Boostrix Polio solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Boostrix Polio, Injectable suspension in pre-filled syringe

Diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (adsorbed, reduced antigen content)

Read the entire leaflet carefully before you or your child receives this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed for you or your child only, and must not be given to other people.
• If you or your child experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Boostrix Polio is a vaccine indicated for booster vaccination in children from 3 years of age, adolescents and adults to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and poliomyelitis (polio). The vaccine works by helping the body produce its own protection (antibodies) against these diseases.

• Diphtheria: Diphtheria mainly affects the respiratory tract and sometimes the skin. The respiratory tract usually becomes inflamed (swollen), causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison) that can cause nerve damage, heart problems and even death.

• Tetanus (lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds particularly prone to infection include burns, fractures, deep wounds or wounds contaminated with dirt, dust, horse manure or wood splinters. The bacteria release a toxin (poison) that can cause muscle stiffness, painful muscle spasms, seizures and even death. Muscle spasms can be so severe that they cause spinal fractures.

• Pertussis (whooping cough): Pertussis is a highly infectious condition. The disease affects the respiratory tract, causing severe coughing fits that can interfere with normal breathing. The cough is often accompanied by a "whoop" sound, hence the common name whooping cough. The cough can last 1–2 months or longer. It may also lead to ear infections, long-lasting bronchitis, pneumonia, seizures, brain damage and even death.

• Poliomyelitis (polio): Poliomyelitis, sometimes simply called "polio", is a viral infection that can have varying effects. It often causes a mild illness, but in some people it leads to permanent disability or even death. In its most severe form, polio infection causes paralysis of the muscles (muscles cannot move), including those needed for breathing and walking. The limbs affected by the disease may become painfully deformed.

None of the components of the vaccine can cause diphtheria, tetanus, pertussis or poliomyelitis.

The use of Boostrix Polio during pregnancy will help protect your baby from pertussis during the first months of life, before they receive their primary immunization.

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

Do not administer Boostrix Polio:

• if you or your child has previously had any allergic reaction to Boostrix Polio or to any of the other components of this vaccine (listed in section 6), or to neomycin, polymyxin (antibiotics), or formaldehyde. Signs of an allergic reaction may include itchy rash, difficulty breathing, or swelling of the face or tongue
• if you or your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis, or poliomyelitis
• if you or your child has experienced neurological problems (encephalopathy) within 7 days after a previous vaccination with a pertussis-containing vaccine
• if you or your child has previously had a temporary reduction in blood platelets (which increases the risk of bleeding or bruising) or brain or nervous system problems after a prior vaccination with a diphtheria and/or tetanus-containing vaccine
• if you or your child has a severe infection with a high fever (above 38°C). A minor illness should not be a problem, but consult your doctor first.

Warnings and precautions

Consult your doctor or pharmacist before you or your child receives Boostrix Polio:

• if you or your child experienced any adverse events after a previous dose of Boostrix Polio or another pertussis-containing vaccine, especially:
  • Fever (above 40°C) within 48 hours after vaccination
  • Collapse or shock-like state within 48 hours after vaccination
  • Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours after vaccination
  • Seizures, with or without fever, occurring within 3 days after vaccination
• if your child has an undiagnosed or progressive neurological disease or uncontrolled epilepsy. The vaccine should be administered only once the condition is under control
• if you or your child has bleeding disorders or bruises easily
• if you or your child has a history of febrile seizures or if there is a family history of such seizures
• if you or your child has persistent immune system problems due to any cause (including HIV infection). You or your child may still receive Boostrix Polio, but protection against infections after vaccination may not be as effective as in individuals with normal immune responses.

Fainting (syncope) may occur before or after any injection (particularly in adolescents). Inform your doctor or nurse if you or your child has previously fainted after receiving an injection.

As with all vaccines, Boostrix Polio may not provide complete protection in all vaccinated individuals.

Use of Boostrix Polio with other medicines

Inform your doctor or pharmacist if you or your child is using, has recently used, or might need to use any other medicines, or if you or your child has recently received another vaccine.

Boostrix Polio may be administered at the same time as certain other vaccines. A different injection site should be used for each vaccine.

Boostrix Polio may not produce an adequate immune response if you or your child is taking medications that suppress the immune system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

It is unknown whether Boostrix Polio is excreted in human milk. Your doctor will advise you on the potential risks and benefits of administering Boostrix Polio during breastfeeding.

Driving and using machines

It is unlikely that Boostrix Polio will have any effect on the ability to drive or operate machinery.

Boostrix Polio contains neomycin and polymyxin

This vaccine contains neomycin and polymyxin (antibiotics). Please inform your doctor if you or your child has had an allergic reaction to these components.

Boostrix Polio contains para-aminobenzoic acid, phenylalanine, sodium, and potassium

Boostrix Polio contains para-aminobenzoic acid. This may cause allergic reactions (possibly delayed) and, rarely, bronchospasm.

This vaccine contains 0.0298 micrograms of phenylalanine per dose. Phenylalanine may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly metabolize it.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; therefore, it is essentially “sodium-free.”

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; therefore, it is essentially “potassium-free.”

3. How to use Boostrix Polio

• Boostrix Polio will be administered as an injection into the muscle.

• The vaccine must never be given intravenously.

• You or your child will receive a single injection of Boostrix Polio.

• Your doctor will check whether you or your child has previously received diphtheria, tetanus, pertussis, and/or poliomyelitis vaccines.

• Boostrix Polio may be used in case of suspected tetanus infection, although additional measures should also be taken to reduce the risk of disease manifestation, such as wound care and/or administration of tetanus antitoxin.

• Your doctor will advise you to repeat the vaccination.

4. Possible adverse effects

Like all medicines, Boostrix Polio may cause adverse effects, although not everyone will experience them.

As with all injectable vaccines, very rarely (up to a maximum of 1 in 10,000 doses of the vaccine), severe allergic reactions (anaphylactic and anaphylactoid reactions) may occur. These can be recognized by:

• Skin rashes such as itching or blisters,
• Swelling of eyes and face,
• Difficulty breathing or swallowing,
• Sudden drop in blood pressure and loss of consciousness.

These reactions may occur before leaving the doctor's office. However, if you or your child experiences any of these symptoms, you must contact your doctor immediately.

Adverse effects observed in 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, drowsiness.

Common (may occur in up to 1 in 10 doses of the vaccine): fever equal to or above 37.5°C (including fever above 39°C), bleeding, itching, and hardening at the injection site, extensive swelling of the limb where the vaccine was administered, loss of appetite, irritability, headache.

Uncommon (may occur in up to 1 in 100 doses of the vaccine): diarrhea, nausea, vomiting, stomach pain, swelling of glands in the neck, armpits, or groin (lymphadenopathy), sleep disturbances, apathy, dry throat, fatigue.

Coadministration with measles, mumps, rubella (MMR) or measles, mumps, rubella, varicella (MMRV) vaccines in children aged 3–6 years

In studies where Boostrix Polio was administered simultaneously with MMR or MMRV vaccines, skin rashes and upper respiratory tract infections (including runny nose and sore throat) were frequently reported. Fever, irritability, fatigue, loss of appetite, and gastrointestinal disorders (including diarrhea and vomiting) were reported more frequently (very common) compared to studies where Boostrix Polio was administered alone.

Adverse effects observed in 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, fatigue, headache.

Common (may occur in up to 1 in 10 doses of the vaccine): fever equal to or above 37.5°C, bruising, itching, hardening, warmth with tingling at the injection site, stomach pain, nausea, vomiting.

Uncommon (may occur in up to 1 in 100 doses of the vaccine): fever above 39°C, extensive swelling of the limb where the vaccine was administered, chills, pain, dizziness, joint pain, muscle pain, itching, oral herpes, swelling of glands in the neck, armpits, or groin (lymphadenopathy), loss of appetite, tingling or numbness in hands or feet (paresthesia), somnolence, asthma.

The following adverse effects have occurred during routine use of Boostrix Polio and are not specific to any age group: collapse or loss of consciousness, swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema), seizures or fits (with or without fever), hives (urticaria), unusual weakness (asthenia).

Additionally, the following adverse effects were reported during clinical trials with Boostrix (GlaxoSmithKline's booster vaccine against diphtheria, tetanus, and pertussis):

Adverse effects observed in children aged 4 to 8 years

Uncommon (may occur in up to 1 in 100 doses of the vaccine): attention disorders, itchy eye and eyelid discharge with crusting (conjunctivitis), pain.

Adverse effects observed in adults, adolescents, and children aged 10 years and older

Very common (may occur in more than 1 in 10 doses of the vaccine): general malaise.

Common (may occur in up to 1 in 10 doses of the vaccine): induration or abscess at the injection site.

Uncommon (may occur in up to 1 in 100 doses of the vaccine): upper respiratory tract infection, sore throat and discomfort when swallowing (pharyngitis), fainting (syncope), cough, diarrhea, excessive sweating (hyperhidrosis), skin rash, joint stiffness, muscle and joint stiffness, influenza-like symptoms such as fever, sore throat, runny nose, cough, and chills.

Following administration of tetanus-containing vaccines, cases of temporary nerve inflammation causing pain, weakness, and paralysis in the limbs—often extending to the chest and face—have been reported very rarely (up to a maximum of 1 in 10,000 doses of the vaccine) (Guillain-Barré syndrome).

Reporting of adverse effects

If you or your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Boostrix Polio

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 CAD. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze. Freezing destroys the vaccine.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Boostrix Polio

• The active substances are:

Diphtheria toxoid1 not less than 2 International Units (IU) (2.5 Lf)

Tetanus toxoid1 not less than 20 International Units (IU) (5 Lf)

Bordetella pertussis antigens

Pertussis toxoid1 8 micrograms

Filamentous haemagglutinin1 8 micrograms

Pertactin1 2.5 micrograms

Inactivated polioviruses

Type 1 (Mahoney strain)2 40 antigen D units

Type 2 (MEF-1 strain)2 8 antigen D units

Type 3 (Saukett strain)2 32 antigen D units

1 adsorbed onto hydrated aluminium hydroxide (Al(OH)3) 0.3 milligrams Al3+

and aluminium phosphate (AlPO4) 0.2 milligrams Al3+

2 propagated on Vero cells

Aluminium hydroxide and aluminium phosphate are included in the vaccine as adjuvants.

Adjuvants are substances included in certain vaccines to accelerate, enhance and/or prolong the protective effect of the vaccine.

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

Appearance of the product and contents of the pack

Injectable suspension in a pre-filled syringe.

Boostrix Polio is a white, slightly milky liquid supplied in a pre-filled syringe (0.5 ml).

Boostrix Polio is available in 1-dose pre-filled syringes with or without separate needles; pack sizes of 1 and 10.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline, S.A.

P.T.M - C/ Severo Ochoa, 2

28760 Tres Cantos

Madrid

Tel: 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89; 1330 Rixensart

Belgium

This medicinal product is authorised in the European Economic Area member states under the following names:

Boostrix Polio: Belgium, Bulgaria, Czech Republic, Denmark, Germany, Greece, Spain, Iceland, Latvia, Lithuania, Luxembourg, Hungary, Netherlands, Norway, Austria, Poland, Portugal, Slovenia, Finland, Sweden

Boostrix Polio Lag: Slovak Republic

Boostrix Tetra: France

IPV-Boostrix: Ireland, Malta

Polio Boostrix: Italy

Boostrix-IPV: Romania

Date of the most recent review of this summary: April 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Prior to use, the vaccine should be allowed to reach room temperature and shaken well to obtain a white, turbid, homogeneous suspension. Before administration, the vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. If either of these conditions is observed, the vaccine must not be administered.

Instructions for the pre-filled syringe

Waste disposal:

Disposal of unused medicinal product and of all materials that have been in contact with it shall be carried out in accordance with local regulations.