injection , suspension in prefilled syringe 
vaccine against diphtheria , tetanus, pertussis (acellular component) and Polio (inactivated), adsorbed , with a reduced antigen content

Read all of this leaflet carefully before you or your child start using this vaccine. It contains information that is important to you.

  • Save this information. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This vaccine has been prescribed for you or your child only. Do not give it to others.
  • If you or your child experience side effects, talk to a doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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 Boostrix Polio should be given 
4. Possible side effects 
5. How Boostrix Polio should be stored 
6. Contents of the packaging and other information 

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

Boostrix Polio is a vaccine used as a supplement dose for children from 3 years of age, adolescents and adults to prevent four diseases: diphtheria , tetanus ( tetanus ), pertussis (pertussis) and polio (poliomyelitis). The vaccine works by helping the body to produce its own antibodies (protection) 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 can also cause ear infections, tracheitis that can last for a long time, pneumonia , seizures, brain damage and in the worst case, death.
  • Polio (poliomyelitis): Poliomyelitis, which is simply called polio, is a viral infection that can manifest itself in various ways. It often causes only mild illness but can also cause permanent damage or, in the worst case, death. In its most severe form, polio infection can cause paralysis of the muscles (the muscles can not move), including the respiratory muscles and the muscles needed to be able to walk. The body parts affected by the disease can become painfully deformed.

None of the ingredients in the vaccine can cause diphtheria , tetanus, pertussis or polio.

Using Boostrix Polio 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 Polio

Boostrix Polio should not be given

  • if you or your child have previously had an allergic reaction to Boostrix Polio or any of the other ingredients of this vaccine (listed in section 6) or neomycin or polymyxin ( antibiotics ). Signs of an allergic reaction may include 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, pertussis or polio.
  • if you or your child have developed a neurological disease ( encephalopathy ) within 7 days after previous vaccination with pertussis vaccine.
  • 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.
  • 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.

Warnings and cautions

Talk to your doctor or pharmacist before you or your child receive Boostrix Polio.

  • if you or your child have previously had a health problem in connection with previous vaccination with 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, 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 Polio but may not receive as good 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 Polio may not provide full protection in all people who are vaccinated.

Other medicines and Boostrix Polio

Tell your doctor or pharmacist if you or your child have recently taken or might be taking other medicines or have recently received any other vaccine.

Boostrix Polio can be given at the same time as some other vaccines. The injection site should be changed for each type of vaccine.

Boostrix Polio may have a worse effect if you or your child is taking medicines that reduce the immune system’s ability to fight infection .

Pregnancy, breastfeeding and fertility

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 Polio passes into breast milk. Your doctor will talk to you about the possible risks and benefits of Boostrix Polio vaccination during breast-feeding.

Driving and using machines

It is unlikely that Boostrix Polio will 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 attention. 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 Polio contains neomycin, polymyxin and sodium

This vaccine contains neomycin and polymyxin ( antibiotics ). Tell your doctor or your child’s doctor if you or your child has had an allergic reaction to any of these ingredients.

This medicine contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.

3. How to give Boostrix Polio

  • Boostrix Polio 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 Polio.
  • Your or your child’s doctor will check if you or your child have previously been vaccinated against diphtheria , tetanus, pertussis and / or polio.
  • Boostrix Polio can be used for infection with suspected tetanus infection , but other additional treatment such as thorough wound cleaning and / or administration of tetanus antibodies (counteracts the toxin of the tetanus bacterium) is also given to reduce the risk of tetanus.
  • Your or your child’s 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 4-8 years
Very common (may affect more than 1 in 10 vaccine doses)
  pain, redness and swelling at the injection sitesomnolence.
Common (may affect up to 1 in 10 vaccine doses)
  fever 37.5 ° C or higher (including fever above 39 ° C)bleeding, itching and hardening at the injection sitesevere swelling of the vaccinated body partloss of appetiteirritabilityheadache.
Uncommon (may affect up to 1 in 100 vaccine doses)
  diarrhea, nausea, vomitingstomach acheswollen glands in the throat, armpit or groin ( lymphadenopathy )sleeping problemsapathydry mouthfatigue.
Concomitant vaccination against measles-mumps-rubella (MPR) or measles-mumps-rubella-chickenpox (MPR / V) in children aged 3-6 years.
In studies in which Boostrix Polio was co-administered with MPR or MPR / V vaccines, upper respiratory tract infections (including runny nose and sore throat) and rash were reported as common side effects . Fever, irritability, fatigue, decreased appetite and gastrointestinal upset (including diarrhea and vomiting) were reported with a higher frequency (very common) than in studies where only Boostrix Polio was given.
Side effects that have occurred in clinical trials in adults, adolescents and children from 10 years of age:
Very common (may affect more than 1 in 10 vaccine doses)
  pain, redness and swelling at the injection sitefatigueheadache.
Common (may affect up to 1 in 10 vaccine doses)
  fever 37.5 ° C or higherbruising, itching , calluses, numbness with a feeling of heat at the injection sitestomach pain, nausea, vomiting.
Uncommon (may affect up to 1 in 100 vaccine doses)
  fever above 39 ° Csevere swelling of the vaccinated body partoverindulgepaindizzinessjoint pain, muscle achesitchingoral herpesswollen glands in the throat, armpit or groin ( lymphadenopathy )decreased appetitestinging sensation or numbness in hands or feet ( paresthesia )somnolenceasthma .
The following side effects occurred during routine use of Boostrix Polio and are not specific to any age group
  collapse or periods of unconsciousness or decreased consciousnessswelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing ( angioedema )seizures or seizures (with or without fever)hives ( urticaria )unusual weakness ( asthenia ).
In addition, the following side effects have been reported during clinical trials with Boostrix (GlaxoSmithKline Biologicals booster vaccine against diphtheria , tetanus and pertussis):
Side effects that have occurred in children from 4 to 8 years of age
Uncommon (may affect up to 1 in 100 vaccine doses)
  attention deficit disorderssecretions from the eyes with itching and crusts on the eyelids ( conjunctivitis )pain
Side effects that have occurred in adults, adolescents and children from the age of 10 and up
Very common (may affect more than 1 in 10 vaccine doses)
  general malaise.
Common (may affect up to 1 in 10 vaccine doses)
  hard lump or abscess at the injection site.
Uncommon (may affect up to 1 in 100 vaccine doses)
  upper respiratory tract infectionsore throat and discomfort when swallowing ( pharyngitis )fainting ( syncope )coughdiarrheaheavy sweating ( hyperhidrosis )rashjoint and muscle stiffnessflu-like symptoms , e.g. fever, sore throat, runny nose, cough and chills.
 
   

Following administration of tetanus vaccines, temporary inflammation of the nerves has 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 Polio

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 label of the pre-filled syringe, 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
  Inactivated polioviruses  
    type 1 (Mahoney strain) 2 40 D antigen units
    type 2 (MEF-1 strain) 2 8 D antigen units
    type 3 (Saukett strain) 2 32 D antigen units
  adsorbed on hydrated aluminum hydroxide (Al (OH) 3 ) 0.3 milligrams Al 3+
  and aluminum phosphate (AlPO 4 ) 0.2 milligrams of Al 3+
  2 grown on VERO cells
Aluminum hydroxide and aluminum phosphate are included in this vaccine as an adjuvant . Adjuvants are substances that are included in some vaccines to accelerate, improve and / or prolong the protective effect of the vaccine.
The other ingredients are: Medium 199 (as a stabilizer containing amino acids , mineral salts and vitamins ), sodium chloride and water for injections

What the medicine looks like and contents of the pack

Injection , suspension in prefilled syringe .

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder / Information provided by:

GlaxoSmithKline AB

Box 516

169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

In Finland  
Marketing Authorisation Holder: Information provided by:
GlaxoSmithKline Biologicals saRue de l’Institut 89B-1330 RixensartBelgium GlaxoSmithKline OyBishop’s Bridge 9A02230 EspooTel. 010 30 30 30
   
Manufacturer:  
GlaxoSmithKline Biologicals saRue de l’Institut 89B-1330 RixensartBelgium

This medicinal product is authorized under the European Economic Area under the following names:

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

Boostrix Tetra : France

IPV-Boostrix: Ireland, Malta

Polio Boostrix: Italy

Boostrix IPV: Romania, UK

Muhammad Nadeem

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