BOOSTRIX VACCINE 0.5 ml

BUSTRIKS WHAT IS AND WHAT IT IS USED

Bustriks is a vaccine used as a booster (booster) dose in children aged 4 years, 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:

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:

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 can interfere with normal breathing. Coughing is called "whooping cough". Can last 1-2 months or longer. Pertussis infection can also lead to inflammation of the ear, bronchitis can last long, pneumonia, seizures, brain damage and even death.

The vaccine does not contain ingredients that can cause diphtheria, tetanus and pertussis.

 BEFORE YOU TAKE / USE BUSTRIKS

Bustriks shall not apply if:

 you or your child have an allergic reaction to Bustriks or any component of the vaccine. Active and excipients contained in Bustriks are listed at the end of this 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 have 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). Minor infection such as a cold should not be a problem, but your doctor first.

 You or your child have a transient thrombocytopenia (reduction in blood platelet count, which increases risk of bleeding or bruising) or neurological complications following previous 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.

    Persistent crying lasting 3 or more hours, occurring within 48 hours after vaccination

  convulsions or seizures, with or without fever, occurring within 3 days

 If your child suffers from an undiagnosed or progressive brain disease or uncontrolled epilepsy. After control of the disease the vaccine should be administered.

 if you or your child have a bleeding disorder 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 may not achieved adequate response to the vaccine.

Like 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 infections.

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 implementing Bustriks during pregnancy.

It is unknown whether Bustriks passes into breast milk. Your doctor will discuss with you the possible risks and benefits of implementing Bustriks during lactation.

Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery

Bustriks is unlikely to affect your ability to drive or operate machinery.

 HOW TO USE / USE BUSTRIKS

Bustriks will be administered by intramuscular injection.

The vaccine should never be administered intravascularly.

For you or your child will be made from an injection 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 reducing the risk of developing this disease will take additional measures, ie clean the wound and / or administration of tetanus antitoxin.

Your doctor will advise you on vaccination.

 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 exhibit severe allergic reactions (anaphylactic and anaphylactoid reactions).

They can be recognized by:

 rashes that may be itchy or blistering

 swelling of the eyes and face

 difficulty breathing or swallowing

 a 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 is experiencing any of these symptoms should contact a doctor immediately.

The frequency of possible side effects listed below is defined as follows:

  Very common (may occur in 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 vaccine)

  Rare (may occur with up to 1 in 1,000 doses of vaccine)

  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 where the vaccine is injected

 vomiting and diarrhea

Uncommon:

 infection of the upper respiratory tract

 disorders of attention

discharge and itching of the eyes and eyelids covered with dried secretions (conjunctivitis)

skin rash

 hard lump at the vaccine injection

 pain

 Adverse reactions observed in clinical trials in adults, adolescents and children 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 the 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)

 urticaria

 unusual weakness (asthenia).

Following administration of 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.

 HOW TO STORE BUSTRIKS

Keep out of reach of children.

Bustriks Do not use after the expiry date stated on the carton and on the label of a 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.

ADDITIONAL INFORMATION

What Bustriks

The active substances are:

  Diphtheria Toxoid (Diphtheria toxoid) 1 is 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 hemagglutinin (Filamentous Haemagglutinin) 1 8 micrograms

 pertactin (Pertactin) 1 2.5 micrograms

adsorbed 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 as adjuvants in vaccines. Adjuvants are substances included in certain vaccines to enhance, improve and / or extend the protective effects of the vaccine.

 The other ingredients are:

Sodium chloride, formaldehyde, polysorbate 80, glycine and water for injections. 

Bustriks looks like and contents of pack 

Suspension for injection in pre-filled syringe.

Bustriks is a turbid white suspension in a prefilled syringe. The outer packaging of the product contains 1 prefilled syringe with suspension for injection (1 dose; 0,5 ml) and 2 separate sterile needles: needle for administration of the vaccine in adults (blue tip, 1 × 23 TW; 0,6 mm × 25 mm ) and needle for use in children (orange tip, 25 × 5/8 TW; 0,5 mm × 16 mm).

Marketing Authorisation Holder: Bulgaria 

Manufacturer: Belgium 

The following information is intended for healthcare professionals only:

The vaccine should be stored at room temperature, well shaken to obtain a homogeneous turbid white suspension.