Adacel polio: detailed information

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Patient Information Leaflet

ADACEL POLIO
Injection suspension in pre-filled syringe
Vaccine against diphtheria, tetanus, pertussis (acellular, combined) and poliomyelitis (inactivated), 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 questions, please consult your doctor, pharmacist or nurse.
This vaccine has been prescribed for a specific individual only. Do not pass it on to others.
If any adverse reactions occur in adults or children, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

What ADACEL POLIO vaccine is and what it is used for
Important information before vaccination with ADACEL POLIO
How to use ADACEL POLIO vaccine
Possible side effects
How to store ADACEL POLIO vaccine
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. Vaccines work by stimulating the body to produce its own protection against bacteria or viruses that cause specific diseases.
This vaccine is used to boost protection against diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio) in children from the age of 3 years, adolescents and adults who have completed the primary vaccination series.
Administration of ADACEL POLIO vaccine to pregnant women allows transfer of protection to the unborn child during pregnancy, providing protection against pertussis during the first few months of life.
Limitations of protection provided
ADACEL POLIO vaccine only protects against diseases caused by the specific bacteria or viruses targeted by the vaccine. It is still possible to contract similar diseases if they are caused by other bacteria or viruses.
ADACEL POLIO vaccine does not contain any live bacteria or viruses and cannot cause any of the infectious diseases it protects against.
Please remember 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 an adult or child,
it is important to inform the doctor or nurse if any of the following points
apply to the person to be vaccinated. If anything is unclear, please ask
the doctor or nurse for an explanation.
When not to use ADACEL POLIO vaccine

if there is an allergic reaction:
to vaccines against diphtheria, tetanus, pertussis or poliomyelitis,
to any of the other components (listed in section 6),

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to any of the substances remaining from the manufacturing process (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin), which may be present in trace amounts,
if a severe reaction involving the brain 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 preclude vaccination. The doctor will decide whether the adult or child can receive the ADACEL POLIO vaccine.

Warnings and precautions
Before administration of the vaccine, inform the doctor or nurse:

if a booster dose of diphtheria or tetanus vaccine was received within the last 4 weeks. In such a case, the patient should not receive ADACEL POLIO vaccine and the doctor will decide, based on official recommendations, when the next dose may be given.
if Guillain-Barré syndrome (a temporary loss of ability to move or feel in all or some parts of the body) occurred within 6 weeks after a previous tetanus-containing vaccine. The doctor will decide whether ADACEL POLIO vaccine should be administered.
of 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.
of a weakened or suppressed immune system due to
medical treatment (e.g. steroids, chemotherapy or radiotherapy)
HIV infection or AIDS
any other disease. The vaccine may not protect as effectively as in individuals with a healthy immune system. If possible, vaccination should be postponed until such illness or treatment has ended.
of any blood disorders causing easy bruising or prolonged bleeding after minor injury (e.g. due to blood diseases such as haemophilia or thrombocytopenia, or use of blood-thinning medications).

Fainting may occur after or even before any injection. Therefore, inform the doctor or nurse if the patient has previously fainted following injections.
ADACEL POLIO vaccine and other vaccines or medicines
Tell the 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 POLIO vaccine does not contain live bacteria or viruses and can usually be administered at the same time as other vaccines or immunoglobulins, but at different injection sites. Studies have shown that ADACEL POLIO vaccine can be given simultaneously with the following vaccines: inactivated influenza vaccine and hepatitis B virus vaccine. Additionally, ADACEL POLIO vaccine can be administered at the same time as human papillomavirus (HPV) vaccine and/or conjugated meningococcal polysaccharide vaccines (serogroups A, C, W and Y) (all three vaccines or in pairs). When administering more than one vaccine at the same time, injections will be given in different limbs.
For treatment affecting the blood or immune system (such as blood-thinning medications, steroids or chemotherapy), see section "Warnings and precautions" above.
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Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or nurse. The doctor will help decide whether the patient should receive ADACEL POLIO vaccine during pregnancy.
Driving and using machines
The effect of the vaccine on the ability to drive and use machines has not been studied.
ADACEL POLIO vaccine has no effect or negligible effect on the ability to drive motor vehicles and operate machinery.
ADACEL POLIO vaccine contains ethanol
ADACEL POLIO vaccine contains 1.01 milligrams of alcohol (ethanol) in each 0.5 ml dose.
The small amount of alcohol in this medicine will not cause a noticeable effect.

3. How to use the ADACEL POLIO vaccine

When to receive the vaccine
Your doctor will determine whether using the ADACEL POLIO vaccine 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 the appropriate interval between vaccinations.
If you are pregnant, your doctor will help you decide whether you 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 vaccine administration, at a clinic or medical facility equipped to manage rare severe allergic reactions to vaccines.

Dosage
All individuals, regardless of age, for whom the ADACEL POLIO vaccine is indicated, should receive a single injection (0.5 milliliters).

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

The ADACEL POLIO vaccine may be used for booster vaccination. Your doctor will provide advice 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, the buttocks, or under the skin.
In patients with bleeding disorders, the doctor or nurse may decide to administer the vaccine subcutaneously, although this may result in more local adverse reactions, including a small subcutaneous nodule.

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

Like any medicinal product, the ADACEL POLIO vaccine may cause adverse reactions, although
they do not occur in everyone.
Severe allergic reactions
If any of the following symptoms occur after leaving the place where the injection was given,
seek immediate medical advice:
difficulty breathing
blueness 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 3 to 6 years
Very common (may affect more than 1 in 10 people):

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

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

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

Adolescents (aged 11 years and older) and adults
Adolescents are slightly more likely to experience adverse reactions than adults. Most
adverse reactions 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

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chills

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

vomiting
diarrhoea
fever (temperature of 38.0°C or higher)

Following the introduction of the ADACEL POLIO vaccine into 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
in relation to the estimated number of vaccinated individuals.
Lymph node disorders, allergic reactions / serious allergic reactions, seizures,
fainting, partial or complete paralysis of limbs or body (Guillain-Barré syndrome),
facial nerve paralysis, myelitis, brachial neuritis (inflammation of nerves in the arm),
transient loss or alteration of sensation in the limb where the vaccine was administered,
dizziness, limb pain at the injection site, extensive limb swelling (often associated
with redness and sometimes with blisters), feeling unwell, pale skin, hard lump
(induration) at the injection site, abdominal pain.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
inform a doctor, pharmacist, or nurse. 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: +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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicinal product.

5. How to store the ADACEL POLIO vaccine

The medicinal product should be stored out of sight and reach of children.
Do not use the ADACEL POLIO 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 (between 2°C and 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Syringes should be stored in their outer packaging to protect them from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 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
Inactivated poliovirus (grown on Vero cells):
Type 1 (Mahoney) 29 D-antigen units
Type 2 (MEF1) 7 D-antigen units
Type 3 (Saukett) 26 D-antigen units
Adsorbed onto aluminium phosphate 1.5 mg (0.33 mg Al)
These antigen amounts are exactly equivalent to the previously stated 40-8-32 D-antigen units,
respectively for virus types 1, 2 and 3, measured by another appropriate immunochemical method.
Aluminium phosphate acts as an adjuvant in this vaccine. Adjuvants are substances included in
some vaccines to accelerate, enhance and/or prolong the vaccine's protective effect.
Other components are: phenoxyethanol, ethanol, polysorbate 80, water for injections

What ADACEL POLIO vaccine looks like and contents of the pack
ADACEL POLIO vaccine is a suspension for injection in a pre-filled syringe (0.5 ml):

without attached needle – pack sizes of 1, 10 or 20
with 1 or 2 separate needles – pack sizes of 1 or 10

Not all pack sizes may be marketed.
The vaccine appears as a uniform, cloudy, white suspension. During storage, a white sediment may form.
After shaking, it becomes a uniformly white liquid.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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 authorised for marketing in the European Economic Area countries 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

The following information is intended for healthcare professionals only:
Instructions for use
Due to lack of compatibility studies, ADACEL POLIO vaccine must 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 such conditions are present, the product must not be administered.
For syringes without attached needles, a separate needle should be firmly pressed onto the tip of the pre-filled syringe and twisted through 90 degrees.
Needle caps must not be reattached after use.