Igantet 500

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Igantet 500

250 IU/ml, solution for injection,
Human tetanus immunoglobulin
Read the leaflet carefully before using the medicine, as it contains important information for the patient.
This information is important for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Igantet 500 and what is it used for
• 2. Important information before using Igantet 500
• 3. How to use Igantet 500
• 4. Possible side effects
• 5. How to store Igantet 500
• 6. Contents of the pack and other information

1. What is Igantet 500 and what is it used for

Igantet 500 is a solution for injection in a 2 ml syringe-ampoule.
It is obtained from plasma from donors containing specific antibodies against tetanus toxin.
Indications for use
Igantet 500 is used:

• to prevent tetanus in people with fresh wounds that may be infected with tetanus spores; in people who have not been vaccinated in the last 10 years, or have been vaccinated inconsistently or have an unknown vaccination history,
• to treat tetanus.

2. Important information before using Igantet 500

When not to use Igantet 500

• if there is hypersensitivity to any component of the medicine,
• in case of hypersensitivity to human immunoglobulin. Particular caution should be exercised when using Igantet 500
• in case of IgA deficiency and presence of anti-IgA antibodies,
• Ensure that the needle is not in a blood vessel, by withdrawing the syringe plunger, as intravascular administration may cause anaphylactic shock.
• Allergic reactions after administration of human tetanus immunoglobulin are possible, although they occur rarely. In case of anaphylactic shock, act according to the principles of anaphylactic shock treatment.
• After administration of Igantet 500, the patient should remain under medical observation for at least 20 minutes.

Warnings and precautions

In the process of manufacturing medicines from human blood or plasma, certain procedures are used to prevent the transmission of infections to patients. These procedures include the selection of blood and plasma donors, whose purpose is to exclude donors who may be a source of infection;
testing of plasma for the presence of infectious agents. Manufacturers of these medicines use processes that inactivate or eliminate viruses. Despite the use of preventive measures, it is not possible to completely exclude the possibility of transmitting an infection, if medicines manufactured from human blood or plasma are administered. This also applies to unknown or newly discovered viruses and other pathogens.
The risk of transmitting infectious agents is significantly reduced by using appropriate procedures:

• donor selection based on medical history and screening tests of individual donations and plasma pools for the presence of HBsAg and anti-HIV and HCV antibodies,
• testing of plasma pools for the presence of HCV genetic material,
• use of virus inactivation and removal processes during production, validated using model viruses. These processes are considered effective against HIV, HCV, HAV, and HBV viruses.

The above measures may have limited value in the case of pathogens such as parvovirus B19. So far, the data indicate that immunoglobulin preparations do not transmit hepatitis A virus or parvovirus B19. It is assumed that the presence of antibodies plays a significant role in protecting against viral infections.
For the benefit of patients, it is recommended that whenever possible, the name and batch number of the administered Igantet 500 should be recorded.

Igantet 500 and other medicines

Inform your doctor about all medicines you have taken recently, including those that are available without a prescription. Inform your doctor about any recent vaccinations.
Vaccines containing live attenuated viruses
The use of immunoglobulins may weaken the effectiveness of vaccines containing live attenuated viruses for at least 6 weeks to 3 months
after administration.
Effect on serological test results
After administration of immunoglobulins, there is a transient increase in passively introduced antibodies in the patient's blood, which may cause false-positive serological test results.

Pregnancy and breastfeeding

The safety of using the medicine during pregnancy has not been the subject of controlled clinical trials, therefore it should be used with caution in pregnant or breastfeeding women. Long-term clinical experience with the use of immunoglobulins, in particular anti-D immunoglobulin, does not indicate that one should expect a negative effect on the course of pregnancy, fetal development, or the newborn.
Immunoglobulins are excreted in human milk, which may contribute to the transfer of protective antibodies to the newborn.

Driving and using machines

No effect of human tetanus immunoglobulin on the ability to drive and use machines has been observed.

3. How to use Igantet 500

Before administration, warm the medicine to room temperature or body temperature.

• Administer slowly intramuscularly.
• If larger doses are required (5 ml or more), it is recommended to divide the dose and administer it in different locations.
• In case of concurrent administration of tetanus immunoglobulin and vaccine, use separate syringes and needles. Administer the injections in different parts of the body.

After cleaning the wound, removing foreign bodies, and dead tissue, assess the indication for active immunization with tetanus vaccine and concurrent administration of human tetanus immunoglobulin, intramuscularly in a different part of the body, according to the following guidelines:

• Clean and minor wounds

It is not recommended to vaccinate or use tetanus immunoglobulin in patients who have received a booster dose of tetanus vaccine in the last 10 years or have been vaccinated according to the tetanus vaccination program.
Vaccination is recommended for patients who have not received a booster dose in the last 10 years or have not been vaccinated according to the tetanus vaccination program, as well as for those with an unknown vaccination history. Administration of tetanus immunoglobulin is not necessary.

• Contaminated and large wounds

It is not recommended to vaccinate patients who have received a booster dose of tetanus vaccine in the last 5 years or have been vaccinated according to the tetanus vaccination program.
Vaccination should be administered if more than 5 years have passed since the last booster dose.
In both cases, administration of tetanus immunoglobulin is not necessary.
In patients who have not been vaccinated according to the tetanus vaccination program or have an unknown vaccination history, vaccination should be administered concurrently with tetanus immunoglobulin.
For active immunization, a vaccine containing only tetanus toxoid (T) or tetanus and diphtheria toxoids (Td vaccine for adults) can be used. The Td vaccine should not be used in patients with impaired immunity.
The doctor should assess the risk of tetanus based on the likelihood of wound infection with Clostridium tetani.
Doses for children and adults are the same.

• Tetanus prevention

250 IU intramuscularly.
The dose should be doubled (500 IU) in case of complicated wounds (deep wounds with damaged tissue, contaminated), or if more than 24 hours have passed since the injury, or in case of overweight adults.

• Tetanus treatment

Results of several studies suggest the importance of using single doses of 3000 to 6000 IU of human tetanus immunoglobulin in the treatment of tetanus, concurrently with other appropriate treatment methods.

Using a higher than recommended dose of Igantet 500

The consequences of overdose are not known.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pain and tenderness may occur at the injection site. This can be prevented by dividing the dose and administering it in different locations.
Sometimes, fever, chills, and skin reactions may occur. Rarely, the following have been observed: nausea, vomiting, hypotension, tachycardia, and allergic and anaphylactic reactions, including anaphylactic shock.
There is no precise information on the frequency of side effects from clinical trials and post-marketing experience.
Information on the risk of virus transmission, see Warnings and precautions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. 22 49 21 301, fax (22) 49 21 309; e-mail:
ndl@urpl.gov.pl.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Igantet 500

Store in a refrigerator (2°C – 8°C).
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging..
Use immediately after opening.
Visually inspect the medicine before use. It should be clear and free of sediment.
Do not use Igantet 500 if the liquid is cloudy or contains sediment.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Igantet 500 contains

Active substance:
1 ml of solution contains:
Human plasma protein
160 mg
including immunoglobulin G ≥ 95%
Tetanus immunoglobulin
250 IU
Other ingredients are: glycine, sodium chloride, and water for injections

What Igantet 500 looks like and contents of the pack

1 syringe-ampoule of 2 ml in a cardboard box.

Marketing authorization holder and manufacturer

INSTITUTO GRIFOLS, S.A.
Poligono Levante Can Guasch, 2
08150 Parets del Vallès, Barcelona, Spain

Other sources of information

For more detailed information, please contact the representative of the marketing authorization holder:
Grifols Polska Sp. z o.o., ul. Grzybowska 87, 00-844 Warsaw
Phone: +48 22 378 85 61, fax: +48 22 378 85 61

Date of last revision of the leaflet: