaglobulinaemia  in  patients  after  allogeneic  haematopoietic 
  stem cell transplantation (HSCT).
•   Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults. 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 count.
•   Guillain Barre syndrome.
•   Kawasaki disease.
CONTRA-INDICATIONS
Intratect® is contraindicated in patients who are intolerant to homologous immu-
noglobulins, especially in very rare cases�

מאפייני מוצר

Package Insert
INTRATECT®
50 g/l; solution for infusion
ACTIVE SUBSTANCE
Human normal immunoglobulin (IVIg)
COMPOSITION
1 ml solution contains
–
active substance(s):
Human normal immunoglobulin 50 mg
thereof immunoglobulin G ≥ 96 %
–
excipient(s):
glycine (300 μmol), water for injections.
The distribution of IgG subclasses is defined around 57 % IgG1, 37 %
IgG2, 3 % IgG3
and 3 % IgG4.
The IgA content is ≤ 900 micrograms/ml.
PHARMACEUTICAL FORM
Solution for infusion
PRESENTATIONS
Vial with 20 ml, 50 ml, 100 ml and 200 ml.
Each vial of 20 ml contains: 1 g of human normal immunoglobulin
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin
Each vial of 100 ml contains: 5 g of human normal immunoglobulin
Each vial of 200 ml contains: 10 g of human normal immunoglobulin
PHARMACOTHERAPEUTIC GROUP
Human normal immunoglobulin for intravenous administration
NAME AND ADDRESS OF MANUFACTURER
Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany
INDICATIONS
Replacement therapy in adults. and children and adolescents (0-18
years) in:
•
Primary immunodeficiency syndromes (PID) with impaired antibody
production.
•
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. 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 count.
•
Guillain Barre syndrome.
•
Kawasaki disease (in conjunction with acetylsalicylic acid).
•
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
•
Multifocal motor neuropathy (MMN)
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CONTRA-INDICATIONS
Hypersensitivity to the active substance (human immunoglobulins) or to
any of the excipients.
Patients with se