Boostrix polio

Package leaflet: Information for the user

Boostrix Polio, Suspension for injection in prefilled syringe
Vaccine against diphtheria, tetanus, pertussis (acellular, combined) and poliomyelitis (inactivated), adsorbed, with reduced antigen content

Please read all of this leaflet carefully before the vaccine is administered, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any adverse reactions after vaccination, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Boostrix Polio is a vaccine used for booster vaccination in children from 3 years of age, adolescents and adults to prevent four diseases: diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis (polio). 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. Inflammation and swelling in the respiratory tract can cause serious breathing difficulties and, in some cases, 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 a cut, scratch or wound in the skin. Injuries that pose the greatest risk of tetanus infection include: burns, fractures, deep wounds, or wounds contaminated with soil, dust, horse manure, or wood 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 lead to 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 in this disease is very characteristic – it is often said that people with pertussis "cough until they gasp for breath." The cough may last for 1–2 months or longer. Pertussis bacteria may also cause ear infections, prolonged bronchitis, pneumonia, seizures, brain damage, and even death.
• Poliomyelitis (Polio): Poliomyelitis, sometimes simply called polio, is a viral infection with a range of symptoms. It often causes a mild illness, but in some people it can lead to permanent disability or even death. In its most severe form, the disease causes muscle paralysis (muscles unable to perform their normal functions), including paralysis of the respiratory muscles or muscles needed for independent movement. Limbs affected by this condition may become deformed and painful.

None of the components of this vaccine can cause diphtheria, tetanus, pertussis or poliomyelitis.
Administration of Boostrix Polio 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 using Boostrix Polio vaccine

When not to use Boostrix Polio vaccine:

• if there has ever been an allergic (hypersensitivity) reaction to Boostrix Polio or any of the ingredients of this vaccine (listed in section 6), including neomycin, polymyxin (antibiotics), or formaldehyde. Symptoms of allergy may include itchy skin rash, difficulty breathing, swelling of the face or tongue.
• if there has ever been an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), or poliomyelitis.
• if any nervous system disorders occurred within 7 days after a previous dose of pertussis (whooping cough) vaccine.
• if after previous vaccinations against diphtheria or tetanus, there was a temporary decrease in blood platelets (which increases the risk of bleeding or bruising) or if brain and nerve disorders occurred.
• if a high fever (above 38.0°C) is present. A mild infection, such as a cold, should not be a reason to delay vaccination, but you should inform your doctor first.

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

• if any health problems occurred after previous vaccination with Boostrix Polio 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 suffers from an undiagnosed or progressive brain disease or from epilepsy that does not respond to treatment. The vaccine should be administered only after the condition has been controlled.
• if bleeding or easy bruising occurs
• if there is a history of fever-related seizures, or such cases have occurred in the family
• if, for various reasons, long-term immune system disorders are present (including HIV infection). In such cases, Boostrix Polio vaccine may be administered, but vaccinated individuals may not achieve the same level of protection against infections as people with a normally functioning immune system.

Fainting may occur after, or even before, receiving any injectable vaccine (especially in adolescents). Therefore, inform your doctor or nurse if the patient has ever fainted during an injection.
As with any vaccine, a protective immune response may not develop in all vaccinated individuals.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this vaccine.
It is not known whether Boostrix Polio passes into breast milk. Your doctor will discuss with you the potential risks and benefits of using Boostrix Polio vaccine during breastfeeding.

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

Boostrix Polio contains neomycin and polymyxin
Boostrix Polio vaccine contains neomycin and polymyxin (antibiotics). Inform your doctor if you have previously experienced allergic (hypersensitivity) reactions to these substances.

Boostrix Polio contains para-aminobenzoic acid, phenylalanine, sodium, and potassium
Boostrix Polio contains para-aminobenzoic acid. It may cause allergic reactions (including delayed-type reactions) and exceptionally, bronchospasm.
The vaccine contains 0.0298 micrograms of phenylalanine per dose. Phenylalanine may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body because it is not properly eliminated.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, meaning the vaccine is considered "sodium-free".
This vaccine contains potassium, less than 1 mmol (39 mg) of potassium per dose, meaning the vaccine is considered "potassium-free".

3. How to use the Boostrix Polio vaccine

• The Boostrix Polio vaccine will be administered as an intramuscular injection.
• Under no circumstances should the vaccine be administered 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, pertussis, and/or poliomyelitis.
• The Boostrix Polio vaccine may be used when there is suspicion of tetanus infection due to injury. The doctor will also take additional measures such as wound care and/or administration of tetanus antitoxin to reduce the risk of disease occurrence.
• The doctor will inform you if a repeat dose of the vaccine is necessary.

4. Possible adverse reactions

Like any medicine, this vaccine may cause adverse reactions, although not everybody will experience them.
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 reactions). Such reactions may be recognized by the following symptoms:

• Rash, which may be itchy or blistering,
• Swelling around the eyes and face,
• Difficulty breathing and swallowing,
• Sudden drop in blood pressure and loss of consciousness. These reactions usually occur before leaving the doctor's office. However, in any such case, medical advice must be sought immediately.

Adverse reactions observed in clinical trials in children aged 4 to 8 years:
Very common (may occur in more than 1 in 10 vaccine doses): pain, redness and swelling at the injection site, drowsiness.
Common (may occur in up to 1 in 10 vaccine doses): fever equal to or higher than 37.5 °C (including fever above 39 °C), bleeding, itching and hard lump at the injection site, extensive swelling of the limb into which the vaccine was administered, loss of appetite, irritability, headache.
Uncommon (may occur in up to 1 in 100 vaccine doses): diarrhoea, nausea, vomiting, abdominal pain, swelling of cervical, axillary or inguinal lymph nodes (lymphadenopathy), sleep disturbances, apathy, sore throat, fatigue.

Concomitant administration with measles, mumps and rubella (MMR) vaccine or measles, mumps, rubella and varicella (MMRV) vaccine in children aged 3–6 years
In studies where Boostrix Polio vaccine was administered simultaneously with MMR or MMRV vaccine, skin rash and upper respiratory tract infections (including runny nose and sore throat) were regularly reported. Fever, irritability, fatigue, loss of appetite, and gastrointestinal disorders (including diarrhoea and vomiting) were reported more frequently (very commonly) than in studies where only Boostrix Polio vaccine was administered.

Adverse reactions observed in clinical trials in adults, adolescents and children aged 10 years and older:
Very common (may occur in more than 1 in 10 vaccine doses): pain, redness and swelling at the injection site, fatigue, headache.
Common (may occur in up to 1 in 10 vaccine doses): fever equal to or higher than 37.5 °C, bruising, itching, hard lump, warmth, numbness at the injection site, abdominal pain, nausea, vomiting.
Uncommon (may occur in up to 1 in 100 vaccine doses): fever above 39 °C, extensive swelling of the limb into which the vaccine was administered, chills, pain, dizziness, joint pain and muscle pain, itching, cold sores, swelling of cervical, axillary or inguinal lymph nodes (lymphadenopathy), decreased appetite, tingling or numbness of hands or feet (paraesthesia), drowsiness, asthma.

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

Additionally, the following adverse reactions were reported during clinical trials of another diphtheria, tetanus and acellular pertussis vaccine (with reduced antigen content) from GlaxoSmithKline Biologicals (Boostrix):

Adverse reactions observed in clinical trials in children aged 4 to 8 years:
Uncommon (may occur in up to 1 in 100 vaccine doses): attention disorders, eye discharge and itching, eyelid abscess (conjunctivitis), pain.

Adverse reactions observed in clinical trials in adults, adolescents and children aged 10 years and older:
Very common (may occur in more than 1 in 10 vaccine doses): general malaise.
Common (may occur in up to 1 in 10 vaccine doses): hard lump or abscess at the injection site.
Uncommon (may occur in up to 1 in 100 vaccine doses): upper respiratory tract infections, sore throat and difficulty swallowing (pharyngitis), fainting, cough, diarrhoea, increased sweating, rash, joint stiffness, joint and muscular stiffness, influenza-like symptoms such as fever, sore throat, runny nose, cough and chills.

After administration of tetanus-containing vaccines, transient nerve inflammation causing pain, weakness and paralysis of limbs, often also affecting the chest and face (Guillain-Barré syndrome), has been very rarely reported (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 Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 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 Polio vaccine

Keep out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the outer carton and on the label of the prefilled syringe under "EXP". The expiry date refers to the last day of the specified month.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Boostrix Polio vaccine contains

• The active substances in the vaccine 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 pertussis antigens
Pertussis toxoid 8 micrograms
Filamentous haemagglutinin 8 micrograms
Pertactin 2.5 micrograms
Inactivated poliovirus
type 1 (Mahoney strain) 40 D-antigen units
type 2 (MEF-1 strain) 8 D-antigen units
type 3 (Saukett strain) 32 D-antigen units
adsorbed on hydrated aluminium hydroxide, 0.3 milligrams Al
and on aluminium phosphate, 0.2 milligrams Al
propagated in VERO cell culture

Aluminium hydroxide and aluminium phosphate act as adjuvants in this vaccine. Adjuvants are substances included in some vaccines to accelerate, enhance, and/or prolong the protective immune response.

• Other components of Boostrix Polio vaccine are: Medium 199 (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances), sodium chloride, water for injections.

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

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

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Boostrix Polio: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, Greece, Spain, Netherlands, Iceland, Lithuania, Luxembourg, Latvia, Germany, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden, Hungary
Boostrix Tetra: France
IPV-Boostrix: Ireland, Malta
Polio Boostrix: Italy
Boostrix IPV: Romania

Further information
Detailed information on this medicine 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 uniform, cloudy, white suspension.
Prior to administration, the vaccine should be visually inspected for the presence of any foreign particles and (or) any changes in the physical appearance of the vaccine. If such are observed, the vaccine must not be administered.

Instructions for use of the prefilled syringe

Hold the prefilled syringe by the barrel, not by the plunger.
Luer Lock
adapter
Remove the cap of the prefilled syringe by unscrewing it counterclockwise.
Plunger
Barrel
Cap
Attach a needle to the prefilled syringe by connecting the needle hub to the Luer Lock adapter (LLA) and rotating it a quarter turn clockwise until a click is felt, indicating that the needle is securely locked.

Needle hub

Do not remove the plunger from the syringe barrel. If this occurs, do not administer the vaccine.

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