Igantet

Package leaflet: Information for the patient

IGANTET 250 UI/1 ml solution for injection in pre-filled syringe for intramuscular use, 500 UI/2 ml solution for injection in pre-filled syringe for intramuscular use

Human anti-tetanus 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Igantet is and what it is used for

Igantet is an injectable solution for intramuscular use. It is supplied in a pre-filled syringe containing human anti-tetanus immunoglobulins, which are specific antibodies against tetanus toxin.
The medicine belongs to the pharmacotherapeutic group: immune sera and immunoglobulins.
Administration of Igantet is indicated for:

1. Post-exposure prophylaxis:

Immediate prophylaxis after wounds potentially at risk of tetanus in patients who are not adequately vaccinated, in patients whose immunization status is unknown, and in patients with severe deficiency in antibody production.

2. Treatment of clinically manifest tetanus.

Active tetanus vaccination should always be administered in conjunction with anti-tetanus immunoglobulin, unless contraindications exist or prior adequate vaccination has been confirmed.

2. What you should know before using Igantet

Do not use Igantet
If you are allergic to human immunoglobulin or to any of the other ingredients of this
medicinal product (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Igantet.

• Ensure that Igantet is not administered intravenously, as this may cause shock.
• Injections must be given intramuscularly. Aspirate with the syringe before injecting to make sure the needle has not entered a blood vessel.
• If subcutaneous administration is required due to contraindications, caution is recommended (see section 3, "How to use Igantet").
• True hypersensitivity reactions to tetanus antitoxin human immunoglobulin administered intramuscularly are rare.
• Igantet contains a small amount of IgA. If you are IgA-deficient, you may develop antibodies against IgA and may experience anaphylactic reactions after administration of blood products containing IgA. Your doctor will assess the benefit of treatment with Igantet against the potential risk of hypersensitivity reactions.
• Rarely, human anti-tetanus immunoglobulin may induce a drop in blood pressure associated with an anaphylactic reaction, even in patients who have previously tolerated treatment with human immunoglobulin well.
• If symptoms of allergic or anaphylactic reactions (shock) occur, the doctor will immediately stop administration of the medicinal product and initiate standard medical procedures for the treatment of shock.
• Patients should be monitored for at least 20 minutes after administration of the product.

Viral safety
When medicinal products derived from human blood or plasma are manufactured, specific safety measures are applied to prevent transmission of infectious agents to patients. These measures include:

• careful selection of blood and plasma donors to exclude potential carriers of infection,
• testing of each donation and plasma pool for markers of viral/infectious agents,
• inclusion of manufacturing steps capable of inactivating or removing viruses.

Despite these measures, when medicinal products prepared 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), hepatitis B virus (HBV), and hepatitis C virus (HCV).
The measures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19.
Clinical experience shows that treatment with immunoglobulins has not been associated with transmission of hepatitis A or parvovirus B19 infections, probably because the antibodies against these infections contained in the product provide a protective effect.
It is strongly recommended that each time Igantet is administered to a patient, the name and batch number of the product be recorded, in order to maintain traceability between the patient and the batch of product used.

Children and adolescents
The same warnings mentioned for adults are expected to apply to the paediatric population.

Other medicines and Igantet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Interference with vaccinations
Igantet may reduce the effectiveness of certain types of vaccines, such as live attenuated virus vaccines (e.g. mumps, rubella, and varicella vaccines). Administration of such vaccines should be performed at least 3 months after the last dose of Igantet. For measles vaccination, this interference may last up to 5 months. Therefore, if you have received a measles vaccination, you should undergo periodic checks to assess your antibody levels.

Interference with blood tests
Inform your doctor or nurse if you have been treated with Igantet and need to undergo blood tests.
After administration of human anti-tetanus immunoglobulins, a transient increase in various antibodies in your blood may occur, which could alter laboratory test results and lead to false-positive outcomes.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor before using this medicinal product.
The safety of this medicinal product during pregnancy has not been demonstrated by controlled clinical studies and, therefore, Igantet should be administered with caution in pregnant or breast-feeding women.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, the fetus, or the newborn are expected.
Immunoglobulins are excreted in breast milk, thus contributing to the transfer of antibodies to the newborn.
Clinical experience with human immunoglobulins suggests that no harmful effects on fertility are expected.

Driving and using machines
Igantet does not affect or has negligible effect on the ability to drive or use machinery.

Igantet contains sodium
This medicinal product contains 0.05 mmol (1.18 mg) of sodium per ml. Depending on the required dosage, this should be taken into account.
In case of prophylaxis of potentially tetanus-prone wounds:
The amount of sodium per dose of medicinal product (250 or 500 IU) is less than 1 mmol (23 mg), meaning the product is practically "sodium-free".
In case of treatment of clinically manifest tetanus:
The amount of sodium per dose of medicinal product (3000–6000 IU) corresponds to 0.6–1.2 mmol (13.8–27.6 mg). This should be considered in patients on a low-sodium (hypersodium-restricted) diet.

3. How to use Igantet

Use this medicinal product exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Igantet must be administered by intramuscular injection.
If a high dose is required (> 2 ml in children or > 5 ml in adults), it is recommended to administer it in divided doses at different anatomical sites.
When vaccination is simultaneously required, immunoglobulins and the vaccine must be administered at two different injection sites.
The medicine should be brought to room temperature or body temperature before administration.
The product should be inspected visually before administration for the presence of particulate matter or discoloration. Do not use solutions that appear cloudy or contain deposits.
Igantet must not be mixed with other medicinal products.
In the prophylaxis of wounds at risk of tetanus, if intramuscular administration is contraindicated (due to coagulation disorders), the injection may be given subcutaneously.
However, it should be noted that there are no clinical efficacy data supporting subcutaneous administration. After administration, firm manual pressure should be applied at the injection site using a gauze pad.
For acute treatment of clinically manifest tetanus, if intramuscular administration is not considered clinically appropriate, an alternative product for intravenous use may be used, if available.
For further information, refer to the section at the end of this leaflet entitled “The following information is intended exclusively for physicians or healthcare professionals”.
If you use more Igantet than you should
Data related to overdose are not available.
If you administer a higher dose than recommended, inform your doctor or pharmacist immediately.
If you forget to use Igantet
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with all normal human immunoglobulins administered intramuscularly, the following reactions may occur:
Fever, allergic reactions, chills, headache, dizziness, vomiting, nausea, arthralgia, hypotension, and mild backache may occasionally occur.
Rarely, human immunoglobulins may cause a sudden drop in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has not shown hypersensitivity to previous administrations.
Local reactions at the injection site may occur, such as swelling, soreness, hardening, redness, local warmth, itching, bruising, and skin rashes. These can be avoided by administering doses at different injection sites.
From post-marketing experience with the use of Igantet, the following adverse reactions have been reported with unknown frequency: allergic-type reactions (hypersensitivity), hypotension, skin reaction, erythema, itching, malaise, and injection site reactions (swelling, pain, erythema, induration, warmth, itching, and skin rashes).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Igantet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the wording
Exp. The expiry date refers to the last day of that month.
The expiry date refers to the product kept in its original, unopened packaging and stored as directed.
Store in a refrigerator (2 ºC - 8 ºC) and protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Igantet Contains

• The active substance is human antitetanus immunoglobulin.

1 ml of solution contains:

• 160 mg of human proteins, of which human G immunoglobulins (IgG) not less than 95%;
• specific antibodies against tetanus toxin equivalent to 250 IU per container (250 IU/1 ml or 500 IU/2 ml).
• The other components are glycine, sodium chloride, and water for injections.

(See section 2. “What you need to know before using Igantet” for further information on excipients).

Description of the Appearance of Igantet and Package Contents

Igantet is an injectable solution for intramuscular use, supplied in a pre-filled syringe.
The solution is clear and ranges from pale yellow to light brown. During storage, it may show slight opalescence or a small amount of particulate matter.

Packaging:
Igantet 250 IU/1 ml solution for injection in 1 ml pre-filled syringe
Igantet 500 IU/2 ml solution for injection in 2 ml pre-filled syringe

Marketing Authorization Holder and Manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN

The following information is intended exclusively for physicians or healthcare professionals:

Dosage
Prophylaxis of potentially tetanus-prone wounds:

• 250 IU unless the risk of infection is considered extremely high.

• the dose may be increased to 500 IU in the following cases:

  o Infected wounds not subjected to adequate surgical treatment within 24 hours.
  o Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as wounds involving foreign bodies (e.g., bites, punctures, or gunshot wounds).

Treatment of clinically manifest tetanus:
Single dose of 3000–6000 IU by intramuscular route, administered in conjunction with other appropriate treatments.

It is also advisable to follow the guidelines of the World Health Organization and other official recommendations regarding the appropriate use of intramuscular antitetanus immunoglobulins.

Paediatric Population
Children and adults should receive the same dosage.

Method of Administration
Human antitetanus immunoglobulin must be administered by intramuscular injection.
The product should be brought to room temperature or body temperature before administration.
The solution should be inspected visually prior to administration. Do not use cloudy solutions or those containing deposits.
Igantet must not be mixed with other medicinal products.
If a high dose is required (> 2 ml in children or > 5 ml in adults), it is recommended to administer it as divided doses at different anatomical sites.
When vaccination is simultaneously required, immunoglobulins and the vaccine must be administered at two different injection sites.

In prophylaxis, if intramuscular administration is contraindicated (due to coagulation disorders), subcutaneous injection may be performed. However, it should be noted that there are no clinical efficacy data supporting subcutaneous administration. After injection, firm manual pressure should be applied with a gauze pad at the injection site.

For acute treatment, if intramuscular administration is not considered clinically appropriate, an alternative product for intravenous use may be used, if available.

In addition to thorough wound cleaning and administration of human antitetanus immunoglobulin, active immunization with a tetanus vaccine should be initiated simultaneously, according to the following guidelines:

• Minor and clean wounds

Re-vaccination or administration of antitetanus immunoglobulin is not recommended for individuals who received their last booster dose within the past 10 years and who completed the previous tetanus vaccination series.
A vaccine dose is recommended for individuals who have not received a booster within the last 10 years, or for those with incomplete or unknown tetanus vaccination history. In these cases, antitetanus immunoglobulin administration is not necessary.

• Major or dirty wounds

Re-vaccination is not necessary for individuals who received their last booster within the past 5 years and who completed the previous tetanus vaccination series. Otherwise, if more than 5 years have passed since the last booster, a vaccine dose should be administered. In both cases, antitetanus immunoglobulin administration is not necessary.
A dose of vaccine together with antitetanus immunoglobulin should be administered to individuals with unknown prior tetanus vaccination status or whose vaccination was incomplete.

* Use different syringes, needles, and injection sites.
Note: When using different anatoxin preparations, the volume of the single booster dose must be
adjusted as described in the package leaflets, including the label.
The tetanus vaccine to be used may contain tetanus toxoid only or tetanus toxoid plus diphtheria toxoid (adult dT vaccine). The latter vaccine must not be administered to immunocompromised individuals with wounds.
Physicians are advised to assess whether a minor wound carries a risk of tetanus by evaluating the possibility that Clostridium tetani may have been present on the object that caused the injury.