BOOSTRIX 0.5 ML Инъекционная суспензия

Содержание инструкции

1. What Boostrix is and what it is used for
2. What you need to know before you or your child receive Boostrix
3. How to use Boostrix
4. Possible side effects
5. How to store Boostrix
6. Package Contents and Other Information

Boostrix, injectable suspension in pre-filled syringe
Vaccine (adsorbed, low antigen content) diphtheria, tetanus and pertussis (acellular component)

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 or pharmacist.
• This vaccine has been prescribed only for you or your child. Never give it to others.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Boostrix is and what it is used for

Boostrix is a vaccine used as a booster dose in children from 4 years of age, adolescents and adults for the
prevention of three diseases: diphtheria, tetanus, pertussis (whooping cough). The vaccine works by stimulating the body
to produce a protection (antibodies) against these diseases.

• Diphtheria:diphtheria leads to disorders especially of the respiratory tract and sometimes of the skin. Generally, the respiratory tract becomes inflamed (swollen) causing serious breathing problems and sometimes leading to suffocation. The bacteria that cause diphtheria also release a toxin (toxic substance) that can cause damage to the nervous system, heart problems and even death.
• Tetanus:tetanus bacteria enter the body following cuts, scratches or skin wounds. Wounds at higher risk of infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure or wood splinters. The bacteria release a toxin (toxic substance) that can cause muscle stiffness, painful muscle spasms, convulsions and even death. Muscle spasms can be so violent as to cause fractures of the bones of the spine.
• Pertussis(whooping cough): pertussis is a very contagious disease. The disease affects the respiratory tract causing severe repeated coughing fits that can interfere with normal breathing. The cough is often accompanied by a convulsive inspiration, hence the common name of "whooping cough". The cough can last for 1-2 months or more. Pertussis can also cause ear infections, bronchitis that can last a long time, pneumonia, convulsions, brain damage and even death.

None of the ingredients contained in the vaccine can cause diphtheria, tetanus or whooping cough.
The use of Boostrix during pregnancy will help protect your baby from pertussis in the first
months of life before they receive primary immunization.

2. What you need to know before you or your child receive Boostrix

Boostrix must not be given:

• if you or your child have previously had an allergic reaction to Boostrix or to any of the other ingredients in this vaccine (listed in section 6) or to formaldehyde. Signs of an allergic reaction can include itchy, red skin, shortness of breath, swelling of the face or tongue
• if you or your child have previously had an allergic reaction to any other vaccine against diphtheria, tetanus or pertussis (whooping cough)
• if you or your child have experienced problems relating to the nervous system (encephalopathy) within 7 days of a previous vaccination with a pertussis (whooping cough) vaccine
• if you or your child have a severe infection with a high fever (over 38°C). A mild infection does not pose a problem, but you should tell your doctor beforehand
• if you or your child have experienced a temporary reduction in platelets in the blood (which increases the risk of bleeding or bruising) or problems with the brain or nerves after a previous vaccination with a diphtheria and/or tetanus vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before you or your child receive Boostrix:

• if you or your child have experienced health problems after the previous administration of Boostrix or other vaccines against pertussis (whooping cough), especially:
• High fever (over 40°C) within 48 hours of vaccination;
• Collapse or shock within 48 hours of vaccination;
• Persistent crying, lasting 3 hours or more, occurring within 48 hours of vaccination;
• Seizures/convulsions with or without high fever that occur within 3 days of vaccination
• if your child has a progressive or undiagnosed brain disorder or uncontrolled epilepsy. The vaccine should be administered after the disease has been controlled
• if you or your child have bleeding problems or are prone to bruising
• if you or your child are prone to febrile seizures/convulsions or have a family history of similar events
• if you or your child have long-standing problems with the immune system of any kind (including HIV infection). In this case, you or your child may receive Boostrix, but protection against infections after receiving the vaccine may not be comparable to that achieved in children or adults with a normal immune response to infections.

Fainting (especially in adolescents) can occur following, or even before any injection
with a needle. Therefore, inform your doctor or nurse if you or your child have fainted with a
previous injection.
Like all vaccines, Boostrix may not fully protect people who are vaccinated.

Other medicines and Boostrix
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
might take any other medicines, or have recently received other vaccinations.
Boostrix can be given at the same time as some other vaccines. A different injection site
will be used for each type of vaccine.
Boostrix may not work as well if you or your child are taking medicines that reduce the effectiveness
of your immune system in fighting infections.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before you are given this vaccine.
It is not known whether Boostrix passes into breast milk. Your doctor will inform you about the possible risks and benefits of
receiving Boostrix while breastfeeding with breast milk.

Driving and using machines
It is unlikely that Boostrix will affect your ability to drive or operate machinery.

Boostrix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Boostrix

• Boostrix is administered as an intramuscular injection.
• The vaccine should never be administered into blood vessels.
• You or your child will receive a single injection of Boostrix.
• The doctor will check if you or your child have previously received vaccines against diphtheria, tetanus and/or whooping cough.
• Boostrix can be administered in the event of suspected tetanus infection, although further measures will be necessary, such as properly dressing the wound and/or administering tetanus antitoxin, to reduce the risk of developing the disease.
• The doctor will inform you about booster vaccinations.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
As with all injectable vaccines, serious allergic reactions (anaphylactic and anaphylactoid reactions) can
occur very rarely (up to 1 case per 10,000 doses of vaccine). These may be recognised
by:

• Skin rashes such as itching or the appearance of blisters
• Swelling of the eyes and face
• Difficulty breathing or swallowing
• Sudden drop in blood pressure and loss of consciousness.These reactions can occur before leaving the doctor's office. However, if you or yourchild experience any of these symptoms, you should contact a doctor immediately.

Side effects that occurred during clinical trials in children aged 4 to 8 years

Very common(may affect more than 1 in 10 doses of vaccine): pain, redness and swelling at the
injection site, irritability, drowsiness, fatigue.

Common(may affect up to 1 in 10 doses of vaccine): loss of appetite, headache, fever
equal to or greater than 37.5° C (including fever above 39°C), widespread swelling of the limb where the vaccination was given, vomiting and
diarrhoea.

Uncommon(may affect up to 1 in 100 doses of vaccine): upper respiratory tract infection,
attention disorders, itchy eye discharge and crusting (conjunctivitis),
skin redness, hard swelling where the injection was given, pain.

Side effects that occurred during clinical trials in adults, adolescents and children from 10

years of age

Very common(may affect more than 1 in 10 doses of vaccine): pain, redness and swelling at the
injection site, headache, fatigue, general malaise.

Common(may affect up to 1 in 10 doses of vaccine): fever equal to or greater than 37.5°C, dizziness,
nausea, hard swelling and abscess at the injection site.

Uncommon(may affect up to 1 in 100 doses of vaccine): fever above 39°C, pain, muscle and joint stiffness, vomiting, diarrhoea, joint stiffness, joint pain, muscle pain, itching, excessive sweating (hyperhidrosis), skin redness, swollen glands in the neck, armpit or groin (lymphadenopathy), sore throat and pain when swallowing (pharyngitis), upper respiratory tract infection, cough, fainting (syncope), flu-like symptoms such as fever, sore throat,
runny nose, cough and chills.

The following side effects have been reported during routine use of Boostrix and are not specific to

age group:

• Swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema)
• Collapse or periods of unconsciousness or lack of awareness
• Convulsions (with or without fever)
• Hives (urticaria)
• Unusual weakness (asthenia)

Very rarely (up to 1 case per 10,000 doses of the vaccine) temporary inflammation of the nerves has been reported after administration of the tetanus vaccine, causing pain, weakness and paralysis of the limbs, which often spreads to the chest and face (Guillain-Barré syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Boostrix

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the packaging and on the label of the pre-filled syringe after the word EXP. The expiry date refers to the last day of the month.
Store in a refrigerator (2  C – 8  C)
Do not freeze. Freezing will damage the vaccine.
Store in the original packaging to protect the medicine from light.
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 Boostrix contains

• The active ingredients are: Diphtheria toxoid not less than 2 International Units (IU) (2.5 Lf) Tetanus toxoid not less than 20 International Units (IU) (5 Lf) Bordetella pertussisantigens: Pertussis toxoid 8 micrograms Filamentous hemagglutinin 8 micrograms Pertactin 2.5 micrograms adsorbed on aluminum hydroxide, hydrate (Al(OH) ) 0.3 mg Al and aluminum phosphate (AlPO ) 0.2 mg Al

Aluminum hydroxide and aluminum phosphate are included in this vaccine as adjuvants.
Adjuvants are substances included in some vaccines to accelerate, enhance and/or prolong the
protective effect of the vaccine.

• The other ingredients are: sodium chloride and water for injections.

Description of Boostrix and package contents
Injectable suspension in a pre-filled syringe.
Boostrix is a white, slightly cloudy liquid contained in a pre-filled syringe (0.5 ml).
Boostrix is available in pre-filled syringes of 1 dose, with or without separate needles, packs of 1 and 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.- Viale dell’Agricoltura 7 - 37135 Verona - Italy

Manufacturer responsible for batch release
GlaxoSmithKline Biologicals s.a., rue de l’Institut 89 – 1330 Rixensart (Belgium)

Other sources of information
Detailed information on this medicine is available on the website of the Italian Medicines Agency
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The following information is intended for healthcare professionals only:
Before use, the vaccine must be at room temperature and must be shaken well to obtain a
homogeneous, cloudy white suspension. Before administration, the vaccine must be visually inspected
to check for the absence of particles and/or changes in physical appearance. If any of these phenomena are observed, do not administer the vaccine.
Instructions for the pre-filled syringe

Hold the syringe by the body, not by the plunger.

Unscrew the syringe cap by rotating counterclockwise.

To attach the needle to the syringe, gently connect the
needle hub to the Luer Lock Adapter and rotate a
quarter turn clockwise until a click is felt.

Do not pull the syringe plunger out of the body. If this
happens, do not administer the vaccine.
Disposal
Any unused medicine or waste material should be disposed of in accordance with local
regulations.