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

Package leaflet: Information for the user

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, 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Igamad is and what it is used for

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

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

The administration of Igamad is indicated for:

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

• Antenatal prophylaxis

• Planned antenatal prophylaxis

• Antenatal prophylaxis following pregnancy complications including:

  Spontaneous abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death, fetomaternal hemorrhage due to antepartum bleeding, amniocentesis, chorionic biopsy, obstetric invasive procedures (e.g. external cephalic version, invasive interventions, cordocentesis, blunt abdominal trauma, or fetal therapeutic interventions).

• Postnatal prophylaxis

• Following delivery of an Rh(D)-positive infant (D, weak D, partial D).

Treatment of Rh(D)-negative individuals following an incompatible transfusion of blood or other products containing Rh(D)-positive erythrocytes, e.g. platelet concentrate.

2. Before using Igamad

Do not use Igamad

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

Take special care with Igamad

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

• After childbirth, this medicine will be administered only to the mother and not to the newborn.

• This medicine must 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 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 may develop anti-IgA antibodies and experience allergic reactions following administration of blood-derived products containing IgA. Your doctor must weigh the benefits of treatment with Igamad against the potential risks of hypersensitivity reactions.

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

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

Special safety precautions

When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent transmission of infections to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, testing for specific markers of infection in individual donations and pooled plasma, and inclusion of manufacturing steps designed to inactivate or remove viruses. Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging viruses, viruses of unknown origin, or other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus. However, the measures may have limited effectiveness against 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 healthcare personnel administer a dose of Igamad, they record the name of the medicine and the batch number administered, in order to maintain a record of batches used.

Use of other medicines

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

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

Effects on blood tests

Inform the laboratory staff or your doctor that you have received this medicine if you undergo blood testing after receiving Igamad. The levels of certain antibodies may be increased.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Igamad is used during pregnancy.

Driving and using machines

Igamad has no influence on the ability to drive or operate machinery.

Important information about some of the ingredients of Igamad

Special warnings about ingredients: This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Igamad

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

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

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

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

• Antenatal prophylaxis: According to general recommendations, the currently administered doses range between 50 – 330 micrograms or 250 – 1650 IU.

• 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 within 72 hours, and if necessary, repeated at intervals of 6 – 12 weeks during pregnancy.

• Postnatal prophylaxis: According to general recommendations, the currently administered doses range between 100 – 300 micrograms or 500 – 1500 IU. If the lowest dose (100 micrograms or 500 IU) is administered, the extent of fetomaternal hemorrhage must be determined.

For postnatal use, the product should be administered to the mother as soon as possible and within 72 hours after delivery of an Rh-positive infant (D, Dweak, Dpartial). If more than 72 hours have passed, administration should not be delayed and must be given as soon as possible.

The postnatal dose should be administered even if antenatal prophylaxis has already been performed and even if residual activity from 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 magnitude should be determined using an appropriate method, e.g. acid elution test (Kleihauer-Betke) to detect fetal HbF, or flow cytometry specifically identifying Rh(D)-positive cells. Additional doses of human anti-D (Rh) immunoglobulin should be administered (10 micrograms or 50 IU for each 0.5 ml of fetal erythrocytes).

Incompatible red blood cell transfusions

The recommended dose is 20 micrograms (100 IU) of human anti-D (Rh) immunoglobulin per 2 ml of transfused Rh(D)-positive blood or per 1 ml of red blood cell concentrate. The appropriate dose should be determined in consultation with a blood transfusion specialist. Follow-up tests for Rh(D)-positive erythrocytes should be performed every 48 hours, and human anti-D (Rh) immunoglobulin should be administered until all Rh(D)-positive erythrocytes have been cleared from circulation. A maximum dose of 3000 micrograms (15000 IU) is sufficient in cases of large incompatible transfusions, regardless of whether the transfused volume exceeds 300 ml of Rh(D)-positive erythrocytes.

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 must be administered by intramuscular injection.

If a large volume is required (> 2 ml in children or > 5 ml in adults), it is advisable to administer it in divided doses at different anatomical sites.

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

Igamad must not be mixed with other medicines.

If you use more Igamad than you should

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

The consequences of overdose are not known.

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

If you forget to use Igamad

Contact your doctor or pharmacist immediately and follow their instructions.

4. Possible adverse effects

Like all medicines, Igamad may cause adverse effects, although not everyone will experience them.

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

• Occasionally, fever, malaise, headache, skin reactions, and chills may occur.

• Rarely reported are: nausea, vomiting, hypotension, tachycardia, and allergic or anaphylactic reactions, including difficulty breathing and shock, even in patients who did not show allergy following previous administrations.

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Igamad

Keep out of the reach and sight of children.

Do not use Igamad after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Must be brought to room temperature or body temperature before use.

The colour may vary from colourless to pale yellow or light brown. The solution should be clear or slightly opalescent, and a small amount of particles may appear during storage. Solutions should be inspected visually before administration. Do not use Igamad if the solution appears cloudy or contains sediments.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional information

Composition of Igamad

• The active substance 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 injectable preparations.

(See section 2, “Before using Igamad”, for more information about the components).

Appearance of the medicinal product and contents of the pack

Igamad is an injectable solution in a pre-filled syringe. The solution is clear and ranges in color from pale yellow to light brown. 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 Manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This patient information leaflet was approved in

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/