Hippie vaccination. Instructions for use of the act-hib vaccine. Vaccination Act Hib: contraindications

Hib infection

Hib infection (hemophilic infection) is a group of diseases caused by the most dangerous Haemophilus influenzae type b. The causative agent of this infection is the cause of severe

  • purulent meningitis (inflammation brain),
  • epiglottitis (inflammation of the epiglottis),
  • sepsis ( blood poisoning),
  • pneumonia ( pneumonia),
  • otitis ( ear infection),
  • arthritis (inflammation of the joints)
  • acute respiratory diseases (ARI), etc.

Most forms of infection are very severe, causing various complications leading to disability: mental and motor retardation, hearing loss (up to complete deafness), impaired motor activity and others. Hemophilus infection is difficult to treat, as the pathogen is resistant to some antibiotics. Some cases of hemophilic infection are fatal.

How can you get Hib infection?

The pathogen is transmitted from a sick person or a carrier of the infection when talking, coughing, sneezing, with saliva, through toys and household items.

Who is at risk of getting sick?

Haemophilus influenzae has a special protective capsule that makes this microorganism "invisible" to some cells immune system children under the age of 5 years. For this reason, they do not form a full-fledged defense against this infection. Therefore, children can carry this disease repeatedly.

Most high risk development severe forms Hib infection is present in

  • Often and long-term ill children.
  • Children with chronic inflammatory diseases respiratory tract.
  • HIV-infected children.

For such children, vaccination is prescribed not only for preventive purposes, but also for therapeutic purposes.
The risk of developing Haemophilus influenzae is higher in

  • Children under the age of 5 who are in closed groups (orphanages).
  • Children aged 6-12 months who are on artificial feeding.
  • Children attending or preparing to attend pre-school institutions.

How to effectively prevent Hib infection?

It is impossible to protect a child from meeting with Haemophilus influenzae. So it is necessary to "prepare" him for this meeting. Only effective way to prevent the development of Hib infection in a child is the introduction of a vaccine.

What vaccines are used to prevent Hib infection in modern medical practice?

To prevent Hib infection, highly effective vaccines are used, created using modern technologies. Their efficiency approaches 100%.
The introduction of such vaccines is well tolerated. Local reactions to the injection (redness, induration at the injection site) are observed in 4-5 children out of 100 vaccinated. Temperature reactions are recorded in isolated cases. In case of occurrence, these reactions do not affect the usual way of life of the child.
Hib vaccines do not contain live pathogens, so you cannot get an infection from the vaccine.

What are the schedules for administering the vaccine?

It is advisable to start vaccination of children from the age of 3 months to classical pattern. In this case, basic immunity will be provided by vaccination, consisting of three vaccinations with an interval of 1 month. At the age of 18 months it is necessary to carry out a single revaccination (supportive vaccination).

How older child, the higher the ability of his immune system to form protection against Hib infection. Therefore, if a child is immunized according to an individual schedule, vaccination can begin at the age of 6 to 12 months and consist of two vaccinations with an interval of 1-1.5 months, followed by a revaccination at 18 months. In the case of the start of immunization at the age of over 12 months, one vaccination is enough to form a complete protection against Hib infection (without subsequent revaccination).

Haemophilus influenzae vaccine can be administered simultaneously with vaccines against whooping cough, diphtheria and tetanus, poliomyelitis, viral hepatitis B and other infections. Simultaneous administration of vaccines against several (5-6) infections does not overload the immune system, which is capable of simultaneously processing tens of thousands of antigens.

What are the contraindications to the introduction of the vaccine against Haemophilus influenzae?

The vaccine is not administered in the presence of an allergy to the components of the vaccine (tetanus or diphtheria components, etc.). Vaccination is delayed until the symptoms of an acute or exacerbation of a chronic disease disappear.

Before vaccinating the child, the doctor will definitely examine and give an opinion on the possibility of administering the vaccine to him.

Prepared by:
Head of the Immunoprophylaxis Department of the Minsk City Center for Hygiene and Epidemiology Glinskaya I.N.,
Epidemiologist of the Immunoprophylaxis Department of the Minsk City Center for Hygiene and Epidemiology Volosar L. A.

Hemophilus influenzae can rightly be considered one of the most harmful. According to studies, Haemophilus influenzae type b, CIB, is the cause of half of the cases of purulent a in children under 5 years of age with a frequency of severe, crippling complications, reaching 40%.

However main danger Hib infections are not even s, but acute respiratory infections, including pneumonia and, because it is these forms of it, according to the World Health Organization and the Russian Ministry of Health, that are the most common in countries where routine vaccination against this infection is not carried out. Unfortunately, Russia is also among these countries. We asked Professor Mikhail Petrovich KOSTINOV, head of the Clinical Center for Immunoprophylaxis of Children's Infections, to answer questions about this infection.

Mikhail Petrovich, what is Hib infection and why is so little known about it?

Haemophilus influenzae (HIB) infection is a group of diseases caused by Haemophilus influenzae type b. It is spread through saliva when sneezing and coughing, as well as through toys and household items that children drag into their mouths. Haemophilus influenzae can cause pneumonia, acute respiratory infections, and other diseases. Unfortunately, on a national scale in Russia, they are just beginning to detect and register this infection and, accordingly, to train doctors. It is for this reason that it is relatively unknown. However, there is no doubt that this problem is very relevant for our country as well.

How common is haemophilus influenzae?

According to Russian studies, in children's groups, the proportion of carriers of Haemophilus influenzae can reach 40%, which explains the frequent colds in children attending or starting to attend kindergartens and nurseries.


Unlike older children and adults, children under the age of 5, due to insufficient development of the immune system, cannot form immunity to CIB on their own, without vaccination. Therefore, sometimes they carry this infection repeatedly.

How often does Haemophilus influenzae cause disease?

In Russia, HIB is one of the main causes of acute respiratory infections,

causes up to half of purulent ov, a third of pneumonia and ov.

For whom this infection poses the greatest threat?

Hib-infection affects all children without exception under the age of 5 years inclusive. First of all, those who attend a nursery or kindergarten. According to WHO, formula-fed children who do not receive antibodies to this infection from their mothers, babies with weakened immune systems are more at risk of getting sick with HiB. Chronic diseases of the heart and lungs, by weakening the immune system, also facilitate the penetration of Hib infection into the body.

How easy is Hib to treat?

Hib infection is just very difficult to treat, since this bacillus is record-breaking resistant to antibiotics. For this reason, even timely treatment modern medicines is often unsuccessful. For some common drugs, such as erythromycin, chloramphenicol, tetracycline, the percentage of resistance of Haemophilus influenzae is 80-100%, and these are Russian data. Therefore, treatment should ideally begin with the determination of individual sensitivity to antibiotics.

How to protect a child from a hemophilic infection?

Vaccination is the only, simple and reliable means of preventing Haemophilus influenzae infection. Modern Hib vaccines are actually 100% effective and reliably protect the child during the entire dangerous period.

Abroad, vaccinations against HiB infection have been made since 1989. More than 100 countries around the world are routinely vaccinated against it. In some of them, such as the USA, Great Britain, France, Canada, Finland, vaccinations against this infection are mandatory and are included in national vaccination schedules. By the way, since 2006, Hib vaccination has been included in the calendar mandatory vaccinations Ukraine. We in Russia have been vaccinated against Haemophilus influenzae for more than 10 years. Since there is no Russian vaccine against Hib yet, immunization is carried out by the French, Pasteur, which can rightly be called the "gold standard" - with its advent, in fact, the history of vaccination against HiB all over the world began.

According to our studies, as well as studies conducted almost throughout Russia, it well reduces the level of carriage of Haemophilus influenzae and significantly, by 4-10 times, reduces the incidence of acute respiratory infections. Vaccinated children really begin to get sick less often. While this vaccination can only be done for money, in pay centers vaccination, although some regions have already begun to purchase this vaccine for children from special risk groups.

How easily do children tolerate this vaccine and is it necessary to prepare for it?

The vaccine consists of only one antigen, so it is well tolerated and does not require any preparation. Temperature reactions to it are very rare, not more than 1% of those vaccinated, and mild reactions at the injection site (redness, slight seal) occur in no more than 5% of children.

Children 1 to 5 years of age only need one shot. If possible, then for such babies, ideally, it should be supplemented with a vaccination against pneumococcal infection, and then the child will be protected as much as possible from acute respiratory infections, not worse than children in the same USA.

4.5 out of 5

Vaccine Act Hib (Act-HIB) is a polysaccharide conjugate vaccine against Haemophilus influenzae type b.- against the so-called Hib infection, which is caused by Haemophilus influenzae. Produced in France. The Akt Hib vaccine contains a capsular polysaccharide antigen of Haemophilus influenzae, which is covalently linked to tetanus toxoid, used as a carrier protein. Thanks to this, the antigen can form immunity even in infants.

The Act Hib vaccine is produced in the form of disposable sterile syringes with a needle treated with a special solution, which makes it possible to reduce pain during the injection.

The vaccine does not contain active microorganisms, which is its indisputable advantage. In addition, it helps to produce antibodies before the most dangerous (in terms of Hib-meningitis, not counting other forms of infection) age begins at 6-12 months. The drug promotes the appearance of antibodies and the formation of characteristic resistance to Haemophilus influenzae.

The vaccine is well tolerated and side effects from it are very rare and slightly expressed (approximately 10% of children). Typically, this is a rapidly transient rise in temperature or local reactions. An increase in temperature above 38 ° C occurs in 1% of patients. With subsequent vaccinations, the reactions do not change.

The experience of using the Hib Act vaccine in Russia shows that the number of Haemophilus influenzae in the body decreases in children, and as a result, the incidence of acute respiratory diseases(ORZ) among children in closed groups.

Prevention of infections caused by Haemophilus influenzae type b, such as meningitis, spiceemia, pneumonia, epiglottitis and others, is provided in 95% of those vaccinated.

Vaccination Act Hib: indications

  • premature;
  • Are on artificial feeding;
  • From large or low-income families;
  • Will enter preschool institutions;
  • Have any form of immunodeficiency;
  • Have blood disorders
  • Survived an operation to remove the spleen.

Vaccination Act Hib: vaccination schedule

According to standard scheme immunizations, children are given four DTP vaccines: at 3, then at 4-5, at 6 and 18 months (abroad 2, 4, 6 and 18 months). Act-HIB vaccine is combined with DTP in one syringe or is done separately. If vaccination begins when the child is already six months old, two doses must be given a month later and then a booster at 18 months (one and a half years). If the child is already one year old, one vaccination is enough.

The duration of the vaccination is up to the age of five, at the onset of which the body will already be able to develop immunity to hemophilic infection itself.

Vaccination Act Hib: contraindications

Among the contraindications - hypersensitivity to the components, acute illnesses or exacerbations chronic diseases. There is one specific contraindication - in case of intolerance to tetanus toxoid.

In addition, the injection should not be administered intravenously and care must be taken that the needle does not fall into blood vessel.

The drug is stored at a temperature of 2-8 ° C for no more than three years.

The question of whether or not to vaccinate is up to everyone to decide for themselves and their children. However Act Hib reviews say that the vaccine is mild enough and easily tolerated. At the same time, children who attend kindergarten practically do not get acute respiratory infections after this vaccination.

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Frequent acute respiratory infections, otitis and even meningitis - that's all backfire presence in the body of the child. According to statistics, 40% of preschoolers are carriers of the infection, which can be transmitted during sneezing, through saliva and household items. To protect the child from such a scourge, the schedule routine vaccination included HIB.

What is the Akt-HIB vaccine against?

The essence and purpose of the HiB (HIB) vaccination become clear after deciphering the abbreviation: Haemophilus influenzae, which in Latin means nothing more than Haemophilus influenzae, and “B”, in turn, is its type. It is CIB that is the most dangerous and pathogenic of all 6 existing strains and can cause serious illness in children. Since only this microbe has a special capsule that tries in every possible way to hide the presence of an “enemy agent” from an immature immune system small child. The infection is resistant to antibiotics, while the diseases caused by it can affect many organs and systems child's body. The only possibility to protect the baby from the insidious Haemophilus influenzae type b - this is the Akt-HIB vaccine, which has already been successfully used in all developed countries long years. The drug was developed by the French pharmaceutical company Sanofi Pasteur in 1989. Its effectiveness has been proven by research and practice. So, during the period of use, the incidence among children of garden age decreased by 95-98%, and the number of carriers to 3%. They also speak in favor of the Akt-HIB vaccine positive reviews pediatricians and caregivers who strongly recommend that the child be vaccinated before visiting kindergarten, especially the nursery.

When answering the question of what Act-HIB is vaccinated against, a whole list of diseases can be announced: acute respiratory infections, bronchitis, pneumonia, meningitis, epiglottitis, otitis - just a small list possible consequences infections that can be avoided by vaccination.

Immunization schedule

In order to have time to develop immunity to the insidious Haemophilus influenzae in time, vaccination should be carried out according to the prescribed scheme. As a rule, babies begin to be vaccinated at 3 one month old then re-vaccinate at 4.5 and 6 months. After receiving three injections, revaccination is carried out in a year, that is, when the child reaches 18 months. This scheme allows you to protect the baby from the so-called Hib-meningitis, which is especially susceptible to six-month-old crumbs.

If parents aim to prepare the child for attending kindergarten and start vaccination after a year, then one injection will be enough to develop immunity for the baby.

But in any case, the immunization schedule depends on the child's health, living conditions and in without fail agreed with the local pediatrician.

conjugate vaccine for the prevention of infections caused by Haemophilus influenzae type b

Registration certificate P N013850/01

PHARMACEUTICAL FORM
Lyophilisate for solution preparation for intramuscular and subcutaneous injection complete with a solvent of sodium chloride solution of 0.4%.

COMPOUND
Lyophilizate:
One dose of the vaccine contains:
Active substances:
Haemophilus influenzae type b polysaccharide......10 mcg;
Conjugated tetanus protein ......... 18-30 mcg;
Excipients:
Trometamol ............................................................ .......0.6mg;
Sucrose ................................................. ............42.5 mg;
Solvent (sodium chloride solution 0.4%)
0.5 ml of solvent contains:
Sodium chloride................................................ ...2.0 mg;
Water for injection .................................................. up to 0, 5 ml

DESCRIPTION
The vaccine is a white homogeneous lyophilisate. The solvent is a clear, colorless liquid.

PURPOSE
Prevention of purulent-septic diseases (meningitis, sepsis, arthritis, epiglottitis, pneumonia) caused by Haemophilus influenzae type b (HIB infection) in children from three months of age.

CONTRAINDICATIONS
Allergy to vaccine ingredients, especially tetanus toxoid.
-Allergic reaction prior administration of a vaccine to prevent infection caused by Haemophilus influenzae type b (HIB infection).
-Acute diseases, exacerbation of chronic diseases - vaccinations are carried out after 2-4 weeks. after recovery (remission). In mild forms of respiratory and intestinal infection vaccination can be carried out immediately after normalization of temperature.

METHOD OF APPLICATION AND DOSES
Introduce the entire contents of the syringe with the solvent into the vial with the vaccine, shake the vial until the lyophilisate is completely dissolved. The resulting solution should be colorless and transparent.
The vaccine is administered intramuscularly or deep subcutaneously in a single dose of 0.5 ml. Before insertion, make sure that the needle does not enter a blood vessel.
Children under 2 years of age- the introduction of the vaccine is carried out in the middle third of the anterolateral region of the thigh.
In children older than 2 years- the introduction of the vaccine is carried out in the region of the deltoid muscle.
Vaccination COURSE
At the beginning of vaccination before the age of 6 months: 3 injections with an interval of 1-2 months. Revaccination is carried out once a year after the 3rd vaccination.
When starting vaccination between 6 and 12 months of age:
2 injections 1 month apart. Revaccination is carried out once at the age of 18 months.
At the beginning of vaccination at the age of 1 to 5 years: a single injection.

ADVERSE REACTIONS
During clinical research noted:
Usually (1-10% or more) local reactions: soreness, erythema, swelling and / or inflammation, induration at the injection site, irritability, vomiting.
Perhaps (no more than 10%) an increase in body temperature, prolonged crying.
Sometimes (no more than 1%) increase in body temperature above 39 ° C.
During practical application Based on data from passive pharmacovigilance, very rarely (less than 0.01% of cases of use) were noted:
- peripheral edema of the lower extremities (see section " special instructions»)
hypersensitivity reactions, febrile or afebrile convulsions, urticaria, rash and itching.
In extremely preterm infants (born at or before 28 weeks of gestation), within 2-3 days after vaccination, there may be cases of lengthening of the time intervals between respiratory movements(see section "Special Instructions").

SPECIAL INSTRUCTIONS
ACT-HIB does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of a different etiology. The tetanus protein contained in the vaccine cannot be considered a substitute for tetanus vaccination.
Immunosuppressive therapy or immunodeficiency states may cause a weak immune response to the vaccine.
Isolated cases of peripheral edema of the lower extremities occurred in children under the age of 4 months. after the 1st or 2nd injection of a vaccine containing the Hib component (71% of cases), more than half of the cases occurred within 6 hours. Such reactions developed with the introduction of the Hib component in combined vaccines (for example, against diphtheria, whooping cough and tetanus ).
The edema spread to one or both lower limbs(with a predominance of edema on the extremities where the vaccine was introduced). These reactions may be accompanied by soreness, unusual or high-pitched crying, cyanosis or discoloration of the skin, redness, petechiae or transient purpura, fever, rash. These cases resolved spontaneously within 24 hours without any residual effects, they are not associated with any adverse events on the part of the heart and respiratory system. Potential risk the development of apnea and the need to monitor breathing for 48-72 hours should be considered when conducting primary course immunization in very preterm infants born at or before 28 weeks of gestation, especially those with a history of respiratory immaturity.
Because the benefit of immunizing this group of children is high, vaccination should not be delayed or considered contraindicated.

INTERACTION WITH OTHER DRUGS
ACT-HIB can be used simultaneously with other vaccines national calendar vaccinations and calendar preventive vaccinations on epidemic indications subject to the use of different syringes and injection into different parts of the body.
The physician should be informed of the recent or concurrent administration of any other vaccination to the child. medicinal product(including over-the-counter).

RELEASE FORM
1 dose of the vaccine in a vial and 0.5 ml of solvent in a syringe (with or without a fixed needle) in a closed cell package. If the syringe does not have a fixed needle, then 2 separate sterile needles are put into the package.
1 closed cell package with instructions for use in a cardboard box.

Best before date
3 years.
An expired drug should not be used.

STORAGE CONDITIONS
In the refrigerator (at a temperature of 2 to 8 ° C). Do not freeze.
Keep out of the reach of children.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
Released by prescription.
Report all unusual vaccine reactions to the National Health Authority. immuno biological preparations FGUN State Scientific Research Institute for Standardization and Control of Medical Biological Preparations. L.A. Tarasevich Rospotrebnadzor (119002, Moscow, per. Sivtsev-Vrazhek, 41) and the representative office of the manufacturer (115035, Moscow, Sadovnicheskaya st., 82, building 2).

MANUFACTURER
Sanofi Pasteur S.A., 2, Avenue Pont Pasteur 69007, Lyon, France.

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