solution for injection in a pre-filled syringe
A vaccine against diphtheria , tetanus and pertussis (acellular component), adsorbed , with a reduced antigen content
1. What Boostrix is and what it is used for
Boostrix is a vaccine used as a booster dose for children from 4 years of age, adolescents, and adults to prevent three diseases: diphtheria, tetanus ( tetanus ), and pertussis (pertussis). The vaccine works by helping the body to produce its own protection ( antibodies ) against these diseases.
- Diphtheria: Diphtheria mainly affects the airways and sometimes the skin. The airways usually become inflamed (swollen) which can cause severe breathing problems and in the worst-case suffocation. The bacteria also release a toxin that can cause nerve damage, heart problems, and, in the worst case, death.
- Tetanus ( Tetanus ): Tetanus bacteria enter the body through cuts, scratches, or wounds in the skin. Injuries that are particularly prone to infection are burns, fractures, deep wounds, and wounds contaminated with soil, dust, horse manure/manure, or wood chips. The bacteria release a toxin that can cause muscle stiffness, painful muscle spasms, seizures, and even death. Muscle spasms can be so severe that they cause bone fractures in the spine.
- Whooping cough (pertussis): Whooping cough is a highly contagious disease that affects the airways and causes severe attacks of coughing that can interfere with normal breathing. The cough is often accompanied by a “peeping” sound, hence the name whooping cough. The cough lasts 1-2 months or longer. Whooping cough in children can also cause ear infections, tracheitis that can last for a long time, pneumonia, seizures, brain damage, and in the worst case, death.
None of the ingredients in the vaccine can cause diphtheria, tetanus, or pertussis.
Using Boostrix during pregnancy helps protect your baby against whooping cough during the first months of life before he/she is vaccinated.
2. What you need to know before you or your child receive Boostrix
Boostrix should not be given
- if you or your child have previously had an allergic reaction to Boostrix or any of the other ingredients of the vaccine (listed in section 6). Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face and 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 developed a neurological disease ( encephalopathy ) within 7 days after previous vaccination with the pertussis vaccine.
- if you or your child have a severe infection with a high fever (above 38 ° C). A mild infection such as a common cold is probably not a problem, but talk to your doctor first.
- if you or your child have had a temporary decrease in the number of platelets(which increases the risk of bleeding or bruising) or a neurological disease after previous vaccination with a vaccine against diphtheria and/or tetanus.
Warnings and cautions
Talk to your doctor or pharmacist before you or your child receive Boostrix
- if you or your child have previously had a health problem related to previous Boostrix vaccination or any other pertussis vaccine, such as:
- high fever (above 40 ° C) within 48 hours after vaccination
- collapse or shock-like condition within 48 hours after vaccination
- persistent, inconsolable crying that lasted 3 hours or longer, within 48 hours after vaccination
- seizures with or without fever within 3 days after vaccination.
- if your child has an undiagnosed or ongoing brain disease or epilepsy that is not under control. The vaccine should be given when the disease is under control.
- if you or your child have an increased risk of bleeding or are prone to bruising
- if you or your child or anyone else in the family has a tendency to have febrile seizures
- If you or your child have longstanding problems with their immune system (including HIV – infection ). You or your child may still receive Boostrix but may not receive as much protection against infection after vaccination as adults and children with a complete immune system against infection.
Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if you or your child have fainted from a previous injection.
As with all vaccines, Boostrix may not provide full protection for all 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 any other vaccine.
Boostrix may be less effective if you or your child are taking medicines that reduce the immune system’s ability to fight infection.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
It is not known if Boostrix passes into breast milk. Your doctor will talk to you about the possible risks and benefits of Boostrix vaccination during breast-feeding.
Driving and using machines
It is unlikely that Boostrix would have any effect on the ability to drive and use machines. However, you are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Boostrix contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How to give Boostrix
- Boostrix is given as an injection into the muscle.
- The vaccine should never be given in a blood vessel.
- You or your child will receive an injection of Boostrix.
- Your doctor will check if you or your child have previously been vaccinated against diphtheria, tetanus, and/or pertussis.
- Boostrix can be used in a suspected tetanus infection, but other additional treatment such as thorough wound cleaning and/or administration of tetanus antitoxin (counteracts the toxin of the tetanus bacterium) is also given to reduce the risk of tetanus.
- Your doctor will advise you on further vaccinations.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them
As with all vaccines for injection, severe allergic reactions (anaphylactic and anaphylactoid reactions) may occur very rarely (up to 1 in 10,000 vaccine doses). These are recognizable by
| skin rash with blisters or itchingswelling of eyes and facedifficulty breathing or swallowingsudden drop in blood pressure and unconsciousness | |
| Such reactions usually occur before leaving the reception. If you or your child experience any of these symptoms, contact a doctor immediately. Side effects that have occurred during clinical trials in children from 4 to 8 years of age Very common (may affect more than 1 in 10 vaccine doses) | |
| pain, redness and swelling at the injection siteirritabilitysomnolencefatigue. | |
| Common (may affect up to 1 in 10 vaccine doses) | |
| loss of appetiteheadachefever 37.5 ° C or higher (including fever higher than 39 ° C)severe swelling of the vaccinated body partvomiting, diarrhea. | |
| Uncommon (may affect up to 1 in 100 vaccine doses) | |
| upper respiratory tract infectionattention deficit disorderssecretions from the eyes with itching and crusts on the eyelids ( conjunctivitis )rashhard lump where injection one was givenpain. | |
| Side effects that have occurred during clinical trials in adults, adolescents, and children aged 10 years and older Very common (may affect more than 1 in 10 vaccine doses) | |
| pain, redness and swelling at the injection siteheadachefatiguegeneral malaise. | |
| Common (may affect up to 1 in 10 vaccine doses) | |
| fever above 37.5 ° C or higherdizzinessnauseahard lump and abscess at the injection site. | |
| Uncommon (may affect up to 1 in 100 vaccine doses) | |
| fever above 39 ° Cpainjoint and muscle stiffnessvomitingdiarrheajoint stiffness, joint pain, muscle achesitchingheavy sweating ( hyperhidrosis )rashswollen glands in the throat, armpit or groin ( lymphadenopathy )sore throat or discomfort when swallowing ( pharyngitis )upper respiratory tract infectioncoughfainting ( syncope )flu-like symptoms , e.g. fever, sore throat, runny nose, cough and chills. | |
| The following side effects occurred during routine use of Boostrix 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 )collapse or periods of unconsciousness or decreased consciousnessseizures or seizures (with or without fever)hives ( urticaria )unusual weakness ( asthenia ). |
Following administration of tetanus vaccines, temporary inflammation of the nerves have very rarely (up to 1 in 10,000 vaccine doses), causing pain, weakness, and paralysis of the arms and legs which can also rise upwards towards the chest and face ( Guillain-Barrés syndrome ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Boostrix
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and the pre-filled syringe label after EXP. The expiration date is 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 package. Sensitive to 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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are:
| Diphtheria toxoid 1 | not less than 2 International Units (IU) (2.5 Lf) |
| Tetanus toxoid 1 | not less than 20 International Units (IU) (5 Lf) |
Bordetella pertussis – antigen
| Pertussis toxoid 1 | 8 micrograms |
| Filamentous hemagglutinin 1 | 8 micrograms |
| Pertactin 1 | 2.5 micrograms |
| 1 adsorbed on hydrated aluminum hydroxide (Al (OH) 3 ) | 0.3 milligrams Al 3+ |
| and aluminum phosphate (Alpo 4 ) | 0.2 milligrams of Al 3+ |
Aluminum hydroxide and aluminum phosphate are included in this vaccine as an adjuvant. Adjuvants are substances that are included in some vaccines to accelerate, strengthen, and/or prolong the vaccine’s protective effect.
- The other ingredients are sodium chloride and water for injections.
What the medicine looks like and the contents of the pack
Injection, suspension in the prefilled syringe.
Boostrix is a white, milky liquid provided in a pre-filled syringe (0.5 ml).
Boostrix is available in pack sizes of 1, 10, 20, 25, or 50 with or without needles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
GlaxoSmithKline Biologicals sa, Rue de l’Institut 89, B-1330 Rixensart, Belgium
This medicine is authorized in the European Economic Area under the name Boostrix in Belgium, Denmark, Finland, Ireland, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, United Kingdom, Germany, and Austria.