BOOSTRIX  VACCINE 0.5 ml.

BOOSTRIX WHAT IS AND WHAT IT IS USED

Boostrix is a vaccine that is administered as a booster ( booster ) dose for children 4 years and older , adolescents and adults to protect against three diseases: diphtheria, tetanus , pertussis (whooping cough) . The vaccine works by causing the body to produce its own protection (antibodies ) against these diseases.
 Diphtheria: Diphtheria mainly affects the airways and sometimes the skin . Generally the airways become inflamed ( swollen) causing severe breathing difficulties and sometimes suffocation . The bacteria release a toxin ( poison) that can cause nerve damage , heart problems and even death.
 Tetanus : the tetanus bacterium enters the body through cuts , scratches or wounds in the skin . Wounds that are especially prone to infection are burns , fractures, deep wounds or wounds contaminated with soil, dust , horse manure or wood . Bacteria release a toxin (poison ) that can cause muscle stiffness , painful muscle spasms, convulsions and even death. Muscle spasms can be strong enough to cause bone fractures of the spine.
 Pertussis (whooping cough) : Pertussis is a highly contagious disease. The disease affects the airways causing severe spells of coughing that may interfere with normal breathing. Coughing is called " whooping cough ." Can last 1-2 months or longer . Pertussis infection can also cause ear infections , bronchitis which may not last long, pneumonia , seizures , brain damage and even death.
 
The vaccine does not contain ingredients that can cause diphtheria, tetanus and pertussis .
 



2 . BEFORE YOU TAKE / USE BOOSTRIX

Boostrix should not be applied if :
 You or your child has had an allergic reaction to Bustriks or any component of the vaccine . Active and other ingredients contained in Bustriks are listed at the end of the leaflet. Symptoms of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
 You or your child has had an allergic reaction to any vaccine against diphtheria , tetanus and pertussis (whooping cough) .
 You or your child have problems of the nervous system (encephalopathy ) within 7 days after vaccination with a vaccine against pertussis (whooping cough) .
 You or your child has an infection with a high temperature ( over 38 ° C). A minor infection such as a cold should not be a problem, but your doctor first .
 You or your child have a transient thrombocytopenia (reduced number of blood cells platelets, which increases risk of bleeding or bruising ) or neurological complications following an earlier immunization against diphtheria and / or tetanus.
 
Take special care with Bustriks :
 If you or your child have any health problems after previous administration of Boostrix or another vaccine against pertussis , such as: temperature higher than 40 ° C which occurred within 48 hours of vaccination ;
Collapse or shock-like state within 48 hours after vaccination ;
 Persistent crying lasting 3 or more hours, occurring within 48 hours of vaccination ;
 convulsions or seizures, with or without fever , occurring within 3 days after vaccination.

 if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy. After control of the disease the vaccine should be administered ;
 if you or your child have a bleeding problem or bruise easily ;
 If you or your child is prone to seizures caused by fever, or you know that the family had such cases;
 If you or your child has sustained immune system problems due to any reason ( including HIV infection) . However, you may be given Bustriks , but can not be achieved an adequate response to the vaccine .
 

Fainting can occur (usually adolescents ) following, or even before , any needle injection . Therefore tell your doctor or nurse if you fainted / your child fainted with a previous injection .
As with all vaccines Bustriks may not fully protect all people who are vaccinated .
 

Using other medicines or vaccines
Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes recently received any other vaccine .
Bustriks may not work as well if you or your child are taking medicines that affect the immune system to fight infection .
 

Pregnancy and lactation
Take special care with Bustriks if you are or think you may be pregnant, or plan to become pregnant. Your doctor will discuss with you the possible risks and benefits of the implementation of Bustriks during pregnancy .
It is not known whether Boostrix passes into breast milk . Your doctor will discuss with you the possible risks and benefits of the implementation of Bustriks during lactation .
Ask your doctor or pharmacist before taking any medicine.
 

Driving and using machines
Bustriks unlikely to affect the ability to drive and use machines.
 

3 . HOW TO USE / USE BOOSTRIX

Bustriks will be administered by intramuscular injection.
The vaccine should never be administered intravascularly .
You or your child will be made one injection of Bustriks .
Your doctor will check you or your child have received a previous course of injections against tetanus.
Bustriks can be applied in case of suspicion of infection with tetanus, although the reduction in the risk of developing this disease will take further measures , ie cleaning the wound and / or administration of tetanus antitoxin .
Your doctor will advise you on vaccination.
 

4 . POSSIBLE SIDE EFFECTS

Like all medicines, Bustriks can cause side effects, although not everybody gets them.
As with all injectable vaccines rarely ( up to 1 in 10,000 doses of the vaccine ) can be experiencing a severe allergic reaction ( anaphylactic and anaphylactoid reactions) .
They can be recognized by:
 rashes that may be itchy or blistering ;
 swelling of the eyes and face;
 difficulty swallowing or breathing ;
 sudden drop in blood pressure and loss of consciousness.
 
These reactions may occur before leaving the doctor 's office. However, if for you or your child is experiencing any of these symptoms should contact a doctor immediately.
 
The frequency of possible side effects listed below are defined as follows :
 Very common ( may affect more than 1 in 10 doses of the vaccine) ;
 Common ( may affect up to 1 in 10 doses of the vaccine) ;
 Uncommon ( may occur with up to 1 in 100 doses of the vaccine) ;
 Rare ( may occur with up to 1 in 1,000 doses of vaccine) ;
 Very Rare ( may occur with up to 1 in 10 000 doses of vaccine) .
 
Side effects that occurred during clinical trials in children aged 4 to 8 years
Very common:
 pain, redness and swelling at the injection site ;
 irritability ;
 drowsiness;
 fatigue.
 
Common:
 loss of appetite ;
 headache ;
 fever ≥ 37,5 ° C ( including over 39 ° C);
 large swelling of the limb , wherein the vaccine is injected ;
 vomiting and diarrhea .
 
Uncommon:
 infection of the upper respiratory tract ;
 attention disorders ;
 discharge and itching of the eyes and eyelids , caked with mucus ( conjunctivitis) ;
 skin rash ;
 solid lump at the injection of the vaccine;
 pain.
 
Side effects that occurred during clinical trials in adults, adolescents and children aged over 10 years
Very common:
 pain, redness and swelling at the injection site ;
 headache ;
 fatigue ;
 general feeling of malaise .
 
Common:
 fever ≥ 37,5 ° C;
 dizziness ;
 nausea ;
 hard lump and abscess at the injection site .
 
Uncommon:
 fever over 39 ° C;
 pain ;
 Joint and muscle stiffness ;
 vomiting ;
 diarrhea ;
 stiffness , joint pain , muscle pain ;
 itching;
 increased sweating ( hyperhidrosis )
 skin rash ;
 swollen glands in the neck, armpit or groin ( lymphadenopathy ) ;
 sore throat and discomfort when swallowing ( pharyngitis ) ;
 infection of the upper respiratory tract ;
 cough ;
 fainting ( syncope) ;
 flu-like symptoms such as fever, sore throat , runny nose, cough and chills .
 
The following adverse reactions have been identified during routine use of Bustriks and are not specific to any age group :
 swelling of your face , lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) ;
 collapse or periods of unconsciousness or lack of orientation ;
 convulsions or seizures (with or without fever) ;
 hives;
 unusual weakness ( asthenia) .
 
After vaccination with tetanus very rare ( up to 1 in 10,000 doses of the vaccine) has been reported for temporary inflammation of the nerves, causing pain , weakness and paralysis in the extremities and often progressing to the chest and face ( Guillain- Barre ) .
 If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
 
 
 
5 . HOW TO STORE BUSTRIKS
Keep out of reach of children.
Bustriks not use after the expiry date stated on the carton and on the label of the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze . Freezing destroys the vaccine.
Store in the original package 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 to protect the environment.
 

6 . ADDITIONAL INFORMATION
What does Boostrix
The active substances are :
 Diphtheria Toxoid (Diphtheria toxoid) 1 - not less than 2 International Units (IU) (2,5 Lf);
 Tetanus toxoid (Tetanus toxoid) 1 - not less than 20 International Units (IU) ( 5 Lf);
 Antigens of Bordetella pertussis (Bordetella pertussis antigens):
 Pertussis toxoid (Pertussis toxoid) 1-8 micrograms ;
 Filamentous haemagglutinin (Filamentous Haemagglutinin) 1-8 micrograms ;
 Pertactin (Pertactin) 1 to 2.5 micrograms
 
1adsorbed on : aluminum hydroxide, hydrated (Al (OH) 3 ) - 0.3 milligrams Al3 + and aluminum phosphate (AlPO4) - 0,2 milligrams Al3 +.
 
Aluminum hydroxide and aluminum phosphate are included in the vaccine as adjuvants . Adjuvants are substances included in certain vaccines to enhance , improve and / or extend the protective effects of the vaccine.
 

Other ingredients are:
Sodium chloride , formaldehyde , polysorbate 80, glycine, and water for injection.
 

Boostrix looks like and contents of pack
Suspension for injection in pre-filled syringe.
Bustriks is a turbid white suspension in a prefilled syringe. Outer packaging of the product contains 1 prefilled syringe with injectable suspension ( 1 dose ; 0,5 ml) and 2 separate sterile needles : needle for administration of the vaccine in adults (blue bar; 23 × 1 TW; 0,6 mm × 25 mm ) and needle for use in children (orange tip , 25 × 5/8 TW; 0,5 mm × 16 mm).