TETRAVAC 0.5 ML Инъекционная суспензия

Содержание инструкции

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

Tetravac,Injectable suspension in pre-filled syringe
Vaccine (adsorbed) against diphtheria, tetanus, pertussis (acellular component)
and poliomyelitis (inactivated).
Read this leaflet carefully before your child is vaccinated, as it contains
important information.

• 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 your child. Do not give it to others.
• If your child experiences any side effects, ask your doctor, pharmacist or nurse. This also applies if any side effects not listed in this leaflet occur. See section 4.

Contents of this leaflet:

• 1. What Tetravac is and what it is used for
• 2. What you need to know before Tetravac is given to your child
• 3. How to administer Tetravac
• 4. Possible side effects
• 5. How to store Tetravac
• 6. Contents of the pack and other information. See section 4

1. What Tetravac is and what it is used for

Tetravac is a vaccine (DTaP-IPV vaccine) used to protect against infectious diseases.
Tetravac helps to protect your child from diphtheria, tetanus, whooping cough (pertussis) and
poliomyelitis.
It is given as a primary vaccination course in children from 2 months of age and for booster
vaccination in children who have previously received this vaccine or a similar vaccine when they were
younger.
When a dose of Tetravac is given, the body's natural defenses will develop
protection against these different diseases.

• Diphtheria is an infectious disease that usually initially affects the throat. In the throat, the infection causes pain and swelling that can lead to suffocation. The bacteria responsible for the disease also produce a toxin (poison) that can damage the heart, kidneys and nerves.
• Tetanus (often described as “locked jaw”) is caused by tetanus bacteria that penetrate through a deep wound. The bacteria produce a toxin (poison) that causes muscle spasms, leading to an inability to breathe with the possibility of suffocation.
• Pertussis (often called whooping cough) is an infection of the airways, which can occur at any age but more frequently affects infants and young children in early childhood and small children. Increasingly intense and frequent coughing fits, which can last for several weeks, are characteristic of the disease. The coughing fits may be followed by a convulsive scream.
• Poliomyelitis (often called polio) is a disease caused by viruses that affect the nerves. It can lead to paralysis or muscle weakness, usually of the legs. Paralysis of the muscles that control breathing and swallowing can be fatal.

Important
Tetravac will only help prevent these diseases if they are caused by the same bacteria or viruses used to
produce the vaccine. Your child may still contract these infectious diseases if caused by different viruses or
bacteria.

2. What you need to know before Tetravac is given to your child

It is important to inform your doctor, pharmacist or healthcare professional if any of the following points
apply to your child, so that they can be sure that Tetravac can be given to your
child.

Do not use Tetravac

• if your child is allergic to: the active substances of Tetravac or any of the excipients of Tetravac (see section 6) other vaccines containing any of the substances listed in section 6 any vaccine that protects against whooping cough
• if your child has any active brain disease (evolving encephalopathy);
• if your child has had a severe reaction that affected the brain after any vaccine that protects against whooping cough

Warnings and precautions
Tell your doctor or healthcare professional before vaccination:

• If your child has a fever or an acute illness (for example, fever, sore throat, cough, cold or flu). It may be necessary to postpone vaccination until your child feels better.
• If your child has received a whooping cough vaccine in the past and any of the following events occurred immediately afterwards: Fever of 40°C or higher within 48 hours, not due to another identifiable cause. Collapse or shock-like state with hypotonic-hyporesponsive episode within 48 hours of vaccination. Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination. Seizures with or without fever, occurring within 3 days of vaccination.
• If your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin and polymyxin
• B. This is because these substances are used in the manufacture of Tetravac and may still be present in untraceable amounts in the vaccine.
• If your child has previously experienced febrile convulsions, not related to a previous vaccine injection; in this case it is particularly important that the temperature is monitored for 48 hours after vaccination and that antipyretic treatment is administered regularly to help reduce fever, for 48 hours.
• If your child has had a temporary loss of motor skills and sensation (Guillain-Barré syndrome) or loss of motor skills, pain and numbness in the arm and shoulder (brachial neuritis) following a previous injection with a vaccine containing tetanus the doctor or nurse will decide whether to administer Tetravac to your child
• If your child has an immunodeficiency or is receiving treatment that suppresses their immune defenses, as the immune response to the vaccine may be reduced. It is recommended to wait until the end of such illness or treatment before vaccination. Administering Tetravac to children with chronic immunodeficiency (including HIV infection) is recommended but protection against infection may be limited.
• If your child suffers from thrombocytopenia (low platelet count) or bleeding problems (such as hemophilia), as it may bleed at the injection site.

Fainting can occur following, or even before, any injection with a needle. Therefore, inform your doctor
or nurse if your child has fainted after a previous injection.

Other medicines/vaccines and Tetravac
Tetravac can be given at the same time as:

• Act-HIB ( Haemophilus influenzaetype b conjugate)
• Vaccines containing measles-mumps-rubella and varicella
• Hepatitis B vaccine but at separate injection sites.

In the event that your child needs to receive Tetravac at the same time as other vaccines
other than those already mentioned, consult your doctor or pharmacist for more information.
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicine.

Pregnancy and breastfeeding
Not applicable. This vaccine is intended for pediatric use only.

Tetravac contains phenylalanine, ethanol and sodium
Tetravac contains 12.5 micrograms of phenylalanine in each 0.5 mL dose. Phenylalanine may be
harmful if you suffer from phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates
because the body is unable to eliminate it properly.
Tetravac contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this
medicine will not have noticeable effects.
Tetravac contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially "sodium-free".

3. How to administer Tetravac

Always use this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor.

Dosage:

Primary vaccination and first booster:
Schedules include primary vaccination, consisting of:

• two injections (with an interval of at least two months),
• or three injections (with an interval of at least one month), followed by a booster vaccination starting from the age of 12 months.

Additional booster vaccination:
An additional booster dose is recommended between 4 and 13 years of age.
This vaccine must be used in accordance with official recommendations.

Method of administration:
The vaccine must be administered by a doctor or healthcare professional who has been trained in the use
of vaccines and who is equipped to intervene if any serious, uncommon allergic reaction occurs following the injection.
Tetravac is administered by injection into a muscle [intramuscular route (IM)] in the upper part of the
thigh or arm of your child. The vaccine must never be administered into a blood vessel.

If your child misses a dose of Tetravac
If your child misses a scheduled injection, your doctor will decide when to administer the missed
dose.

If you use more Tetravac than you should
Since the doctor or nurse administers Tetravac to your child, an overdose is unlikely. If
you believe that your child has received too much Tetravac or that the interval between two injections was too
short, inform your doctor or nurse.
If you have further questions regarding the use of this medicine, ask your doctor, healthcare professional, or
pharmacist.

4. Possible side effects

Like all vaccines and medicines, Tetravac can cause side effects, although not everybody gets them.

Serious allergic reactions
If any of these symptoms occur after leaving the place where the vaccine was administered to
your child, you should consult a doctor IMMEDIATELY.
There is a possibility (with unknown frequency) that serious allergic reactions may occur after the
administration of any vaccine. These may include the following:

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

When these signs or symptoms occur, they usually develop quickly after
the injection is given and while the child is still in the hospital or doctor's office.

Other side effects
If your child shows any of the following side effects or if you notice any side effects
not listed in this leaflet, inform your doctor, nurse or pharmacist.

• Very common reactions (may affect more than 1 in 10 users) are:
• Vomiting
• Loss of appetite (feeding disorders)
• Drowsiness (lethargy)
• Headache
• Nervousness (irritability)
• Abnormal crying
• Muscle pain (myalgia)
• Redness at the injection site
• Pain at the injection site
• Swelling at the injection site
• Fever equal to or higher than 38°C
• General feeling of being unwell.
• Common reactions (may affect 1 in 100 users) are:
• Diarrhea
• Sleep disorders (insomnia)
• Hard skin (induration) at the injection site
• Uncommon (may affect 1 in 1,000 users) are:
• Prolonged, inconsolable crying
• Redness and swelling larger than 5 cm at the injection site
• Fever equal to or higher than 39°C
• Rare reactions (may affect 1 to 10 users in 10,000) are:
• Fever above 40°C
• Reactions with unknown frequency (frequency cannot be estimated based on available data) are:
• Seizures (convulsions) with or without fever
• Fainting (syncope)
• Skin rash, redness and itching of the skin (erythema, urticaria)
• Extensive reactions at the injection site (>5 cm), including extensive swelling of the limb from the injection site to beyond one or both joints. These reactions occur within 24-72 hours of vaccination, may be associated with redness, warmth, sensitivity or pain at the injection site, and resolve spontaneously within 3-5 days without the need for any specific treatment. The risk appears to depend on the number of previous doses of vaccines containing acellular pertussis, with a higher risk after the 4th and 5th dose.
• Swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy).

Other reactions that may occur when Tetravac is given at the same time as the vaccine
against Haemophilus influenzaetype b:

• Swelling of one or both lower limbs. This may occur simultaneously with the appearance of a bluish discoloration of the skin (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and loud crying. If this reaction occurs, it mainly happens after the first (primary) injections within the first few hours of vaccination. All symptoms will disappear completely within 24 hours without the need for any specific treatment.

Potential side effects(i.e., have not been directly reported with Tetravac, but with other
vaccines containing one or more of the antigenic components of Tetravac) are as follows:

• Temporary loss of mobility or sensitivity (Guillain-Barré syndrome) and loss of mobility, pain and numbness (brachial neuritis) of the arm and shoulder.
• Episodes in which your child enters a state similar to shock or is pale, floppy and unresponsive for a period of time (hyporesponsive hypotonic episodes).
• In very premature infants (born at the 28th week of gestation or earlier), longer than normal intervals between breaths may be observed for 2-3 days after vaccination.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, 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 .
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Tetravac

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Do not use this medicine after the expiry date indicated on the label and on the packaging after the wording
“EXP.” The expiry date refers to the last day of the month indicated.
Do not dispose of any medicine in 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 Tetravac contains
The active ingredients are:
One dose (0.5 mL) contains:
Diphtheria toxoid not less than 20 IU (30 Lf)
Tetanus toxoid not less than 40 IU (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid ……… 25 micrograms
Filamentous hemagglutinin ...... 25 micrograms
Poliovirus (Inactivated)
Type 1 (Mahoney) 29 units of antigen D
Type 2 (MEF-1) 7 units of antigen D
Type 3 (Saukett) 26 units of antigen D
Adsorbed on hydrated aluminum hydroxide ( 0.3 Al )
As a lower confidence limit (p = 0.95) and not less than 30 U.I. as the average value
Or equivalent activity determined by immunogenicity assessment
As a lower confidence limit (p = 0.95)
Cultivated on Vero cells
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 hydroxide is included in this vaccine as an adsorbent. Adsorbents are substances included in
some vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.
The other excipients are: Medium 199 Hanks without phenol red (a complex mixture of amino acids including
phenylalanine, mineral salts, vitamins and other substances such as glucose), formaldehyde, glacial acetic acid and/or
sodium hydroxide for pH adjustment, phenoxyethanol, anhydrous ethanol and water for injections.
The vaccine may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B which are
used during the manufacturing process.

Description of the appearance of Tetravac and contents of the packs
Tetravac, injectable suspension, is available in a pre-filled single-dose syringe (0.5 mL).
Packs contain 1 or 10, without a needle, with a pre-attached needle, with 1 or 2 needles supplied separately.
Not all pack sizes may be marketed.

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

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

Manufacturer
The manufacturer responsible for batch release is Sanofi Pasteur with registered office in:
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
(France)

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:
_______________________________________________________________________________________
The following information is intended for healthcare professionals only
Instructions for use - Tetravac, injectable suspension.
Diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine.
For syringes without attached needles, the separate needle must be firmly inserted into the syringe, rotating it
by a quarter turn.
Shake before injection until a homogeneous, whitish-turbid suspension is obtained.
Visually inspect the suspension before administration. If any foreign particulate matter is present and/or a change in
physical appearance is observed, discard the pre-filled syringe.
Tetravac can be administered by reconstituting the Act-HIB vaccine (Haemophilus influenzaetype b
conjugate) as follows:
Shake the pre-filled syringe until the contents become homogeneous and reconstitute the solution
by injecting the suspension of the diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine
into the vial containing the powder of the Haemophilustype b conjugate vaccine.

• Gently shake the vial until the powder is completely dissolved. After reconstitution, the whitish-turbid appearance of the suspension is normal.
• Immediately draw the reconstituted suspension into the syringe.
• The whitish-turbid suspension must be used immediately after reconstitution and shaken before injection.
• After reconstitution and aspiration into the syringe, separation of the suspension into a clear phase and a gel-like phase may occur.

In this case, the syringe must be shaken vigorously again before administration.
Tetravac must be administered intramuscularly. The recommended injection sites are the anterolateral side of the upper thigh in infants and young children and the deltoid muscle
in older children.