Normal Immunoglobulin-VF

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG)

זמין מ:

CSL Behring (NZ) Ltd

INN (שם בינלאומי):

Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG)

כמות:

160 mg/mL

טופס פרצבטיות:

Solution for injection

הרכב:

Active: Immunoglobulin G 160 mg/mL (Immunoglobulin ex NZ 16% IgG) Excipient: Glycine

יחידות באריזה:

Vial, glass, 2ml vial, 2 mL

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

CSL Behring (Australia) Pty Ltd

סממני תרפויטית:

Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness.

leaflet_short:

Package - Contents - Shelf Life: Vial, glass, - 2 mL - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, - 5 mL - 156 weeks from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

תאריך אישור:

1992-07-09

מאפייני מוצר

NEW ZEALAND DATA SHEET
Normal Immunoglobulin-VF NZ DS 13.00
Page
1
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10
1 PRODUCT NAME
Normal Immunoglobulin-VF, 160 mg/mL, solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Normal Immunoglobulin
Normal Immunoglobulin-VF is a sterile solution with no preservatives
containing 160 mg/mL human
plasma proteins. At least 98% of the protein is immunoglobulins
(mainly IgG).
Normal Immunoglobulin-VF is presented in single vials as follows:
•
2 mL of solution containing 320 mg of human normal immunoglobulin.
•
5 mL of solution containing 800 mg of human normal immunoglobulin.
Normal Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
Normal Immunoglobulin-VF is manufactured from human plasma donated by
New Zealand’s
voluntary and non-remunerated donors.
EXCIPIENTS WITH KNOWN EFFECT
Glycine (22.5 mg/mL)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The pH of the solution is 6.6.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMARY AND SECONDARY HYPOGAMMAGLOBULINAEMIA
Normal Immunoglobulin-VF is indicated in the management of congenital
and acquired forms of
primary hypogammaglobulinaemia. It may also be of value in treating
secondary forms of this
disorder as in leukaemia, nephrosis and acute protein-losing
enteropathy, particularly when there is a
tendency to recurrent infection.
In susceptible contacts of hepatitis A, measles and poliomyelitis,
Normal Immunoglobulin-VF may be
of value in preventing or modifying the disease. In general, the
earlier in the incubation period of
these diseases Normal Immunoglobulin-VF is given, the greater its
effectiveness.
NEW ZEALAND DATA SHEET
Normal Immunoglobulin-VF NZ DS 13.00
Page
2
of
10
HEPATITIS A
Routine passive protection is recommended in persons exposed less than
one week previously for the
following categories of individuals:
•
Household contacts of an index case, who have not already had
hepatitis A or have no serological
evidence of immunity to the virus.
•
Common sour