Active ingredient
- human anti-d immunoglobulin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 15036/0019.
Rhophylac 300 (1500 IU)
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.
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 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 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.
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 300:
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).
2. What you need to know before you are given Rhophylac
Do not take Rhophylac:
Warnings and Precautions
When stopping the administration may be required
Your doctor or healthcare professional will take special care
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:
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
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.
Other medicines and Rhophylac
Vaccinations
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.
Pregnancy and breast-feeding
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.
Driving and using machines
No effects of Rhophylac on the ability to drive and use machines are expected.
Rhophylac contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially “sodium-free”.
3. How to use Rhophylac
This medicine 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. For example, if your body mass index (BMI) is greater or equal to 30, he or she should rather inject this medicine directly into a vein (see also section 2).
The syringe should be brought to room temperature (25°C) before use.
One syringe should be used for one patient only (even if product is left over then).
You should be observed for at least 20 minutes after having received Rhophylac.
If you receive more Rhophylac than you should
Consequences of an overdosage are not known.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Such side effects may occur even if you previously received human immunoglobulins and tolerated them well.
Allergic reactions (hypersensitivity reactions) have been observed rarely (affects 1 to 10 users in 10,000). Early signs may appear as small itching bubbles on your skin (hives) or all over your body (generalised urticaria). They may progress to severe hypersensitivity / anaphylactic reactions such as a sudden fall in blood pressure or shock (e.g. you may feel light-headed, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heart beat or chest pain, tightness of the chest, wheezing or have blurred vision) even when you have shown no hypersensitivity on previous administrations.
If you are given this medicine into a muscle, you may feel local pain and tenderness at the injection site.
The following side effects were uncommon (affects 1 to 10 users in 1000):
The following side effects were rare (affects 1 to 10 users in 10,000):
Reporting of side effects
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:
or search for MHRA Yellow Card in the Google Play or Apple App store
Malta:
Ireland:
5. How to store Rhophylac
6. Contents of the pack and other information
What this medicine contains
What Rhophylac looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in: 06/2019
4 Milton Road, Haywards Heath, West Sussex, RH16 1AH, UK
+44 (0)1444 447 400
+44 (0)1444 447 405
+44 (0)1444 447 402
+44 (0)1444 447 403
+44 (0)1444 447 405