CSL CMV IMMUNOGLOBULIN VF (human) 1.5 million units/vial injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

human immunoglobulin G, Quantity: 50 mg/mL; cytomegalovirus immunoglobulin, Quantity: 1500000 U

Tilgjengelig fra:

CSL Behring Australia Pty Ltd

INN (International Name):

cytomegalovirus immunoglobulin,human immunoglobulin G

Legemiddelform:

Injection, intravenous infusion

Sammensetning:

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

Administreringsrute:

Intravenous

Enheter i pakken:

potency fill

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

CMV Immunoglobulin-VF is indicated for the prevention of CMV infection following bone marrow and renal transplants. Specifically, the product is indicated when the recipient is seronegative for CMV and receives a graft from a CMV positive donor. CMV Immunoglobulin-VF may also be a helpful adjunct to therapy in patients with established CMV infection, e.g. CMV pneumonitis.

Produkt oppsummering:

Visual Identification: Clear, colourless, slightly viscous solution; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-11-04

Informasjon til brukeren

CMV Immunoglobulin-VF AU CMI 16.00
Page 1 of 4
CMV IMMUNOGLOBULIN-VF
Human Cytomegalovirus Immunoglobulin, solution for intravenous
infusion.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about CMV
Immunoglobulin-VF. The letters
CMV stand for
cytomegalovirus, a type of virus.
It does not contain complete
information about CMV
Immunoglobulin-VF. 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 CMV
IMMUNOGLOBULIN-VF
IS USED FOR
CMV Immunoglobulin-VF is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood. Donations
are selected on the basis that
they contain high levels of
specific antibody to the
cytomegalovirus. CMV
Immunoglobulin-VF contains
protein substances called
antibodies, which can provide
protection against
cytomegalovirus infection.
CMV Immunoglobulin-VF is
used to prevent cytomegalovirus
infection in specific transplant
patients. It may also help in the
treatment of cytomegalovirus
infection.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY CMV
IMMUNOGLOBULIN-VF HAS BEEN
PRESCRIBED FOR YOU.
Your
doctor will have assessed the
risks and benefits associated
with the use of this medicine for
you.
BEFORE YOU ARE GIVEN
CMV
IMMUNOGLOBULIN-VF
MAKE SURE YOU TELL YOUR
DOCTOR OF ANY REASONS YOU
KNOW OF WHY YOU SHOULD NOT
BE GIVEN THIS MEDICINE.
INFORM YOUR DOCTOR OF YOUR
BLOOD GROUP, IF KNOWN.
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE:
•
a history of allergy to
human immunoglobulin
products (allergic reactions
may include skin rash, face
swelling, wheezing or
breathing difficulties) or
previ

Preparatomtale

CMV Immunoglobulin-VF AU PI 18.00
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
CMV IMMUNOGLOBULIN-VF
(HUMAN CYTOMEGALOVIRUS IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS
INFUSION
1
NAME OF THE MEDICINE
Human Cytomegalovirus Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CMV Immunoglobulin-VF is a sterile, preservative free solution
containing 50–70 mg/mL
human plasma protein of which at least 98% is immunoglobulin (mainly
IgG), with a
cytomegalovirus (CMV) immunoglobulin activity of 1.5 million units per
vial. The content of
CMV immunoglobulin is defined in terms of EIA (enzyme immunoassay)
units. One unit is
equivalent to the specified volume of a standard CMV Immunoglobulin.
The distribution of the IgG subclasses closely resembles that found in
normal human plasma
(approximate mean ranges: 52.5–64.9% IgG
1
, 29.0–42.2% IgG
2
, 3.1–6.8% IgG
3
, 0.4–
1.2% IgG
4
).
CMV Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
The pH value of the ready-to-use solution is 4.25.
CMV Immunoglobulin-VF is manufactured from human plasma collected by
Australian Red
Cross Lifeblood.
Isotonicity is achieved by the addition of 292 mmol/L maltose.
3
PHARMACEUTICAL FORM
Solution for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CMV Immunoglobulin-VF is indicated for the prevention of CMV infection
following bone
marrow and renal transplants. Specifically, the product is indicated
when the recipient is
seronegative for CMV and receives a graft from a CMV positive donor.
CMV Immunoglobulin-VF may also be a helpful adjunct to therapy in
patients with
established CMV infection, e.g. CMV pneumonitis.
CMV Immunoglobulin-VF AU PI 18.00
Page 2 of 11
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Because there is currently no international standard for CMV
Immunoglobulin-VF,
recommended dosage remains empirical. For prophylactic use it is
recommended that patients
receive 25,000 units/kg on days -4, -2, on the day of transplantation
(intra-operatively) and
then weekly for a fu