CSL Rh(D) IMMUNOGLOBULIN VF (human) 250 IU injection vial

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

anti-D Rho immunoglobulin, Quantity: 250 IU; anti-D Rho immunoglobulin, Quantity: 10 mg/mL

Tersedia dari:

CSL Behring Australia Pty Ltd

INN (Nama Internasional):

anti-D Rho immunoglobulin

Bentuk farmasi:

Injection, solution

Komposisi:

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

Rute administrasi :

Intramuscular

Unit dalam paket:

1 x 3mL vial

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Rh(D) Immunoglobulin is indicated for the prevention of Rh sensitisation in Rh(D)negative females at or below child bearing age.

Ringkasan produk:

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

Status otorisasi:

Registered

Tanggal Otorisasi:

2000-11-13

Selebaran informasi

Rh(D) Immunoglobulin-VF AU CMI 14.00
Page 1 of 3
RH(D) IMMUNOGLOBULIN-VF
Human Anti-D Rh
o
Immunoglobulin, solution for intramuscular injection.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Rh(D) Immunoglobulin-VF. It
does not contain complete
information about
Rh(D) 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 RH(D)
IMMUNOGLOBULIN-VF
IS USED FOR
Rh(D) Immunoglobulin-VF is
manufactured from human
plasma (the liquid component of
blood) collected by Australian
Red Cross Lifeblood.
Rh(D) Immunoglobulin-VF
contains protein substances
called antibodies which are an
important component of the
body’s natural defence system.
If a pregnant woman has an
Rh(D) negative blood group and
her baby is Rh(D) positive, the
baby’s blood is incompatible
with the mother’s and this could
cause Haemolytic Disease of the
Newborn (HDN). HDN may
lead to serious complications
such as severe anaemia, brain
damage and even death of the
baby in rare cases. The
antibodies in Rh(D)
Immunoglobulin-VF can
prevent HDN from developing.
Rh(D) Immunoglobulin-VF is
also given to a woman who has
an Rh(D) negative blood group
after she has given birth to an
Rh(D) positive baby to prevent
HDN from occurring during the
next pregnancy. Sometimes it is
given on other occasions when a
woman of child-bearing age
may become exposed to Rh(D)
positive blood: for example,
after blood transfusion,
amniocentesis (taking a sample
of the fluid surrounding the
unborn baby), miscarriage or
stillbirth.
Ask your doctor if you have any
questions about why
Rh(D) Immunoglobu

Karakteristik produk

Rh(D) Immunoglobulin-VF AU PI 15.00
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
RH(D) IMMUNOGLOBULIN-VF
(
HUMAN ANTI-D RH
O IMMUNOGLOBULIN
) – SOLUTION FOR INTRAMUSCULAR
INJECTION
1
NAME OF THE MEDICINE
Human Anti-D Rh
o
Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rh(D) Immunoglobulin-VF is a sterile, preservative-free solution
containing human plasma
protein of which at least 98% is immunoglobulin (mainly IgG), with an
anti-D (Rh
o
)
antibody content of 625 IU per vial/ ≥10 mg/mL human plasma proteins
or 250 IU per vial/
≥10 mg/mL human plasma proteins.
The pH value of the ready-to-use solution is 6.6.
Rh(D) Immunoglobulin-VF is manufactured from human plasma collected by
Australian Red
Cross Lifeblood.
Rh(D) Immunoglobulin-VF contains 22.5 mg/mL glycine.
3
PHARMACEUTICAL FORM
Solution for intramuscular injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Rh(D) Immunoglobulin-VF is indicated for the prevention of Rh
sensitisation in Rh(D)
negative females at or below child bearing age.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_SENSITISING EVENTS IN PREGNANCY (unless the blood type of the foetus
is confirmed to be _
_Rh(D) negative) _
The recommended dose of anti-D immunoglobulin is:
•
250 IU after sensitising events in the first trimester of pregnancy
and
•
625 IU after sensitising events beyond the first trimester.
Rh(D) Immunoglobulin-VF AU PI 15.00
Page 2 of 10
If the gestational age is not known with certainty and the possibility
exists that the gestational
age is 13 weeks or more, 625 IU should be given.
In twin and multiple pregnancies in the first trimester, 625 IU should
be given.
The dose should be given as soon as possible and within 72 hours of
the event.
Sensitising events include normal delivery, miscarriage, termination
of pregnancy, ectopic
pregnancy, chorionic villus sampling, amniocentesis, cordocentesis,
abdominal trauma
considered sufficient to cause foeto-maternal haemorrhage, antepartum
haemorrhage and
external cephalic version.
Since evidence of the ef