CSL NORMAL IMMUNOGLOBULIN VF (human) 320mg/2mL injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

normal immunoglobulin, Quantity: 320 mg

Prieinama:

CSL Behring Australia Pty Ltd

Vaisto forma:

Injection, solution

Sudėtis:

Excipient Ingredients: glycine; human immunoglobulin A

Vartojimo būdas:

Intramuscular

Vienetai pakuotėje:

2mL x 1

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Normal Immunoglobulin-VF is indicated in the management of congenital and acquired forms of primary hypogammaglobulinaemia. It may also be of value in treating secondary forms of this disorder as in leukaemia, nephrosis and acute protein-losing enteropathy, particularly when there is a tendency to recurrent infection. In susceptible contacts of hepatitis A, measles and poliomyelitis, Normal Immunoglobulin-VF may be of value in preventing or modifying the disease. In general, the earlier in the incubation period of these diseases Normal Immunoglobulin-VF is given, the greater its effectiveness. Hepatitis A-Routine passive protection is recommended in persons exposed less than one week previously for the following categories of individuals, Household contacts of an index case, who have not already had hepatitis A or have no serological evidence of immunity to the virus. Common source exposures. When a vehicle such as food or water is identified as a common source of infection for multiple hepatitis cases, administration of Normal Immunoglobulin-VF should be considered for all those exposed to the source. Institutional contacts. Staff in institutions where hepatitis is endemic. Routine prophylaxis is not recommended for school, office, factory or hospital contacts. Rubella, Although Normal Immunoglobulin-VF can prevent or modify the clinical disease in susceptible rubella contacts if given within 72 hours of exposure, it does not prevent viraemia in such patients. It should, therefore, not be relied upon to prevent congenital malformations due to rubella if given to susceptible pregnant women during the first trimester. Measles (Morbilli), Normal Immunoglobulin-VF is indicated for protection against measles in persons exposed less than one week previously. It is recommended in children under six months of age whose mothers have not had the disease, in children between six months and three years of age who have not been actively immunised and in immunosuppressed contacts of the index case. Poliomyelitis, Normal Immunoglobulin-VF is recommended for susceptible contacts who have not been immunised against poliomyelitis.

Produkto santrauka:

Visual Identification: Clear to opalescent, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

1998-10-21

Pakuotės lapelis

Normal Immunoglobulin-VF AU CMI 10.00
Page 1 of 3
NORMAL IMMUNOGLOBULIN-VF
Human Normal Immunoglobulin, solution for intramuscular injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Normal Immunoglobulin-VF. It
does not contain complete
information about Normal
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 NORMAL
IMMUNOGLOBULIN-VF
IS USED FOR
Normal Immunoglobulin-VF is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood. Normal
Immunoglobulin-VF contains
protein substances called
antibodies which can provide
protection against some
infectious diseases. It can
prevent infection if given to
people with low levels of
antibodies.
Normal Immunoglobulin-VF is
used to treat conditions where
low antibody levels in the blood
are inherited, and in other
diseases where a lack of
antibody may cause frequent
infections.
It is also used to prevent
infection by viruses such as
poliomyelitis, hepatitis A, and
measles in those coming in
contact with a source of
infection, such as family
members.
Ask your doctor if you have any
questions about why Normal
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
NORMAL
IMMUNOGLOBULIN-VF
Normal Immunoglobulin-VF
must not be used if you have a
history of allergy to this
medicine. Tell your doctor if
you have allergies to any other
medicines, or if you have ever
had an allergic reaction to an
injection.
TELL YOUR DOCTOR

Prekės savybės

Normal Immunoglobulin-VF AU PI 11.00
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
NORMAL IMMUNOGLOBULIN-VF
(
HUMAN NORMAL IMMUNOGLOBULIN
)
1
NAME OF THE MEDICINE
Human Normal Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Normal Immunoglobulin-VF is a sterile, preservative-free solution
containing 160 mg/mL
human plasma proteins and 22.5 mg/mL glycine. At least 98% of the
protein is
immunoglobulins (mainly IgG).
Normal Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A
(IgA).
Normal Immunoglobulin-VF is manufactured from human plasma collected
by Australian
Red Cross Lifeblood.
3
PHARMACEUTICAL FORM
Solution for intramuscular injection.
The solution has a pH of 6.6.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Normal Immunoglobulin-VF is indicated in the management of congenital
and acquired
forms of primary hypogammaglobulinaemia. It may also be of value in
treating secondary
forms of this disorder as in leukaemia, nephrosis and acute
protein-losing enteropathy,
particularly when there is a tendency to recurrent infection.
In susceptible contacts of hepatitis A, measles and poliomyelitis,
Normal
Immunoglobulin-VF may be of value in preventing or modifying the
disease. In general, the
earlier in the incubation period of these diseases Normal
Immunoglobulin-VF is given, the
greater its effectiveness.
HEPATITIS A
Routine passive protection is recommended in persons exposed less than
one week previously
for the following categories of individuals:
•
Household contacts of an index case, who have not already had
hepatitis A or have no
serological evidence of immunity to the virus.
Normal Immunoglobulin-VF AU PI 11.00
Page 2 of 10
•
Common source exposures. When a vehicle such as food or water is
identified as a
common source of infection for multiple hepatitis cases,
administration of Normal
Immunoglobulin-VF should be considered for all those exposed to the
source.
•
Institutional contacts.
•
Staff in institutions where hepatitis is endemic.
Routine prophylaxis is not recommended