KIOVIG normal immunoglobulin (human) 30g/300mL solution for injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

normal immunoglobulin, Quantity: 30 g

Tillgänglig från:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International namn):

normal immunoglobulin

Läkemedelsform:

Injection, solution

Sammansättning:

Excipient Ingredients: glycine; water for injections

Administreringssätt:

Subcutaneous, Intravenous

Enheter i paketet:

1 x 300mL vial

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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).

Produktsammanfattning:

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

Bemyndigande status:

Licence status A

Tillstånd datum:

2013-05-29

Bipacksedel

KIOVIG
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TREATED WITH KIOVIG?
KIOVIG contains the active ingredient normal immunoglobulin (human).
KIOVIG is used for the treatment of patients who do
not have sufficient antibodies (replacement therapy). KIOVIG is also
used for the treatment of patients with certain inflammatory
disorders (immunomodulation).
For more information, see Section 1. Why am I treated with KIOVIG? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH KIOVIG?
Do not use if you have ever had an allergic reaction to
immunoglobulins or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with KIOVIG? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KIOVIG and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS KIOVIG GIVEN?
•
KIOVIG is a 10% solution (100 mg/mL) for intravenous or a subcutaneous
infusion.
More instructions can be found in Section 4. How is KIOVIG given? in
the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH KIOVIG?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are being
treated with KIOVIG
•
Tell your doctor, if you are suffering from an immunoglobulin A
deficiency or planning to receive an
immunization
•
Discuss with your doctor, the progress you have experienced following
the treatment.
THINGS YOU
SHOULD NOT DO
•
Do not attempt to self-administer unless you have been trained by your
healthcare professional
•
Use of KIOVIG during pregnancy or breast-feeding is not recommended.
LOOKING AFTER
YOUR MEDICINE
•
Store at

Produktens egenskaper

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