PENTAGLOBIN INJECTION 50 mgml

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

IMMUNOGLOBULIN (HUMAN)

זמין מ:

GRIFOLS ASIA PACIFIC PTE. LTD.

קוד ATC:

J06BA02

כמות:

50 mg/ml

טופס פרצבטיות:

INJECTION

הרכב:

IMMUNOGLOBULIN (HUMAN) 50 mg/ml

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

Prescription Only

תוצרת:

BIOTEST AG

מצב אישור:

ACTIVE

תאריך אישור:

1999-10-29

עלון מידע

185081
003
INSTRUCTIONS FOR USE / PATIENT INFORMATION LEAFLET
Active ingredient: Human normal immunoglobulin for intravenous
administration
COMPOSITION
1 ml solution contains:
–  ACTIVE INGREDIENT:
  Human plasma protein  

50 mg
  of which immunoglobulin is 
at least  95 %
  Immunoglobulin M (IgM) 

  6 mg
  Immunoglobulin A (IgA) 

  6 mg
  Immunoglobulin G (IgG) 

38 mg
–  EXCIPIENTS:
  Glucose monohydrate (27.5 mg), sodium chloride (78 µmol), 
  water for injections ad 1 ml
The distribution of IgG subclasses is approx. 63 % IgG1, 26 %
IgG2,
4 % IgG3 and 7 % IgG4
PRESENTATIONS AND CONTENTS OF CONTAINER
Solution for intravenous infusion.
Ampoule with 10 ml (0.5 g)
Vial with   50 ml (2.5 g), infusion set on request
Vial with 100 ml (5.0 g), infusion set on request
PHARMACOTHERAPEUTIC GROUP
Human immunoglobulin
NAME AND ADDRESS OF AUTHORISATION HOLDER AND MANUFACTURER
Biotest Pharma GmbH 
Landsteinerstrasse 5 
63303 Dreieich
Germany
INDICATIONS
Adjuvant therapy of severe bacterial infections additional to
antibiotic therapy.
Product is only intended for use in high risk patients with proven bacterial sepsis and 
who are unlikely to have underlying IgA deficiency.
Immunoglobulin substitution in immunocompromized patients.
CONTRAINDICATIONS
Hypersensitivity to any of the components of the product.
Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA 
deficiency, when the patient has antibodies against IgA.
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PREGNANCY AND LACTATION
The safety of this medicinal product for use in human pregnancy has not been estab-
lished in controlled clinical trials and therefore should only be given with caution to 
pregnant women and breast-feeding mothers. Clinical experience with immunoglobu-
lins suggests that no harmful effects on the course of pregnancy, or on the foetus and 

מאפייני מוצר

1
Package leaflet: Information for the user
PENTAGLOBIN®
Active substance:
Human normal immunoglobulin for intravenous administration
COMPOSITION
One ml solution contains:
-
Active substance:
Human plasma protein
50 mg
of which immunoglobulin is at least
95%
Immunoglobulin M (IgM)
6 mg
Immunoglobulin A (IgA)
6 mg
Immunoglobulin G (IgG)
38 mg
-
excipients:
Glucose monohydrate (27.5 mg) corresponding to 25mg glucose, sodium
chloride (78 µmol),
water for injections ad 1 ml
The distribution of IgG subclasses is approx. 63% IgG1, 26% IgG2, 4%
IgG3 and 7% IgG4
PHARMACEUTICAL FORM AND CONTENTS OF CONTAINER
Solution for intravenous infusion.
Pack size of 1 vial with 10 ml (0.5 g), 50 ml (2.5 g) or 100 ml (5.0
g) solution.
PHARMACOTHERAPEUTIC GROUP
Immunoglobulins, normal human, for intravascular administration
NAME AND ADDRESS OF AUTHORISATION HOLDER AND MANUFACTURER
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
INDICATIONS
Adjuvant therapy of severe bacterial infections additional to
antibiotic therapy.
Product is only intended for use in high risk patients with proven
bacterial sepsis and who are unlikely
to have underlying IgA deficiency.
Immunoglobulin substitution in immunocompromized patients.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed above.
Hypersensitivity to human immunoglobulins, especially in patients with
antibodies against IgA.
PREGNANCY AND LACTATION
The safety of this medicinal product for use in human pregnancy has
not been established in controlled
clinical trials and therefore should only be given with caution to
pregnant women and breast-feeding
mothers. IVIg products have been shown to cross the placenta,
increasingly during the third trimester.
Pentaglobin also contains IgM which does not cross the placenta.
Clinical experience with
immunoglobulins suggests that no harmful effects on the course of
pregnancy, or on the foetus and the
neonate are to be expected.
IgG are excreted into the milk and may contribute to the transfer of
p