KIOVIG normal immunoglobulin (human) 1g/10mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

normal immunoglobulin, Quantity: 100 mg/mL

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

normal immunoglobulin

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Subcutaneous

Units in package:

1 X 10mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KIOVIG administered intravenously is indicated for:,1. Replacement therapy indications,? Primary immunodeficiency disorders (PID);,? Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. Immunomodulation indications,? Idiopathic thrombocytopenia purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? Guillain Barr? Syndrome;,? Kawasaki Disease;,? Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults.,? Multifocal Motor Neuropathy (MMN).,KIOVIG administered subcutaneously is indicated for:,1. Replacement therapy indications,? Primary immunodeficiency disorders (PID).

Product summary:

Visual Identification: The solution should be relatively clear with a slight opalescense.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2008-09-02

Patient Information leaflet

KIOVIG
_Normal Immunoglobulin (Human)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about the KIOVIG. It does
not contain all of the available
information. All medicines have risks
and benefits.
Your doctor has weighed the risks
against the benefits for you by using
KIOVIG.
It does not take the place of talking to
your doctor or pharmacist. If you
have any concerns about having this
medicine, ask your doctor or
pharmacist. Please read this leaflet
carefully and keep it for future
reference. Please also note that this
leaflet is subjected to change,
therefore, ask your doctor whether
this is the latest information
regarding this medicine.
WHAT KIOVIG IS USED
FOR
KIOVIG is used for:
TREATMENT OF PATIENTS WHO DO NOT
HAVE SUFFICIENT ANTIBODIES
(REPLACEMENT THERAPY):
-
Primary immunodeficiency
disorders
-
Disease or medical treatment that
leads to a lack of antibody
production and frequent infection
(secondary
hypogammaglobulinaemia).
TREATMENT OF PATIENTS WITH CERTAIN
INFLAMMATORY DISORDERS
(IMMUNOMODULATION):
-
Idiopathic thrombocytopenic
purpura (ITP, a disease where
patients do not have enough
blood platelets), who are at high
risk of bleeding or prior to
surgery to correct the platelet
count.
-
Guillain Barré syndrome (a
disease with multiple
inflammations of the nervous
system of the whole body)
-
Kawasaki disease (a disease
which results in multiple
inflammations of several organs)
-
Chronic inflammatory
demyelinating
polyradiculoneuropathy (CIDP)
in adults
-
Multifocal motor neuropathy
HOW DOES KIOVIG
WORK
KIOVIG belongs to a class of
medicines called immunoglobulins.
These medicines contain human
antibodies, which are also present in
your blood. Antibodies help your
body to fight infections.
Immunoglobulins are used in patients
who do not have enough antibodies
in their blood and tend to get
frequent infections. They can also be
used in patients who need additional
antibodies for the treatment of certain
inflammatory disorders.
The active component in KIOV

Summary of Product characteristics

KIOVIG PI V3.0 (CCDS v1.0)
1
AUSTRALIAN PRODUCT INFORMATION
KIOVIG
® (NORMAL IMMUNOGLOBULIN (HUMAN))
1
NAME
OF
THE
MEDICINE
Normal Immunoglobulin (Human).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KIOVIG vials contain 1.0 g in 10 mL, 2.5 g in 25 mL, 5.0 g in 50 mL,
10.0 g in 100 mL, 20.0
g in 200 mL or 30.0 g in 300 mL of the active normal immunoglobulin
(Human)
[Immunoglobulin G (IgG) 100 mg/mL].
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
DESCRIPTION
The active ingredient in KIOVIG is a human plasma-derived
immunoglobulin, concentration
of 100 mg/mL (10% w/v), produced from large pools of human plasma by a
modified Cohn-
Oncley cold ethanol fractionation, yielding an intermediate
immunoglobulin G (IgG), referred
to as Precipitate G. During the cold ethanol plasma fractionation
manufacturing process, the
level of viral burden in a plasma pool has been largely reduced to a
certain extent, as
demonstrated by viral spiking experiment. Precipitate G is further
purified by means of a weak
cation-exchange and anion-exchange chromatography.
To reduce further a possible viral transmission to a minimal level, a
triple step of viral
inactivation (TVR inactivation), [solvent detergent (S/D),
nano-filtration (35nm), and
incubation at a low pH and elevated temperature (30ºC to 32 ºC,
pasteurisation for 21 to 23
days) has been incorporated into the downstream purification. Thus,
the active ingredient
formulated in KIOVIG has been subjected to a rigorous elimination for
both lipid and non-
lipid enveloped viruses.
The manufacturing processes do not affect the composition of the
immunoglobulin in the
normal human plasma origin. The distribution of the IgG sub-classes
formulated in this
product comprises IgG1 ≥ 56.9%, IgG2 ≥ 26.6 %, IgG3 ≥ 3.4%, and
IgG4 ≥ 1.7%.
It contains immunoglobulin A (IgA) at a trace level, which is not more
than 0.14 mg/mL. The
preparation is a sterile, nonpyrogenic, isotonic solution with
osmolality of 240 to 300
mOsmol/kg and a pH of 4.6 to 5.1. At this low pH the f