Rhophylac 300mcg/2ml Solution for Injection in pre-filled syringe

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

ANTI, D IMMUNOGLOBULIN, HUMAN

Verfügbar ab:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC-Code:

J06BB01

INN (Internationale Bezeichnung):

ANTI-D IMMUNOGLOBULIN, HUMAN 150 µg/ml

Darreichungsform:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Zusammensetzung:

ANTI-D IMMUNOGLOBULIN, HUMAN 150 µg/ml

Verschreibungstyp:

POM

Therapiebereich:

IMMUNE SERA AND IMMUNOGLOBULINS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2017-04-25

Gebrauchsinformation

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
RHOPHYLAC
® 300 MICROGRAMS / 2 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Human anti-D immunoglobulin
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor or healthcare
professional.
-
If you get any side effects, talk to your doctor or healthcare
professional. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Rhophylac is and what it is used for
2.
What you need to know before you are given Rhophylac
3.
How to use Rhophylac
4.
Possible side effects
5.
How to store Rhophylac
6.
Contents of the pack and other information
1.
WHAT RHOPHYLAC IS AND WHAT IT IS USED FOR
WHAT RHOPHYLAC IS
This medicine 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 “immunoglobulins”, also called antibodies.
The active ingredient of
Rhophylac 300 is a specific antibody called “anti-D (Rh)
immunoglobulin”. This antibody
works against Rhesus factor type D.
WHAT RHESUS FACTOR TYPE D IS
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 ANTI-D (RH) IMMUNOGLOBULIN IS
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, their immune system will recognise the Rh(D) positive
red blood cells as
“foreign” to their body, and will attempt to destroy them. For
this purpose, the immune
system will build specific antibodies ag

Fachinformation

Page
1
of
10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 1500 IU (300 micrograms) human anti-D
immunoglobulin*.
One ml contains 750 IU (150 micrograms) human anti-D immunoglobulin.
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.
Distribution of the IgG subclasses (approximate values):
IgG
1
84.1 %
IgG
2
7.6 %
IgG
3
8.1 %
IgG
4
1.0 %
The content of immunoglobulin A (IgA) is not more than 5
micrograms/ml.
*Produced from the plasma of human donors.
Excipient with known effect:
The maximal sodium content is 11.5 mg (0.5 mmol) per syringe.
Rhophylac contains no preservatives.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear or slightly opalescent and colourless or pale
yellow.
Rhophylac has an osmolality of at least 240 mosmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of Rh(D) isoimmunisation in Rh(D) negative women
•
Antepartum prophylaxis
-
Planned antepartum prophylaxis
-
Antepartum prophylaxis following complications of pregnancy including:
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole,
intrauterine fetal
death, transplacental haemorrhage resulting from ante-partum
haemorrhage,
Page
2
of
10
amniocentesis, chorionic biopsy, obstetric manipulative procedures
e.g. external
version, invasive interventions, cordocentesis, blunt abdominal trauma
or fetal
therapeutic intervention.
•
Postpartum prophylaxis
-
Delivery of a Rh(D) positive (D, D
weak
, D
partial
) baby
An Rh(D) incompatible pregnancy is assumed if the fetus/baby is either
Rh(D) positive or Rh(D)
unknown or if the father is either Rh(D) positive or Rh(D) unknown.
Treatment of Rh(D) negative adults, children and adolescents (0-18
years) after in