Boostrix suspension for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Boostrix, Injectable suspension in pre-filled syringe

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

Read the entire leaflet carefully before you or your child receives this vaccine, because 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 only for you or your child, and you must not give it to others.
• 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 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 indicated for booster vaccination in children from 4 years of age, adolescents and adults to prevent three diseases: diphtheria, tetanus (lockjaw) and pertussis (whooping cough). 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): the tetanus bacterium enters 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 "whooping" sound, hence the common name whooping cough. The cough may last 1–2 months or longer. It can also lead to ear infections, long-lasting bronchitis, pneumonia, seizures, brain damage and even death.

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

The use of Boostrix 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

Boostrix must not be given:

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

Warnings and precautions

Talk to your doctor or pharmacist before you or your child receives Boostrix:

• if you or your child experienced any problems after a previous dose of Boostrix 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 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 have bleeding disorders or bruise easily.

• if you or your child have a tendency to febrile seizures/convulsions or if there is a family history of such events.

• if you or your child have persistent immune system problems due to any cause (including HIV infection). You or your child may still receive Boostrix, but protection against infections after vaccination may not be as effective as in individuals with normal immune responses.

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

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

Use of Boostrix with other medicines

Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines, or if you or your child have recently received another vaccine.

Boostrix can be given at the same time as other vaccines. A different injection site should be used for each vaccine. Boostrix may not produce an adequate immune response if you or your child are taking medicines that reduce the effectiveness of the immune system against infections.

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.

There are no data available on whether Boostrix passes into human breast milk. Your doctor will advise you on the potential risks and benefits of receiving Boostrix during breastfeeding.

Driving and using machines

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

Boostrix contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

3. How to use Boostrix

• Boostrix 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.

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

• Boostrix may be used in case of suspected tetanus infection; however, other 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 recommend repeating the vaccination.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

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

• Skin rashes such as itching or blisters,
• Swelling of the 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 a doctor immediately.

Adverse effects 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 above 37.5 °C (including fever above 39 °C), extensive swelling of the limb where the vaccine was administered, vomiting, and diarrhea.

Uncommon (may occur in up to 1 in 100 doses of the vaccine): upper respiratory tract infection, attention disorders, itchy eye and eyelid discharge with crusting (conjunctivitis), skin rash, induration, pain at the injection site.

Adverse effects 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, malaise.

Common (may occur in up to 1 in 10 doses of the vaccine): fever equal to or above 37.5 °C, dizziness, nausea, induration, and 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, diarrhea, joint rigidity, joint pain, muscle pain, itching, excessive sweating (hyperhidrosis), skin rash, swelling of the glands in the neck, armpits, or groin (lymphadenopathy), sore throat and discomfort 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 adverse effects have been reported during routine use of Boostrix and are not specific to any age group: swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema), collapse or loss of consciousness, seizures or fits (with or without fever), hives (urticaria), unusual weakness (asthenia).

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 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 at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Boostrix

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the packaging and on the label of the pre-filled syringe after EXP. 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 will destroy the vaccine.

Keep in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Boostrix

• 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

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

and aluminium phosphate (AlPO4) 0.2 milligrams Al3+

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.

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

Appearance of the product and contents of the pack

Injectable suspension in a pre-filled syringe.

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

Boostrix 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

Date of the most recent revision of this leaflet: April 2023

Other sources of information

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

This information is intended for healthcare professionals only:

Prior to administration, the vaccine should be at room temperature and shaken well to obtain a white, turbid, homogeneous suspension. It should be inspected visually for any foreign particles and/or physical changes in appearance before administration. If any such conditions are 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 come into contact with it must be carried out in accordance with local regulations.