RHOPHYLAC 300 MICROGRAMS / 2 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance: ANTI-D (RHO) IMMUNOGLOBULIN

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Rhophylac 300 micrograms /
2 ml, solution for injection in
pre-filled syringe
Human anti-D immunoglobulin
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 any further questions, 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 300 is and what it is used for
2. What you need to know before you are given
Rhophylac 300
3. How to use Rhophylac 300
4. Possible side effects
5. How to store Rhophylac 300
6. Contents of the pack and other information

1. What Rhophylac 300 is and
what it is used for
What is Rhophylac 300?
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 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 300 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 300 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 300 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 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 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;

B) You are a Rh(D) negative adult, children or adolescent
(0–18 years), 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.

2. What you need to know before
you are given Rhophylac 300
t Read

this section carefully. The information given
should be taken into consideration by you and your
doctor before you are given this medicine.

Do not take Rhophylac 300
• if you are allergic (hypersensitive) to human immunoglobulins or any of the other ingredients of this
medicine (listed in section 6).
t 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.
t 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.
Warnings and Precautions
t Talk to your doctor or healthcare professional before
you are given Rhophylac 300.
• 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.
When stopping the administration may be required?
• Rhophylac 300 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 had
tolerated them well.
t 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.
t 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 3,000 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.



Package leaflet: Information for the user

• when your doctor needs to perform testing methods
for fetal 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).

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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 300 the name and batch number of the
product are recorded in order to maintain a record of the
batches used.
Blood tests
t Tell your doctor or healthcare professional that you
were treated with Rhophylac 300 if you or your newborn 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.
Other medicines and Rhophylac 300
t 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
t Tell your doctor or healthcare professional prior to
treatment if you have just had a vaccination within
the last 2–4 weeks.
Inform also your vaccinating doctor after the
treatment. He 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). Such vaccinations should
therefore not be given for 3 months after you were last
given Rhophylac 300.
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 300 on the ability to drive and use
machines are expected.
Rhophylac contains sodium
This medicine contains up to 11.5 mg (0.5 mmol) per
syringe. Your doctor or healthcare professional will take
that into consideration if you are on a controlled sodium
diet.

3. How to use Rhophylac 300
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 300 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/she should rather inject this
medicine directly into a vein (see also section 2).
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).
If you receive more Rhophylac 300 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 (generalized 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.
t Tell your doctor or healthcare professional
immediately if you notice such signs during the
administration of Rhophylac. He or she will decide to
stop the administration completely and start the
appropriate treatment.
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 1,000):
• fever and chills (shivering),
• generally feeling unwell (malaise),
• headache,
• skin reaction, redness of the skin (erythema), itching
(pruritus).
The following side effects were rare (affects 1 to 10 users
in 10,000):
• nausea and/or vomiting,
• low blood pressure (hypotension),
• rapid heartbeat or pulse rate (tachycardia),
• joint pain (arthralgia),
• difficulty in breathing (dyspnoea),
• reactions at the injection site.
Reporting of side effects
t 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 via the national reporting
system listed in Appendix V. By reporting side effects
you can help provide more information on the safety
of this medicine.

5. How to store Rhophylac 300





Keep out of the sight and reach 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 this medicine if you notice that the solution
is cloudy or has deposits.
• Do not use this medicine after the expiry date which is
stated on the outer carton and the syringe label after
EXP. The expiry date refers to the last day of that
month.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What this medicine 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,
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 300 contains not more than
5 micrograms/ml human immunoglobulins (antibodies)
of the IgA type.
What Rhophylac 300 looks like and contents of
the pack
This medicine is a clear or slightly pearly and colourless or
pale yellow solution for injection. It comes in a glass
syringe pre-filled with 2 ml of solution containing 1,500 IU
(300 micrograms) of anti-D immunoglobulin.
Each 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
<[To be completed nationally]>
This leaflet was last revised in {MM/YYYY}.
<[To be completed nationally]>

00000 /00

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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