GAMMANORM normal immunoglobulin (human) 3300mg/20mL solution for intramuscular injection or subcutaneous infusion vial

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

normal immunoglobulin, Quantity: 3300 mg

Fáanlegur frá:

Octapharma Australia Pty Ltd

INN (Alþjóðlegt nafn):

normal immunoglobulin

Lyfjaform:

Injection, solution

Samsetning:

Excipient Ingredients: tributyl phosphate; sodium chloride; water for injections; human immunoglobulin A; glycine; polysorbate 80; sodium acetate

Stjórnsýsluleið:

Subcutaneous, Intramuscular

Einingar í pakka:

10 x 20mL vial, 20 x 20mL vial, 1 x 20mL vial

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Replacement therapy in adults and children in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency (CVID), severe combined immunodeficiencies, IgG subclass deficiencies with recurrent infections. Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Vörulýsing:

Visual Identification: Clear to slightly opalescent and pale yellow to light brown solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2008-01-18

Upplýsingar fylgiseðill

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CONSUMER MEDICINE INFORMATION (CMI)
GAMMANORM
®
HUMAN NORMAL IMMUNOGLOBULIN 165 MG/ML, SOLUTION FOR INTRAMUSCULAR
INJECTION OR SUBCUTANEOUS INFUSION
gammanorm
®
contains human normal immunoglobulin G (IgG) (165 mg/mL) with a
broad spectrum of antibodies against infectious agents. gammanorm
®
also contains
low levels of IgA (

82.5 microgram/mL).
10 ML VIAL
AUST R 128703
20 ML VIAL
AUST R 128705
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about gammanorm
®
. It does not contain
complete information about gammanorm
®
. It does not take the place of talking to
your doctor. If you have any concerns about using this product, ask
your doctor.
Follow your doctor's advice even if it is different from what this
leaflet says.
Please read this leaflet carefully and keep it for future reference.
However, the
information in this leaflet is subject to change. Please check with
your doctor whether
there is any new information about this product that you should know
since you were
last treated with this product.
WHAT GAMMANORM IS USED FOR
gammanorm
®
is prepared from blood obtained from donors. gammanorm
®
contains
proteins known as antibodies which can provide protection against some
infections.
gammanorm
®
is used to treat patients who need replacement of antibodies due to an
inherited disease (where antibody levels are low) or in other diseases
where a lack of
antibodies may cause frequent infections.
Ask your doctor if you have any questions about why gammanorm
®
has been
prescribed for you. Your doctor will have assessed the risks and
benefits for you
associated with the use of this product.
BEFORE YOUR DOCTOR GIVES YOU GAMMANORM
_SPECIAL WARNING _
This product is made from human plasma obtained from donors. When
medicines are
made from human blood or plasma, certain measures are put in place to
prevent
infections being passed on to patients. These include careful
selection of the blood
and plasma donors to make sure those at risk of carrying infections
are excluded, and

Vara einkenni

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PRODUCT INFORMATION
GAMMANORM
®
NAME OF DRUG
gammanorm
®
, Human Normal Immunoglobulin (SC/IMIg), 165 mg/mL, solution for
intramuscular injection or subcutaneous infusion
One vial of 10 mL gammanorm
®
contains 1650 mg human normal immunoglobulin.
One vial of 20 mL gammanorm
®
contains 3300 mg human normal immunoglobulin.
DESCRIPTION
gammanorm
®
contains human normal immunoglobulin G (IgG) ≥ 95%, with a broad
spectrum of antibodies against infectious agents. The Immunoglobulin A
(IgA) content is ≤
82.5 micrograms/mL. It is composed of the following distribution of
IgG subclasses:
IgG
1
ca. 59%
IgG
2
ca. 36%
IgG
3
ca. 4.9%
IgG
4
ca. 0.5%
gammanorm
®
contains all the IgG antibodies which are present in the normal
population. It is
prepared from pooled material from more than 1000 donors.
Quantitative composition
1 mL of solution contains:
Protein, of which at least 95% is
Human Normal Immunoglobulin G
165 mg
Glycine
20 mg
Sodium chloride and sodium acetate
corresponding to sodium
2.5 mg
Polysorbat 80
30 µg
Water for Injections
1 mL
IgA
≤ 82.5 micrograms
PHARMACOLOGY
_PHARMACODYNAMIC PROPERTIES _
ATC code: J06B A01
Human normal immunoglobulin contains the IgG antibodies present in the
normal population,
with a broad spectrum of antibodies against infectious agents.
gammanorm
®
has a distribution
of IgG subclasses closely proportional to that in native human plasma.
Adequate doses of
gammanorm
®
may restore abnormally low IgG levels to the normal range.
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_PHARMACOKINETIC PROPERTIES _
With subcutaneous administration of human normal immunoglobulin, peak
levels are
achieved in the recipient’s circulation after approximately 4-6
days.
In a clinical study the kinetics of IgG and IgG subclasses were
studied in 23 patients with
Common Variable Immunodeficiency (CVID) who received human normal
immunoglobulin
subcutaneously (SC) at a dose of 100 mg/kg/week for a period of 18
months . Seventeen of
these patients had been treated previously by the IM or IV routes. Out
of the