Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe

• 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.

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

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.

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.

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 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 their immune system will destroy the foreign Rh(D) positive red blood cells immediately.

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.

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 300:

• 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 fertilised 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 foetal 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).

• If you are allergic (hypersensitive) to human immunoglobulins or any of the other ingredients of this medicine (listed in section 6).
  • Tell your doctor or healthcare professional prior to treatment about any medicine which you have not well tolerated earlier.
• You must not receive injections into a muscle, if you suffer from a severe reduction in the number of platelets (thrombocytopenia) or any other severe blood clotting disorder.
  • Tell your doctor or healthcare professional prior to treatment if this applies to you. In this case this medicine may be given to you only by injection into a vein.

• Talk to your doctor or healthcare professional before you are given Rhophylac.

• For protecting Rh(D) negative women after delivery of a Rh(D) positive baby, this medicine is always given to the mother, not to the new-born baby.
• This medicine is not intended for use in Rh(D) positive persons, nor for individuals already immunised to Rh(D) antigen.

When stopping the administration may be required

• Rhophylac may trigger hypersensitivity reactions (allergic-type). In rare cases, allergic reactions such as a sudden fall in blood pressure or shock may occur (see also section 4 ‘Possible side effects’) even if you have previously received human immunoglobulins and tolerated them well.
  • Tell your doctor or healthcare professional immediately if such reactions occur. He or she will then stop the administration of the product and treat you depending on the nature and severity of the side effect.

Your doctor or healthcare professional will take special care

• if you have low levels of the IgA type immunoglobulins you are more likely to experience a hypersensitivity reaction.
  • Tell your doctor or healthcare professional if you have low levels of IgA. He or she will then very thoroughly weigh the benefit of treatment with this medicine against the increased risk of hypersensitivity reactions.
• if you are treated with this medicine after a mismatched transfusion, you may receive quite a large amount of the product (up to 3000 micrograms, equivalent to 20 ml or 10 syringes). In this case a so called haemolytic reaction occurs. This results from the intended destruction of the foreign Rh(D)-positive red blood cells. For this reason, your doctor or healthcare professional will monitor you closely and may need to do special blood tests.
• if your body mass index (BMI) is greater or equal to 30 (calculated by dividing your body mass by the square of your height), the injection of Rhophylac into a muscle may not be fully effective. In this case, your doctor or healthcare professional should rather inject this medicine into a vein.

Information on safety with respect to infections

This medicine is made from human blood plasma (this is the liquid part of the blood).

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• the testing of each donation and pools of plasma for signs of virus/infections,
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus.

The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections, which are contained in the product, are protective.

It is strongly recommended that every time you receive a dose of Rhophylac, the name and batch number of the product are recorded in order to maintain a record of the batches used.

Blood tests

• Tell your doctor or healthcare professional that you were treated with Rhophylac if you or your new-born baby have any blood tests (serological testing).

After you were given this medicine, the results of some blood tests may be altered for a certain period of time. If you are a mother having received this medicine before delivery, the results of some blood tests in your new-born baby may also be affected.

• Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines. This also applies to medicines obtained without a prescription.

Vaccinations

• Tell your doctor or healthcare professional prior to treatment if you have just had a vaccination within the last 2 to 4 weeks. Also inform your vaccinating doctor after the treatment. He or she can then plan to check the efficacy of your vaccination.

This medicine may impair the efficacy of vaccinations with live virus vaccines, for example against measles, mumps, rubella (German measles) or varicella. Such vaccinations should therefore not be given for 3 months after you were last given Rhophylac.

This medicinal product is used in pregnancy or early after delivery.

Immunoglobulins are excreted in human milk. In clinical studies, 432 mothers received this medicine before delivery and 256 of them again after delivery, and no side effects were seen in their children.

No effects of Rhophylac on the ability to drive and use machines are expected.

This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially “sodium-free”.

Consequences of an overdosage are not known.

If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

UK:

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Malta:

Ireland:

• 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.
• This 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.

This medicine is a clear or slightly pearly and colourless or pale yellow solution for injection. Rhophylac 300 is provided in a pre-filled glass syringe with 2 ml of ready-to-use sterile solution containing 300 micrograms (1500 IU) of anti-D immunoglobulin.

Rhophylac 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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: