RHOPRYLAC

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rhophylac 200 micrograms/2 ml

Injectable solution in a pre-filled syringe
Human anti-D immunoglobulin
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or healthcare professional.
• If you get any side effects, talk to your doctor or healthcare professional. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Rhophylac 200 is and what it is used for
2. What you need to know before using Rhophylac 200
3. How to use Rhophylac 200
4. Possible side effects
5. How to store Rhophylac 200
6. Contents of the pack and other information

1. WHAT RHOPHYLAC 200 IS AND WHAT IT IS USED FOR

What Rhophylac 200 is
This medicine is a ready-to-use injectable solution presented in a pre-filled syringe. The solution contains special proteins isolated from human plasma. These proteins belong to the class of "immunoglobulins", also known as antibodies. The active substance in Rhophylac 200 is a specific antibody called "anti-D (Rh) immunoglobulin". This antibody neutralizes the Rhesus factor type D.

What is the Rhesus factor type D
The Rhesus factor refers to specific characteristics of human red blood cells. Approximately 85% of the population carries the so-called Rhesus factor type D (abbreviated as "Rh(D)"). Individuals belonging to this group are referred to as Rh(D)-positive. Conversely, those who do not have this Rhesus factor type D are defined as Rh(D)-negative.

What is anti-D (Rh) immunoglobulin
Anti-D (Rh) immunoglobulin is an antibody produced in humans by the immune system that neutralizes the Rhesus factor type D. When an Rh(D)-negative individual receives Rh(D)-positive blood, their immune system will recognize the Rh(D)-positive red blood cells as "foreign" and attempt to destroy them by producing specific antibodies directed against the Rhesus factor type D. This process, known as "immunization", takes some time (2–3 weeks). Therefore, Rh(D)-positive red blood cells will not be destroyed immediately upon first exposure, and typical symptoms are generally not apparent. However, when the same Rh(D)-negative individual receives Rh(D)-positive blood a second time, the antibodies will be "ready to attack", and their immune system will immediately destroy the foreign Rh(D)-positive red blood cells.

How Rhophylac 200 works
Immunization against the Rhesus factor type D can be prevented by administering a sufficient amount of human anti-D (Rh) immunoglobulin to an Rh(D)-negative individual. This effect can be achieved by starting treatment with Rhophylac 200 before the first exposure to Rh(D)-positive red blood cells or, at the very least, shortly after such exposure. The anti-D (Rh) immunoglobulins contained in this medicine immediately destroy the foreign Rh(D)-positive red blood cells. As a result, the individual's immune system is not stimulated to produce specific antibodies.

What Rhophylac 200 is used for
This medicine is used in two different situations:
A) If you are an Rh(D)-negative pregnant woman and the fetus is Rh(D)-positive
In this particular situation, you may become immunized by Rh(D)-positive fetal red blood cells that pass into your bloodstream. Usually, the first child is not affected and will be perfectly healthy. However, if you have a second Rh(D)-positive child, your antibodies may destroy the baby's red blood cells during pregnancy. This condition can lead to serious consequences for the development of your next baby, including possible death.
For this reason, you may receive Rhophylac 200:

• during pregnancy or immediately after delivery of an Rh(D)-positive baby;
• if you do not carry to term a pregnancy with an Rh(D)-positive fetus (intrauterine fetal death, miscarriage, or threatened miscarriage);
• in the presence of serious pregnancy complications (ectopic pregnancy or pregnancy with a non-viable fertilized egg (hydatidiform mole));
• when it is likely that Rh(D)-positive fetal red blood cells have entered your bloodstream (transplacental hemorrhage resulting from antepartum bleeding events). This may occur, for example, if vaginal bleeding episodes occur during pregnancy;
• when your doctor performs diagnostic tests to detect possible fetal abnormalities (amniocentesis, chorionic villus biopsy, cordocentesis);
• when your doctor or midwife determines the need to externally manipulate the fetus (e.g., external correction of abnormal fetal presentation or other obstetric manipulative procedures);
• following abdominal trauma involving the stomach or abdomen.

This medicine may also be used if you are an Rh(D)-negative pregnant woman and it is unknown whether your fetus is Rh(D)-positive.

B) If you are an Rh(D)-negative adult, child, or adolescent (0–18 years) who has accidentally received infusions (transfusions) of Rh(D)-positive blood or other blood products containing Rh(D)-positive red blood cells, such as "platelet concentrate" (transfusion error).

2. WHAT YOU SHOULD KNOW BEFORE RECEIVING RHOPHYLAC 200

► Please read this section carefully. The information provided must be considered by you and your doctor before this medicine is administered to you.
You must not receive Rhophylac 200

• If you are allergic (hypersensitive) to human immunoglobulins or to any of the excipients in this medicine (listed in section 6). ► Before treatment, inform your doctor or healthcare professional about any medicine you have previously not tolerated.
• You must not receive intramuscular injections if you have severe thrombocytopenia (a significantly reduced platelet count) or any severe blood coagulation disorder. ► Before treatment, inform your doctor or healthcare professional if you have either or both of the above conditions. In such cases, you may receive this medicine only via intravenous injection.

Warnings and precautions
► Talk to your doctor or healthcare professional before receiving Rhophylac 200.

• For the protection of Rh(D)-negative women after delivery of an Rh(D)-positive newborn, this medicine must always be administered to the mother, never to the newborn.
• This medicine must not be used in Rh(D)-positive individuals, nor in individuals already immunized against the Rh(D) antigen.
  When administration may need to be discontinued
• Rhophylac 200 may cause hypersensitivity reactions (allergy-like). Rarely, allergic reactions such as sudden drop 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. ► Immediately inform your doctor or healthcare professional if such reactions occur. They will immediately stop administration of the medicine and initiate appropriate treatment depending on the nature and severity of the adverse event.

Your doctor or healthcare professional will take special care

• If you have low levels of IgA immunoglobulins, you may be at higher risk of hypersensitivity reactions. ► Inform your doctor or healthcare professional if your IgA immunoglobulin level is low. They will carefully evaluate the benefit of treatment with this medicine against the increased risk of hypersensitivity reactions.
• If you are being treated with this medicine following an incompatible transfusion, you may require a large dose (up to 3,000 micrograms, equivalent to 30 ml or 15 syringes). In this case, you may experience a so-called hemolytic reaction. This is due to the expected destruction of foreign Rh(D)-positive red blood cells present in your blood. Therefore, your doctor or healthcare professional will monitor you closely and specific blood tests may be required.
• If your body mass index (BMI) is greater than or equal to 30 (calculated by dividing body weight by the square of your height), intramuscular injection of Rhophylac may not be fully effective. In this case, your doctor or healthcare professional should preferably administer the medicine intravenously.

Information on safety regarding infections
This medicine is made from human blood plasma (the liquid part of blood). For medicines derived from human blood or plasma, measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors, excluding those with potential infection risks
• testing of each individual donation and plasma pools for viral infections
• inclusion of manufacturing steps that can inactivate or remove viruses.
  Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This applies also to unknown or emerging viruses or other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV, AIDS virus), hepatitis B virus, and hepatitis C virus.
The measures taken may have limited effectiveness against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins are not associated with transmission of hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in the product are protective.
It is strongly recommended that each time you receive a dose of Rhophylac 200, the name and batch number of the product are recorded, to establish a link with the batch used.

Blood tests
► Inform your doctor or healthcare professional that you have been treated with Rhophylac 200 if you or your newborn are to undergo any blood tests (serological tests).
After receiving this medicine, results of certain blood tests may be altered for a period of time. If you are a mother who received the medicine before delivery, the results of certain blood tests in your newborn may be affected.

Other medicines and Rhophylac 200
► Inform your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

Vaccinations
► Inform your doctor or healthcare professional before treatment if you have received a vaccination within the last 2–4 weeks.
After treatment, also inform the doctor who administered the vaccination. They may then plan to check the effectiveness of the vaccination you received.
This medicine may impair the efficacy of live virus vaccines, such as those against measles, mumps, rubella (German measles), or varicella. Therefore, such vaccinations must not be administered within 3 months after the last dose of Rhophylac 200.

Pregnancy and breastfeeding
This medicine is used during pregnancy or immediately after delivery.
Immunoglobulins are excreted in human milk. In clinical studies involving 432 mothers treated with this medicine before delivery and 256 of them treated again after delivery, no adverse events were observed in their children.

Driving and using machines
No effects on the ability to drive vehicles or use machines are expected with Rhophylac 200.

Rhophylac contains sodium
This medicine contains less than one mmol of sodium (23 mg) per syringe and is therefore essentially “sodium-free”.

3. HOW TO USE RHOPHYLAC 200

The injection of this medicine will be administered by your doctor or healthcare professional either
intramuscularly or intravenously. Your doctor will determine the dose of Rhophylac 200 to be
administered and which route of administration is most appropriate. For example, if your
body mass index (BMI) is greater than or equal to 30, he should preferably inject the
drug directly into the vein (see also section 2).
The syringe should be brought to room temperature (25°C) before use.
One syringe must be used only once and for one single patient (even if some product
remains in the syringe).
You must be monitored for at least 20 minutes after receiving Rhophylac.
If you receive more Rhophylac 200 than you should
There are no available data regarding the consequences of an overdose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. These adverse reactions may occur even if you have previously received human immunoglobulins that were well tolerated.
Allergic reactions (hypersensitivity reactions) have been observed rarely (affecting 1 to 10 patients per 10,000). Initial signs may appear as small itchy blisters on the skin (urticaria) or affecting the entire body (generalized urticaria). These may progress to severe hypersensitivity reactions/anaphylactic reactions, such as sudden drop in blood pressure or shock (for example, you may feel lightheadedness, dizziness, weakness when standing, cold hands and feet, sensation of irregular heartbeat or chest pain, tightness in the chest, wheezing and blurred vision), even if you have not previously shown hypersensitivity to earlier administrations.
► Inform your doctor or healthcare professional immediately if you notice these symptoms during administration of Rhophylac. They will decide to completely stop the infusion and initiate appropriate treatment.
If this medicine is administered into a muscle, you may experience localized pain and tenderness at the injection site.

The following adverse reactions have a uncommon frequency (occurring in 1 to 10 out of 1,000 treated subjects):

• fever and chills (shivering),
• general feeling of discomfort,
• headache,
• skin reactions, redness of the skin (erythema), itching.

The following adverse reactions have a rare frequency (occurring in 1 to 10 out of 10,000 treated subjects):

• allergic reactions, anaphylactic shock,
• nausea and/or vomiting,
• low blood pressure (hypotension),
• increased heart rate or pulse (tachycardia),
• joint pain (arthralgia),
• breathing difficulties (dyspnea),
• local reactions at the site of administration.

Reporting of adverse reactions
► If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or healthcare professional. You may also report adverse reactions via the website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE RHOPHYLAC 200

► Keep out of the sight and reach of children.
► Store in a refrigerator (between +2 and +8 °C).
► Do not freeze.
► Keep the syringe (in its sealed plastic housing) in the cardboard packaging to protect it from light.
► Do not use this medicine if the solution appears cloudy or contains particles.
► Do not use this medicine after the expiry date stated on the outer packaging and on the syringe label after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
► Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What this medicinal product contains

• The active substance is human anti-D (Rh) immunoglobulin (IgG antibodies against Rhesus factor D).
• Other excipients are human albumin, glycine, sodium chloride, and water for injections.
• The product contains a maximum of 25 mg/ml of human plasma proteins, of which 10 mg/ml consist of human albumin as a stabilizer. At least 95% of the other plasma proteins are human IgG immunoglobulins (antibodies). Rhophylac 200 contains no more than 5 micrograms/ml of human IgA immunoglobulins (antibodies).
  • Rhophylac does not contain preservatives.

Description of the appearance of Rhophylac 200 and contents of the pack
This medicinal product is a clear or slightly opalescent, colourless or pale yellow injectable solution. Rhophylac 200 is supplied as a pre-filled glass syringe containing 2 ml of sterile ready-to-use solution with 200 micrograms (1,000 IU) of anti-D immunoglobulin.
Each pack contains 1 pre-filled syringe and 1 injection needle, both contained in a blister (a sealed clear plastic container with a paper-laminated foil sheet).
Marketing Authorization Holder
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg, Germany
This leaflet was last updated on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rhophylac 300 micrograms/2 ml

Injectable solution in pre-filled syringe
Human anti-D immunoglobulin
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or healthcare professional.
• If you experience any side effect, contact your doctor or healthcare professional. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Rhophylac 300 is and what it is used for
2. What you need to know before using 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 Rhophylac 300 is
This medicine is a ready-to-use injectable solution presented in a pre-filled syringe. The solution contains special proteins isolated from human plasma. These proteins belong to the class of "immunoglobulins", also known as antibodies. The active substance in Rhophylac 300 is a specific antibody called "anti-D (Rh) immunoglobulin". This antibody targets and neutralizes the Rhesus factor type D.

What the Rhesus factor type D is
The Rhesus factor refers to specific characteristics of human red blood cells. Approximately 85% of the population carries the so-called Rhesus factor type D (abbreviated as "Rh(D)"). Individuals belonging to this group are referred to as Rh(D)-positive. Conversely, those who do not have this Rhesus factor type D are defined as Rh(D)-negative.

What anti-D (Rh) immunoglobulin is
Anti-D (Rh) immunoglobulin is an antibody produced in humans by the immune system that neutralizes the Rhesus factor type D. When an Rh(D)-negative individual receives Rh(D)-positive blood, their immune system recognizes the Rh(D)-positive red blood cells as "foreign" and attempts to destroy them by producing antibodies specifically directed against the Rhesus factor type D. This process, known as "immunization", takes some time (2–3 weeks). Therefore, the Rh(D)-positive red blood cells are not destroyed immediately upon first exposure, and typically no symptoms are evident. However, when the same Rh(D)-negative individual receives Rh(D)-positive blood a second time, the antibodies are "ready to attack" and the immune system immediately destroys the foreign Rh(D)-positive red blood cells.

How Rhophylac 300 works
Immunization against the Rhesus factor type D can be prevented by administering a sufficient amount of human anti-D (Rh) immunoglobulin to an Rh(D)-negative individual. This effect can be achieved by starting treatment with Rhophylac 300 before the first exposure to Rh(D)-positive red blood cells occurs, or at least shortly thereafter. The anti-D (Rh) immunoglobulins contained in this medicine immediately destroy the foreign Rh(D)-positive red blood cells. As a result, the individual's immune system is not stimulated to produce specific antibodies.

What Rhophylac 300 is used for
This medicine is used in two different situations:

A) If you are an Rh(D)-negative pregnant woman and the fetus is Rh(D)-positive
In this particular situation, you may become immunized by fetal Rh(D)-positive red blood cells that pass into your bloodstream. Usually, the first child is unaffected and perfectly healthy. However, if you become pregnant again with another Rh(D)-positive baby, your antibodies may destroy the baby's red blood cells during pregnancy. This condition can lead to serious consequences for the development of your unborn child, including possible fetal death.

For this reason, you may receive Rhophylac 300:

• during pregnancy or shortly after delivery of an Rh(D)-positive baby;
• if you do not carry the pregnancy to term (intrauterine fetal death, miscarriage, or threatened miscarriage);
• in cases of severely complicated pregnancy (ectopic pregnancy or pregnancy with a non-viable fertilized egg (hydatidiform mole));
• when fetal red blood cells are likely to have entered your bloodstream (transplacental haemorrhage due to pre-delivery bleeding events); this may occur, for example, if vaginal bleeding develops during pregnancy;
• when your doctor performs diagnostic tests to detect possible fetal abnormalities (amniocentesis, chorionic villus biopsy, cordocentesis);
• when your doctor or midwife determines the need to externally manipulate the fetus (e.g., external correction of abnormal fetal presentation or other obstetric manipulative procedures);
• following abdominal trauma (blunt trauma to the abdomen or stomach).

This medicine may also be used if you are an Rh(D)-negative pregnant woman and it is not known whether your fetus is Rh(D)-positive.

B) If you are an Rh(D)-negative adult, child, or adolescent (0–18 years) who has accidentally received infusions (transfusions) of Rh(D)-positive blood or other blood products containing Rh(D)-positive red blood cells, such as "platelet concentrate" (transfusion error).

2. WHAT YOU SHOULD KNOW BEFORE RECEIVING RHOPHYLAC 300

► Please read this section carefully. The information provided should be considered by you and your doctor before this medicine is administered to you.
Do not receive Rhophylac 300

• If you are allergic (hypersensitive) to human immunoglobulins or to any of the excipients in this medicine (listed in section 6). ► Before treatment, inform your doctor or healthcare professional about any medicine you have previously not tolerated.
• You must not receive intramuscular injections if you have severe thrombocytopenia (a significantly reduced platelet count) or any severe blood coagulation disorder. ► Before treatment, inform your doctor or healthcare professional if you have one or both of the above conditions. In such cases, you may only receive this medicine via intravenous injection.

Warnings and precautions
► Talk to your doctor or healthcare professional before receiving Rhophylac 300.

• For the protection of Rh(D)-negative women after delivery of an Rh(D)-positive newborn, this medicine must always be administered to the mother, never to the newborn.
• This medicine must not be used in Rh(D)-positive individuals, nor in individuals already immunized against the Rh(D) antigen. When administration may need to be stopped
• Rhophylac 300 may cause hypersensitivity reactions (allergy-like reactions). Rarely, allergic reactions such as sudden drop 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. ► Immediately inform your doctor or healthcare professional if such reactions occur. They will immediately stop administration of the medicine and initiate appropriate treatment depending on the nature and severity of the adverse event.

Your doctor or healthcare professional will take special care

• If you have low levels of IgA immunoglobulins, you may be at increased risk of hypersensitivity reactions. ► Inform your doctor or healthcare professional if your IgA immunoglobulin level is low. They will carefully evaluate the benefit of treatment with this medicine against the increased risk of hypersensitivity reactions.
• If you are being treated with this medicine after an incompatible transfusion, you may require a large amount of product (up to 3,000 micrograms, equivalent to 20 mL or 10 syringes). In this case, you may experience a so-called hemolytic reaction. This is due to the expected destruction of foreign Rh(D)-positive red blood cells present in your blood. Therefore, your doctor or healthcare professional will monitor you closely, and specific blood tests may be required.
• If your body mass index (BMI) is greater than or equal to 30 (calculated by dividing body weight by the square of height), intramuscular injection of Rhophylac may not be fully effective. In this case, your doctor or healthcare professional should preferably administer the medicine intravenously.

Infection safety information
This medicine is made from human plasma (the liquid part of blood).
For medicines derived from human blood or plasma, measures are taken to prevent transmission of infections to patients. These include:

• careful selection of blood and plasma donors, excluding those with potential infection risks,
• testing of each individual donation and plasma pools for viral infections,
• inclusion of manufacturing steps that can inactivate or remove viruses. Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infections cannot be completely ruled out. This applies also to unknown or emerging viruses and other types of infections.

The measures taken are considered effective against enveloped viruses such as the human immunodeficiency virus (HIV, AIDS virus), hepatitis B virus, and hepatitis C virus.
The measures taken may have limited effectiveness against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins are not associated with transmission of hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in the product are protective.
It is strongly recommended that each time you receive a dose of Rhophylac 300, the name and batch number of the product be recorded, to allow traceability to the specific batch used.

Blood tests
► Inform your doctor or healthcare professional that you have been treated with Rhophylac 300 if you or your newborn baby need to undergo any blood tests (serological tests).
After receiving this medicine, results of certain blood tests may be altered for a period of time. If you are a mother who received the medicine before delivery, the results of certain blood tests in your newborn baby may be affected.

Other medicines and Rhophylac 300
► Inform your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Vaccinations
► Inform your doctor or healthcare professional before treatment if you have received any vaccination within the last 2–4 weeks.
After treatment, also inform the doctor who administered the vaccination. They may then plan to check the effectiveness of the vaccination you received.
This medicine may impair the effectiveness of live virus vaccines, such as those against measles, mumps, rubella (German measles), or varicella. Therefore, such vaccinations should not be administered within 3 months after your last dose of Rhophylac 300.

Pregnancy and breastfeeding
This medicine is used during pregnancy or immediately after delivery.
Immunoglobulins are excreted in human milk. In clinical studies involving 432 mothers treated with this medicine before delivery and 256 of them re-treated after delivery, no adverse events were observed in their infants.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery are expected with Rhophylac 300.

Rhophylac contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per syringe and is therefore essentially "sodium-free".

3. HOW TO USE RHOPHYLAC 300

The injection of this medicine will be administered by your doctor or healthcare professional either
intramuscularly or intravenously. Your doctor will decide the dose of Rhophylac 300 to be given
and which route of administration is most appropriate. For example, if your body mass index (BMI)
is greater than or equal to 30, the drug should preferably be injected directly into a vein (see also
section 2).
The pre-filled syringe should be brought to room temperature (25°C) before use.
One syringe must be used only once and for one single patient (even if some product remains
in the syringe).
You must be monitored for at least 20 minutes after receiving Rhophylac.
If you receive a higher dose of Rhophylac 300 than you should
There are no data available regarding the consequences of overdose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them. These adverse reactions may occur even if you have previously received human immunoglobulins that were well tolerated.
Allergic reactions (hypersensitivity reactions) have been observed rarely (affecting 1 to 10 patients per 10,000). Initial signs may include itchy skin rashes (urticaria) or widespread rash over the body (generalized urticaria). These may progress to severe hypersensitivity reactions/anaphylactic reactions, such as a sudden drop in blood pressure or shock (for example, you may feel lightheadedness, dizziness, weakness when standing, cold hands and feet, sensation of an irregular heartbeat or chest pain, tightness in the chest, wheezing, or blurred vision), even if you have not previously shown hypersensitivity following earlier administrations.
► Immediately inform your doctor or healthcare professional if you notice any of these symptoms during administration of Rhophylac. They will decide to completely stop the infusion and initiate appropriate treatment.
If this medicine is administered into a muscle, you may experience localized pain and tenderness at the injection site.
The adverse reactions listed below occur with uncommon frequency (in 1 to 10 out of 1,000 treated patients):

• fever and chills (shivering),
• general feeling of discomfort,
• headache,
• skin reactions, skin redness (erythema), itching.

The adverse reactions listed below occur with rare frequency (in 1 to 10 out of 10,000 treated patients):

• allergic reactions, anaphylactic shock,
• nausea and/or vomiting,
• low blood pressure (hypotension),
• increased heart rate or pulse (tachycardia),
• joint pain (arthralgia),
• breathing difficulties (dyspnea),
  • local reactions at the site of administration.

Reporting of adverse reactions
► If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or healthcare professional. You may also report adverse reactions via the website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide further 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 (between +2 and +8 °C).
• Do not freeze.
• Store the syringe (in its sealed plastic packaging) inside the cardboard box to protect it from light.
• Do not use this medicine if the solution appears cloudy or contains particles.
• Do not use this medicine after the expiry date stated on the outer packaging and on the syringe label after the abbreviation EXP. The expiry date refers to the last day of the month.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What this medicine contains

• The active substance is human anti-D (Rh) immunoglobulin (IgG type antibodies to Rhesus factor D).
• Other excipients: human albumin, glycine, sodium chloride, water for injections.
• The product contains a maximum of 30 mg/ml of human plasma proteins, of which 10 mg/ml are human albumin used as a stabilizer. At least 95% of the other plasma proteins are human immunoglobulins (antibodies) of the IgG type. Rhophylac 300 contains no more than 5 micrograms/ml of human immunoglobulins (antibodies) of the IgA type.
  • Rhophylac does not contain preservatives.

Description of the appearance of Rhophylac 300 and contents of the pack
This medicine is a clear or slightly opalescent, colourless or pale yellow injectable solution.
Rhophylac 300 is supplied as a pre-filled glass syringe containing 2 ml of sterile ready-to-use solution with 300 micrograms (1,500 IU) of anti-D immunoglobulin.
Rhophylac 300 is available in single packs containing one pre-filled syringe and one injection needle, both enclosed in a blister (a sealed plastic container with a paper-laminated foil) or in multipacks containing 5 single packs. Not all pack sizes may be marketed.
Marketing Authorization Holder
CSL Behring GmbH
Emil-von Behring-Strasse, 76
35041 Marburg - Germany
This leaflet was last updated on