CSL Behring
Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe
Active substance: Human anti-D immunoglobulin
Please read all of this leaflet carefully before you are given this medicine
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or healthcare professional.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
In this leaflet:
1. What Rhophylac is and what it is used for
2. Before you are given Rhophylac
3. How Rhophylac will be administered
4. Possible side effects
5. How to store Rhophylac
6. Further information
What Rhophylac Is And What It 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" 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 red blood cells immediately.
How Rhophylac works
If a Rh(D)-negative person is given a sufficient amount of human anti-D (Rh) immunoglobulin, immunisation 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 Rhophylac 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
Rhophylac 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 red blood cells from your baby passing over into your own blood circulation. If this happens, the first baby is not usually affected and fully healthy. But in the next Rh(D)-positive baby, the mother's antibodies would destroy the baby's red blood cells already during pregnancy. This may lead to serious complications with the baby, including his/her possible death.
As a Rh(D)-negative pregnant woman, you may receive anti-D (Rh) immunoglobulins in the following situations:
- when you carry or have just delivered a Rh(D)-positive baby;
- when you lose a Rh(D)-positive baby (miscarriage, threatened miscarriage or abortion);
- when your pregnancy is severely complicated (ectopic pregnancy or hydatidiform mole);
- when it is likely that your baby's 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);
- 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).
B) You are a Rh(D)-negative person, who has accidentally received infusions (transfusions) of Rh(D)-positive blood (mismatched transfusion). This also applies to any blood products containing Rh(D)-positive red blood cells.
Before You Are Given Rhophylac
You should not receive Rhophylac
- If you are hypersensitive (allergic)
- to human immunoglobulins,
- to human albumin or
- to any of the other ingredients of Rhophylac (please see section 6 of this leaflet for a full statement of all ingredients).
Please tell your doctor or healthcare professional prior to treatment about any medicine or food 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),
- any other severe blood clotting disorder.
Please tell your doctor or healthcare professional prior to treatment if this applies to you. In this case Rhophylac may be given to you only by injection into a vein.
Special care should be taken with Rhophylac
- For protecting Rh(D)-negative women after delivery of a Rh(D)-positive baby, Rhophylac is always given to the mother, not to the newborn baby.
- Rhophylac is not intended for use in Rh(D)-positive persons.
- Rhophylac may trigger hypersensitivity reactions (allergic responses).
Early signs of hypersensitivity reactions may appear as- small itching bubbles on your skin (hives) or all over your body (generalised urticaria),
- tightness of the chest,
- wheezing,
- fall in blood pressure (hypotension) or a shock-like state (anaphylaxis).
- Rhophylac may also contain human immunoglobulins (antibodies) of the IgA type.
Persons who have low levels of the IgA type immunoglobulins are thus more likely to experience a hypersensitivity reaction.- Should you have low levels of the IgA type immunoglobulins, please tell your doctor or healthcare professional. Your doctor will then very thoroughly weigh the benefit of treatment with Rhophylac against the increased risk of hypersensitivity reactions.
- For your safety, your doctor or healthcare professional will observe you for at least 20 minutes after receiving Rhophylac.
Information on safety with respect to infections
Rhophylac 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,
and
- the testing of each donation and pools of plasma for signs of virus/infections.
Manufacturers of these products also include 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 and other types of infections.
The measures taken for Rhophylac are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus.
The measures may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins like Rhophylac have not been associated with hepatitis A or parvovirus B19 infections. This is possibly because antibodies against these infections are also present in immunoglobulins. These antibodies may help preventing hepatitis A or parvovirus B19 infections.
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.
Taking other medicines
- Always tell your doctor or healthcare professional if you are taking or have recently taken any other medicines. This also applies to medicines obtained without a prescription.
Interactions of Rhophylac with other treatments have not been investigated in clinical studies. The information given in this section is derived from the literature and from current guidelines.
Vaccinations
Rhophylac may impair the efficacy of vaccinations with live virus vaccines, for example against measles, mumps, rubella (German measles) or varicella (chicken pox).
- Such vaccinations should therefore not be given until 3 months after you were last given Rhophylac. Please inform your vaccinating doctor about your treatment with Rhophylac.
- If you have just had a vaccination within the last 2–4 weeks
- Please tell your doctor or healthcare professional prior to treatment.
- Please also inform your vaccinating doctor after the treatment. He can then plan to check the efficacy of your vaccination.
Laboratory tests
After you were given Rhophylac, the results of some blood tests (serological testing) may be altered for a certain period of time. If you are a mother having received Rhophylac before delivery, the results of some blood tests in your newborn baby may also be affected.
- Should you or your newborn baby have such blood tests, please inform your doctor or healthcare professional that you were treated with Rhophylac.
Pregnancy and breast-feeding
This medicinal product is used in pregnancy or early after delivery. In clinical studies with 432 mothers who received Rhophylac before delivery, no side effects were seen in their children.
Driving and operating machines:
No effects of Rhophylac on the ability to drive and use machines are expected.
How To Use Rhophylac
- Rhophylac will be injected by your doctor or healthcare professional into a muscle or directly into a vein.
- Your doctor will decide how much Rhophylac you should receive and which is the appropriate route of administration.
- The syringe should be brought to room or body temperature before use.
- One syringe should be used for one patient only (even if product is left over then).
Please note the early signs of hypersensitivity reactions given in section 2 of this leaflet. If such symptoms occur, please tell your doctor or healthcare professional immediately.
If you receive more Rhophylac than the usual dose
No data are available on overdosage.
If you are treated with Rhophylac after a mismatched transfusion, you may receive quite a large amount of the product (up to 3,000 micrograms, equivalent to 20 ml or 10 syringes). In this case there is an increased risk for a special complication called haemolytic reaction. This results from the intended destruction of the foreign Rh(D)-positive red blood cells. For this reason your doctor or healthcare person will monitor you closely and may need to do special blood tests.
In other Rh(D)-negative people more frequent or more severe side effects are not expected, even after large amounts of Rhophylac ("overdosage").
Possible Side Effects
Like all medicines, Rhophylac can cause side effects, although not everybody gets them.
If you are given Rhophylac into a muscle, you may feel local pain and tenderness at the injection site.
The following side effects may occur occasionally (between 1 in 100 and 1 in 1,000 persons treated):
- fever and chills (shivering),
- generally feeling unwell (malaise),
- headache,
- skin reactions.
The following side effects may occur rarely (between 1 in 1,000 and 1 in 10,000 persons treated):
- nausea and/or vomiting,
- low blood pressure (hypotension),
- rapid heartbeat or pulse rate (tachycardia),
- hypersensitivity reactions (allergic or anaphylactic type), including difficulty in breathing (dyspnoea) and shock.
Please note the early signs of hypersensitivity reactions given in section 2 of this leaflet. If such symptoms occur, please tell your doctor or health care professional immediately.
Such side effects may occur even when you have previously received human immunoglobulins and had tolerated them well.
- Please tell your doctor or healthcare professional
- if any of the side effects gets serious, or
- if you notice any side effects not listed in this leaflet.
How To Store Rhophylac
- Keep out of the reach and sight of children.
- Store in a refrigerator (+2 to +8 °C).
- Do not freeze.
- Keep the syringe in the outer carton (in its sealed plastic pack) in order to protect from light.
Do not use Rhophylac after the expiry date. It is stated on the outer carton and the syringe label in the format MM.YYYY (M = month, Y = year). The expiry date refers to the last day of that month.
Do not use Rhophylac if you notice that the solution is cloudy or has deposits.
Further Information
What Rhophylac contains
- The active substance is human anti-D (Rh) immunoglobulin (antibodies of the IgG type against the so called Rhesus factor type D).
- The other ingredients are human albumin, glycine and sodium chloride.
- 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.
What Rhophylac looks like and contents of the pack
Rhophylac 300 is a clear or slightly pearly solution for injection. It comes in a glass syringe prefilled with 2 ml of solution containing 1,500 IU (300 micrograms) of anti-D immunoglobulin.
The pack contains 1 pre-filled syringe and 1 injection needle, both packed in one blister pack (a clear plastic container sealed with a paper foil).
Marketing Authorisation Holder and Manufacturer
This leaflet was last approved in: 06/2010
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