Boostrix

Package leaflet: Information for the user

Boostrix, Suspension for injection in prefilled syringe
Vaccine against diphtheria, tetanus and pertussis (acellular, combined), adsorbed,
with reduced antigen content
Please read all of this leaflet carefully before the vaccine is administered, as it
contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and should not be passed on to others.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Boostrix vaccine is and what it is used for
2. Important information before receiving Boostrix vaccine
3. How to use Boostrix vaccine
4. Possible side effects
5. How to store Boostrix vaccine
6. Contents of the pack and other information

1. What Boostrix vaccine is and what it is used for

Boostrix is used for booster vaccination in children from 4 years of age, adolescents and adults to prevent three diseases: diphtheria, tetanus and pertussis (whooping cough). The vaccine stimulates the body to produce its own immunity (antibodies) against these diseases.

• Diphtheria: Diphtheria usually affects the respiratory tract and sometimes the skin. In the respiratory tract, inflammation and swelling develop, which can cause serious breathing difficulties and sometimes suffocation. Diphtheria bacteria also produce toxins (poisons) that may damage nerves, cause heart disease, and even lead to death.
• Tetanus: Tetanus bacteria enter the human body through cuts, scratches or wounds in the skin. Injuries that pose the highest risk of tetanus infection include: burns, fractures, deep wounds, or wounds contaminated with soil, dust, horse manure, or wooden splinters. These bacteria produce toxins (poisons) that may cause muscle stiffness, painful muscle spasms, seizures, and even death. Muscle spasms can be so severe that they result in spinal fractures.
• Pertussis (whooping cough): Pertussis is a highly contagious disease. It affects the respiratory tract, causing severe coughing fits that may interfere with normal breathing. The cough associated with this disease is very characteristic – affected individuals are said to "cough until they are hoarse". The cough may persist for 1–2 months or longer. Pertussis bacteria may also cause ear infections, prolonged bronchitis, pneumonia, seizures, brain damage, and even death.

None of the vaccine components can cause diphtheria, tetanus or pertussis.
Administration of Boostrix vaccine during pregnancy helps protect the baby against pertussis during the first few months of life, before the baby receives primary vaccination.

2. Important information before receiving the Boostrix vaccine

When not to use Boostrix vaccine:

• if you have ever had an allergic reaction (hypersensitivity) to Boostrix or any of the ingredients contained in this vaccine (listed in section 6) or to formaldehyde. Symptoms of allergy may include itchy rash, difficulty breathing, swelling of the face or tongue.
• if you have ever had an allergic reaction to any vaccine against diphtheria, tetanus, or pertussis (whooping cough).
• if you experienced any neurological disorders within 7 days after a previous dose of pertussis (whooping cough) vaccine.
• if you have a high fever (above 38.0°C). A mild infection, such as a cold, should not prevent vaccination, but you should inform your doctor first.
• if you previously developed low platelet count (which increases the risk of bleeding or bruising) or brain and nerve disorders after diphtheria and/or tetanus vaccination.

Warnings and precautions
Before receiving Boostrix vaccine, consult your doctor or pharmacist.

• if you previously experienced any health problems after receiving Boostrix or another pertussis (whooping cough) vaccine, particularly:
  • High fever (above 40°C) within 48 hours after vaccination
  • Collapse or shock-like state within 48 hours after vaccination
  • Persistent crying lasting at least three hours within 48 hours after vaccination
  • Seizures or convulsions with or without fever within 3 days after vaccination
• if the child has an undiagnosed or progressive neurological disease or uncontrolled epilepsy. The vaccine should be administered only after the condition has been stabilized.
• if you have bleeding disorders or bruise easily
• if you have a history of febrile seizures, or such cases occurred in the family
• if, for various reasons, you have long-term immune system disorders (including HIV infection). In such cases, Boostrix may still be given, but vaccinated individuals may not achieve the same level of protection against infections as people with normal immune function.

Fainting may occur after or even before any injectable vaccine is given (particularly in adolescents). Therefore, inform your doctor or nurse if you have ever fainted during or after an injection.
As with any vaccine, an immune response providing protection may not develop in all vaccinated individuals.

Boostrix vaccine and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, and any vaccines you recently received.
Boostrix vaccine may be administered at the same time as certain other vaccines. Each vaccine will be given at a different injection site.
Boostrix vaccine may not work properly if administered simultaneously with medicines that reduce the immune system's ability to fight infections.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before receiving this vaccine.
It is not known whether Boostrix passes into breast milk. Your doctor will discuss the potential risks and benefits of using Boostrix during breastfeeding.

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

Boostrix vaccine contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free".

3. How to use the Boostrix vaccine

• The Boostrix vaccine will be administered as an intramuscular injection and must never be given intravenously.
• The patient will receive a single dose of the vaccine.
• The doctor will determine whether the patient has previously been vaccinated against diphtheria, tetanus, and/or pertussis.
• Boostrix may be used when there is a suspicion of tetanus infection due to a wound. The doctor will also take additional measures, such as wound care and/or administration of tetanus antitoxin, to reduce the risk of developing the disease.
• The doctor will advise if a repeat dose of the vaccine is necessary.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although they do not occur in everyone.
As with all injectable vaccines, there is a very small risk (up to 1 in 10,000 vaccine doses) of allergic reactions (anaphylactic and anaphylactoid). Such a reaction may be recognized by the following symptoms:

• Rash, which may be itchy or blistering,
• Swelling of the eyes and face,
• Difficulty breathing and swallowing,
• Sudden drop in blood pressure and loss of consciousness. Such reactions usually occur before leaving the doctor's office. However, in any such case, immediate contact with a doctor is required.

Adverse reactions observed during clinical trials in children aged 4 to 8 years:
Very common (may occur in more than 1 in 10 doses of the vaccine): pain, redness and swelling at the injection site, irritability, drowsiness, fatigue.
Common (may occur in up to 1 in 10 doses of the vaccine): loss of appetite, headache, fever equal to or higher than 37.5°C (including higher than 39°C), extensive swelling of the limb into which the vaccine was administered, vomiting and diarrhoea.
Uncommon (may occur in up to 1 in 100 doses of the vaccine): upper respiratory tract infection, attention disorders, eye discharge and itching, eyelid inflammation (conjunctivitis), rash, hard lump at the injection site, pain.

Adverse reactions observed during clinical trials in adults, adolescents and children aged 10 years and older:
Very common (may occur in more than 1 in 10 doses of the vaccine): pain, redness and swelling at the injection site, headache, fatigue, general malaise.
Common (may occur in up to 1 in 10 doses of the vaccine): fever equal to or higher than 37.5°C, dizziness, nausea, hard lump or abscess at the injection site.
Uncommon (may occur in up to 1 in 100 doses of the vaccine): fever above 39°C, pain, muscle and joint stiffness, vomiting, diarrhoea, joint stiffness, joint pain, muscle pain, itching, increased sweating, rash, swelling of cervical, axillary or inguinal lymph nodes (lymphadenopathy), sore throat and difficulty swallowing (pharyngitis), upper respiratory tract infection, cough, fainting, influenza-like symptoms such as fever, sore throat, runny nose, cough and chills.

The following adverse reactions have been reported during routine use of the Boostrix vaccine and are not specific to any age group: swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema), fainting or episodes of loss of consciousness or awareness, seizures (with or without fever), blisters (urticaria), unusual weakness (asthenia).

After administration of tetanus-containing vaccines, transient neuropathy causing pain, weakness and paralysis of limbs, often also affecting the chest and face (Guillain-Barré syndrome), has been reported very rarely (up to 1 in 10,000 vaccine doses).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 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 to provide more information on the safety of the medicine.

5. How to store Boostrix vaccine

Keep out of sight and reach of children.
Do not use the vaccine after the expiry date stated on the outer carton and on the prefilled syringe label after "EXP". The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2°C – 8°C).
Do not freeze. Freezing destroys the vaccine.
Store in the original packaging to protect 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 Boostrix vaccine contains

• The active substances in the vaccine are:
  Diphtheria toxoid not less than 2 International Units (I.U.) (2.5 Lf)
  Tetanus toxoid not less than 20 International Units (I.U.) (5 Lf)
  Bordetella pertussis antigens
  Pertussis toxoid 8 micrograms
  Filamentous haemagglutinin 8 micrograms
  Pertactin 2.5 micrograms

adsorbed on hydrated aluminium hydroxide (Al(OH)_) 0.3 milligrams Al
and on aluminium phosphate (AlPO_) 0.2 milligrams Al
Aluminium hydroxide and aluminium phosphate act as adjuvants in this vaccine. Adjuvants are
substances included in some vaccines intended to accelerate, enhance, and/or prolong the protective immune response to the vaccine.

• Other components are: sodium chloride and water for injections.

What Boostrix looks like and contents of the pack
Injectable suspension in a pre-filled syringe.
Boostrix is a white, slightly milky liquid in a pre-filled syringe (0.5 ml).
Boostrix vaccine is available as a 0.5 ml single-dose pre-filled syringe, in packs of 1 or 10, with needles included or without needles.
Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Information intended exclusively for healthcare professionals:

Before administration, the vaccine should reach room temperature. The prefilled syringe should be shaken vigorously to obtain a homogeneous, cloudy, white suspension.
The vaccine should be inspected visually for the presence of any foreign particles and (or) any changes in its physical appearance prior to administration. If such changes are observed, the vaccine should not be administered.

Instructions for the prefilled syringe

Hold the prefilled syringe by the barrel, not by the plunger.
Luer Lock
adapter
Plunger
Barrel
Cap

Needle adaptor
Attach the needle to the prefilled syringe by connecting the needle adaptor to the Luer Lock adapter (LLA) and rotating it one-quarter turn clockwise until a click is felt, indicating that the needle is securely locked.
Do not remove the plunger from the barrel of the prefilled syringe. If this occurs, do not administer the vaccine.

Disposal
Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.