Adacel

Package leaflet: Information for the user

ADACEL
Suspension for injection in prefilled syringe
Diphtheria, tetanus and pertussis (acellular, component) vaccine, adsorbed,
with reduced antigen content
Please read all of this leaflet carefully before the vaccine is administered to an adult or child, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If any side effects occur in the adult or child, including any side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What ADACEL vaccine is and what it is used for
2. What you need to know before receiving ADACEL
3. How ADACEL is given
4. Possible side effects
5. How to store ADACEL
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 help protect against infectious diseases. Vaccines work by 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 the age of 4 years, adolescents and adults who have completed a full primary vaccination course.
Administration of the ADACEL vaccine to a pregnant woman enables transfer of protection to the unborn child during pregnancy, thereby protecting the infant against pertussis during the first few months of life.
Limitations of protection provided
The ADACEL vaccine prevents only those diseases caused by the bacteria against which the vaccine is directed. It is still possible to get 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 can provide complete, lifelong protection in all vaccinated individuals.

2. Important information before receiving the ADACEL vaccine

To ensure that the ADACEL vaccine is suitable for an adult or child, it is important to inform the doctor or nurse if any of the following apply to the individual or child. If anything is unclear, please ask the doctor or nurse to explain.

When not to use ADACEL vaccine

• if there is an allergic reaction:
• to vaccines against diphtheria, tetanus or pertussis,
• to any of the other components (listed in section 6), Page 1 of 10
• to any substances remaining from the manufacturing process (formaldehyde, glutaraldehyde), which may be present in trace amounts.
• if a severe brain-related reaction occurred within one week after a previous dose of pertussis-containing vaccine,
• if there is an acute, serious illness with fever. Vaccination should be postponed until recovery. A mild illness without fever usually does not require delaying vaccination. The doctor will decide whether the adult or child can receive the ADACEL vaccine.

Warnings and precautions

Before vaccination, inform the doctor or nurse:

• if a booster dose of diphtheria- or tetanus-containing vaccine was received within the last 4 weeks. In such a case, the individual or child should not receive the ADACEL vaccine, and the doctor will decide, based on official recommendations, when the next dose can be given.
• if Guillain-Barré syndrome (temporary loss of movement or sensation in all or some parts of the body) occurred within 6 weeks after a previous tetanus-containing vaccine. The doctor will decide whether the ADACEL vaccine should be administered.
• about any progressive disease affecting the brain and/or nerves, or uncontrolled seizures. The doctor will first initiate treatment and then administer the vaccine once the patient's condition has stabilized.
• about a weakened or suppressed immune system due to:
• medical treatments (e.g. steroids, chemotherapy or radiotherapy),
• HIV infection or AIDS,
• or any other illness.

The vaccine may not provide as strong protection as in individuals with a healthy immune system. If possible, vaccination should be postponed until such illness or treatment has ended.

• about any blood disorders causing easy bruising or prolonged bleeding after minor injury (e.g. due to blood diseases such as hemophilia or thrombocytopenia, or due to taking blood-thinning medications).

Fainting may occur after or even before any injection with a needle. Therefore, inform the doctor or nurse if the patient or their child has previously fainted during injections.

Before administering the ADACEL vaccine, inform the doctor, pharmacist or nurse if the individual or child has an allergic reaction to latex. The prefilled syringes (1.5 mL) with soft needle caps contain a derivative of natural rubber latex, which may cause an allergic reaction.

ADACEL vaccine and other vaccines or medicines

Tell the doctor, nurse or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.

The ADACEL vaccine does not contain live bacteria and therefore can usually be given at the same time as other vaccines or immunoglobulins, but at different injection sites. Studies have shown that the ADACEL vaccine can be administered simultaneously with any of the following vaccines: hepatitis B vaccine, poliomyelitis vaccine (inactivated or oral), and inactivated influenza vaccine.

Additionally, the ADACEL vaccine can be given at the same time as the human papillomavirus (HPV) vaccine and/or conjugated polysaccharide meningococcal vaccines (serogroups A, C, W and Y) (all three vaccines or in pairs). Administration of more than one vaccine at the same time will be performed in different limbs.

For treatments affecting the blood or immune system (such as blood-thinning medications, steroids or chemotherapy), see the section "Warnings and precautions" above.

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Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or nurse. The doctor will help decide whether the patient should receive the ADACEL vaccine during pregnancy.

Driving and using machines

The effect of the vaccine on the ability to drive or operate machinery has not been studied.

The ADACEL vaccine has no effect or has a negligible effect on the ability to drive motor vehicles and operate machinery.

3. How to use the ADACEL vaccine

When to receive the vaccine
Your doctor will determine whether ADACEL vaccination is appropriate based on:

• the types of vaccines previously administered,
• the number of doses of similar vaccines previously received,
• the time elapsed since the last dose of a similar vaccine. Your doctor will decide on the required interval between vaccinations. If you are pregnant, your doctor will help you decide whether you should receive the ADACEL vaccine during pregnancy.

Dosage and method of administration
Who will administer the ADACEL vaccine?
The ADACEL vaccine should be administered by a healthcare professional trained in vaccine administration, at a clinic or medical facility equipped with equipment to manage rare severe allergic reactions to the vaccine.

Dosage
All individuals across age groups for whom the ADACEL vaccine is indicated should receive one injection (0.5 milliliters).

In case of an injury requiring tetanus prophylaxis, your doctor may decide to administer the ADACEL vaccine with (or) without tetanus immunoglobulin.

The ADACEL vaccine may be used for booster vaccination. Your doctor will advise you regarding booster doses.

Method of administration
Your doctor or nurse will administer the vaccine into the muscle of the upper arm (deltoid muscle).

Your doctor or nurse will not administer the vaccine into a blood vessel, into the buttocks, or subcutaneously (under the skin). In patients with coagulation disorders, your doctor or nurse may decide to administer the vaccine subcutaneously, although this may lead to more local adverse reactions, including a small lump under the skin.

If you have any further questions about the use of this medicinal product, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, the ADACEL vaccine can cause adverse reactions, although not everyone will
experience them.
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Severe allergic reactions
If any of the following symptoms occur after leaving the place where the injection was given,
seek medical advice IMMEDIATELY:
difficulty breathing
bluish discoloration of the tongue or lips
rash
swelling of the face or throat
low blood pressure causing dizziness or collapse
The above symptoms usually occur very quickly after injection, while the person is still at the
clinic or medical facility. Severe allergic reactions are very rare following any vaccine (may affect up
to 1 in 10,000 people).
Other adverse reactions:
The following adverse reactions were observed during clinical trials conducted in specific age groups:
Children aged 4 to 6 years
Very common (may affect more than 1 in 10 people):

• decreased appetite
• headache
• diarrhoea
• 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
• enlarged or painful axillary lymph nodes

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

• headache
• diarrhoea
• 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
• enlarged or painful axillary lymph nodes

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

• headache
• diarrhoea
• 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
• enlarged or painful axillary lymph nodes

After ADACEL vaccine was placed on the market, the following additional adverse reactions have
been observed across various age groups for which the vaccine is recommended. The frequency of
these adverse reactions cannot be precisely estimated because these are voluntary reports and
must be considered relative to the estimated number of vaccinated individuals.
Allergic reactions / serious allergic reactions (how to recognize such a reaction, see the beginning
of section 4.), tingling sensation and numbness or paralysis of part or all of the body (Guillain-Barré
syndrome), nerve inflammation in the arm (brachial neuritis), dysfunction of the facial nerve muscles
(facial nerve paralysis), seizures (convulsions), fainting, inflammation of the spinal cord, inflammation
of the heart muscle, itching, urticaria, myositis, extensive limb swelling associated with redness,
warmth, tenderness or pain at the injection site, bruising, abscess or small nodule at the injection
site.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist
or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug
Reactions 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store the ADACEL vaccine

The medicinal product should be stored out of sight and reach of children.
Do not use the ADACEL vaccine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of the specified 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 their outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 haemagglutinin 5 micrograms
Pertactin 3 micrograms
Fimbriae types 2 and 3 5 micrograms
Adsorbed onto aluminium phosphate 1.5 mg (0.33 mg Al)
Aluminium phosphate acts as an adjuvant in this vaccine. Adjuvants are substances included in
some vaccines to accelerate, enhance and/or prolong the protective immune response.
Other ingredients: phenoxyethanol, 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 needle – pack sizes of 1 or 10
• with 1 or 2 separate needles – pack sizes of 1 or 10
• with a separate needle in a safety shield – pack sizes of 1 or 10

Not all pack types may be marketed.
The vaccine normally appears as a white, cloudy suspension. During storage, a white sediment may form, along with granular or flaky aggregates. After shaking, it becomes a uniformly white liquid. If aggregates are present, the product may be shaken again until a uniform suspension is obtained.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 authorised for sale in the European Economic Area under the following names:
Austria, Germany: Covaxis
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Belgium, Denmark, Finland, France, Greece, Spain, the 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

Information intended for healthcare professionals only:
As compatibility studies have not been carried out, ADACEL vaccine must not be mixed with other medicinal products.

Preparation for administration
The pre-filled syringe may be supplied with a Luer Lock tip fitted with a soft tip cap (Figure A) or a hard tip cap (Figure B). The syringe containing the suspension for injection should be inspected visually before administration. If any foreign particulate matter, leakage, premature plunger movement or damage to the tip seal is observed, the pre-filled syringe must be discarded. The syringe is intended for single use only and must not be reused.

Instructions for use of the pre-filled syringe with Luer Lock tip
Figure A: Syringe with Luer Lock tip and soft tip cap

Step 1: Holding the syringe tip in one hand (avoid holding the plunger or syringe barrel), remove the tip cap.

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Step 2: To attach the needle to the syringe, gently screw it into the tip until slight resistance is felt.

Figure B: Syringe with Luer Lock tip and rigid tip cap

Step 1: Holding the Luer Lock tip in one hand (avoid holding the plunger or syringe barrel), unscrew the cap by turning it.
Step 2: To attach the needle to the syringe, gently screw it into the Luer Lock tip until slight resistance is felt.

Lock:
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Perform Steps 1 and 2 above to prepare the Luer Lock syringe and needle for attachment.

Figure C: Needle in safety shield (in housing)	Figure D: Components of the needle safety shield (prepared for use)
Step 3: Remove the needle housing. The needle is protected by the safety shield and the protective cap.
Step 4: A: Slide the safety shield away from the needle towards the syringe barrel at the angle shown. B: Remove the protective cap.
Step 5: After injection, lock (activate) the safety shield using one of the three (3) illustrated 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 check the function of the safety shield. The safety shield should be fully locked (activated), as shown in Figure C.

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

Any unused portions of the medicinal product or waste material must be disposed of in accordance with local regulations.
Do not re-cap needle shields.
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