IMMUNORHO 300 MCG Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. IMMUNORHO 200 micrograms (1000 IU) Powder and solvent for injectable solution for use
2. IMMUNORHO 300 micrograms (1500 IU) Powder and solvent for injectable solution for use
   1. What is IMMUNORHO and what is it used for
   2. What you need to know before using IMMUNORHO
3. IMMUNORHO is intended for use during pregnancy and can be used during breastfeeding.
   1. How to use IMMUNORHO
   2. Possible side effects
   3. How to store IMMUNORHO
   4. Contents of the pack and other information
4. IMMUNORHO 200 micrograms (1000 IU) Powder and solvent for injectable solution for use
5. IMMUNORHO 300 micrograms (1500 IU) Injectable solution for intramuscular use
   1. What is IMMUNORHO and what is it used for
   2. What you need to know before using IMMUNORHO
   3. How to use IMMUNORHO
   4. Possible side effects
   5. How to store IMMUNORHO
   6. Content of the pack and other information

IMMUNORHO 200 micrograms (1000 IU) Powder and solvent for injectable solution for use

intramuscular

IMMUNORHO 300 micrograms (1500 IU) Powder and solvent for injectable solution for use

intramuscular
Human anti-D immunoglobulin
Read this leaflet carefully before you use this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is IMMUNORHO and what is it used for

What is IMMUNORHO
IMMUNORHO is a human anti-D immunoglobulin solution, an antibody produced in humans by the
immune system that inhibits the D-type Rhesus factor.
The D-type Rhesus factor is a particular characteristic of red blood cells present in human blood: individuals
carrying the D-type Rhesus factor are said to be Rh(D)-positive; individuals in whom it is not
present are defined as Rh(D)-negative.
How IMMUNORHO works
When an Rh(D)-negative individual comes into contact with Rh(D)-positive blood, such as when
in a pregnant woman the Rh(D)-negative mother's blood comes into contact with that of the Rh(D)-
positive fetus, the immune system of the Rh(D)-negative person (mother) recognizes the Rh(D)-positive
red blood cells (fetus) as foreign and produces antibodies specifically directed against the D-type Rhesus factor.
This phenomenon, called immunization, takes about 2-3 weeks, which is why Rh(D)-positive red blood cells are not
destroyed upon first contact and no signs or symptoms appear. Only when the same Rh(D)-negative individual
comes into contact with Rh(D)-positive blood for the second time will the antibodies produced destroy the
Rh(D)-positive red blood cells of the fetus, causing damage to it.
If an Rh(D)-negative subject is given human anti-D immunoglobulin, immunization
against the D-type Rhesus factor can be prevented, preventing the formation of antibodies directed against
Rh(D)-positive red blood cells by the subject. This can be achieved by starting treatment with
IMMUNORHO before or shortly after the first contact with Rh(D)-positive red blood cells.

IMMUNORHO
This medicine is used in the treatment of:

• Rh(D)-negative women of childbearing age during a pregnancy in which the fetus is Rh(D)-positive, in:
• Scheduled pre-delivery prophylaxis
• Pre-delivery prophylaxis following pregnancy complications including: Abortion/threatened abortion, ectopic pregnancy or formation of masses within the uterus (hydatidiform mole), passage of fetal blood into the mother's circulatory system normally separated or intrauterine fetal death, transplacental hemorrhage following a pre-delivery hemorrhage, such as during amniocentesis, chorionic villus biopsy, obstetric manipulation procedures such as manual rotation of the baby into a correct position within the uterus (external cephalic version), invasive procedures, fetal blood sampling from the umbilical vein (cordocentesis), blunt abdominal trauma or therapeutic interventions on the fetus within the uterus
• Birth of an Rh(D)-positive baby (D, D , D )
• Rh(D)-negative women of childbearing age who have accidentally received incompatible transfusions of Rh(D)-positive blood or other products containing red blood cells, e.g. platelet concentrates.

2. What you need to know before using IMMUNORHO

Do not use IMMUNORHO
If you are allergic (hypersensitive) to human immunoglobulins, especially if you have developed anti-IgA antibodies,
or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before using IMMUNORHO.

• IMMUNORHO must not be administered into a blood vessel, due to the risk of shock.
• In the case of postpartum use, the product must be administered to the mother. It must not be administered to the newborn.
• Serious hypersensitivity reactions are rare, but allergic-type reactions to human anti-D immunoglobulin may occur (see section 4 “Possible side effects”). IMMUNORHO contains small amounts of IgA. Although anti-D immunoglobulin has been used successfully in selected subjects with IgA deficiency, if you have low levels of IgA you may develop anti-IgA antibodies and experience anaphylactic reactions after the administration of plasma derivatives containing IgA. In this case, your doctor must therefore assess the benefit of treatment with IMMUNORHO against the potential risk of hypersensitivity reactions.
• Rarely, human anti-D immunoglobulins may induce a decrease in blood pressure with anaphylactic reaction (see section 4 “Possible side effects”); even if you have previously tolerated previous treatments with human immunoglobulins, you may experience a decrease in blood pressure values.
• Contact your doctor immediately if you experience allergic or anaphylactic reactions. In these cases, the doctor will immediately stop administering the medicine and start the necessary treatment, which will depend on the type and severity of the reactions.
• If you are receiving very high doses of anti-D immunoglobulin due to incompatible transfusions, you should know that you may have a hemolytic reaction (destruction of red blood cells). For this reason, your doctor will monitor you carefully and assess the need to perform specific blood tests.
• If you suffer from episodes of thrombosis.

IMMUNORHO
If you experience symptoms such as difficulty breathing, pain and swelling in the limbs, loss of movement or
sensation in a part of the body (focal neurological deficits) and chest pain, you should contact
your doctor immediately, as you may be experiencing a thrombotic event.
Viral safety
When medicines are prepared from human blood or plasma, certain measures are taken to
prevent the transmission of infections to patients. These measures include:

• careful selection of blood and plasma donors to ensure that potentially infected donors are excluded;
• testing of each donation and pool (a collection of multiple donations) of plasma to detect any presence of infections/viruses;
• inclusion of blood or plasma processing steps capable of inactivating or removing viruses.

Despite these measures, when medicinal products prepared from human blood or plasma are administered, the possibility of transmission of infectious agents cannot be completely excluded. This also applies to
viruses or other types of infectious agents, emerging or unknown.
The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV), the hepatitis C virus (HCV) and for the
non-enveloped hepatitis A virus (HAV).
The measures taken have limited value against the non-enveloped parvovirus B19 virus.
Treatment with immunoglobulins has not been associated with the transmission of hepatitis A or
parvovirus B19 infections, probably because the antibodies present are protective against these infections.
It is strongly recommended that each time you receive a dose of IMMUNORHO, the name and
batch number of the product are recorded, in order to maintain traceability of the batch used.
Blood tests
Tell your doctor that you have been treated with IMMUNORHO if you or your newborn need blood tests (serological tests).
After you have been administered this medicine, the results of some blood tests may be falsely positive due to the transient increase in antibodies against red blood cell antigens, e.g., A,
B and D, passively transferred into your blood.
If you are a mother who received this medicine before delivery, the results of
some blood tests of your newborn for red blood cell antibodies, for example the antiglobulin test (Coombs test), may be altered.

Children
No specific measures or monitoring are required.

Other medicines and IMMUNORHO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Children
Although specific interaction studies have not been conducted in the pediatric population, no differences are expected compared to adult patients.
Vaccination
IMMUNORHO may reduce the effectiveness of vaccination with live attenuated virus vaccines, such as those
for measles, rubella and mumps. An interval of 3 months must elapse after the administration of IMMUNORHO before proceeding with vaccination with live attenuated virus vaccines.
Before treatment, tell your doctor if you have been vaccinated in the last 2-4
weeks. Human anti-D immunoglobulins should be administered 2 or 4 weeks after
vaccination with live virus vaccines; if the administration of human anti-D

IMMUNORHO
is necessary within 2-4 weeks of vaccination with live virus vaccines, the effectiveness of that
vaccination may be reduced, therefore your doctor will schedule a check of the effectiveness of
the vaccinations you have received.

Pregnancy, breastfeeding and fertility

IMMUNORHO is intended for use during pregnancy and can be used during breastfeeding.

Immunoglobulins are excreted in breast milk.
Fertility studies with IMMUNORHO have not been conducted.
Clinical experience with human anti-D immunoglobulins suggests that no harmful effects on fertility are to be expected.

Driving and operating machinery
IMMUNORHO has no effect on the ability to drive and use machinery.

IMMUNORHO contains sodium
This medicine contains up to a maximum of 7.8 mg of sodium (the main component of table salt) per 2 ml vial.
This is equivalent to 0.38% of the maximum recommended daily intake with the diet of an adult.

3. How to use IMMUNORHO

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor
or pharmacist.
Your doctor will determine the appropriate dose for you and the duration of treatment.
reserved for doctors and healthcare professionals.
If you are administering the product yourself, always use IMMUNORHO following
exactly the instructions in the “Instructions for correct use” section.
Method of administration
IMMUNORHO must be administered intramuscularly.
If a large volume is required (> 2 ml for children or > 5 ml for adults), it is recommended to administer
the medicine in divided doses at different sites.
If intramuscular administration is contraindicated (coagulation disorders), an alternative medicine for intravenous use must be used.
Overweight patients
In the case of overweight/obese patients, the use of an intravenous anti-D product should be considered.

Use in children
The safety and efficacy of IMMUNORHO in children have not yet been established. The appropriate
dosage must be calculated in consultation with a specialist in transfusion medicine.

Instructions for correct use
IMMUNORHO must not be mixed with other medicinal products.
The product must be brought to room temperature before use.

• 1. Remove the central protection on the rubber stopper of the vial containing the lyophilized powder.
• 2. Aspirate the contents of the solvent vial with a syringe.

IMMUNORHO

• 3. Inject the liquid into the vial containing the lyophilized powder. During this step, ensure that you do not lacerate the rubber stopper of the vial, in order to avoid contamination of the reconstituted solution.
• 4. Gently shake and aspirate the resulting solution with the syringe; replace the needle and inject.

Imperfect solubilization results in a loss of activity.
Complete reconstitution is achieved on average within 5 minutes.
The product after reconstitution appears as a liquid from colorless to pale yellow.
Reconstituted products must be visually inspected for the presence of particles in
suspension, or abnormal coloration, before administration.
Do not use solutions that present turbidity or deposits.
The lyophilized product must be used immediately after reconstitution with the solvent.
Unused medicines and waste derived from them must be disposed of in accordance with local
regulations.

If you use more IMMUNORHO than you should
The consequences of an overdose are unknown.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur with products containing human anti-D immunoglobulin for intramuscular use
are listed below.

If you experience any of these side effects, contact your doctor or healthcare professional immediately:

• allergic reaction (hypersensitivity);
• anaphylactic shock.

Other side effects:

• headache;
• fast heartbeat (tachycardia);
• low blood pressure (hypotension);
• nausea, vomiting;
• skin reactions, such as skin redness (erythema), itching, pruritus;
• joint pain (arthralgia);
• fever, malaise, chills;
• reactions at the injection site such as swelling, pain, skin redness (erythema), hardening, warmth, itching, rash, sensation of pruritus.

Additional side effects in children
No specific data are available for the paediatric population.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

IMMUNORHO
For the risk associated with transmissible agents, see section 2 “What you need to know before you use
IMMUNORHO”.

5. How to store IMMUNORHO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°C.
Do not freeze.
Store in the original packaging to protect the medicine from light.
The reconstituted product must be used immediately.
Do not use this medicine if you notice that the solution is cloudy or contains deposits.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What IMMUNORHO contains
The active substance is human anti-D immunoglobulin.
1 ml of injectable solution after reconstitution of the lyophilised powder with the solvent and 1 ml of injectable solution
contains:

The activity is determined using the European Pharmacopoeia method. The equivalence in International Units
of the International Reference Preparation is defined by the World Health Organization.
Distribution of IgG subclasses:
IgG 66.0%
IgG 30.0%
IgG 2.5%
IgG 1.5%
Maximum IgA content 300 micrograms/ml.

IMMUNORHO
Produced from human donor plasma.
The other components are: glycine, sodium chloride and water for injections.

Description of the appearance of IMMUNORHO and contents of the pack

IMMUNORHO 200 micrograms (1000 IU) Powder and solvent for injectable solution for use

intramuscularly.
Contains: a vial of powder of 200 micrograms and a vial of solvent of 2 ml.
IMMUNORHO 300 micrograms (1500 IU) Powder and solvent for injectable solution for use
intramuscularly.
Contains: a vial of powder of 300 micrograms and a vial of solvent of 2 ml.
The lyophilized preparation appears as a white or slightly yellow hygroscopic powder or as a
friable solid mass.

Marketing Authorisation Holder
Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca).

Manufacturer
Kedrion S.p.A. - S.S. 7 bis Km 19,5, S. Antimo (Napoli).
-----------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals (see
section 3 "How to use IMMUNORHO").
Dosage
The dose of anti-D immunoglobulin must be established based on the level of exposure to Rh(D)-positive
red blood cells and on the fact that 0.5 ml of Rh(D)-positive concentrated red blood cells or 1 ml of Rh(D)-positive blood
are neutralized by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.
Consideration should also be given to the dosage and dosage schedule for human anti-D immunoglobulins
for intramuscular use recommended in other official guidelines or of Member States.
Prevention of Rh(D) immunisation in Rh(D)-negative women:

• Pre-partum prophylaxis. According to general recommendations, the doses currently administered range from 50 to 330 micrograms or from 250 to 1650 IU.
• Programmed pre-partum prophylaxis: A single dose between the 28th and 30th week of pregnancy or two doses in weeks 28 and
• 34.
• Pre-partum prophylaxis following complications during pregnancy: A single dose should be administered as soon as possible and in any case within 72 hours and, if necessary, should be repeated at intervals of 6-12 weeks for the entire duration of the pregnancy.
• Post-partum prophylaxis. According to general recommendations, the doses currently administered range from 100 to 300 micrograms or from 500 to 1500 IU. If the lowest dose (100 micrograms or 500 IU) is administered, a test should be performed to establish the extent of foeto-maternal haemorrhage.

IMMUNORHO
In postpartum use, the product should be administered to the mother as soon as possible within 72
hours of the birth of an Rh-positive (D, d, D) newborn. If more than 72 hours have elapsed since delivery,
the product should still be administered as soon as possible.
The postpartum dose should still be administered even if pre-partum prophylaxis has been performed, even if residual activity of the pre-partum prophylaxis is still present in the maternal serum.
If massive maternal-foetal haemorrhage is suspected [> 4 ml (0.7-0.8% of women)], for example in case of
foetal/neonatal anaemia or intrauterine foetal death, its extent should be determined using the appropriate method, for example, the acid elution test of Kleihauer-Betke for the determination of foetal HbF
(foetal haemoglobin) level or flow cytometry that selectively identifies Rh(D)-positive cells.
Further doses of anti-D immunoglobulin should be administered accordingly (10 micrograms or
50 IU per 0.5 ml of foetal red blood cells).
Incompatible red blood cell transfusions
The recommended dose is 20 micrograms (100 IU) of anti-D immunoglobulin per 2 ml of Rh(D)-positive blood
transfused or per 1 ml of concentrated red blood cells.
Consultation with a specialist in transfusion medicine is recommended to assess the applicability of a
red blood cell exchange procedure to reduce the load of D-positive red blood cells in circulation and to define
the dose of anti-D immunoglobulin necessary to suppress immunisation. Follow-up tests for
Rh(D)-positive red blood cells should be performed every 48 hours and further
anti-D immunoglobulin should be administered until the total disappearance of Rh(D)-positive red blood cells from the bloodstream. In
any case, due to a possible risk of haemolysis, it is suggested not to exceed a maximum dose of 3000
micrograms (15000 IU).
The use of an alternative intravenous product is recommended, as it allows to
immediately achieve adequate plasma levels. In the absence of a product for intravenous use, the very high dose must be administered intramuscularly for several days.
Thromboembolism
Arterial and venous thromboembolic events such as myocardial infarction, stroke, deep vein thrombosis and
pulmonary embolism have been associated with the use of immunoglobulins. Although no thromboembolic events have been observed in patients treated with
IMMUNORHO, these patients must be
sufficiently hydrated before the use of immunoglobulins.
Caution is recommended in patients with pre-existing risk factors for thrombotic events (such as hypertension,
diabetes mellitus and a history of vascular or thrombotic episodes, patients with hereditary or acquired thrombophilic disorders, patients immobilised for a prolonged period, patients severely hypovolaemic,
patients with diseases that increase blood viscosity), especially when high doses of IMMUNORHO are prescribed.
Patients should be informed about the early symptoms of thromboembolic events such as dyspnoea, pain and
swelling of the limbs, focal neurological deficits and chest pain and should be advised to contact
their doctor immediately if these symptoms occur.

IMMUNORHO

IMMUNORHO 300 micrograms (1500 IU) Injectable solution for intramuscular use

Human anti-D immunoglobulin
Read this leaflet carefully before you use this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

2. What is IMMUNORHO and what is it used for

What is IMMUNORHO
IMMUNORHO is a human anti-D immunoglobulin solution, an antibody produced by the human
immune system that inhibits the D type Rhesus factor.
The D type Rhesus factor is a particular characteristic of red blood cells present in human blood: individuals
carrying the D type Rhesus factor are said to be Rh(D)-positive; individuals in whom it is not
present are defined as Rh(D)-negative.
How does IMMUNORHO work
When an Rh(D)-negative individual comes into contact with Rh(D)-positive blood, such as when
in a pregnant woman the Rh(D)-negative mother's blood comes into contact with that of the Rh(D)-
positive fetus, the immune system of the Rh(D)-negative person (mother) recognizes the Rh(D)-positive
red blood cells (fetus) as foreign and produces antibodies specifically directed against the D type Rhesus factor.
This phenomenon, called immunization, takes about 2–3 weeks, which is why Rh(D)-positive red blood cells
are not destroyed upon first contact and no signs or
symptoms appear. Only when the same Rh(D)-negative individual comes into contact with Rh(D)-positive blood
for the second time will the produced antibodies destroy the Rh(D)-positive red blood cells of the fetus
causing damage to it.
If an Rh(D)-negative subject is given human anti-D immunoglobulin, immunization
against the D type Rhesus factor can be prevented, preventing the formation of antibodies directed against
the Rh(D)-positive red blood cells by the subject. This can be achieved by starting treatment with
IMMUNORHO before or shortly after the first contact with Rh(D)-positive red blood cells.
This medicine is used in the treatment of:

• Rh(D)-negative women of childbearing age during a pregnancy in which the fetus is Rh(D)-positive, in:
• Scheduled pre-delivery prophylaxis IMMUNORHO
• Pre-delivery prophylaxis following pregnancy complications including: Abortion/threatened abortion, ectopic pregnancy or formation of masses inside the uterus (hydatidiform mole), passage of fetal blood into the mother's normally separate bloodstream or intrauterine fetal death, transplacental hemorrhage following a pre-delivery hemorrhage, such as during amniotic fluid sampling with a syringe (amniocentesis), chorionic villus biopsy, obstetric manipulation procedures such as manual rotation of the baby into a correct position inside the uterus (external cephalic version), invasive procedures, fetal blood sampling from the umbilical vein (cordocentesis), blunt abdominal trauma or therapeutic interventions on the fetus inside the uterus
• Birth of an Rh(D)-positive baby (D, D , D )
• Rh(D)-negative women of childbearing age who have accidentally received incompatible transfusions of Rh(D)-positive blood or other products containing red blood cells, e.g. platelet concentrates.

2. What you need to know before using IMMUNORHO

Do not use IMMUNORHO
If you are allergic (hypersensitive) to human immunoglobulins, especially if you have developed anti-IgA antibodies,
or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before using IMMUNORHO.

• IMMUNORHO must not be administered into a blood vessel, due to the risk of shock.
• In the case of postpartum use, the product must be administered to the mother. It must not be administered to the newborn.
• Serious hypersensitivity reactions are rare, but allergic-type reactions to human anti-D immunoglobulin may occur (see section 4 “Possible side effects”). IMMUNORHO contains small amounts of IgA. Although anti-D immunoglobulin has been used successfully in selected subjects with IgA deficiency, if you have low levels of IgA, you may develop anti-IgA antibodies and experience anaphylactic reactions after the administration of plasma derivatives containing IgA. In this case, your doctor must therefore assess the benefit of treatment with IMMUNORHO against the potential risk of hypersensitivity reactions.
• Rarely, human anti-D immunoglobulins may induce a decrease in blood pressure with anaphylactic reaction (see section 4 “Possible side effects”); even if you have previously tolerated previous treatments with human immunoglobulins, you may experience a decrease in blood pressure values.
• Contact your doctor immediately if you experience allergic or anaphylactic reactions. In these cases, the doctor will immediately stop administering the medicine and start the necessary treatment, which will depend on the type and severity of the reactions.
• If you are receiving very high doses of anti-D immunoglobulin due to incompatible transfusions, you should know that you may have a hemolytic reaction (destruction of red blood cells). For this reason, your doctor will monitor you carefully and assess the need to perform specific blood tests.
• If you suffer from thrombotic events. If you experience symptoms such as difficulty breathing, pain and swelling in the limbs, loss of movement or sensation in a part of the body (focal neurological deficits) and chest pain, you should contact your doctor immediately, as you may have an ongoing thrombotic event.

Viral safety
When medicines are prepared from human blood or plasma, certain measures are put in place to
prevent the transmission of infections to patients. These measures include:

IMMUNORHO

• careful selection of blood and plasma donors to ensure that potentially infected donors are excluded;
• testing of each donation and pool (a collection of multiple donations) of plasma to detect any presence of infections/viruses;
• inclusion of blood or plasma processing steps capable of inactivating or removing viruses.

Despite these measures, when medicines prepared from human blood or plasma
are administered, the possibility of transmitting infectious agents cannot be completely excluded. This also applies to
viruses or other types of infectious agents, emerging or unknown.
The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV), the hepatitis C virus (HCV) and for the
non-enveloped hepatitis A virus (HAV).
The measures taken have limited value against the non-enveloped parvovirus B19 virus.
Treatment with immunoglobulins has not been associated with the transmission of hepatitis A or
parvovirus B19 infections, probably because the antibodies present are protective against these infections.
It is strongly recommended that each time you receive a dose of IMMUNORHO, the name and
batch number of the product are recorded, in order to maintain traceability of the batch used.
Blood tests
Tell your doctor that you have been treated with IMMUNORHO if you or your newborn need blood tests (serological tests).
After you have been administered this medicine, the results of some blood tests may be falsely positive due to the transient increase in antibodies against red blood cell antigens, e.g., A,
B and D, passively transferred into your blood.
If you are a mother who has received this medicine before delivery, the results of
some blood tests of your newborn for red blood cell antibodies may be altered, for example the antiglobulin test (Coombs test).

Children
No specific measures or monitoring are required.

Other medicines and IMMUNORHO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Children
Although specific interaction studies have not been conducted in the pediatric population, no differences are expected compared to adult patients.
Vaccination
IMMUNORHO may reduce the effectiveness of vaccination with live attenuated virus vaccines, such as those
for measles, rubella and mumps. An interval of 3 months must elapse after the administration of IMMUNORHO before proceeding with vaccination with live attenuated virus vaccines.
Before treatment, tell your doctor if you have been vaccinated in the last 2-4
weeks. Human anti-D immunoglobulins should be administered 2 or 4 weeks after
vaccination with live virus vaccines; if the administration of human anti-D immunoglobulins
is necessary within 2-4 weeks of vaccination with live virus-based vaccines, the effectiveness of such
vaccination may be decreased, therefore your doctor will schedule a check of the effectiveness of
the vaccinations that have been administered to you.

Pregnancy, breastfeeding and fertility
IMMUNORHO is intended for use in pregnancy and can be used during breastfeeding. Immunoglobulins
are excreted in breast milk.

IMMUNORHO
No fertility studies have been conducted with IMMUNORHO.
Clinical experience with human anti-D immunoglobulins suggests that no harmful effects on
fertility are to be expected.

Driving and using machines
IMMUNORHO has no effect on the ability to drive and operate machines.

IMMUNORHO contains sodium
This medicine contains up to a maximum of 7.8 mg of sodium (the main component of table
salt) per pre-filled syringe of 2 ml.
This is equivalent to 0.38% of the recommended maximum daily intake with the diet of an adult.

3. How to use IMMUNORHO

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
Your doctor will determine the appropriate dose for you and the duration of treatment.
for doctors and healthcare professionals only.
If you are administering the product yourself, always use IMMUNORHO following
the instructions in the “Instructions for correct use” section exactly.
Method of administration
IMMUNORHO must be administered intramuscularly.
If a large volume is required (> 2 ml for children or > 5 ml for adults), it is recommended to administer
the medicine in divided doses at different sites.
If intramuscular administration is contraindicated (coagulation disorders), an alternative medicine for intravenous use should be used.
Overweight patients
In the case of overweight/obese patients, the use of an intravenous anti-D product should be considered.

Use in children
The safety and efficacy of IMMUNORHO in children have not yet been established. The appropriate dosage
must be calculated with the advice of a transfusion medicine specialist.

Instructions for correct use
IMMUNORHO must not be mixed with other medicinal products.
The product must be brought to room or body temperature before use.
The solution may be colorless or pale yellow or light brown; slight opalescence or a small amount of suspended particles may occur during storage.
Do not use solutions that are cloudy or with deposits.
Screw on the plunger rod of the pre-filled syringe and inject.
Unused medicines and waste materials derived from them must be disposed of in accordance with current
local regulations.

If you use more IMMUNORHO than you should
The consequences of an overdose are unknown.

IMMUNORHO

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur with products containing human anti-D immunoglobulin for intramuscular use
are listed below.

If you experience any of these side effects, contact your doctor or healthcare professional immediately:

• allergic reaction (hypersensitivity);
• anaphylactic shock.

Other side effects:

• headache;
• fast heartbeat (tachycardia);
• low blood pressure (hypotension);
• nausea, vomiting;
• skin reactions, such as skin redness (erythema), itching, pruritus;
• joint pain (arthralgia);
• fever, malaise, chills;
• reactions at the injection site such as swelling, pain, skin redness (erythema), hardening, warmth, itching, rash, sensation of pruritus.

Additional side effects in children
No specific data are available for the paediatric population.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
For the risk associated with transmissible agents, see section 2 “What you need to know before you use
IMMUNORHO”.

5. How to store IMMUNORHO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store in a refrigerator (2°C -8°C). Do not freeze.
Before use and within the expiry date, the product may be stored at room temperature,
not exceeding 25°C, for a maximum of 30 consecutive days. After this period the product must be
discarded. In any case, the product must not be returned to the refrigerator if stored at room
temperature.
Record the date of start of storage at room temperature on the outer pack.
Store in the original packaging to protect the medicine from light.

IMMUNORHO
Do not use this medicine if you notice that the solution is cloudy or contains deposits.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Content of the pack and other information

What IMMUNORHO contains
The active ingredient is human anti-D immunoglobulin.
1 ml of injectable solution in pre-filled syringe contains:

The activity is determined using the method of the European Pharmacopoeia. The equivalence in International Units
of the International Reference Preparation is defined by the World Health Organization.
Distribution of IgG subclasses:
IgG 66.0%
IgG 30.0%
IgG 2.5%
IgG 1.5%
Maximum IgA content 300 micrograms/ml.
Produced from human donor plasma.
The other components are: glycine, sodium chloride and water for injections.

Description of the appearance of IMMUNORHO and contents of the pack
IMMUNORHO 300 micrograms (1500 IU) Injectable solution for intramuscular use.
Contains: one pre-filled syringe with 300 micrograms in 2 ml of solution.
The injectable solution is clear and colourless or pale yellow or light brown; during storage
a slight opalescence or a small amount of particles in suspension may appear.

Marketing authorisation holder
Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca).

Manufacturer
Kedrion S.p.A. - S.S. 7 bis Km 19,5, S. Antimo (Napoli).

IMMUNORHO

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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The following information is intended exclusively for doctors or healthcare professionals (see
paragraph 3 "How to use IMMUNORHO").
Dosage and administration
The dose of anti-D immunoglobulin must be established based on the level of exposure to Rh(D)-positive
red blood cells and on the fact that 0.5 ml of Rh(D)-positive red blood cell concentrates or 1 ml of Rh(D)-positive
blood are neutralised by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.
The dosage and treatment schedule for human anti-D immunoglobulins
for intramuscular use recommended in other official guidelines or Member States should also be taken into account.
Prevention of Rh(D) immunisation in Rh(D)-negative women:

• Antenatal prophylaxis. According to general recommendations, the doses currently administered range from 50 to 330 micrograms or from 250 to 1650 IU.
• Scheduled antenatal prophylaxis: A single dose between the 28th and 30th week of pregnancy or two doses in weeks 28 and
• 34.
• Antenatal prophylaxis following complications during pregnancy: A single dose should be administered as soon as possible and in any case within 72 hours and, if necessary, should be repeated at intervals of 6-12 weeks for the entire duration of the pregnancy.
• Postnatal prophylaxis. According to general recommendations, the doses currently administered range from 100 to 300 micrograms or from 500 to 1500 IU. If the lowest dose (100 micrograms or 500 IU) is administered, a test must be performed to establish the extent of foeto-maternal haemorrhage.

In postnatal use, the product must be administered to the mother as soon as possible within 72
hours of delivery of an Rh-positive (D, d, d) newborn. If more than 72 hours have elapsed since delivery,
the product should still be administered as soon as possible.
The postnatal dose should still be administered even if antenatal prophylaxis has been performed, even if residual activity from the antenatal prophylaxis is still present in the maternal serum.
If massive maternal-foetal haemorrhage is suspected [> 4 ml (0.7-0.8% of women)], for example in case of
foetal/neonatal anaemia or intrauterine foetal death, its extent must be determined using the appropriate method, for example the acid elution test of Kleihauer-Betke for the determination of foetal Hb
(foetal haemoglobin) level or flow cytometry that selectively identifies Rh(D)-positive cells.
Further doses of anti-D immunoglobulin must be administered accordingly (10 micrograms or
50 IU per 0.5 ml of foetal red blood cells).
Incompatible transfusions of red blood cells
The recommended dose is 20 micrograms (100 IU) of anti-D immunoglobulin per 2 ml of Rh(D)-positive
blood transfused or per 1 ml of packed red blood cells.

IMMUNORHO

Consultation with a specialist in transfusion medicine is recommended to assess the applicability of a
red blood cell exchange procedure to reduce the load of D-positive red blood cells in circulation and to define
the dose of anti-D immunoglobulin necessary to suppress immunisation. Follow-up tests for
Rh(D)-positive red blood cells should be performed every 48 hours and further
anti-D immunoglobulin should be administered until the total disappearance of Rh(D)-positive red blood cells from the bloodstream. In
any case, due to a possible risk of haemolysis, it is suggested not to exceed a maximum dose of 3000
micrograms (15000 IU).
It is recommended to use an alternative intravenous product, as it allows to immediately reach adequate plasma levels. In the absence of a product for intravenous use, the very high dose must be administered intramuscularly over several days.
Thromboembolism
Arterial and venous thromboembolic events such as myocardial infarction, stroke, deep vein thrombosis and
pulmonary embolism have been associated with the use of immunoglobulins. Although no thromboembolic events have been observed in patients treated with
IMMUNORHO, these patients must be
sufficiently hydrated before the use of immunoglobulins.
Caution is recommended in patients with pre-existing risk factors for thrombotic events (such as hypertension,
diabetes mellitus and a history of vascular or thrombotic episodes, patients with hereditary or acquired thrombophilic
disorders, patients immobilised for a prolonged period, severely hypovolaemic patients,
patients with diseases that increase blood viscosity), especially in cases where high doses of IMMUNORHO are prescribed.
Patients should be informed about the early symptoms of thromboembolic events such as dyspnoea, pain and
swelling of the limbs, focal neurological deficits and chest pain and should be advised to contact
their doctor immediately if these symptoms occur.

IMMUNORHO