PATIENT INFORMATION LEAFLET

Igamad 750 UI/ml pre-filled syringe injectable solution

Human anti-D immunoglobulin

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. See section 4.

Igamad is presented as an injectable solution in a preloaded syringe. Each Igamad package contains a preloaded syringe with human anti-D (Rh) immunoglobulin, which are specific antibodies against the D (Rh) antigen of human red blood cells.

This medication belongs to the pharmacotherapeutic group called immune sera and immunoglobulins.

The administration of Igamad is indicated for:

Prevention of Rh(D) immunization in Rh(D) negative women.

• Prenatal prophylaxis

Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death, transplacental hemorrhage caused by prepartum hemorrhage, amniocentesis, chorionic biopsy, obstetric manipulation procedures (e.g. external cephalic version, invasive interventions, cordocentesis, blunt abdominal trauma or fetal therapeutic intervention).

• Prenatal prophylaxis

Treatment of Rh(D) negative individuals after an incompatible blood transfusion or other products containing Rh(D) positive red blood cells, e.g. platelet concentrate.

No use Igamad

• If you are allergic (hypersensitive) to human immunoglobulins or any of the other components of Igamad.

Tenga especial cuidado con Igamad

• Ensure that Igamad is not administered through a blood vessel, due to the possibility of shock.

• This medication will only be administered to the mother after delivery and not to the newborn.

• This medication should not be used in women who are Rh(D) positive or in women who have already been immunized against the Rh(D) antigen.

• Infrequent allergic reactions may occur, with symptoms including skin rash, generalized urticaria, chest tightness, difficulty breathing, hypotension, and anaphylaxis.

• Igamad contains a small amount of IgA. If you have IgA deficiency, you may develop anti-IgA antibodies and experience allergic reactions after administration of blood-derived products containing IgA. Your doctor must weigh the benefits of treatment with Igamad against the potential risks of hypersensitivity reactions.

• Infrequently, human anti-D (Rh) immunoglobulin may induce a drop in blood pressure with allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.

• If you receive an incompatible transfusion and are administered very high doses of human anti-D (Rh) immunoglobulin, you must be closely monitored and undergo some type of test to assess the risk of a hemolytic reaction.

Precautions for special safety

When administering human plasma or blood-derived products, certain measures must be taken to prevent the transmission of infections to patients. These measures include a careful selection of donors to exclude those at risk of being carriers of infectious diseases, analysis of specific markers of infections in individual donations and plasma mixtures, and inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering human blood or plasma-derived products, the possibility of transmission of infectious agents cannot be entirely ruled out. This also applies to emerging or unknown viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and for non-enveloped hepatitis A virus. The measures taken may have limited value for non-enveloped viruses such as 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 highly recommended that each time healthcare personnel administer a dose of Igamad, they record the name of the medication and batch number administered in order to maintain a record of the batches used.

Use of other medications

• Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

• Effects on vaccines: Igamad may reduce the effectiveness of certain types of vaccines such as measles, rubella, mumps, and varicella.

Effects on blood tests

Inform the analyst or your doctor that you have received this medication, if a blood test is performed after receiving Igamad. The level of some antibodies may increase.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Igamad is used during pregnancy.

Driving and operating machinery

The influence of Igamad on the ability to drive and operate machinery is negligible.

Important information about one of the components of Igamad

Special warnings about components: This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

Follow these instructions unless your doctor has given you different instructions.

The dose of human anti-D immunoglobulin (Rh) must be determined based on the level of exposure to Rh(D) positive red blood cells and based on the fact that approximately 10 micrograms (50 units) of human anti-D immunoglobulin (Rh) neutralize about 0.5 ml of Rh(D) positive red blood cell concentrate or 1 ml of Rh(D) positive blood.

The following doses are recommended based on clinical studies conducted with human anti-D immunoglobulin (Rh).

Prevention of Rh(D) immunization in Rh(D) negative women

• Antenatal prophylaxis:The currently administered doses are included between 50 - 330 micrograms or 250 - 1650 units.

A single dose at 28 - 30 weeks of gestation or two doses at 28 and 34 weeks.

A single dose should be administered as soon as possible and before 72 hours, and if necessary, repeat at intervals of 6 - 12 weeks during pregnancy.

• Postnatal prophylaxis:The currently administered doses are included between 100 - 300 micrograms or 500 - 1500 units. If the lowest dose (100 micrograms or 500 units) is administered, the magnitude of fetal-maternal hemorrhage should be determined.

For postnatal use, the product should be administered to the mother as soon as possible and within 72 hours following delivery of an Rh-positive child (D, Dweak, Dpartial). If more than 72 hours have passed, do not delay and administer as soon as possible.

The postnatal dose should be administered even if antenatal prophylaxis has been performed and even if residual activity of antenatal prophylaxis is demonstrated in maternal serum.

If a large fetal-maternal hemorrhage is suspected ([> 4 ml (0.7% - 0.8% of women)], e.g. fetal/neonatal anemia or intrauterine fetal death, its importance should be determined by an appropriate method, e.g. Kleihauer-Betke acid elution test to detect fetal HbF or flow cytometry which specifically identifies Rh(D) positive cells. Additional doses of human anti-D immunoglobulin (Rh) (10 micrograms or 50 units per 0.5 ml of fetal red blood cells) should be administered.

Incompatible red blood cell transfusions

The recommended dose is 20 micrograms (100 units) of human anti-D immunoglobulin (Rh) per 2 ml of Rh(D) positive blood transfused or per 1 ml of red blood cell concentrate. The appropriate dose should be determined by consulting a blood transfusion specialist. Follow-up tests for Rh(D) positive red blood cells should be performed every 48 hours and human anti-D immunoglobulin (Rh) should be administered until all Rh(D) positive red blood cells have been eliminated from the circulation. A maximum dose of 3000 micrograms (15,000 units) is sufficient in the case of large incompatible transfusions regardless of whether the volume of the transfusion exceeds 300 ml of Rh(D) positive red blood cells.

The use of an alternative intravenous product is recommended to achieve adequate plasma levels immediately. If an intravenous product is not available, the high dose should be administered intramuscularly over a period of several days.

Igamad should be administered intramuscularly.

If a high volume (> 2 ml in children or > 5 ml in adults) is required, it is recommended to administer the dose in divided fractions and in different anatomical regions.

If intramuscular administration is contraindicated (coagulation disorders), patients should be treated with other medications.

Igamad should not be mixed with other medications.

If you use more Igamad than you should

If you have been administered more Igamad than you should, consult your doctor or pharmacist immediately.

The consequences of an overdose are unknown.

In case of overdose or accidental administration, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use Igamad

Consult your doctor or pharmacist immediately and follow their instructions.

Like all medications, Igamad may produce adverse effects, although not all people will experience them.

• Local pain and increased sensitivity at the injection site may be observed; this can be prevented by dividing high doses into multiple injections applied in different anatomical regions.

• Fever, discomfort, headache, skin reactions, and chills may occasionally appear.

• Rarely, nausea, vomiting, hypotension, tachycardia, and allergic or anaphylactic reactions, including difficulty breathing and shock, have been described, even in patients who had not shown allergy to previous administrations.

No consistent data on the frequency of adverse reactions are available from clinical studies or post-marketing experience.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Igamad after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).

It must be brought to room temperature or body temperature before use.

The color may vary from colorless to pale yellow to light brown. The solution must be clear or slightly opalescent and during storage, a small amount of particles may appear. Products in solution must be subject to visual inspection before administration. Do not use Igamad if you observe that the solution is turbid or presents sediments.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and medicines that you do not need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Igamad Composition

• The active ingredient is:

* 100 micrograms of human anti-D Rh immunoglobulin correspond to 500 international units (IU).

• The other components are glycine, sodium chloride, and water for injection preparations.

(Seesection 2. “Before using Igamad” for more information on components).

Product Appearance and Packaging Contents

Igamad is a pre-filled injection solution. The solution is clear and pale yellow to light brown in color. During storage, a slight opalescence or a small amount of particles may appear.

Presentations:

Igamad 750 IU/ml

Pre-filled syringes of 1000 IU/1.33 ml, 1250 IU/1.67 ml, and 1500 IU/2 ml.

Marketing Authorization Holder and Responsible Manufacturer

Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This leaflet has been approved in

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/