Tuberculosis is a dangerous infectious disease caused by Mycobacterium tuberculosis, or Mycobacterium tuberculosis. The disease develops rapidly, has a lot of consequences and complications, leaving an imprint on the body for life. Unfortunately, like many others, the disease is easier to prevent than to stop the existing infection. Currently, the only method is BCG vaccination. Consequences, complications and contraindications are in the article.

Decoding the BCG vaccine

What does the abbreviation BCG stand for? Decoding Latin name BCG is interpreted as bacillus Calmette-Guerin. Translated into Russian, this means “Bacillus Calmette-Guérin.” Thus, the abbreviation BCG is not at all abbreviated. This decoding is a direct reading of the Latin abbreviation written in Cyrillic.

BCG vaccine: what is it?

The BCG vaccine is a suspension of weakened bovine mycobacterium with loss of virulence for humans. There are two varieties:

1. BCG - the content of Mycobacterium tuberculosis in the vaccine is too low to cause infection. However, this amount is enough for the body to develop immunity against a dangerous disease. In all countries, regardless of the manufacturer, the composition of the vaccine is the same. That is why it is inappropriate to organize a “race” for foreign products based on the personal conviction that they are better than domestic ones.
2. BCG-M - thanks reduced content microbial bodies (half as much as in the regular BCG vaccine), it is used to vaccinate premature, weakened children against tuberculosis. In addition, if for some reason the child was “overlooked” in the maternity hospital and the vaccine was not administered on time, BCG-M is used in hospitals.

Is vaccination really necessary?

It's no secret that the vaccine does not provide a 100% guarantee that tuberculosis infection will not occur subsequently. So then what is it for, you ask. The fact is that BCG produces anti-tuberculosis immunity, which can provide powerful protection during primary infection, as well as during possible subsequent contacts with carriers of tuberculosis infection. If the body still turns out to be weaker than the disease, then the vaccine will prevent the development of particularly severe, generalized forms of tuberculosis (disseminated and miliary forms). Thus, while not providing complete protection against infection, vaccination will somewhat alleviate the course of the disease in case of infection.

1. Newborns. All children should already be vaccinated with BCG at one year. Especially in regions with a high prevalence of tuberculosis.
2. Persons in constant contact with people infected with tuberculosis (usually medical staff of tuberculosis dispensaries, etc.).

At what age is BCG vaccination given?

When is BCG done? Primary vaccination is usually carried out in healthy people at 3-7 days of life. First, the doctor must examine the child, conduct thermometry (at elevated body temperatures, the procedure is contraindicated), take into account medical history data and everything. possible contraindications. In addition, BCG vaccinations for children are carried out only after consultation with a specialist doctor ready results blood and urine tests.

The vaccine should be administered intradermally, into the outer surface of the left shoulder, the dose should not exceed 0.05 mg. The technique of performing the procedure involves gradual insertion to ensure that the needle enters at the desired angle. If everything is done correctly, then a papule with a diameter of 7-9 millimeters will form at the injection site, white, usually disappearing 15-20 minutes after the procedure.

Children who, for one reason or another, were not vaccinated in the maternity hospital, are vaccinated at the first opportunity. If more than two months have passed since birth, then before vaccination it is necessary to carry out positive result BCG is prohibited.

IN medical card For a newborn, the doctor is required to make a note about the vaccination performed, indicating the date of vaccination, series and control number of the vaccine. In addition, the history includes the expiration date of the administered drug, as well as the manufacturer.

Important! The vaccine site must not be treated with any solutions. Bandaging is also not allowed.

Why such a rush?

Doctors are also often asked why BCG is done so early. When they get vaccinated, parents are perplexed why a newborn, still fragile child is subjected to such a test on the third day. The fact is that the situation with tuberculosis is such that not all patients know about their problem and continue to lead their usual lifestyle. Being carriers dangerous infection, they visit freely public places, which poses a great threat, especially to small child. The risk of a baby encountering bacteria is very high. That is why the vaccination is carried out as early as possible, so that at the time of discharge the child has already begun to develop immunity to Mycobacterium tuberculosis.

Revaccination with BCG

Children aged 7 and 14 years are subject to repeated vaccination, but only if they have a negative reaction to the Mantoux test. The interval between Mantoux and revaccination should not exceed two weeks.

Unfortunately, in epidemiologically unfavorable regions of the country, children become infected with mycobacteria long before the first revaccination, so they are not re-exposed to BCG.

What processes occur in the body after BCG?

Macrophages (or monocytes, a type of leukocyte) immediately begin to arrive at the site of vaccine administration, absorbing the pathogen and dying along with the macrophages, resulting in the formation of necrotic caseous masses. When they come out, they provoke the formation of a scar at the site of vaccine administration.

The reaction is the development of papules at the injection site, usually appearing in newborns 4-6 weeks after vaccination. A scar should form at the vaccination site, the size of which can be used to judge the acquired anti-tuberculosis immunity. So, if after BCG a scar measuring 2-4 mm has formed, then they say that the vaccinated body will resist the disease for 3-5 years. If the size is 5-7 mm, then the body is protected for 5-7 years, and with 8-10 mm - for 10 years.

Usually the vaccine is well tolerated, but sometimes reactions occur:

• BCG blushed. If the redness does not spread to surrounding tissues and is observed exclusively during vaccination reaction, then this is the norm. IN in rare cases in addition to redness, swelling may form and there may be no cause for concern: this is how the skin reacts to the drug.
• BCG festers. Suppuration and abscesses - normal reaction on the components of the vaccination, which will take place soon. You should consult a doctor if, in addition to suppuration, redness and swelling appear around the vaccination site: the wound may have become infected, which must be treated.
• BCG is inflamed. You should only worry and consult a doctor if swelling and inflammation spread to the skin of the shoulder, beyond the vaccination site.
• BCG itches. Itching at the injection site - normal phenomenon, however, doctors advise to apply gauze pad on the wound to keep the child from scratching.
• Temperature after BCG. An increase in body temperature in a newborn to 38 degrees is normal, but if a seven-year-old child experiences an increase in temperature after revaccination, you should immediately consult a doctor.

What does the lack of reaction mean?

If after vaccination a scar does not form at the injection site, then this is a sign that the vaccine was ineffective, because immunity to the most dangerous disease not formed. There should be no cause for concern in this case: some time after receiving a negative reaction to the Mantoux test, revaccination can be carried out without waiting until the age of 7.

Failure to respond to the first vaccination is uncommon, occurring in 5-10% of children. In addition, about 2% of the world's population have innate immunity to tuberculosis. This means that in principle they cannot get sick during their life.

Contraindications to vaccination

Contraindications for BCG are not so extensive, they include:

1. The newborn's body weight is less than 2500 g (with 2-4 degrees of prematurity).
2. Acute diseases or periods of exacerbation chronic diseases. In this case, vaccination should be carried out only after complete cure when the clinical manifestations of the disease disappear completely.
3. Congenital immunodeficiency.
4. Presence of a generalized BCG infection in the newborn's family.
5. HIV infection of the mother.
6. Leukemia.
7. Lymphoma.
8. Therapy with immunosuppressive drugs.

Contraindications to revaccination

Contraindications to revaccination are:

1. Exacerbation of chronic diseases or any acute diseases at the time BCG vaccination. Body temperature (elevated) is a serious argument for postponing vaccination. Typically, revaccination is carried out a month after recovery.
2. Malignant neoplasms.
3. State of immunodeficiency.
4. Tuberculosis (including at the recovery stage).
5. Positive reaction to the Mantoux test.
6. Complications after primary vaccination.

Persons temporarily exempt from vaccination due to contraindications must be under the supervision and registration of medical personnel until full recovery and vaccinations. Persons who have undergone revaccination are also under observation and must appear for a vaccination reaction check 1, 3, 6, 12 months after the procedure.

What does vaccination reaction testing include?

Such a check is carried out 1-3 months, six months and a year after vaccination and revaccination, it includes:

• Size registration local reaction.
• Registration of the nature of the reaction (it is assessed whether the formation of a papule, pustule with a crust or a scar has occurred). In addition, pigmentation at the grafting site is checked.

BCG vaccination: possible complications?

Is the vaccine completely safe? Does it have Consequences that may manifest itself in the form of:

• Osteitis is bone tuberculosis. The development of the disease usually occurs 0.5-2 years after vaccination; it causes serious disorders of the immune system.
• Generalized BCG infection is formed when a child has congenital immune disorders.
• Inflammation of the lymph node - immediate surgical intervention is required if it occurs sharp increase lymph node in size (more than 1 cm in diameter).
• Cold abscess - requires surgical intervention. This phenomenon is a consequence of subcutaneous (instead of intradermal) administration BCG vaccines. The vaccination, the consequences of which are as follows, was carried out illiterately.
• A keloid scar is red, swollen skin at the site of the graft. If there is a scar, revaccination is not carried out at the age of seven.
• An extensive ulcer indicates high sensitivity child to the components of the drug. Local treatment is usually prescribed.

Compatibility with other vaccines

BCG is a specific vaccine, the simultaneous use of other drugs with which is unacceptable. In addition, it is not allowed to carry out additional vaccinations not only on the day of BCG placement, but also for 4-6 weeks after, during the period of reactions to the drug. After the BCG injection, at least 35-45 days must pass before any other vaccination.

Before BCG vaccination, a child may be vaccinated against hepatitis B. The only condition is a period of immunological rest, that is, any vaccinations are contraindicated for the baby until the age of 3 months.

Caring for a child after BCG

Usually there are no consequences after vaccination, but to be “reinsurance” you should do something:

• Firstly, the child’s diet should remain the same. After vaccination, the baby may experience loose stool, increased body temperature, and vomiting. All these consequences are considered normal; they do not pose a danger to life or health.
• Antipyretics (provided that the child is not sick) should be given at night at temperatures above 38.5 degrees. You can reduce the heat at 37.5 degrees.
• The use of antihistamines is highly undesirable. Redness and swelling should go away on their own: healthy body can handle it on its own.
• Swimming is not prohibited.

You should consult a doctor if the temperature cannot be brought down with antipyretics (paracetamol), if the child is restless and for a long time refuses food. In case of convulsions, loss of consciousness and a purulent abscess at the vaccination site, immediately call an ambulance.

Refusal of BCG

Today, more and more often, parents of children express dissatisfaction with certain routine vaccinations considering them harmful. The practice of refusal is becoming fashionable, and the consequences of refusal can be very disastrous; this is no exception.

You can refuse the tuberculosis vaccine just like any other. The legislation of the Russian Federation confirms this right, thereby shifting responsibility for children to their parents.

What would you like to note about this? Today it is publicly available large number information about absolutely everything. Each person is able to independently study issues relating to the life and health of him and his family, make decisions and bear responsibility for his beliefs.

If you decide not to vaccinate your own child, no one will say anything against it. You just need to write the refusal in your own hand on the card, making sure to indicate that you will not have any claims against the medical staff in the future.

Description

Live mycobacteria of the BCG-1 strain, multiplying in the body of the vaccinated person, lead to the development of long-term immunity to tuberculosis.

Release form

In ampoules containing 0.5 mg of the drug (20 doses) complete with a solvent - sodium chloride injection solution 0.9%, 2 ml per ampoule. One pack contains 5 ampoules of BCG-M vaccine and 5 ampoules of sodium chloride injection solution 0.9% (5 sets).

Compound

For 1 dose:

Live mycobacteria of the BCG-1 vaccine strain - 0.025 mg of BCG microbial cells.

Excipient: sodium glutamate monohydrate (stabilizer) – no more than 0.15 mg.

1 dose is 0.1 ml of diluted suspension.

The drug does not contain preservatives or antibiotics.

Available complete with a solvent – ​​sodium chloride solution for injection 0.9%.

Indications for use

Active specific prevention tuberculosis

Contraindications

1. Prematurity of the newborn - birth weight less than 2000 g.
2. Acute diseases. Vaccination is postponed until completion acute manifestations diseases and exacerbations of chronic diseases ( intrauterine infection, purulent-septic diseases, hemolytic disease newborns of moderate and severe form, severe lesions nervous system with pronounced neurological symptoms, generalized skin lesions etc.).
3. Immunodeficiency state (primary), malignant neoplasms.
4. When prescribing immunosuppressants and radiation therapy vaccination is carried out no earlier than 6 months after the end of treatment.
5. Generalized BCG infection detected in other children in the family.
6. HIV infection in a child with clinical manifestations of secondary diseases.
7. HIV infection in the mother of a newborn who did not receive antiretroviral therapy during pregnancy.

Persons temporarily exempt from vaccinations must be monitored and registered, and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.

Dosage regimen and method of administration

The BCG-M vaccine is used intradermally at a dose of 0.025 mg in a volume of 0.1 ml.
The BCG-M vaccine is vaccinated:

1. In maternity hospitals of all healthy newborns on the 3-7th day of life on the eve or on the day of discharge from the maternity hospital in territories with a tuberculosis incidence rate of no higher than 80 per 100,000 population;
2. In maternity hospitals, premature newborns weighing 2000 grams or more, when restoring their original body weight, on the eve or on the day of discharge from the hospital;
3. In departments for nursing premature newborns medical hospitals(2nd stage of nursing) - children weighing 2300 g or more before discharge from the hospital;
4. In children's clinics, children who did not receive anti-tuberculosis vaccination in the maternity hospital due to medical contraindications and are subject to vaccination in connection with the removal of contraindications.

Children who have not been vaccinated in the first days of life are vaccinated during the first two months in a children's clinic or other medical institution without prior tuberculin diagnostics.
Before vaccination, children aged 2 months and older require a preliminary Mantoux test with 2 TE PPD-L. Children with a negative reaction to tuberculin are vaccinated. The reaction is considered negative when complete absence infiltrate (hyperemia) or the presence of a prick reaction (1.0 mm). The interval between the Mantoux test and vaccination should be at least 3 days and no more than 2 weeks.

Vaccinations should be carried out by specially trained medical personnel of maternity hospitals (departments), departments for the care of premature babies, children's clinics or feldsher-obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. In clinics, the selection of children for vaccination is preliminarily carried out by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history data. If necessary, consultations with medical specialists and blood and urine tests are carried out. To avoid contamination with live mycobacteria BCG, it is unacceptable to combine vaccination against tuberculosis with other parenteral procedures on the same day.

The fact of vaccination is registered in the established registration forms indicating the date of vaccination, manufacturer, batch number and expiration date of the vaccine.

The vaccine is dissolved immediately before use in a sterile
sodium chloride injection solution 0.9% attached to the vaccine. The solvent must be transparent, colorless and free of foreign inclusions.

The neck and head of the ampoule are wiped with alcohol. The vaccine is sealed under vacuum, so first cut it down and carefully, using tweezers, break off the sealing area. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.

Transfer 2 ml of sodium chloride solution for injection 0.9% into the ampoule with the vaccine using a sterile syringe. The vaccine should dissolve within 1 minute. The presence of flakes is allowed, which should be broken by mixing 2-4 times with a syringe. The dissolved vaccine has the appearance of a cloudy, coarse suspension of light yellow color. If there are large flakes in the diluted preparation that do not break up when mixed 3-4 times with a syringe, or sediment, the vaccine is not used and the ampoule is destroyed.
The diluted vaccine must be protected from sunlight and daylight (for example, with a cylinder of black paper) and used immediately after dilution. The diluted vaccine is suitable for use for no more than 1 hour when stored under aseptic conditions at a temperature of 2 to 8 °C. It is mandatory to maintain a protocol indicating the time of dilution of the drug and destruction of the ampoule with the vaccine.

For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a tuberculin syringe, then 0.1 ml of the vaccine is released through a needle into a sterile cotton swab in order to displace the air and bring the syringe piston to the desired graduation - 0.1 ml. Before each set, the vaccine should be carefully mixed 2-3 times using a syringe. One syringe can only administer the vaccine to one child.

The BCG-M vaccine is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder after pre-treatment skin with 70% alcohol. The needle is inserted with the bevel upward into surface layer stretched skin. First, a small amount of the vaccine is injected to make sure that the needle enters exactly intradermally, and then the entire dose of the drug (only 0.1 ml). At correct technique injection, a whitish papule with a diameter of 7-9 mm should form, usually disappearing after 15-20 minutes.

Precautions for use

Injecting the drug under the skin is unacceptable, as this will result in the formation of a “cold” abscess.

For vaccination, disposable sterile tuberculin syringes with a capacity of 1 ml with thin needles with a short bevel are used. To add the solvent into the ampoule with the vaccine, use a disposable sterile syringe with a capacity of 2 ml with a long needle. It is prohibited to use syringes and needles that have expired or insulin syringes, which do not have graduations in ml. It is prohibited to vaccinate with a needleless injector. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% Chloramine B solution or 3% hydrogen peroxide solution) and then centrally destroyed. It is prohibited to use instruments intended for vaccination against tuberculosis for other purposes. The vaccine is stored in a refrigerator (locked) in the vaccination room. Persons unrelated to vaccination are not allowed into the vaccination room.
Vaccine ampoules are carefully inspected before opening.

The drug should not be used if:
- lack of labeling on the ampoule or incorrect filling of the labeling (must contain the abbreviated name of the drug (BCG-M Vaccine), number of doses, dosage - 0.025 mg/dose, batch number (alphanumeric designation), release date, expiration date);
- expired expiration date;
- presence of cracks and notches on the ampoule;
- change physical properties drug (color change, etc.).

It is prohibited to apply a bandage and treat the site of vaccine administration with iodine solution and other disinfectant solutions during the development of a local vaccination reaction: infiltration, papules, pustules, ulcers, about which the child’s parents should be warned.

More full information on the implementation of vaccine prevention of tuberculosis is presented in Order of the Ministry of Health of Russia No. 109 “On improving anti-tuberculosis measures in Russian Federation» dated March 21, 2003

Filterable list

Active ingredient:

Instructions for medical use

Instructions for medical use- RU No.

Date last change: 27.04.2017

Dosage form

Lyophilisate for preparing a suspension for intradermal administration.

Compound

One dose of the drug contains:

Active ingredient: microbial cells BCG - 0.05 mg.

Excipient: sodium glutamate monohydrate (stabilizer) - no more than 0.3 mg.

The drug does not contain preservatives or antibiotics.

Available complete with a solvent - sodium chloride solvent for preparation dosage forms for injection 0.9%.

Description of the dosage form

A porous mass, powdery or in the form of a thin openwork tablet of white or light yellow color, easily separated from the bottom of the ampoule when shaken. Hygroscopic.

Pharmacological group

MIBP vaccine.

Pharmacological (immunobiological) properties

Live mycobacteria vaccine strain Mycobacterium bovis, substrain BCG-I multiplying in the body of the vaccinated person, leading to the development of long-term immunity to tuberculosis.

Indications

Active specific prevention of tuberculosis in children in areas with tuberculosis incidence rates exceeding 80 per 100 thousand population, as well as in the presence of tuberculosis patients in the newborn’s environment.

Contraindications

Vaccination:

1. Prematurity, birth weight less than 2500 g.

2. Intrauterine malnutrition III-IV degrees.

3. Acute diseases and exacerbation of chronic diseases. Vaccination is postponed until the end of acute manifestations of the disease and exacerbation of chronic diseases (intrauterine infection, purulent-septic diseases, moderate and severe hemolytic disease of newborns, severe damage to the nervous system with severe neurological symptoms, generalized skin lesions, etc.).

4. Children born to mothers who were not tested for HIV during pregnancy and childbirth, as well as children born to HIV-infected mothers who did not receive three-stage chemoprophylaxis for mother-to-child transmission of HIV, are not vaccinated until the child’s HIV status is established at the age of 18 months.

5. Immunodeficiency state (primary), malignant neoplasms.

When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.

6. Generalized BCG infection detected in other children in the family.

Vaccination against tuberculosis of children born to mothers with HIV infection and who received three-stage chemoprophylaxis for mother-to-child transmission of HIV (during pregnancy, childbirth and the neonatal period) is carried out in the maternity hospital with the tuberculosis vaccine for gentle primary immunization (BCG-M).

Children who have contraindications to immunization with the BCG tuberculosis vaccine are vaccinated with the BCG-M vaccine in accordance with the instructions for this vaccine.

Revaccination:

1. Acute infectious and non-communicable diseases, exacerbation of chronic diseases, including allergic ones. Vaccination is carried out 1 month after recovery or remission.

2. Immunodeficiency conditions, malignant diseases blood and neoplasms. When prescribing immunosuppressants and radiation therapy, vaccination is carried out no earlier than 6 months after the end of treatment.

3. Patients with tuberculosis, persons who have had tuberculosis and are infected with mycobacteria.

4. Positive and questionable reaction to the Mantoux test with 2 TE PPD-L.

5. Complicated reactions to the previous administration of the BCG vaccine (keloid scar, lymphadenitis, etc.).

6. HIV infection, detection of HIV nucleic acids by molecular methods.

In case of contact with infectious patients in the family, children's institution etc. vaccinations are carried out at the end of the quarantine period or maximum period incubation period For of this disease.

Persons temporarily exempt from vaccinations must be monitored and registered, and vaccinated after full recovery or removal of contraindications. If necessary, appropriate clinical and laboratory examinations are carried out.

Use during pregnancy and breastfeeding

Directions for use and doses

The BCG vaccine is used intradermally at a dose of 0.05 mg in a volume of 0.1 ml of solvent (sodium chloride solvent for the preparation of dosage forms for injection 0.9%).

Primary vaccination is carried out for healthy newborn children on days 3-7 of life (usually on the day of discharge from maternity hospital).

Children who were not vaccinated during the neonatal period due to illness receive the BCG-M vaccine after recovery. Children aged 2 months and older are first given a Mantoux test with 2 TE of purified tuberculin in a standard dilution and only those who are tuberculin-negative are vaccinated.

Children aged 7 years who have negative reaction for Mantoux test with 2 TE PPD-L. The Mantoux test is considered negative in the complete absence of infiltration, hyperemia, or in the presence of a prick reaction (1 mm). Children infected with Mycobacterium tuberculosis who have a negative reaction to the Mantoux test are not subject to revaccination. The interval between the Mantoux test and revaccination should be at least 3 days and no more than 2 weeks.

Vaccinations should be carried out by specially trained medical personnel of maternity hospitals (departments), departments for the care of premature babies, children's clinics or feldsher-obstetric stations. Vaccination of newborns is carried out in the morning in a specially designated room after the children have been examined by a pediatrician. In clinics, children are pre-selected for vaccination by a doctor (paramedic) with mandatory thermometry on the day of vaccination, taking into account medical contraindications and medical history. If necessary, consultations with medical specialists and blood and urine tests are carried out. When carrying out revaccination in schools, all of the above requirements must be met. To avoid contamination with live mycobacteria BCG, it is unacceptable to combine vaccination against tuberculosis with other parenteral procedures on the same day.

The fact of vaccination (re-vaccination) is recorded in the established registration forms indicating the date of vaccination, name of the vaccine, manufacturer, batch number and expiration date of the drug.

The vaccine is dissolved immediately before use with the sterile diluent included with the vaccine. The solvent must be transparent, colorless and free of foreign inclusions.

The neck and head of the ampoule are wiped with alcohol. The vaccine is sealed under vacuum, so first cut it down and carefully, using tweezers, break off the sealing area. Then they file and break off the neck of the ampoule, wrapping the sawed end in a sterile gauze napkin.

To obtain a dose of 0.05 mg of BCG in 0.1 ml of solvent, 1 ml of sodium chloride of solvent for the preparation of dosage forms for injections of 0.9% is transferred into an ampoule containing 10 doses of the vaccine with a sterile syringe. The vaccine should dissolve within 1 minute. The presence of flakes is allowed, which should be broken by gently shaking 3-4 times and mixing the contents by withdrawing them back into the syringe. The dissolved vaccine has the appearance of a coarse suspension of white color with a grayish or yellowish tint, without foreign inclusions. If there are large flakes in the diluted preparation that do not break up when mixed 4 times with a syringe, or sediment, the vaccine is not used and the ampoule is destroyed.

The diluted vaccine must be protected from sunlight and daylight (for example, with a cylinder of black paper) and used immediately after dilution. The diluted vaccine is suitable for use for no more than 1 hour when stored under aseptic conditions at a temperature of 2 to 8 °C. It is mandatory to maintain a protocol indicating the time of dilution and destruction of the vaccine ampoule.

For one vaccination, 0.2 ml (2 doses) of the diluted vaccine is drawn up with a tuberculin syringe, then about 0.1 ml of the vaccine is released through a needle into a sterile cotton swab in order to displace the air and bring the syringe piston to the desired graduation - 0.1 ml. Before each set, the vaccine should be carefully mixed 2-3 times using a syringe. Vaccination is carried out immediately after drawing the vaccination dose into the syringe. One syringe can only administer the vaccine to one child.

The BCG vaccine is administered strictly intradermally at the border of the upper and middle third of the outer surface of the left shoulder after pre-treatment of the skin with 70% ethyl alcohol. The needle is inserted with the cut upward into the superficial area of ​​the stretched skin. First, a small amount of the vaccine is injected to make sure that the needle enters exactly intradermally, and then the entire dose of the drug (only 0.1 ml). With the correct injection technique, a whitish papule with a diameter of 7-9 mm should form, usually disappearing after 15-20 minutes.

Side effects

At the site of intradermal administration of the BCG vaccine, a local specific reaction consistently develops in the form of infiltrate, papules, pustules, and ulcers measuring 5-10 mm in diameter. In primary vaccinated people, a normal vaccination reaction appears after 4-6 weeks. The reaction undergoes reverse development within 2-3 months, sometimes more long terms. In those revaccinated, a local reaction develops after 1-2 weeks. The site of the reaction should be protected from mechanical irritation, especially during water procedures. In 90-95% of vaccinated people, a superficial scar up to 10 mm in diameter forms at the vaccination site.

Complications after vaccination are rare and are usually worn local character(lymphadenitis - regional, often axillary, sometimes supra- or subclavian, less often - ulcers, keloid scar, “cold” abscesses, subcutaneous infiltrates). Persistent and disseminated BCG infection without fatal outcome(lupus, osteitis, osteomyelitis, etc.), post-BCG syndrome of an allergic nature, which occurs soon after vaccination ( erythema nodosum, granuloma annulare, rash, anaphylactic shock), in some cases - generalized BCG infection with congenital immunodeficiency. Complications are detected in different terms after vaccination - from several weeks to a year or more.

Overdose

Cases of overdose have not been established.

Interaction

Other preventive vaccinations can be carried out at intervals of at least 1 month before and after BCG vaccination. The exception is vaccination for prevention viral hepatitis In case of primary immunization.

Precautions

Injecting the drug under the skin is unacceptable, as this will result in the formation of a “cold” abscess.

For vaccination (re-vaccination), disposable sterile tuberculin syringes with a capacity of 1 ml with thin needles with a short cut are used. To add the solvent into the ampoule with the vaccine, use a disposable sterile syringe with a capacity of 2 ml with a long needle. It is prohibited to use syringes and needles that have expired and insulin syringes that do not have ml graduations. It is prohibited to vaccinate with a needleless injector. After each injection, a syringe with a needle and cotton swabs are soaked in a disinfectant solution (5% chloramine B solution or 3% hydrogen peroxide solution) and then centrally destroyed. It is prohibited to use instruments intended for vaccination against tuberculosis for other purposes. The vaccine is stored in a refrigerator (locked) in the vaccination room. Persons unrelated to BCG vaccination are not allowed into the vaccination room.

Vaccine ampoules are carefully inspected before opening.

The drug should not be used if:

• absence of a label on the ampoule or markings that do not allow identification of the drug;
• expired;
• the presence of cracks and notches on the ampoule;
• changing the physical properties of the drug (change in color, etc.).

It is prohibited to apply a bandage and treat the site of vaccine administration with iodine and other disinfectant solutions during the development of a local vaccination reaction: infiltrate, papules, pustules, ulcers.

Vaccine prevention of tuberculosis is carried out in accordance with Order of the Ministry of Health of Russia No. 109 “On improving anti-tuberculosis measures in the Russian Federation” dated March 21, 2003.

Special instructions

Unused vaccine is destroyed by boiling for 30 minutes, autoclaving at a temperature of 126 ºС for 30 minutes or immersing opened ampoules in disinfectant solution(5% solution of chloramine B or 3% solution of hydrogen peroxide) for 60 minutes.

Information about possible impact medicinal product on the ability to manage vehicles, mechanisms.

Not applicable. The drug is used to vaccinate children.

Release form

Lyophilisate for the preparation of a suspension for intradermal administration, 0.05 mg/dose - 10 doses per ampoule. Available complete with a solvent - sodium chloride solvent for the preparation of dosage forms for injection 0.9%. Solvent - 1 ml per ampoule.

The kit consists of 1 ampoule of vaccine and 1 ampoule of solvent.

5 sets in a cardboard pack. The pack contains instructions for use and an ampoule knife or ampoule scarifier.

Storage conditions

Storage conditions.

In accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 °C out of the reach of children.

Transportation conditions.

In accordance with SP 3.3.2.3332-16 at temperatures from 2 to 8 °C.

Best before date

2 years. A drug that has expired cannot be used.

Conditions for dispensing from pharmacies

For medical and preventive institutions.

LS-000574 dated 2015-02-10
Tuberculosis vaccine (BCG) - instructions for medical use - RU No. R N001969/01 dated 2018-07-25
Tuberculosis vaccine (BCG) - instructions for medical use - RU No.

Despite the development of diagnostics, prevention and therapy, the incidence of tuberculosis throughout the world remains high. To reduce the risk of infection, children are vaccinated with BCG in the first days after birth. This vaccine does not allow hidden infection transform into dangerous forms, makes development impossible severe complications illness. A little discomfort is compensated by enormous benefits and protection human body in the future.

Why is vaccination against tuberculosis necessary?

The reaction to the BCG vaccination frightens many parents, and they refuse to administer the vaccine without understanding the issue. This is a reckless decision, because today the incidence of tuberculosis remains high throughout the world.

BCG is the injection of a weakened bovine tuberculosis bacillus. The special composition is safe for humans because it is grown in laboratory conditions specifically for medical purposes. It is not capable of causing a dangerous disease.

The vaccination is well tolerated by infants. Temperature, suppuration, itching are the body’s normal reaction to it. Purpose of introduction active component– prevention of tuberculosis. The vaccine does not save you from the disease itself, but it does not allow its latent form to transform into an open one.

The following beneficial effects are associated with vaccination:

• reducing the likelihood of developing severe complications (meningitis and others);
• reducing the risk of death from infection;
• reduction of morbidity in childhood.
• The first vaccine injections are given to infants who are in the maternity hospital. Subsequently, injections are repeated at 7 and 14 years of age.

Possible pros and cons

Many parents, especially those far from medicine, wonder whether BCG vaccination is necessary. This preventative measure does not enjoy a good reputation among the population; there are many rumors, myths and prejudices about it.

Doctors highlight the following undeniable advantages of the procedure:

• it does not cause dangerous reactions, children tolerate the vaccine normally;
• caring for the affected area is not difficult and does not require special training;
• reduces the risk of infection;
• in case of infection, it makes the disease proceed in a milder form;
• eliminates the likelihood of death due to tuberculosis.

The reason for parents' doubts is adverse consequences vaccinations in some cases.

They are related to:

• Complications. They arise in cases where the doctor does not comply with contraindications, does not know when to give an injection, and when not, administers the composition incorrectly.
• Slow healing of the impact site. As a rule, this process lasts at least 12 months.
  Rumors about harmful ingredients active substance. Word of mouth reports that it includes compounds of aluminum, mercury and other heavy metals that the vaccine is potentially dangerous for the baby. This information is 100% untrue.
• The last word remains with parents, who may refuse vaccination. However, before doing this, you need to study the information about the injection and clarify whether there are any contraindications. The harm caused by BCG is not comparable with the enormous benefits for the health of a small person.

What should an injection mark look like?

The mark from the BCG vaccination appears immediately after the injection. This is a compaction (papule) with a diameter of 1 cm. The appearance of such an area on the skin indicates that the vaccine was administered correctly. The seal dissolves within 15-20 minutes.

How does the BCG vaccine heal? 30 days after the injection, the body’s reaction should appear. A lump appears at the injection site, which can fester. This formation lasts 4-5 months. There is no need to be afraid of such a symptom: this is a normal reaction of the body.

After another couple of weeks, the abscess disappears, leaving a papule, which gradually turns into a blister with liquid inside. After another 2-3 months, it bursts, and in its place a wound forms, which is covered with a crust. The latter cannot be peeled off: it must fall off on its own. It is not recommended to use iodine or brilliant green or to wet the area.

BCG vaccination what should be the reaction?

If the doctor acted correctly, the process develops according to the following scheme:

1. Immediately after the injection, a thickening appears, which quickly disappears;
2. after 1-2 weeks, the needle insertion site turns red;
3. after 4 months, the grafting site thickens and festers;
4. pus may leak out and form again;
5. a bubble with liquid appears in the place that was festering;
6. it bursts and becomes covered with a crust;
7. everything goes away, leaving a scar up to 10 mm in diameter.

This sequence of changes means that the injection went smoothly and parents have nothing to worry about.

Contraindications for vaccination

Administration of the active substance may lead to dangerous reactions body, if contraindications are not followed.

These include the following:

• low weight of the child (up to 2.5 kg);
• malignant tumors, blood diseases;
• illnesses in the acute phase;
• skin lesions;
• immunodeficiency;
• presence of family members with tuberculosis, etc.

Before the procedure, the doctor must assess whether there are any contraindications. Otherwise, the vaccine may be dangerous for the baby. After vaccination with BCG, doctors monitor the body’s reaction for a whole year.

Consequences of using the vaccine

Children who have undergone BCG experience a variety of body reactions that cause concern for parents. Let's consider what consequences are considered normal and do not require seeing a doctor.

Suppuration

The BCG vaccination festers - this is a normal reaction of the body. The treated area may become inflamed a month after the procedure. If there is no reddened and swollen skin around the papule, there is no cause for concern. Otherwise, you need to see a doctor: your baby may have an infection.

The pus should not be squeezed out, and it is forbidden to use antiseptics to treat the wound. If liquid leaks, it is removed with a sterile bandage.

Swelling

After vaccination, the shoulder area begins to swell. This lasts 1-2 days, after which the treated area should not differ in any way from neighboring areas of skin. The abscess forms much later.

Important! If the hand is very swollen, inflamed and does not return to normal condition, you need to consult your doctor.

Fever

This reaction occurs when an abscess forms: inflammation and abscess. As a rule, the temperature does not exceed 38 degrees. To improve the child’s condition, it is enough to give an antipyretic drug.

Important! If your temperature rises immediately after the injection, you should consult your doctor.

Redness

The grafting site takes on a reddish tint after the pus drains out. If the surrounding tissues are not affected, the body temperature is normal, parents have no reason to worry.

Itching

The baby may want to scratch the wound. The consequences of such a “cute prank” can be unfavorable, so it is recommended to apply a bandage to the injection site.

If severe itching appears immediately after vaccination, this may be evidence of an allergic reaction. You should consult your doctor.

Many parents are interested in the question of whether it is possible to bathe their child after vaccination. There are no contraindications for this. However, if in the first days it holds elevated temperature, the BCG vaccination has become very rotten, it is better to hold off on hygiene procedures.

Video

Video - 13 contraindications for vaccination

Adverse effects of injection

Certain consequences of drug administration should alert parents. For example, the BCG vaccine turned red, and then skin no reaction occurred.

The absence of an abscess indicates that either the doctor gave the injection incorrectly, or the child does not have immunity. In such cases, after vaccination, a Mantoux test is done. If the result is negative, BCG is repeated.

Important! The absence of a noticeable scar is sometimes due to the fact that it has formed under the skin. An experienced doctor will determine whether this is so by palpation.

Many dangerous complications vaccinations are due to the fact that the doctor did not take into account contraindications.

These include:

• Lymphadenitis is the entry of bacteria into the lymph nodes. Treated with surgery.
• Cold abscess. Associated with non-compliance with the drug administration technique. Treatment requires surgery.
• Bone tuberculosis, ulcer, osteomyelitis and other complications.

In some cases, a keloid scar appears at the site of BCG: red, tight skin. This means that reintroduction vaccines are contraindicated.

To exclude the effects of BCG side effects, you need to monitor how the body’s reaction proceeds, what happens during healing, how long the redness or fever persists. The task of parents is to notice alarming facts in time and consult a doctor. He will tell you what to do in case of reactions that take longer than usual or are more intense.

Complications after BCG vaccination - rare occurrence. In most cases, the body reacts normally to the vaccine, and only reminds about its administration in an adult small speck on the hand.

The benefits of the procedure have been proven in practice. The sea of ​​positive effects significantly exceeds slight discomfort which the baby and his parents have to endure.

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is a dangerous infectious disease that affects more than 50,000 people in Russia every year, including children under 14 years of age. For protection child population from the most severe forms tuberculosis in many countries around the world, mass immunization of newborns is carried out with the BCG or BCG-m vaccine.

History of vaccine use

BCG is the only existing and internationally recognized vaccine against tuberculosis; it is prepared from weakened bovine tuberculosis bacilli grown in artificial conditions. The first doses of this drug suitable for use in humans were created back in 1921, but immunoprophylaxis of tuberculosis became widespread only after the end of World War II.

Today, BCG vaccination is included in the national immunization calendars in Russia, Ukraine, Belarus, Moldova, Hungary, Poland, Lithuania, Latvia and other countries. Some European countries have abandoned mass immunization of young children against tuberculosis and are vaccinating older children and children at risk.

In 1985, children with contraindications to the BCG vaccine were given the BCG-m vaccine. This immunobiological drug has a lower antigenic load (the number of mycobacteria in one dose of the drug) and is considered more gentle for those vaccinated.

The effectiveness of BCG vaccination

The issue of the effectiveness of BCG vaccination in lately is given special attention. This excitement is caused by large discrepancies in the results of studies on the effectiveness of the tuberculosis vaccine in different regions. Scientists suggest that this ambiguity in the data obtained is due to the following factors:

Important! The only proven fact that does not require confirmation is the protective effect of BCG against two forms of tuberculosis in children (they are the most severe) - tuberculous and disseminated tuberculosis. But vaccinations do not prevent infection with mycobacteria and activation of dormant tuberculosis. This significant disadvantage of the current BCG vaccine provides an incentive for the development and testing of new vaccines against tuberculosis with more pronounced protective properties.

While there are no more effective immunobiological drugs, WHO recommends the use of BCG. Moreover, in countries with a high incidence of tuberculosis and many patients with open forms diseases (when the patient releases mycobacteria into the environment), all children who do not have contraindications must be vaccinated in the coming days after birth.

Adults are not vaccinated against tuberculosis, since almost all of them are positive, and regardless of what caused this reaction (BCG vaccination carried out in childhood, or mycobacterium obtained from environment), additional doses of an immunobiological drug will not enhance anti-tuberculosis immunity.

Should I do BCG?

Russia, Ukraine and other post-Soviet states are among the countries in which tuberculosis is widespread. Both adults and children suffer from it. Many of these patients secrete Mycobacterium tuberculosis and are not isolated, therefore they pose a great danger to others.

In such an unfavorable epidemiological situation, a newborn child can encounter this terrible infection anywhere: at the entrance (after all, you cannot be sure that all the neighbors are healthy), a clinic, a store, and even at home (close families may well not know about their disease ). Therefore, all young children must have protection against tuberculosis, which today can only be provided by BCG vaccination.

BCG: timing

In accordance with Russian national calendar Vaccinations Vaccination against tuberculosis is carried out in the maternity hospital on the 3-7th day of a newborn’s life (usually before discharge). If there are contraindications, immunization is postponed, and when the time comes, it is done not in the maternity hospital, but in the clinic to which the child is assigned.

Delaying BCG vaccination has significant disadvantages:

• If the child will be more than 2 months old at the time of the planned vaccination, he must first have it done.
• Carrying out BCG vaccination not according to schedule leads to a shift in all other vaccinations (after BCG, no immunobiological drugs should be administered for at least 1 month).
• There is no certainty that during the delay, infection with mycobacteria will not occur and the child will not develop a severe form of tuberculosis.

These disadvantages should be paid special attention to those parents who spare their child and postpone vaccinations “for later.”

Revaccination against tuberculosis, unlike other controlled immunoprophylaxis infectious diseases, is not carried out for all children who received the BCG vaccine in infancy. The indication for revaccination, which is carried out at the age of 6-7 years, is negative test Mantoux (this result indicates a lack of immunity to tuberculosis).

BCG: contraindications

Anti-tuberculosis vaccination in the maternity hospital is not carried out if the following contraindications exist:

Children who have contraindications are vaccinated with a weakened BCG-m vaccine after complete recovery.

Revaccination also has its contraindications:

• Positive or questionable Mantoux test.
• Tuberculosis, present or past.
• Any acute diseases.
• Pathological reaction to BCG vaccination.
• Immunodeficiencies.
• Treatment with immunosuppressants and radioactive rays.
• Contact with an infectious patient (re-vaccination is carried out after the end of quarantine).

Scar after BCG vaccination

The BCG vaccine is administered into left shoulder strictly intradermally. In this place, on average, after 4-6 weeks, a red lump appears - this is a local specific reaction, which indicates the formation of immunity to tuberculosis. The compaction gradually transforms into an abscess, after resolution of which a small scar remains.

The BCG-m vaccination also provokes the appearance of a local reaction on the baby’s shoulder, but it is less pronounced and does not leave a scar. After revaccination, a small infiltrate and subsequent abscess appear several weeks faster, since the body is already “familiar” with the injected pathogen.

There is no need to be afraid of these post-vaccination skin reactions. All that needs to be done is not to interfere with their course: treat the abscess with antiseptics and cauterize the abscess, bandage the shoulder, peel off the crust from the wound and carry out other similar manipulations.

Please note: What you need to be afraid of is the lack of reaction to BCG. The absence of changes in the child’s skin within the specified time frame may indicate the low effectiveness of the vaccination.

Possible complications after BCG vaccination

After vaccination and revaccination with BCG, a child may develop complications, but rarely. Among the complications, the most common are local, that is, those occurring at the site of vaccine administration, - lymphadenitis (inflammation of regional lymph nodes), large infiltrate, abscess, ulcer, lesion humerus. All these consequences develop mainly due to improper vaccination.

In weakened children with immunodeficiency, vaccination can provoke a generalized form of BCG infection, and in children prone to allergies, it can cause severe