RHOPHYLAC 1500IU human anti-D immunoglobulin solution for injection syringe

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

anti-D Rho immunoglobulin, Quantity: 1500 IU

Disponível em:

CSL Behring Australia Pty Ltd

DCI (Denominação Comum Internacional):

anti-D Rho immunoglobulin

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: chloride; glycine; sodium; Albumin

Via de administração:

Intravenous, Intramuscular

Unidades em pacote:

2 mL

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Prevention of Rh sensitisation in Rh(D)-negative females at or below child-bearing age and treatment of Rh(D)-negative persons after incompatible transfusions of Rh(D)-positive blood or other products containing red blood cells.

Resumo do produto:

Visual Identification: Clear or slightly opalescent, colourless to pale yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2009-12-22

Folheto informativo - Bula

Rhophylac AU CMI 5.00
Page 1 of 4
RHOPHYLAC
®
Human Anti-D (Rh
0
) Immunoglobulin solution for injection in pre-filled syringe.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Rhophylac
®
. It does not contain
complete information about
Rhophylac
®
. 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 RHOPHYLAC
® IS
USED FOR
WHAT IS RHOPHYLAC
®
?
Rhophylac
®
is a ready-to-use
solution for injection, which
comes in a pre-filled syringe.
The solution contains special
proteins, isolated from human
blood plasma. These proteins
belong to the class of so called
‘immunoglobulins’, also called
antibodies. The active ingredient
of Rhophylac
®
is a specific
antibody called ‘anti-D (Rh)
immunoglobulin’. This antibody
works against Rhesus factor
type D.
WHAT IS RHESUS FACTOR
TYPE D?
Rhesus factors are special
characteristics of human red
blood cells. About 85% of the
population carry the so called
Rhesus factor type D
(abbreviated ‘Rh(D)’). These
people are called
Rh(D)-positive. People who do
not carry Rhesus factor type D
are called Rh(D)-negative.
WHAT IS ANTI-D (RH)
IMMUNOGLOBULIN?
Anti-D (Rh) immunoglobulin is
an antibody, which works
against Rhesus factor type D
and is produced by the human
immune system. When a
Rh(D)-negative person receives
Rh(D)-positive blood, her/his
immune system will recognise
the Rh(D)-positive red blood
cells as ‘foreign’ to her/his
body, and will attempt to
destroy them. For this purpose,
the immune system will build
specific antibodies against
Rhesus factor type D. This
process is called ‘immunisation�

Características técnicas

Rhophylac AU PI 7.00
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
RHOPHYLAC
®
(HUMAN ANTI-D (RH
0
) IMMUNOGLOBULIN) – SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Human Anti-D (Rh
0
) Immunoglobulin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rhophylac
®
is a solution containing 750 IU (150 µg) per mL Human anti-D
immunoglobulin
corresponding to 1500 IU (300 µg)/2 mL.
The product contains a maximum of 30 mg/mL of human plasma proteins of
which
10 mg/mL is human albumin as stabiliser. At least 95% of the other
plasma proteins are IgG.
Rhophylac
®
contains not more than 5 µg/mL IgA.
Rhophylac
®
is a sterile, pyrogen-free liquid solution for intravenous and
intramuscular
administration. It is purified by means of an ion exchange
chromatography isolation
procedure resulting in high recovery of anti-D and a high specificity
of the product.
Solvent-detergent treatment and virus filtration clearance steps
included in the manufacturing
process ensure the viral safety of the product.
The solution also contains glycine, sodium chloride and human albumin.
3
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Rhophylac
®
is indicated for:
•
Prevention of Rh sensitisation in Rh(D)-negative females at or below
child-bearing age
and
•
Treatment of Rh(D)-negative persons after incompatible transfusions of
Rh(D)-positive
blood or other products containing red blood cells.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
It is recommended that prescribed doses of Rhophylac
®
should be expressed as International
Units written in full.
Rhophylac AU PI 7.00
Page 2 of 11
_PREVENTION OF RH(D) SENSITISATION IN RH(D)-NEGATIVE WOMEN _
TABLE 1
provides dosing guidelines for the prevention of Rh(D) sensitisation
in
Rh(D)-negative women.
TABLE 1: DOSING GUIDELINES
INDICATION
TIMING OF ADMINISTRATION
DOSE
Antepartum prophylaxis
At week 28–30 of gestation.
1500 International Units
(300 µg)
Postpartum prophylaxis
(required only if the newborn
is Rh(D) positive)
With