CSL Behring Rhophylac

Rhophylac (anti-D immunoglobulin) is indicated for suppressing rhesus isoimmunization (Rh).

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What is Rhophylac

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 is a specific antibody called “anti-D (Rh) immunoglobulin”. This antibody works against Rhesus factor type D.

How Rhophylac works

If a Rh(D) negative person is given a sufficient amount of human anti-D (Rh) immunoglobulin, isoimmunisation against Rhesus factor type D can be prevented. To achieve this, treatment with

Rhophylac should commence before or early enough after the first contact to Rh(D) positive red blood cells. 

The anti-D (Rh) immunoglobulins contained in this medicine will then destroy the foreign Rh(D) positive red blood cells immediately. Thus, the person`s immune system will not be prompted to build-up its own antibodies.

What Rhophylac is used for

This medicine is used in two distinct situations:
A) You are a Rh(D) negative pregnant woman, who carries a Rh(D) positive baby.
In this special situation you may be immunised by Rh(D) positive red blood cells from your baby passing over into your own blood circulation. If this happens, the first baby is usually not affected and fully healthy.
However in your next Rh(D) positive baby, your antibodies would destroy the baby`s Rh(D) positive red blood cells during pregnancy. This may lead to complications in the development of your next baby, including its possible death.
For that reason, you may receive Rhophylac:
- when you carry or have just delivered a Rh(D) positive baby;
- when you lose a Rh(D) positive baby (death of the unborn child in the womb, miscarriage, threatened miscarriage or abortion);
- when your pregnancy is severely complicated (ectopic pregnancy or a pregnancy with a non-viable fertilized egg (hydatidiform mole));
- when it is likely that your baby`s Rh(D) positive red blood cells have passed over into your own blood circulation (transplacental haemorrhage resulting from antepartum haemorrhage). This
may, for example, happen when you experience vaginal bleedings during pregnancy;
- when your doctor needs to perform testing methods for fetal deformities (amniocentesis, chorionic biopsy, cordocentesis);
- when your doctor or midwife needs to try moving the baby from outside (e.g., external version of the baby or other obstetric manipulative procedures);
- when you have an accident hurting your stomach or gut (abdominal trauma).
This medicine is used also if you are a Rh(D) negative pregnant woman and it is not known if your baby is Rh(D) positive.
B) You are a Rh(D) negative adult, child or adolescent (0 - 18 years), who has accidentally received infusions (transfusions) of Rh(D) positive blood or other preparations containing Rh(D) positive red blood cells like “platelet concentrate” (mismatched transfusion).

What does Rhophylac contain

The active substance is human anti-D (Rh) immunoglobulin (antibodies of the IgG type against the Rhesus factor type D).

The other ingredients are human albumin, glycine, sodium chloride and water for injections.

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 human immunoglobulins (antibodies) of the IgG type. Rhophylac contains not more than 5 micrograms/ml human immunoglobulins (antibodies) of the IgA type.

Rhophylac contains no preservatives.

How to use

This medicine is a clear or slightly pearly and colourless or pale yellow solution for injection. Rhophylac is provided in a pre-filled glass syringe with 2 ml of ready-to-use sterile solution containing 300 micrograms (1,500 IU) of anti-D immunoglobulin.

Rhophylac 300 is available in single packs containing 1 pre-filled syringe and 1 injection needle, both packed in one blister pack (a clear plastic container sealed with a paper foil) or in multipacks comprising 5 single packs. Not all pack sizes may be marketed.

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, 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” and it usually takes some time (2–3 weeks). Therefore, the Rh(D) positive red blood cells will not be destroyed upon the first contact, and no signs or symptoms are usually seen then. But when the same Rh(D) negative person receives Rh(D) positive blood a second time, the antibodies will be “ready at hand” and her/his immune system will destroy the foreign Rh(D) positive red blood cells immediately.


The information presented above does not provide medical advice. It is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis or treatment. Seek professional medical advice to treat your condition.


Η εταιρεία CSL Behring εκπροσωπείται από την Prisum MONO στην Ρουμανία.