Triaxis Polio

Package leaflet: Information for the user

TRIAXIS POLIO

pre-filled syringe injection suspension
Diphtheria, tetanus, pertussis (acellular components) and poliomyelitis (inactivated) vaccine
(adsorbed, reduced antigen content)
Please read all of this leaflet carefully before you or your child are vaccinated, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child only. Do not give it to others.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What TRIAXIS POLIO is and what it is used for
2. What you need to know before TRIAXIS POLIO is given to you or your child
3. How and when to use TRIAXIS POLIO
4. Possible side effects
5. How to store TRIAXIS POLIO
6. Contents of the pack and other information

1. What TRIAXIS POLIO is and what it is used for

TRIAXIS POLIO (dTpa-IPV) is a vaccine. Vaccines are used to protect against infectious diseases.
They work by stimulating the body to produce protection against the bacteria that cause the diseases
against which the vaccine is directed.
This vaccine is used to boost protection against diphtheria, tetanus, pertussis (whooping cough), and
poliomyelitis (polio) in children from three years of age, adolescents, and adults, following a completed primary
vaccination course.
The use of TRIAXIS POLIO during pregnancy allows the transfer of protection to the unborn child, protecting
the baby from pertussis during the first months of life.
Limitations in the protection provided
TRIAXIS POLIO will prevent these diseases only if they are caused by the same bacteria against which the
vaccine acts. You or your child may still contract similar illnesses if they are caused by other bacteria or viruses.
TRIAXIS POLIO does not contain live bacteria or viruses and cannot cause any of the infectious diseases
against which it provides protection.
Please remember that no vaccine can provide complete, lifelong protection in all vaccinated individuals.

2. What you should know before TRIAXIS POLIO is administered to you or your child

To ensure that TRIAXIS POLIO is suitable for you or your child, it is important that you inform your
doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor or nurse for clarification.
Do not use TRIAXIS POLIO if you or your child:

• have had an allergic reaction to:
  • diphtheria, tetanus, pertussis or poliomyelitis vaccines
  • any of the other components (listed in Section 6),
  • any residual components from manufacturing (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin) which may be present in trace amounts.
• have ever had a severe reaction affecting the brain within one week after receiving a previous dose of a whooping cough vaccine.
• have a serious feverish illness in its acute phase. Vaccination should be postponed until you or your child have recovered. A minor illness without fever generally does not constitute a valid reason to delay vaccination. Your doctor will decide whether to administer TRIAXIS POLIO to you or your child.

Warnings and precautions
Talk to your doctor or nurse before vaccination if you or your child:

• have received a booster dose of a diphtheria and tetanus vaccine within the past 4 weeks. In this case, you or your child should not receive TRIAXIS POLIO, and your doctor will decide, based on official recommendations, when you or your child can receive another injection.
• have experienced Guillain-Barré syndrome (temporary loss of movement and sensation in part or all of the body) within 6 weeks after a previous vaccination containing tetanus toxoid. Your doctor will decide whether you or your child should receive TRIAXIS POLIO.
• have a progressive disease affecting the brain/nerves, or uncontrolled seizures. Your doctor will first initiate treatment and proceed with vaccination once the condition has stabilized.
• have a weakened or suppressed immune system due to:
  • medications (e.g. steroids, chemotherapy or radiotherapy)
  • HIV infection or AIDS
  • any other disease. The vaccine may not provide as effective protection as in individuals with a healthy immune system. If possible, vaccination should be postponed until the condition resolves or treatment ends.
• have blood disorders causing easy bruising or prolonged bleeding after minor injuries (e.g. due to blood disorders such as haemophilia or thrombocytopenia, or treatment with blood-thinning medicines). Fainting may occur before or after any injection. Therefore, inform your doctor or nurse if you or your child have fainted following a previous injection.

Other medicines, vaccines and TRIAXIS POLIO
Tell your doctor, nurse or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Since TRIAXIS POLIO does not contain live bacteria or viruses, it can generally be administered
simultaneously with other vaccines or immunoglobulins, but at a different injection site. Studies have
shown that TRIAXIS POLIO can be given at the same time as the following vaccines: inactivated influenza vaccine, hepatitis B vaccine, and recombinant human papillomavirus vaccine, respectively. In addition, TRIAXIS POLIO can be administered simultaneously with the human papillomavirus vaccine and/or conjugated polysaccharide meningococcal vaccines (serogroups A, C, Y and W), either all three vaccines or in pairs. Simultaneous administration of more than one vaccine should be performed in different limbs.
If you or your child are receiving medical treatment affecting the blood or immune system (such as blood-thinning medications, steroids, chemotherapy), refer to the section “Warnings and precautions” above.

Pregnancy, breastfeeding and fertility
Inform your doctor or nurse if you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child. Your doctor will help you decide whether you should receive TRIAXIS POLIO during pregnancy.

Driving and using machines
No studies have been conducted on the effects of the vaccine on the ability to drive vehicles or operate machinery. The vaccine has no or negligible effect on the ability to drive vehicles and use machinery.

TRIAXIS POLIO contains ethanol
TRIAXIS POLIO contains 1.01 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use TRIAXIS POLIO

When you or your child will receive the vaccine
The doctor will determine whether TRIAXIS POLIO is suitable for you or your child based on:

• which vaccines have previously been administered to you or your child
• how many doses of similar vaccines have previously been administered to you or your child
• when the last dose of a similar vaccine was administered to you or your child

The doctor will decide how long you should wait between vaccinations.
If you are pregnant, the doctor will help you decide whether you should receive TRIAXIS POLIO during pregnancy.

Dosage and method of administration

Who will administer TRIAXIS POLIO?
Triaxis Polio must be administered by a healthcare professional trained in vaccine use and in a hospital or clinic equipped to manage any rare, severe allergic reactions to the vaccine.

Dosage
All age groups for which TRIAXIS POLIO is indicated will receive one injection (0.5 millilitres).

If you or your child has sustained an injury requiring preventive action against tetanus, the doctor may decide to administer TRIAXIS POLIO with or without tetanus immunoglobulins.

TRIAXIS POLIO may be used for booster vaccination. The doctor will advise you on when to repeat the vaccination.

Method of administration
The doctor or nurse will administer the vaccine by intramuscular injection into the upper outer part of the arm (deltoid muscle).

The doctor or nurse will not inject the vaccine into a blood vessel, into the buttock, or under the skin.

In case of blood coagulation disorders, they may decide to administer the injection subcutaneously, although this may lead to additional local adverse effects, including the formation of a small nodule under the skin.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, TRIAXIS POLIO can cause side effects, although not everyone experiences them.
Severe allergic reactions
If any of these symptoms occur after you or your child have left the place where the vaccine was administered, you must consult a doctor IMMEDIATELY.

• Difficulty breathing,
• Bluish discoloration of the tongue or lips,
• Skin rash,
• Swelling of the face or throat,
• Low blood pressure causing dizziness or collapse.

When these signs or symptoms occur, they usually develop immediately after administration of the vaccine and while you or your child are still in the hospital or medical office. Severe allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.
Other side effects
The following side effects were observed during clinical studies 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 equal to or greater than 37.5 °C)
• Diarrhea.

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

• Bruising
• Itching and skin inflammation at the injection site
• Headache
• Nausea
• Vomiting
• Skin rashes
• Painful or swollen joints
• Irritability.

Adolescents (from 11 years of age onwards) and adults
Adolescents are slightly more likely than adults to experience side effects.
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
• Painful or swollen joints
• Muscle pain
• Weakness
• Chills.

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

• Vomiting
• Diarrhea
• Fever (temperature equal to or greater than 38.0 °C).

The following additional adverse events have been reported in the different age groups for which the product is indicated, during commercial use of TRIAXIS POLIO. The frequency of these adverse events cannot be precisely determined, as it is based on voluntary reporting relative to the estimated number of vaccinated individuals.
Lymphatic disorder, allergic reactions/severe allergies, seizures, fainting, paralysis of part or all of the body (Guillain-Barré syndrome), facial paralysis, inflammation of the spinal cord, inflammation of nerves in the arm (brachial neuritis), temporary loss or alteration of sensation in the vaccinated limb, dizziness, pain in the vaccinated limb, extensive swelling of the limb (frequently associated with redness and sometimes with blisters), feeling unwell, pallor, a hard nodule (induration) at the injection site, abdominal pain.
Reporting of side effects
If you or your child experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store TRIAXIS POLIO

Keep this medicine out of sight and reach of children.
Do not use TRIAXIS POLIO after the expiry date stated on the label after the word “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. If frozen, the vaccine must be discarded.
Keep the vaccine in its outer carton to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRIAXIS POLIO contains
The active substances contained 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
Type 2 and 3 fimbriae…………………………………………………5 micrograms
Inactivated poliovirus (cultivated on Vero cells)
type 1 (Mahoney)………………………………. D-antigen: 29 units
type 2 (MEF1)…………………………………….D-antigen: 7 units
type 3 (Saukett)………………………………….D-antigen: 26 units
Adsorbed on aluminium phosphate…………………………………1.5 mg (0.33 mg Al)
These antigen quantities are strictly equivalent to those previously expressed as 40-8-32 D-antigen units, respectively for type 1, 2 and 3 viruses, when measured by another suitable immunological method.
Aluminium phosphate is included in this vaccine as an adjuvant. Adjuvants are substances included in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.
Other components: phenoxyethanol, ethanol, polysorbate 80, water for injections.

Description of the appearance of TRIAXIS POLIO and contents of the pack
TRIAXIS POLIO is a ready-to-use injectable suspension supplied in a pre-filled syringe (0.5 mL):

• without pre-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 is a white, cloudy, homogeneous suspension which may sediment during storage. After thorough shaking, the vaccine appears as a uniformly white liquid.

Marketing Authorisation Holder and Manufacturer
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Representative in Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano
Manufacturers responsible for batch release:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
and/or
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 in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for use
In the absence of compatibility studies, TRIAXIS POLIO must not be mixed with other medicinal products.
Parenteral products should be inspected visually before administration to check for the presence of
particulate matter and/or discoloration. If such conditions are present, the product must not be administered.
For syringes without needles, the needle must be firmly attached to the end of the pre-filled syringe and
rotated 90 degrees.
Needles must not be recapped.