INTRAGAM P immunoglobulin-normal (human) 3g/50mL for intravenous use injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
27-11-2018
Summary of Product characteristics
(SPC)
27-11-2018
Public Assessment Report
(PAR)
01-12-2017
Active ingredient:
normal immunoglobulin, Quantity: 60 mg/mL
Available from:
CSL Behring Australia Pty Ltd
INN (International Name):
normal immunoglobulin
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; human immunoglobulin A; maltose
Administration route:
Intravenous
Units in package:
50mL x 1
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Intragam P is indicated in replacement Immunoglobulin G (IgG) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. INDICATIONS AS AT 21 JULY 2000: Replacement IgG therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. Immunomodulatory therapy in: idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; Kawasaki disease. INDICATIONS AS AT 25 FEBRUARY 2003: For replacement immunoglobulin G (IgG) therapy in: Primary immunodeficiency; Myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; Congenital acquired immune deficiency syndrome with recurrent infections. For immunomodulatory therapy in: Idiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; Allogeneic bone marrow transplantation; Kawasaki disease, and; Guillain-Barre Syndrome (GBS).
Product summary:
Visual Identification: A clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
1999-05-28
Patient Information leaflet
Intragam P AU CMI 15.00
Page 1 of 4
INTRAGAM
® P
Human Normal Immunoglobulin, solution for intravenous infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Intragam
®
P. It does not contain
complete information about
Intragam
®
P. It does not take the
place of talking to your doctor.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,_ _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.
The information in this leaflet is
subject to change. Please check
with your doctor whether there
is any new information about
this medicine that you should
know since you were last
treated.
WHAT INTRAGAM
® P IS
USED FOR
Intragam
®
P is manufactured
from human plasma (the liquid
component of blood)
_ _
collected
by the Australian Red Cross
Blood Service. Intragam
®
P is
used for patients who need
replacement of antibodies which
form part of our immune system
and can provide protection
against some infections.
Intragam
®
P is also used in
diseases when the immune
system is overactive, these are
called autoimmune disorders.
Ask your doctor if you have any
questions about why
Intragam
®
P has been prescribed
for you. Your doctor will have
assessed the risks and benefits
for you associated with the use
of this medicine.
_ _
BEFORE YOU ARE GIVEN
INTRAGAM
® P
INTRAGAM
® P MUST NOT BE USED
IF YOU HAVE A HISTORY OF ALLERGY
TO HUMAN IMMUNOGLOBULIN
PRODUCTS. TELL YOUR DOCTOR IF
YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES, OR IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO AN
INJECTION.
TELL YOUR DOCTOR ALSO IF YOU:
•
have previously been
advised that you have
Immunoglobulin A (IgA)
deficiency
•
have previously been
advised that you have
kidney disease
•
have a history of heart, or
blood vessel disease, or
blood clots, have thick
blood, have been immobile
for some time. Also tell the
doctor what medicine you
are using as some
medicines, such as those
that
Read the complete document
Summary of Product characteristics
Intragam P AU PI 15.00
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
INTRAGAM
® P
(HUMAN NORMAL IMMUNOGLOBULIN)
1
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Intragam
®
P is a sterile, preservative free solution for intravenous infusion
containing 6 g of
human protein and 10 g of maltose in each 100 mL. The solution has a
pH of 4.25. Isotonicity
is achieved by the addition of maltose. At least 98% of the protein
has the electrophoretic
mobility of immunoglobulin G (IgG). At least 90% of the protein is IgG
monomer and dimer.
Based on three preclinical and four clinical batches, the distribution
of IgG subclasses present
in Intragam
®
P is, on the average, 61% IgG
1
, 36% IgG
2
, 3% IgG
3
and 1% IgG
4
. Intragam
®
P
contains only trace amounts of IgA (nominally <0.025 mg/mL).
Intragam
®
P is manufactured from human plasma collected by the Australian Red
Cross
Blood Service.
Excipient of known effect: maltose.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Intragam
®
P is indicated for replacement IgG therapy in:
•
Primary Immunodeficiency Diseases (PID)
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
Intragam
®
P is indicated for immunomodulatory therapy in:
•
Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at
high risk of bleeding
or prior to surgery to correct the platelet count
•
Kawasaki disease
•
Guillain-Barré Syndrome (GBS).
Comprehensive evidence-based guidelines describing appropriate
clinical use of intravenous
immunoglobulin in ITP have been published and should be followed
wherever possible to
avoid the inappropriate utilisation of this blood product
1, 2
.
Intragam P AU PI 15.00
Page 2 of 13
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_REPLACEMENT THERAPY _
The optimal dose and frequency of administration of Intragam
®
P must be determined for
each patient
_._
Freedom from recurrent bacterial infections is usually achieved with a
serum
IgG level above
Read the complete document
