IGAMAD 750 IU/ml INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Igamad 750 UI/ml solution for injection in pre-filled syringe

Human anti-D immunoglobulin

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Igamad and what is it used for
2. Before you use Igamad
3. How to use Igamad
4. Possible side effects
5. Storage of Igamad
6. Further information

1. What is Igamad and what is it used for

It is presented as a solution for injection in a pre-filled syringe. Each Igamad container contains a pre-filled syringe with human anti-D immunoglobulin (Rh) which are specific antibodies against the D (Rh) antigen of human red blood cells.

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

The administration of Igamad is indicated in:

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

• Antenatal prophylaxis

• Planned antenatal prophylaxis.

• Antenatal prophylaxis after pregnancy complications including:

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).

• Postnatal prophylaxis

• Birth of an Rh(D) positive child (D, weak D, partial D).

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.

2. Before you use Igamad

Do not use Igamad

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

Take special care with Igamad

• Make sure Igamad is not administered into a blood vessel, due to the possibility of shock.

• After childbirth, this medicinal product should only be administered to the mother and not to the newborn.

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

• Allergic reactions may occur, albeit rarely, with symptoms such as skin rash, generalized urticaria, chest tightness, difficulty breathing, hypotension, and anaphylaxis.

• Igamad contains a small amount of IgA. If you have IgA deficiency, you are likely to develop anti-IgA antibodies and suffer allergic reactions after administration of blood-derived products (hemoderivatives) containing IgA. Your doctor should weigh the benefit of treatment with Igamad against the potential risks of hypersensitivity reactions.

• Rarely, human anti-D immunoglobulin (Rh) may induce a drop in blood pressure with an 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 immunoglobulin (Rh), you should be closely monitored and some type of test should be performed to assess the risk of a hemolytic reaction.

Special precautions for safety

When administering medicinal products derived from human plasma or blood, certain measures must be taken to prevent the transmission of infections to patients. Such measures include careful selection of donors to exclude those at risk of being carriers of infectious diseases, analysis of specific infection markers in individual donations and plasma pools, as well as the inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering medicinal products derived from human blood or plasma, the possibility of transmitting infectious agents cannot be entirely excluded. 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 the 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 contained in the product are protective.

It is highly recommended that each time a healthcare professional administers a dose of Igamad, they record the name of the medicinal product and batch number administered in order to maintain a record of the batches used.

Use of other medicinal products

• Tell your doctor or pharmacist if you are using or have recently used any other medicinal products, including those obtained without a prescription.

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

Effects on blood tests

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

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicinal product.

Igamad is used during pregnancy.

Driving and using machines

Igamad has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Igamad

Special warnings about ingredients: This medicinal product contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use Igamad

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

The dose of human anti-D immunoglobulin (Rh) should be determined according to the level of exposure to Rh(D) positive red blood cells and based on the fact that 0.5 ml of Rh(D) positive red blood cell concentrate or 1 ml of Rh(D) positive blood is neutralized with approximately 10 micrograms (50 UI) of human anti-D immunoglobulin (Rh).

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:According to general recommendations, the doses administered are currently between 50 - 330 micrograms or 250 - 1650 UI.

• Planned antenatal prophylaxis:

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

• Antenatal prophylaxis after pregnancy complications:

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

• Postnatal prophylaxis:According to general recommendations, the doses administered are currently between 100 - 300 micrograms or 500 - 1500 UI. If the lowest dose (100 micrograms or 500 UI) is administered, the magnitude of fetomaternal hemorrhage should be determined.

For postnatal use, the product should be administered to the mother as soon as possible and within 72 hours after the birth of an Rh positive child (D, weak D, partial D). If more than 72 hours have passed, it should not be delayed and should be administered 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 fetomaternal 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. acid elution Kleihauer-Betke 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 UI per 0.5 ml of fetal red blood cells) should be administered.

Incompatible red blood cell transfusions

The recommended dose is 20 micrograms (100 UI) of human anti-D immunoglobulin (Rh) per 2 ml of transfused Rh(D) positive blood or per 1 ml of Rh(D) positive red blood cell concentrate. The appropriate dose should be determined in consultation with 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 circulation. A maximum dose of 3000 micrograms (15000 UI) is sufficient in the case of large incompatible transfusions, regardless of whether the transfusion volume 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 several days.

Igamad should be administered by the intramuscular route.

If a large volume is required (> 2 ml in children or > 5 ml in adults), it is recommended to administer it in fractionated doses and in different anatomical regions.

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

Igamad should not be mixed with other medicinal products.

If you use more Igamad than you should

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

The consequences of an overdose are not known.

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

If you forget to use Igamad

Talk to your doctor or pharmacist immediately and follow their instructions.

4. Possible side effects

Like all medicinal products, Igamad can cause side effects, although not everybody gets them.

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

• Fever, malaise, headache, skin reactions, and chills may occur occasionally.

• Rarely, the following have been described: nausea, vomiting, hypotension, tachycardia, and allergic or anaphylactic reactions, including difficulty breathing and shock, even when the patient had not shown allergy to previous administrations.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Igamad

Keep out of the reach and sight of children.

Do not use Igamad after the expiry date stated on the container after EXP. The expiry date is the last day of the month stated.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the container and any unused medicinal products. This will help protect the environment.

6. Further information

Composition of Igamad

• The active substance is:

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

• The other ingredients are glycine, sodium chloride, and water for injections.

(See section 2. "Before you use Igamad" for more information on ingredients).

Appearance of the product and contents of the pack

Igamad is a solution for injection in a pre-filled syringe. 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.

Presentation:

Igamad 750 UI/ml

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

Marketing authorization holder and manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This leaflet was approved on

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/