TRIAXIS 0,5 ML Injectable suspension in pre-filled syringe

Зміст інструкції

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

TRIAXIS POLIO

injectable suspension in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular components) and poliomyelitis (inactivated) vaccine
(adsorbed, reduced antigenic content)

Read 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 only for you or your child. Do not give it to others.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What TRIAXIS POLIOis and what it is used for
• 2. What you need to know before TRIAXIS POLIOis 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 is TRIAXIS POLIO and what is it used for

TRIAXIS POLIO (dTpa-IPV) is a vaccine. Vaccines are used to protect against infectious diseases. They work by inducing the body to produce protection against the bacteria that cause the diseases against which the vaccine acts.
This vaccine is used to boost protection against diphtheria, tetanus and pertussis (whooping cough) and poliomyelitis (polio) in children from three years of age, adolescents and adults, following a complete primary vaccination course.
The use of TRIAXIS POLIO during pregnancy allows the transfer of protection to the baby in the womb to protect them from pertussis during the first months of life.

Limitations in the protection provided
TRIAXIS POLIOwill only prevent the onset of these diseases if they are caused by the same bacteria against which the vaccine acts. You or your child may still contract similar diseases if they are caused by other bacteria or viruses.

TRIAXIS POLIOdoes not contain live bacteria or viruses and cannot cause any infectious disease against which it protects.
Please remember that no vaccine can provide complete protection, for life, in all vaccinated people.

2. What you need to know before TRIAXIS POLIO is given to you or your child

To make sure that TRIAXIS POLIO is suitable for you or your child, it is important that you inform the
doctor or nurse if any of the points below apply to you or your child. If there is
something you do not understand, ask your doctor or nurse for an explanation.

Do not use TRIAXIS POLIO if you or your child:

• have had an allergic reaction to:
• diphtheria, tetanus, pertussis or polio vaccines
• any of the other ingredients (listed in Section 6),
• any of the residual components derived from production (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin) which may be present in trace amounts.
• have ever had a serious reaction affecting the brain, within a week of receiving a previous dose of vaccine against whooping cough.
• have a severe acute febrile illness. Vaccination should be postponed until you or your child have recovered. A minor illness not accompanied by fever generally does not represent a valid reason to postpone vaccination. Your doctor will decide whether to administer TRIAXIS POLIO to you or your child.

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

• have received a booster dose of a vaccine for diphtheria and tetanus in the last 4 weeks. In this case, you or your child should not receive vaccination with TRIAXIS POLIO and the doctor will decide based on official recommendations when you or your child can receive a further injection.
• have had Guillain-Barré syndrome (temporary loss of movement and sensation in part or all of the body) within 6 weeks of a previous administration of a vaccine containing tetanus toxoid. The doctor will decide whether you or your child should receive TRIAXIS POLIO.
• have a progressive disease affecting the brain/nerves, or uncontrolled seizures. The doctor will first start treatment and when the conditions have stabilized will proceed with vaccination.
• have a weakened or reduced immune system due to:
• medicines (e.g. steroids, chemotherapy or radiotherapy)
• HIV or AIDS infection
• any other illness. The vaccine may not provide as effective protection as that obtained in subjects with a healthy immune system. If possible, vaccination should be postponed until the condition resolves or treatment is completed.
• Have hematological problems that cause easy bruising or prolonged bleeding following minor injuries (e.g. due to hematological disorders such as hemophilia or thrombocytopenia or treatment with blood-thinning medications). Fainting may occur before or after any injection. Therefore, inform your doctor or nurse if you or your child have fainted in relation to a previous injection.

Other medicines or 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 medicine.
Since TRIAXIS POLIO does not contain live bacteria or viruses, it can generally be administered
concurrently with other vaccines or immunoglobulins, but at a different injection site. Studies have
shown that TRIAXIS POLIO can be administered concurrently with any of the
following vaccines: inactivated influenza vaccine, hepatitis B vaccine and recombinant
human papillomavirus vaccine, respectively. Simultaneous administrations of more than one vaccine
should be carried out in different limbs.
If you or your child are receiving medical treatment that affects your or your child's blood or immune system
(such as blood-thinning medications, steroids, chemotherapy), refer to the
“Warnings and precautions” section above.

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

Driving and operating machinery
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 operate 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 receive the vaccine
The doctor will determine if TRIAXIS POLIOis suitable for you or your child, based on:

• which vaccines have been administered, in the past, to you or your child
• how many doses of similar vaccines have been administered, in the past, 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 need to wait between vaccinations.
If you are pregnant, the doctor will help you decide whether to receive TRIAXIS POLIOduring pregnancy.

Dosage and route of administration
Who will administer TRIAXIS POLIOto you?
Triaxis Polio must be administered by a healthcare professional who has been trained in the use of vaccines and in a
hospital or clinic equipped to intervene in the event of any rare, serious allergic reaction to the
vaccine.
Dosage
All age groups for whom TRIAXIS POLIO is indicated will receive an injection (half a millilitre).
If you or your child have suffered an injury that requires preventive action against
tetanus disease, the doctor may decide to administer TRIAXIS POLIO with or without
tetanus immunoglobulins.
TRIAXIS POLIO can be used for booster vaccination. The doctor will advise you on repeating the
vaccination.
Route of administration
The doctor or nurse will administer the vaccine by intramuscular injection into the upper and
outer part of the arm (deltoid muscle).
The doctor or nurse will notinject the vaccine into a blood vessel, into the buttock or under the skin.
In case of blood coagulation disorders, they may decide to perform the injection under the skin,
although this may lead to further undesirable local effects, including the formation of a small nodule
under the skin.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, TRIAXIS POLIO can cause side effects, although not everybody gets them.
manifest.

Serious allergic reactions
If any of these symptoms occur after you or your child have left the place where the
vaccine was given, you should 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 shortly after the administration of the
vaccine and while you or your child are still at the hospital or doctor's office. Serious
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 have been observed during clinical trials conducted in specific age groups.
Children from 3 to 6 years of age
Very common (may affect more than 1 in 10 people):

• pain
• swelling and redness in the area where the vaccine was injected
• 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 in the area where the vaccine was injected
• headache
• nausea
• vomiting
• skin rashes
• painful or swollen joints
• irritability.

Adolescents (11 years of age and older) and adults
Adolescents are slightly more likely than adults to experience side effects.
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 in the area where the vaccine was injected
• headache
• nausea
• painful or swollen joints
• sore muscles
• 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 different age groups in which the product is indicated,
during the commercial use of TRIAXIS POLIO. The frequency of these adverse events cannot be
determined accurately, as it is based on voluntary reports in relation to the estimated number of people
vaccinated.
Lymph node disorder, allergic reactions/serious allergies, convulsions, fainting, paralysis of a part or all
of the body (Guillain-Barré syndrome), facial paralysis, inflammation of the spinal cord, inflammation of the
nerves of the arm (brachial neuritis), temporary loss or alteration of sensitivity in the vaccinated limb,
dizziness, pain in the vaccinated limb, extensive swelling of the limb (often associated with redness and sometimes with
blisters), feeling unwell, pale skin, a hard nodule (hardening) in the area where the vaccine was
injected, abdominal pain.

Reporting of side effects
If you or your child experience any side effects, including those not listed in this
leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store TRIAXIS POLIO

Keep this medicine out of the sight and reach of children.
Do not use TRIAXIS POLIO after the expiry date indicated on the label after the wording “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.
Store the vaccine in the outer packaging to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRIAXIS POLIO contains
The active ingredients 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 hemagglutinin……………………………………... 5 micrograms
Pertactin …………………………………………………………3 micrograms
Type 2 and 3 fimbriae………………………………………………5 micrograms
Inactivated poliovirus (grown on Vero cells)
type 1 (Mahoney)………………………………. Antigen D: 29 units
type 2 (MEF1) …………………………………..Antigen D: 7 units
type 3 (Saukett)………………………………….Antigen D: 26 units
Adsorbed on aluminum phosphate…………………………………………. 1.5 mg (0.33 mg Al )
These amounts of antigen are strictly the same as those previously expressed as 40-8-32
antigen D units, respectively for types 1, 2 and 3 virus, when measured with another suitable
immunochemical method.
Aluminum 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.
The other components are: phenoxyethanol, ethanol, polysorbate 80, water for injections.

Description of the appearance of TRIAXIS POLIO and contents of the pack
TRIAXIS POLIO is presented as an injectable suspension in a pre-filled syringe (0.5 mL):

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

Marketing Authorisation Holder and Manufacturer
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Representative for Italy
Sanofi S.r.l.- Viale L. Bodio, 37/B – 20158 Milan

Manufacturers responsible for batch release:
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon (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 with the following
denominations:

The following information is intended exclusively for doctors 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 detect the presence of any
foreign particles and/or changes in colour. If these conditions exist, the product must not be administered.
For syringes without a needle, the needle must be firmly inserted into the end of the pre-filled syringe and
rotated by 90 degrees.
Needles must not be recapped.