Adacel

Leaflet accompanying the packaging: information for the user

ADACEL

Suspension for injection in a pre-filled syringe

Vaccine against diphtheria, tetanus and pertussis (acellular, composite), 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 that you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for the person named on the label. Do not pass it on to others.
• 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 vaccine is and what it is used for
• 2. Important information before using ADACEL vaccine
• 3. How to use ADACEL vaccine
• 4. Possible side effects
• 5. How to store ADACEL vaccine
• 6. Contents of the pack and other information

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

ADACEL (Tdap) 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 that cause a given disease.
This vaccine is used to boost protection against diphtheria, tetanus, and pertussis (whooping cough) in children from 4 years of age, adolescents, and adults after a complete primary vaccination cycle.
Administering the ADACEL 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 vaccine only prevents diseases caused by the bacteria 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 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 vaccine

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

When not to use ADACEL vaccine

• if there is an allergic reaction:
• to diphtheria, tetanus, or pertussis vaccines,
• to any of the other ingredients (listed in section 6), Page 1 of 10
• to any of the residual substances from the manufacturing process (formaldehyde, glutaraldehyde), 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 vaccine.

Warnings and precautions

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

• about receiving a dose of diphtheria or tetanus vaccine in the last 4 weeks. In such a case, the individual or child should not receive the ADACEL vaccine, and the doctor will decide when it is possible to receive the next dose based on official recommendations.
• if Guillain-Barré syndrome (temporary 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 vaccine should be administered.
• about a progressive brain or nerve disease 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 or AIDS infection
• 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 the use of anticoagulant medications).

Fainting may occur after or even before any needle injection. Therefore, you should inform the doctor or nurse if the patient or their child has experienced fainting during previous injections.
Before administering the ADACEL vaccine, you should inform the doctor, pharmacist, or nurse if the individual or child has an allergic reaction to latex. Pre-filled syringes (1.5 ml) with soft needle hubs contain a derivative of natural latex, which may cause an allergic reaction.

ADACEL vaccine and other vaccines or medicines

You should tell your doctor, nurse, or pharmacist about any medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The ADACEL vaccine does not contain live bacteria, 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 vaccine can be administered at the same time as any of the following vaccines: hepatitis B virus vaccine, poliomyelitis vaccine (inactivated or oral), inactivated influenza vaccine, and human papillomavirus vaccine. Administering more than one vaccine at the same time will be done in different limbs.
In the case of treatment affecting the circulatory or immune system (such as anticoagulant medications, steroids, or chemotherapy), see the "Warnings and precautions" section above.
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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 vaccine.

Driving and using machines

The effect of the vaccine on the ability to drive and use machines has not been studied. The ADACEL vaccine is unlikely to affect the ability to drive or use machines.

3. How to use ADACEL vaccine

When to administer the vaccine

The doctor will decide whether the use of the ADACEL 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 vaccine during pregnancy.

Dosage and administration

Who will administer the ADACEL vaccine?
The ADACEL vaccine should be administered by a healthcare worker trained in vaccine administration, in a clinic or practice equipped with equipment for rare severe allergic reactions to the vaccine.
Dosage
Individuals of all age groups for whom the ADACEL vaccine is indicated will receive one injection (0.5 ml).
In the case of an injury requiring tetanus prevention, the doctor may decide to administer the ADACEL vaccine with or without tetanus immunoglobulin.
The ADACEL vaccine can 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 side effects, including a small lump 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 vaccine can cause side effects, although not everybody gets them.
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Severe allergic reactions

If any of the following symptoms occur after leaving the place where the injection was administered, you should seek medical attention IMMEDIATELY:

difficulty breathing
bluish 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 practice. 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 aged 4 to 6 years
Very common (may affect more than 1 in 10 people):

• loss of appetite
• headache
• diarrhea
• fatigue
• pain
• redness
• swelling at the injection site

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

• nausea
• vomiting
• rash
• body aches or muscle weakness
• joint pain or swelling
• fever
• chills
• enlargement or tenderness of the axillary lymph nodes

Adolescents aged 11 to 17 years
Very common (may affect more than 1 in 10 people):

• headache
• diarrhea
• nausea
• body aches or muscle weakness
• joint pain or swelling
• fatigue/weakness
• malaise
• chills
• pain
• redness and swelling at the injection site.

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

• vomiting
• rash
• fever
• enlargement or tenderness of the axillary lymph nodes

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Adults aged 18 to 64 years
Very common (may affect more than 1 in 10 people):

• headache
• diarrhea
• body aches or muscle weakness
• fatigue/weakness
• malaise
• pain
• redness and swelling at the injection site

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

• nausea
• vomiting
• rash
• joint pain or swelling
• fever
• chills
• enlargement or tenderness of the axillary lymph nodes

After the 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 accurately calculated, as they are based on voluntary reports and should be related to the estimated number of vaccinated individuals.
Allergic reactions / severe allergic reactions (how to recognize such a reaction, see the beginning of section 4), tingling and numbness or numbness, weakness of part or all of the body (Guillain-Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), disorders of the facial nerve function (facial nerve palsy), seizures (convulsions), fainting, inflammation of the spinal cord, inflammation of the heart muscle, itching, hives, inflammation of the muscles, extensive swelling of the limbs, associated with redness, warmth, tenderness, or pain at the injection site, bruising, abscess, or small lump at the injection site.

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ADACEL vaccine

The medicinal product should be stored out of the sight and reach of children.
The ADACEL 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 given month.
Store in a refrigerator (2°C–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.
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6. Contents of the pack and other information

What ADACEL vaccine contains

The active substances in each dose (0.5 ml) of the vaccine are:
Diphtheria toxoid
not less than 2 international units (2 Lf)
Tetanus toxoid
not less than 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
Adsorbed on aluminum phosphate
1.5 mg (0.33 mg Al)
Aluminum phosphate acts 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.
Other ingredients are: phenoxylethanol, water for injections

What ADACEL vaccine looks like and contents of the pack

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

• without a needle - pack of 1 or 10
• with 1 or 2 separate needles - pack of 1 or 10
• with a separate needle in a protective shield - pack of 1 or 10

Not all pack sizes may be marketed.
The correct appearance of the vaccine is a turbid, white suspension. During storage, a white sediment and granular or flaky aggregates may form. After shaking, it becomes a uniformly white liquid; in the presence of aggregates, the product can be shaken again until a uniform suspension is obtained.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly
France

Manufacturer

Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt., Budapest Logistics and Distribution Platform
H-1225 Budapest
Building DC5, Campona utca. 1 (Harbor Park)
Hungary

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

Austria, Germany
Covaxis
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Belgium, Denmark, Finland, France, Greece, Spain, Netherlands, Ireland,
Luxembourg, Norway, Portugal, Sweden, Italy:
Triaxis
Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Lithuania, Latvia, Malta, Poland,
Romania, Slovakia, Slovenia, Hungary, United Kingdom (Northern Ireland):
ADACEL
Date of last revision of the leaflet:January 2025
Information intended for healthcare professionals only:
Since compatibility studies have not been performed, ADACEL vaccine must not be mixed with other medicinal products.

Preparation for administration

The pre-filled syringe may be supplied with a Luer Lock needle hub with a soft needle hub (Figure A) or a rigid needle hub (Figure B). The syringe with the suspension for injection should be visually inspected before administration. If there are any foreign particles, leakage, premature plunger movement, or damage to the needle shield, the pre-filled syringe should be discarded. The syringe is for single use only and must not be reused.
Instructions for using the pre-filled syringe with a Luer Lock needle hub

Figure A: Syringe with Luer Lock needle hub with soft needle hub

Step 1: Holding the needle hub of the syringe in one hand (avoid holding the plunger or syringe body), remove the needle hub.

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Step 2: To attach the needle to the syringe, gently screw it onto the needle hub until a slight resistance is felt.

Figure B: Syringe with Luer Lock needle hub with rigid needle hub

Step 1: Holding the Luer Lock in one hand (avoid holding the plunger or syringe body), unscrew the needle hub by twisting it.
Step 2: To attach the needle to the syringe, gently screw it onto the Luer Lock until a slight resistance is felt.

Follow the above Steps 1 and 2 to prepare the Luer Lock syringe and attach the needle.

Figure C: Needle in protective shield (in housing)	Figure D: Components of the needle protective shield (ready for use)

Step 3: Remove the needle housing. The needle is protected by a shield and a protective cap.
Step 4: A: Move the protective shield away from the needle in the direction of the syringe body at the shown angle. B: Remove the protective cap.
Step 5: After injection, activate (lock) the protective shield, using one of the three (3) one-handed techniques: activation on a flat surface, with the thumb, or with the index finger. Note: Activation is confirmed by an audible and/or palpable “click”.
Step 6: Visually inspect the operation of the protective shield. The protective shield should be fully locked (activated), as shown in Figure C.

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Figure D shows that the protective shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle out of the protective shield.

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Do not re-sheath the needles.
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