Adacel Polio

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

ADACEL POLIO

Suspension for injection in a pre-filled syringe

Vaccine against diphtheria, tetanus, pertussis (acellular, composite) and poliomyelitis (inactivated), adsorbed, with reduced antigen content

You should carefully read the contents of this leaflet before the vaccine is administered to an adult or child, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for this person. It should not be given to anyone else.
• If the adult or child experiences any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What ADACEL POLIO vaccine is and what it is used for

ADACEL POLIO (Tdap-IPV) is a vaccine. Vaccines are used to protect against infectious diseases. The action of vaccines is based on stimulating the body to produce its own protection against the bacteria and viruses that cause the disease.
This vaccine is used to boost protection against diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio) in children from 3 years of age, adolescents, and adults after a complete primary vaccination series.
Administering the ADACEL POLIO vaccine to a pregnant woman allows the transfer of protection to the child during pregnancy to protect against pertussis for the first few months of the child's life.

Limitations of the protection provided

The ADACEL POLIO vaccine only prevents diseases caused by the bacteria or viruses against which the vaccine is directed. It is possible to become infected with similar diseases if they are caused by other bacteria or viruses.
The ADACEL POLIO vaccine does not contain any live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
It should be remembered that no vaccine provides complete, lifelong protection in all vaccinated individuals.

2. Important information before using ADACEL POLIO vaccine

To ensure that the ADACEL POLIO vaccine is suitable for the adult or child, it is essential to inform the doctor or nurse if any of the following points apply to the person to be vaccinated. If anything is unclear, you should ask the doctor or nurse to explain.

When not to use ADACEL POLIO vaccine

• if there is an allergic reaction:
• to diphtheria, tetanus, pertussis, or poliomyelitis vaccines,
• to any of the other ingredients (listed in section 6),
• to any of the residual substances from the manufacturing process (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B, and bovine serum albumin), which may be present in trace amounts,
• if a severe brain reaction occurred within one week after the previous dose of pertussis vaccine,
• if there is an acute severe illness with fever. Vaccination should be postponed until recovery. Mild illness without fever usually does not constitute a reason to postpone vaccination. The doctor will decide whether the adult or child can receive the ADACEL POLIO vaccine.

Warnings and precautions

Before administering the vaccine, you should inform the doctor or nurse:

• about receiving a booster dose of diphtheria or tetanus vaccine in the last 4 weeks. In such a case, the patient should not receive the ADACEL POLIO vaccine, and the doctor will decide when it is possible to receive the next dose based on official recommendations.
• if Guillain-Barré syndrome (transient loss of ability to move or feel in all or some parts of the body) occurred within 6 weeks after the previous dose of tetanus vaccine. The doctor will decide whether the ADACEL POLIO vaccine should be administered.
• about a progressive disease affecting the brain and/or nerves or uncontrolled seizures. The doctor will start treatment first and then administer the vaccine after the patient's condition has stabilized.
• about a weakened or impaired immune system due to
• treatment (e.g., steroids, chemotherapy, or radiation therapy)
• HIV infection or AIDS
• any other disease. The vaccine may not protect as well as in individuals with a healthy immune system. If possible, vaccination should be postponed until the end of such a disease or treatment.
• about any blood problems that cause easy bruising or prolonged bleeding after minor injury (e.g., due to a blood disease such as hemophilia or thrombocytopenia, or taking blood-thinning medications).

Fainting may occur after or even before any needle injection. Therefore, you should inform the doctor or nurse if the patient has experienced fainting during previous injections.

ADACEL POLIO vaccine and other vaccines or medicines

You should tell your doctor, nurse, or pharmacist about the medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
The ADACEL POLIO vaccine does not contain live bacteria or viruses, so it can usually be administered at the same time as other vaccines or immunoglobulins, but in different parts of the body. Studies have shown that the ADACEL POLIO vaccine can be administered at the same time as any of the following vaccines: inactivated influenza vaccine, hepatitis B virus vaccine, recombinant human papillomavirus vaccine. Injection of more than one vaccine at the same time will be performed in different limbs.
In the case of treatment affecting the blood or immune system (such as blood-thinning medications, steroids, or chemotherapy), see "Warnings and precautions" above.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or nurse. The doctor will help decide whether the pregnant patient should receive the ADACEL POLIO vaccine.

Driving and using machines

The effect of the vaccine on the ability to drive and use machines has not been studied.
The ADACEL POLIO vaccine has no or negligible influence on the ability to drive and use machines.

ADACEL POLIO vaccine contains ethanol

The ADACEL POLIO vaccine contains 1.01 milligrams of alcohol (ethanol) per 0.5 ml dose.
The small amount of alcohol in this medicine will not have a noticeable effect.

3. How to use ADACEL POLIO vaccine

When to take the vaccine

The doctor will decide whether the use of the ADACEL POLIO vaccine is appropriate, depending on:

• the type of vaccines administered in the past,
• the number of doses of similar vaccines administered in the past,
• the time of administration of the last dose of a similar vaccine.

The doctor will decide how long the interval between vaccinations should be.
If the patient is pregnant, the doctor will help decide whether the patient should receive the ADACEL POLIO vaccine during pregnancy.

Dosage and administration

Who will administer the ADACEL POLIO vaccine?
The ADACEL POLIO vaccine should be administered by a healthcare professional trained in the administration of vaccines, in a clinic or office equipped with equipment to handle rare severe allergic reactions to the vaccine.
Dosage
Individuals of all age groups for whom the ADACEL POLIO vaccine is indicated receive one injection (0.5 ml).
In the case of an injury requiring tetanus prevention, the doctor may decide to administer the ADACEL POLIO vaccine with or without tetanus immunoglobulin.
The ADACEL POLIO vaccine may be used for booster vaccination. The doctor will provide advice on booster vaccination.
Administration method
The doctor or nurse will administer the vaccine into the muscle in the upper arm (deltoid muscle).
The doctor or nurse will notadminister the vaccine into a blood vessel, buttocks, or under the skin. In the case of coagulation disorders, the doctor or nurse may decide to inject the vaccine under the skin, although this may cause more local reactions, including a small nodule under the skin.
If you have any further questions about the use of this medicinal product, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, the ADACEL POLIO vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions

If any of these symptoms occur after leaving the place where the injection was given, you should IMMEDIATELY consult a doctor:

difficulty breathing
blue discoloration of the tongue or lips
rash
swelling of the face or throat
low blood pressure, causing dizziness or fainting
These symptoms usually occur very soon after the injection, while the person is still in the clinic or office. Severe allergic reactions are very rare after the administration of any vaccine (may affect up to 1 in 10,000 people).

Other side effects:

During clinical trials conducted in specific age groups, the following side effects were observed:
Children from 3 to 6 years of age
Very common (may affect more than 1 in 10 people):

• pain
• swelling and redness at the injection site
• fatigue
• fever (temperature 37.5°C or higher)
• diarrhea

Common (may affect up to 1 in 10 people):

• bruises
• itching and skin inflammation at the injection site
• headache
• nausea
• vomiting
• rash
• joint pain or swelling
• irritability

Adolescents (from 11 years of age) and adults
Adolescents are slightly more likely to experience side effects than adults. Most side effects occur within the first 3 days after vaccination.
Very common (may affect more than 1 in 10 people):

• pain
• swelling and redness at the injection site
• headache
• nausea
• joint pain or swelling
• muscle pain
• weakness
• chills

Common (may affect up to 1 in 10 people):

• vomiting
• diarrhea
• fever (temperature 38.0°C or higher)

After the ADACEL POLIO vaccine was placed on the market, the following additional side effects were observed in various age groups for which the vaccine is recommended. The frequency of these side effects cannot be precisely calculated, as they are based on voluntary reports and should be related to the estimated number of vaccinated individuals.
Lymph node disorders, allergic reactions / severe allergic reactions, seizures, fainting, weakness or paralysis of part or all of the body (Guillain-Barré syndrome), facial nerve palsy, spinal cord inflammation, brachial neuritis (inflammation of the nerves in the arm), transient loss or change of sensation in the limb into which the vaccine was administered, dizziness, pain in the limb into which the vaccine was administered, extensive swelling of the limb (often associated with redness and sometimes with blisters), feeling unwell, pale skin, hard nodule (induration) at the injection site, abdominal pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ADACEL POLIO vaccine

The medicinal product should be stored out of sight and reach of children.
The ADACEL POLIO vaccine should not be used after the expiry date stated on the label after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (between 2°C and 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Syringes should be stored in the outer packaging to protect them from light.
Medicines should not be disposed of via wastewater or household waste. You should 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 ADACEL POLIO vaccine contains

The active substances in each dose (0.5 ml) of the vaccine are:
Diphtheria toxoid at least 2 international units (2 Lf)
Tetanus toxoid
at least 20 international units (5 Lf)
Pertussis antigens:
Pertussis toxoid 2.5 micrograms
Filamentous hemagglutinin 5 micrograms
Pertactin 3 micrograms
Fimbriae types 2 and 3 5 micrograms
Inactivated poliomyelitis virus (grown in Vero cells):
Type 1 (Mahoney) 29 antigen units D
Type 2 (MEF1) 7 antigen units D
Type 3 (Saukett) 26 antigen units D
Adsorbed on aluminum phosphate
1.5 mg (0.33 mg Al )
These antigen amounts are exactly the same as previously expressed as 40-8-32 antigen units D, respectively for virus types 1, 2, and 3, measured by another appropriate immunochemical method.
Aluminum phosphate serves as an adjuvant in this vaccine. Adjuvants are substances that are part of some vaccines and are intended to accelerate, enhance, and/or prolong the protective effect of the vaccine.
The other ingredients are: phenoxylethanol, ethanol, polysorbate 80, water for injections

What ADACEL POLIO vaccine looks like and what the pack contains

The ADACEL POLIO vaccine is a suspension for injection in a pre-filled syringe (0.5 ml):

• without a needle attached - pack of 1, 10, or 20
• with 1 or 2 separate needles - pack of 1 or 10

Not all pack sizes may be marketed.
The correct appearance of the vaccine is a uniform, cloudy, white suspension. During storage, a white sediment may form. After shaking, it becomes a uniform white liquid.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt.
Campona utca. 1 (Harbor Park)
H-1225 Budapest
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Austria, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Norway, Portugal, Sweden,
United Kingdom (Northern Ireland):
REPEVAX
Belgium, Italy, Luxembourg, Netherlands, Spain:
TRIAXIS POLIO
Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia:
ADACEL POLIO
Date of last revision of the leaflet:January 2025
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The following information is intended for healthcare professionals only:

Instructions for use

Due to the lack of compatibility studies, the ADACEL POLIO vaccine should not be mixed with other medicinal products.
Parenteral products should be inspected visually for the presence of foreign particles and/or discoloration before administration. If these conditions exist, the product should not be administered.
Regarding syringes without attached needles, a separate needle should be firmly inserted into the end of the pre-filled syringe and turned 90 degrees.
Needle covers should not be put back on.