CUVITRU normal immunoglobulin (human) infusion 20% for subcutaneous use in glass vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

normal immunoglobulin, Quantity: 1 g

Dostępny od:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Nazwa):

normal immunoglobulin

Forma farmaceutyczna:

Solution

Skład:

Excipient Ingredients: glycine; water for injections

Droga podania:

Subcutaneous

Sztuk w opakowaniu:

2 g in 10 mL, 10 g in 50 mL, 4 g in 20 mL, 8 g in 40 mL, 1 g in 5 mL

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

CUVITRU is indicated as replacement therapy in adult and paediatric patients for,? Primary immunodeficiency diseases (PID) and,? Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Podsumowanie produktu:

Visual Identification: Clear and colourless to pale yellow or light brown solution; 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

Status autoryzacji:

Licence status A

Data autoryzacji:

2017-10-05

Ulotka dla pacjenta

CUVITRU
®
_Normal Immunoglobulin Infusion 20% (Human) for Subcutaneous Use_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CUVITRU.
It does not contain all of the available
information. All medicines have risks
and benefits. Your doctor has
weighed the risks of using your
medicine against the benefit that it
will have for you. 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 CUVITRU IS
Your medicine is CUVITRU, an
immunoglobulin solution for
subcutaneous infusion.
CUVITRU contains human
immunoglobulins. Immunoglobulins
are also known as antibodies and are
found in healthy people’s blood.
Antibodies are part of the immune
system (the body’s natural defences)
and help your body to fight
infections. If you do not have enough
antibodies you may not be able to
fight off infections.
WHAT CUVITRU IS
USED FOR
CUVITRU is used in patients who do
not have enough antibodies in their
blood.
CUVITRU can be used as antibody
replacement therapy to raise antibody
levels in your blood to normal levels.
Your doctor may have prescribed
CUVITRU for another reason.
CUVITRU has not been evaluated in
patients aged < 2 years.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
BEFORE YOU USE
CUVITRU
_ABOUT BLOOD PRODUCTS_
When medicines are made from
human blood or plasma, processes
are used to prevent infections being
passed from the blood/plasma donor
to the person receiving the medicine.
These processes include careful
selection of the people who donate
blood and plasma to make sure that
those who might be carrying
infections are excluded. In addition
each donation and pools of donations
are tested for indicators of virus

Charakterystyka produktu

CUVITRU PI V4.0 (CCDSv5.0)
Page
1
of
20
AUSTRALIAN PRODUCT INFORMATION
CUVITRU
® (NORMAL IMMUNOGLOBULIN SUBCUTANEOUS [HUMAN] 20%) INJECTION
1
NAME
OF
THE
MEDICINE
Normal Immunoglobulin Subcutaneous (Human).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION
TABLE 1: COMPOSITION OF THE CUVITRU 20 % (W/V) [IMMUNOGLOBULIN G (IGG)
200 MG/ML]
NAME OF THE COMPONENTS
NOMINAL VALUES PER VIAL EXPRESSED AS PROTEIN WITH AT LEAST
98% IGG CONTENT
5 ML
10 ML
20 ML
40 ML
ACTIVE INGREDIENT:
Normal Immunoglobulin (human)
contains at least 98% IgG.
1.0 g
2.0 g
4.0 g
8.0 g
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
DESCRIPTION
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 IgG
1
≥ 56.9%, IgG
2
≥ 26.6 %, IgG
3
≥ 3.4%, and IgG
4
≥ 1.7%.
3
PHARMACEUTICAL
FORM
Solution for subcutaneous injection.
APPEARANCE
CUVITRU is a clear and colourless to a pale yellow or light brown
solution.
4
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CUVITRU is indicated as replacement therapy in adult and paediatric
patients for:
•
Primary immunodeficiency diseases (PID) and
•
Symptomatic hypogammaglobulinaemia secondary to underlying disease or
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION ONLY.
CUVITRU should be inspected visually for particulate matter and
discoloration prior to
administration. Do not use if particulate matter and/or discoloration
is observed.
Start the infusion promptly after drawing CUVITRU into the syringe. It
is suggested to
complete the administration within 2 hours due to the potential
formation of particles caused
by siliconised syringes.
CUVITRU PI V4.0 (CCDSv5.0)
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20
CUVITRU must not be diluted.
Replacement therapy should be initiated and monitored under the
supervision of a physician
experienced in the treatment of immunodeficiency. Patients should be
closely monitored and
carefully observed for