Gammanorm

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Immunoglobulin - normal

Disponibil de la:

Octapharma Australia Pty Ltd

Clasă:

Medicine Registered

Prospect

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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

Caracteristicilor produsului

 
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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 
  Polysorbate 
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.  
_PHARMACOKINETIC PROPERTIES _
With subcutaneous administration of human normal immunoglobulin, peak
levels are 
achieved in the recipient’s circulation after approximately 4-6
days.  

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In a clinical study the kinetics of IgG and IgG subclasses
were