EVOGAM normal immunoglobulin (human) 16% w/v, 0.8g/5mL injection solution vial for subcutaneous use

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 0.8 g

Available from:

CSL Behring Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glycine; human immunoglobulin A; water for injections

Administration route:

Subcutaneous

Units in package:

5mL x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Evogam is indicated in adults and children for replacement therapy in: Primary Immunodeficiency Disease (PID) and Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Product summary:

Visual Identification: The solution is clear and pale-yellow to light-brown. If Evogam appears to be turbid or to contain sediment it must not be used.; 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:

2012-03-30

Patient Information leaflet

Evogam
AU CMI 10.00
Page 1 of 6
EVOGAM
®
Normal Immunoglobulin (Human) 16%, solution for subcutaneous
administration.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Evogam
®
.
It does not contain all the
available information. If you
require further information
about this medicine or your
treatment, have any questions,
or are not sure about something
in this leaflet, consult your
doctor.
All medicines have benefits and
risks. Your doctor has weighed
the benefits that Evogam
®
will
have for you against the possible
risks.
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.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT EVOGAM
® IS
USED FOR
Your medicine is Evogam
®
, a
solution for subcutaneous
infusion. Evogam
®
contains
human immunoglobulins and is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood.
Immunoglobulins are also called
antibodies and are a type of
protein found in the blood.
Immunoglobulins are produced
by your body’s immune system
to fight infections caused by
bacteria and viruses. If you do
not have enough antibodies you
may not be able to fight off
diseases. Evogam
®
can be used
as antibody replacement
therapy, to correct this lack of
antibodies.
Your doctor may have
prescribed Evogam
®
for another
reason. Ask your doctor if you
have any questions about why it
has been prescribed for you.
BEFORE YOU RECEIVE
EVOGAM
®
WHEN YOU MUST NOT
HAVE IT
DO NOT HAVE EVOGAM
® IF YOU
ARE ALLERGIC TO:
•
human immunoglobulin
products
•
glycine.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD BE GIVEN THIS
MEDICINE TALK TO YOUR DOCTOR.
BEFORE YOU ARE GIVEN
IT
TELL YOUR DOCTOR IF YOU:
•
are pregnant or
breast-feeding
•
have had any vaccination
within the last two weeks
•
are allergic to any medicine
or food
•
have IgA deficiency
•
have a history of heart, or
blood v

Summary of Product characteristics

Evogam AU PI 10.00
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
EVOGAM
®
(NORMAL IMMUNOGLOBULIN (HUMAN)) – SOLUTION FOR SUBCUTANEOUS INFUSION
1
NAME OF THE MEDICINE
Normal Immunoglobulin (Human)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Evogam
®
is a sterile preservative-free solution containing 16 g/100 mL of
total human
plasma protein of which at least 98% is immunoglobulin G (IgG). At
least 85% consists of
monomers and dimers (typically >90%) and <10% of the IgG are
aggregates.
The distribution of the IgG subclasses closely resembles that found in
normal human plasma
(approximate ranges for Evogam
®
: 47.8–58.1% IgG
1
, 38.8–49.3% IgG
2
, 0.9–1.4% IgG
3
, 1.4–
2.1% IgG
4
).
Evogam
®
contains only trace amounts of IgA, typically <0.025 mg/mL.
The pH value of the ready-to-use solution is 5.5.
Evogam
®
is manufactured from human plasma collected by Australian Red Cross
Lifeblood.
Evogam
®
contains 2.25 g of glycine per 100 mL as a stabiliser.
3
PHARMACEUTICAL FORM
Solution for subcutaneous administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Evogam
®
is indicated in adults and children for replacement therapy in:
•
Primary Immunodeficiency Diseases (PID) and
•
symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Evogam
®
must be administered
SUBCUTANEOUSLY
.
Treatment should be initiated and monitored under the supervision of a
physician experienced
in the treatment of immunodeficiency.
Evogam AU PI 10.00
Page 2 of 13
DOSAGE
The dose and dosage interval must be individualised for each patient
based on their measured
IgG trough levels and ongoing clinical response. The following dose
regimens are given as a
guideline.
A weekly dose in the range 0.05–0.15 g/kg body weight is recommended
(this corresponds to
a total monthly dose of Evogam
®
in the range of 0.2–0.6 g/kg body weight).
As the dose is given by body weight and adjusted to clinical outcome,
the dose in the
paediatric population is not considered to