PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Igantet 250
250 IU/ml, solution for injection
Human tetanus immunoglobulin

Please read all of 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 further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Igantet 250 is and what it is used for
Important information before using Igantet 250
How to use Igantet 250
Possible side effects
How to store Igantet 250
Contents of the pack and other information

1. What Igantet 250 is and what it is used for

Igantet 250 is a solution for injection supplied in a pre-filled syringe with a volume of 1 ml.
It is obtained from plasma donated by individuals containing specific antibodies against Clostridium tetani toxin.

Indications
Igantet 250 is used:

for prophylaxis of tetanus in individuals with fresh wounds that may be contaminated with Clostridium tetani spores; in persons who have not been vaccinated within the last 10 years, who have not completed the vaccination series according to schedule, or whose vaccination history is unknown,
for treatment of tetanus.

2. Important information before using Igantet 250

When not to use Igantet 250

if you are hypersensitive to any component of the medicine,
in case of hypersensitivity to human immunoglobulin. Exercise special caution when using Igantet 250
in case of IgA deficiency with presence of anti-IgA antibodies,
Ensure that the needle is not in a blood vessel by pulling back on the syringe plunger, because intravascular administration may cause shock.
Allergic reactions after administration of human tetanus immunoglobulin are possible, although they occur rarely. In case of shock, treat according to standard shock management principles.
After administration of Igantet 250, the patient should remain under medical supervision for at least 20 minutes.

Warnings and precautions
In the manufacturing process of medicinal products derived from human blood or plasma, specific procedures are implemented to prevent transmission of infections to treated patients. These procedures include selection of blood and plasma donors to exclude those who may be sources of infection, and testing of plasma for infectious agents. Manufacturers of these products apply processes that inactivate or eliminate viruses. Despite these preventive measures, it cannot be completely excluded that administration of products derived from human blood or plasma may transmit infection. This also applies to unknown or newly emerging viruses and other pathogens.
The risk of transmitting infectious agents is significantly reduced by the following procedures:

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

The above measures may have limited effectiveness against pathogens such as parvovirus B19. According to current experience, immunoglobulin preparations do not transmit hepatitis A virus or parvovirus B19. It is considered that the presence of antibodies plays an important protective role against viral infections.
For patient safety, it is recommended, whenever possible, to record the name and batch number of the product each time Igantet 250 is administered.

Igantet 250 and other medicines
You should inform your doctor about all medicines you are currently taking, including those obtained without a prescription. Inform your doctor about any recent vaccinations.

Vaccines containing live attenuated viruses
Administration of immunoglobulins may temporarily reduce, for a period of at least 6 weeks to 3 months, the effectiveness of vaccines containing live attenuated viruses such as measles, mumps, rubella, and varicella.

Effect on serological test results
After administration of immunoglobulins, a transient increase in passively transferred various antibodies occurs in the patient's blood, which may lead to false-positive results in serological tests.

Pregnancy and breastfeeding
The safety of using Igantet 250 during pregnancy has not been studied in clinical controlled trials; therefore, it should be used with caution in pregnant or breastfeeding women. Long-term clinical experience with the use of immunoglobulins, and in particular anti-D immunoglobulin, does not indicate that a negative effect on pregnancy, fetal or neonatal development should be expected.
Immunoglobulins are excreted in human milk, which may contribute to the transfer of protective antibodies to the newborn.

Driving and operating machinery
No influence of human tetanus immunoglobulin on the ability to drive vehicles or operate mechanical equipment has been observed.

3. How to use Igantet 250

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

The medicine must be injected slowly intramuscularly.
If higher doses are necessary (5 ml or more), it is recommended to divide the dose and administer injections at different sites.
When administering both tetanus immunoglobulin and tetanus vaccine simultaneously, separate syringes and needles must be used. Injections should be administered at different body sites.

After cleaning the wound and removing foreign bodies and dead tissue, assess the need for
active immunization with tetanus vaccine and simultaneous administration of human tetanus
immunoglobulin, injected intramuscularly at a different site, according to the following recommendations:

Clean and minor wounds

Vaccination and administration of tetanus immunoglobulin are not recommended for patients
who received their last booster dose of tetanus vaccine within the past 10 years or who have
been vaccinated according to the tetanus vaccination schedule.
Vaccination is recommended for patients who have not received a booster dose within the past
10 years, who have not been vaccinated according to the tetanus vaccination schedule, or whose
vaccination history is unknown. Administration of tetanus immunoglobulin is not necessary.

Contaminated and large wounds

Vaccination is not recommended for patients who received their last booster dose of tetanus
vaccine within the past 5 years or who have been vaccinated according to the tet游戏副本 vaccination schedule.
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.
For patients who have not been vaccinated according to the tetanus vaccination schedule or whose
vaccination history is unknown, tetanus vaccine and tetanus immunoglobulin should be administered
simultaneously.
For active immunization, vaccines containing only tetanus toxoid (T) or combined tetanus and diphtheria toxoids (Td vaccine for adults) may be used. The Td vaccine should not be used in patients with impaired immunity.
It is recommended that the physician assess the risk of tetanus development based on the likelihood of Clostridium tetani infection of the wound.

Dosages for children and adults are the same.

Prevention of tetanus

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

Treatment of tetanus

Results from several studies suggest that a single dose of 3000 to 6000 IU of human tetanus immunoglobulin may be beneficial in the treatment of tetanus, administered concurrently with other appropriate therapeutic measures.

Use of a higher than recommended dose of Igantet 250
The consequences of overdose are unknown.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Pain and tenderness may occur at the injection site. This can be prevented by dividing the dose and administering it at different sites.
Occasionally, fever, chills and skin reactions may occur. In rare cases, nausea, vomiting, hypotension, tachycardia, and allergic and anaphylactic reactions including shock have been observed.
There is no accurate information on the frequency of adverse reactions from either clinical trials or post-marketing experience.
For information on the risk of transmission of viruses, see Warnings and precautions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
By reporting adverse reactions, it is possible to gather more information on the safety of using this medicine.

5. How to store Igantet 250

Store in a refrigerator (2°C – 8°C).
The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
After opening, use immediately.
The solution should be inspected visually. It should be clear and free from particles.
Do not use Igantet 250 if the liquid appears cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Igantet 250 contains
Active substance:
1 ml of solution contains:
Human plasma protein 160 mg
of which immunoglobulin G ≥ 95%
Antibody immunoglobulin 250 IU
The other components are: glycine, sodium chloride and water for injections.

What Igantet 250 looks like and contents of the pack
1 pre-filled syringe-ampoule of 1 ml in a cardboard box.

Marketing authorisation 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, contact the representative of the marketing authorisation holder:
Grifols Polska Sp. z o.o., ul. Grzybowska 87, 05-462 Warsaw, Poland
Tel. No.: +48 22 378 85 61, fax: +48 22 378 85 6