Hexasim vaccine - we will protect ourselves from many diseases

Manufacturer, composition and mechanism of action

The six-component vaccine is produced in France by the famous pharmaceutical company SANOFI.

Available in the form of an injection suspension, which contains:

• inactivated polio antigens of three types (Mahoney, MEF-1, Saukett);
• purified diphtheria and tetanus toxoids;
• hepatitis B surface antigen;
• Haemophilus influenzae type b capsular polysaccharide;
• Bordetella pertussis whooping cough antigens.

The vaccine is designed to protect against six dangerous infections at once. The immune response develops in about a month. The course includes three primary injections and one revaccination.

Mechanism of immune response formation

After the antigens contained in the vaccine enter the body, active production of antibodies (immunoglobulins of different classes) and memory cells occurs. In the case of Hexaxim, this happens already on days 4-7. When the drug is re-administered, the body recognizes foreign bodies, so the fight against them occurs at a deeper (molecular) level. This is how immunological memory is formed.

The effectiveness of the Hexaxim vaccine has been proven by numerous studies. After the primary course of immunization it is 96.6%, after a full course - 98.5%.

What is the Hexaxim vaccine for?

The vaccine is intended for primary immunization and revaccination against:

1. whooping cough;
2. diphtheria;
3. tetanus;
4. polio;
5. hemophilus influenzae type B;
6. hepatitis B.

Age group for which Hexaxim is recommended: children from 6 weeks to 24 months.

Contraindicated

History of anaphylactic reaction to prior administration of Hexaxim® vaccine.

Hypersensitivity to active substances, to any of the additional substances processed in the “Warehouse” section, to excess substances that may be present in the preparation of trace compounds (glutaraldehyde, formaldehyde, neomycin, streptom icin and polymixin B), before any vaccine against cough or in advance with the introduction of the Hexaxim® vaccine or vaccines to contain the same active components or warehouses.

It is necessary to immunize individuals with mild or severe acute fever or infection. The presence of mild infections and/or a slight increase in body temperature is not responsible for the drive for decomposition.

Splitting with the Hexaxim® vaccine is contraindicated in individuals who have vinyl encephalopathy of unknown etiology for 7 days after the first splitting with the vaccine, which has removed the cough component (whole cell or acellular). For such people, vaccination against cough should be administered and the course of vaccination must be continued with a vaccine against diphtheria, hepatitis B, polio and Hib infection.

The Vaccine of the Kashlyuk is not to be introduced to the persons with non -controling neurologic Rosladomabo uncontrollawed by Epіplepsіyu to a recognition of the bay likivannya, I will normalize the pacyt, the navigation of such a chipper will definitely cross the Riziki.

Instructions for use of the Hexaxim vaccine

The vaccination procedure is carried out strictly in a medical facility, in compliance with hygiene standards and rules.

It is permissible to use only the intramuscular injection method. For infants no older than 12 months, it is recommended to have an injection in the anterolateral thigh area, for children of an older age group - in the deltoid muscle of the shoulder.

A single dose is 0.5 ml of immunological substance. The drug is supplied in the form of an individual dose syringe.

Before use, the container with the vaccine must be thoroughly shaken until a homogeneous whitish, cloudy suspension is obtained.

After the procedure is completed, a record is made in the appropriate accounting documents about the name of the drug, date, dose, batch number, as well as possible reactions.

After administration of an immunological substance, the child must remain in a medical facility for at least half an hour, as there is a risk of developing anaphylactic manifestations.

The primary course of immunoprophylaxis can be carried out according to one of the following schemes:

• at 6, 10 and 14 weeks;
• 2, 3 and 4 or 3, 4 and 5 months;
• at 2, 4 and 6 months.

The minimum interval between administrations should not be less than 4 weeks.

Revaccination is carried out in accordance with the official recommendations of the Ministry of Health in a particular country. In Russia, the interval between the last injection of the first stage and the final injection should be exactly one year.

Hexaxim®, vaccine (adsorbed) against diphtheria, tetanus, whooping cough (acellular), hepatitis B (recombinant rDNA), polio (inactivated) and Hemophilus influenza type b conjugated Manufacturer: Sanofi Pasteur S.A. Anatomical-therapeutic-chemical classification: Vaccine against diphtheria, Haemophilus influenzae type b, whooping cough, polio, tetanus, hepatitis B Registration number: No. RK-BP-5№021471 Registration date: 06/25/2015 – 06/25/2020 Instructions Trade name Hexaxim® , vaccine (adsorbed) against diphtheria, tetanus, pertussis (acellular), hepatitis B (recombinant rDNA), polio (inactivated) and Haemophilus influenza type b conjugate International nonproprietary name no Dosage form Suspension for injection, 0.5 ml (1 dose) Composition of 0.5 ml (1 dose) suspension contains active substances: Diphtheria toxoid not less than 20 IU Tetanus toxoid not less than Bordetella pertussis antigens: 40 IU Pertussis toxoid (CA) 25.0 µg Filamentous hemagglutinin (FHA) 25.0 µg Poliovirus* (inactivated) Type 1 (Mahoney ) Type 2 (MEF-1) Type 3 (Saukett) 40 U D antigen 8 U D antigen 32 U D antigen Hepatitis B surface antigen** 10.0 µg Haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein 12.0 µg 22.0 – 36.0 mcg excipients: aluminum 0.6 mg (in the form of aluminum hydroxide), buffer ***, water for injection * virus grown on Vero cells ** produced by yeast cells Hansenula polymorpha using DNA technology *** Buffer composition: sodium hydrogen phosphate (EP *), potassium dihydrogen phosphate (EP*), essential amino acids, including L-phenylalanine (SP company), tris(hydroxymethyl)aminomethane (EP*), sucrose (EP*). Description Turbid suspension, whitish in color. Pharmacotherapeutic group Combination of antiviral and antibacterial vaccines. Vaccine against diphtheria, haemophilus influenza type B, pertussis, poliomyelitis, tetanus, hepatitis B Code ath J07SA09 Pharmacological properties of pharmacokinetics for vaccines do not need to evaluate the pharmacokinetic properties of hexaximal hexaxima is a six -component vaccine containing diphtheria and the collection nye anxins, antigens of cough bordetella perussis, antigens polio virus, hepatitis B surface antigen and Heamophilus influenza type b capsular polysaccharide. Purified diphtheria toxoid is a formaldehyde-detoxified protein obtained from Corynebacterium diphtheriae through fermentation followed by purification. The pertussis component of the vaccine is represented by two antigens: purified pertussis toxoid and purified filamentous hemagglutinin, obtained from the culture of Bordetella pertussis by extraction, followed by purification and detoxification with glutaraldehyde. Purified tetanus toxoid is a formaldehyde-detoxified protein obtained from Clostridium tetani through fermentation and subsequent purification. The inactivated polio component of the vaccine consists of antigens of three types of poliovirus (type 1 - Mahoney, type 2 - MEF-1, type 3 - Saukett), grown on Vero cells, purified by chromatography and inactivated by formaldehyde. Hepatitis B surface antigen (HBsAg) is obtained by recombinant genetic engineering technology using a recombinant yeast strain K3/8 1 Hansenula polymorpha RB11 having a gene encoding the main surface antigen of the hepatitis B virus. Then the resulting hepatitis B surface antigen (HBsAg), isolated from yeast cells, purified by ultracentrifugation, sedimentation and chromatography. The capsular polysaccharide is extracted by precipitation from Haemophilus influenzae type b strain 1482 and then covalently linked to a tetanus carrier protein.

The immunogenicity of the vaccine has been confirmed by various clinical studies. Thus, the protective level of anti-diphtheria antibodies and anti-tetanus antibodies ( 0.01 IU/ml) was observed in 97.6% and 100% of children, respectively, 1 month after the administration of 3 doses of the primary vaccination course. There was a more than 4-fold increase in the level of antibodies against pertussis toxin in 96% of children and against filamentous hemagglutinin in 97% of children 1 month after the introduction of the primary vaccination course. A protective level of antibodies (≥8 (1/dilution)) against all three types of polio virus was observed in 99.9% of children 1 month after administration of 3 doses of the primary vaccination course. A protective level of antibodies against hepatitis B (≥ 10 mIU/ml) was observed in 99.5% of children who had already received 1 dose of the hepatitis B vaccine. In 98.8% of children who had never been vaccinated against hepatitis B, a protective level (≥ 10 mIU/ml) was also observed after 1 month after the course of primary vaccination. The level of protective antibodies (more than 0.15 μg/ml) to the capsular polysaccharide of Haemophilus influenzae type b was observed in 98% of children. Thus, after the course of primary immunization, the effectiveness of the vaccine was 96.7%. After completing the course of childhood immunization (after administration of a booster dose), the effectiveness of the vaccine was 98.5%. Indications for use - primary immunization and revaccination against diphtheria, tetanus, whooping cough, hepatitis B, polio and invasive infection caused by Haemophilus influenzae type b in newborns and children aged 6 weeks to 24 months of life. Method of administration and dosage: Before use, the vaccine must be shaken until a homogeneous whitish, cloudy suspension is obtained. The vaccine should only be administered intramuscularly. In infants under 1 year of age, the vaccine is recommended to be administered intramuscularly into the anterolateral thigh region, and in older children into the deltoid muscle of the shoulder. Primary course of vaccination The primary course of vaccination consists of three doses of 0.5 ml (1 dose), which are administered during the first 6 months of life according to one of the following schedules: at 6 weeks, 10 weeks and 14 weeks; or at 2, 3 and 4 months of life; or at 3, 4 and 5 months of life; or at 2, 4 and 6 months of life, so that the interval between subsequent doses is at least 4 weeks. The vaccination regimen is selected in accordance with the official recommendations adopted in the country. If a dose of hepatitis B vaccine was administered at birth, Hexaxim® can be used as an additional vaccination against hepatitis B from the age of 6 weeks of life. If the second dose of hepatitis B vaccine is required to be administered before this age, then monovalent hepatitis B vaccine can be used. Revaccination After a course of primary vaccination with Hexaxim®, revaccination against hepatitis B and infection caused by Haemophilus influenzae type b should be carried out in the second year of the child’s life or at least 6 months after the last dose of the primary vaccination course. Hexaxim® or any other vaccine containing the hepatitis B component, Haemophilus influenzae type b polysaccharide and poliovirus antigens can be used to complete the booster vaccination. Revaccinations should be carried out in accordance with official recommendations adopted in the country. Side effects The frequency of side effects is determined according to the following criteria: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 to <1/100), rarely ( ≥ 1/10000 to < 1/1000), very rare (< 1/10000). Very often - drowsiness - nervousness, irritability - vomiting - loss of appetite - redness at the injection site - pain at the injection site - swelling at the injection site - fever with a body temperature of more than 38 ºС Often - abnormal crying (prolonged unabated) - diarrhea - thickening at the site injections Uncommon - hypersensitivity reactions - nodular induration at the injection site - fever with body temperature more than 39.6 ºС Rarely - rash - extensive local reactions (> 50 mm), including extensive swelling of the extremities, spreading from the injection site to one or two joints, has been noted in children. Such reactions began 24–72 hours after vaccination, could be accompanied by redness, sensitivity or pain at the injection site, increased local temperature and disappeared without any treatment within 3–5 days. The risk of such reactions depends on the amount of pertussis acellular component administered during primary vaccination and increases after administration of 4 and 5 doses of the vaccine. Very rare - hypotonic reactions or hypotonic-hyporeactive episodes Possible adverse reactions that were observed after administration of other vaccines containing the same components as in the Hexaxim vaccine - anaphylactic reactions - convulsions with / or without fever - Guillain-Barré syndrome and brachial neuritis were observed after administration of tetanus toxoid - peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, demyelination of the central nervous system (multiple sclerosis) were observed after administration of the hepatitis B vaccine - encephalopathies and encephalitis - after administration of vaccines containing the Hib component, cases of swelling of one or both lower extremities (with predominant swelling in the extremity where the vaccine was administered). These reactions were sometimes accompanied by swelling with cyanosis, transient purpura, redness and crying in the first hours after vaccination and went away on their own without any treatment within 24 hours. These reactions appeared after administration of the vaccine against Hib infection. – apnea in very premature infants (≤28 weeks of gestation). Contraindications - anaphylactic reactions to previous vaccination with this vaccine - hypersensitivity reactions to any component of the vaccine or to any ingredients of the vaccine (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B); – encephalopathy of unknown etiology that occurred within 7 days after the previous administration of a vaccine containing a pertussis component (whole cell or acellular). In this case, vaccination with pertussis vaccine should be stopped and the child should be vaccinated only with a vaccine against diphtheria, tetanus, hepatitis B, polio and infection caused by Haemophilus influenzae type b - progressive neurological disorder or uncontrolled epilepsy - fever above 37 ºC or exacerbation of a chronic disease or acute infection. Drug interactions Data obtained from the combined use of Hexaxim® with pneumococcal polysaccharide conjugate vaccine showed the absence of mutual influence on the development of an immune response to each antigen. Data obtained from the combined use of Hexaxim® with the vaccine against measles, mumps and rubella showed the absence of mutual influence on the development of an immune response to each antigen. There may be a clinically significant effect on the immune response when Hexaxim® and Varilrix are used together, therefore the use of these vaccines at the same time is not recommended. Data obtained from the combined use of Hexaxim® with a vaccine against rotavirus infection showed the absence of mutual influence on the development of an immune response to each antigen. Hexaxim® vaccine cannot be mixed in the same syringe with other vaccines and parenteral drugs. When using Hexaxim® simultaneously with other vaccines, they should be administered to different parts of the body. There were no clinically significant interactions with other biological drugs. Immunosuppressive therapy may affect the intensity of the expected immune response. Special instructions In case of serious or severe reactions that occurred within 48 hours after previous immunization with a vaccine containing the same components as in Hexaxim®, vaccination must be prescribed with caution. It is necessary to warn medical personnel responsible for administering the vaccine about possible side effects before administering the drug. As with any injectable vaccine, appropriate medications and appropriate monitoring are required in the event of an anaphylactic reaction following administration. The decision to vaccinate should be made with caution if the following side effects occurred after the previous administration of the pertussis vaccine: – temperature ≥40 ºC within 48 hours after administration of the vaccine, unrelated to the administration of other drugs; – collapse or shock states (hypotonic or hyporesponsive) within 48 hours after vaccination; – constant, unremitting crying, lasting more than 3 hours and occurring within 48 hours after vaccination; - convulsions with/or without fever occurring within 3 days after vaccination. A history of febrile seizures or sudden infant death syndrome is not a contraindication for the use of Hexaxim®. If Guillain-Baré syndrome or brachial neuritis occurs following immunization with a vaccine containing tetanus toxoid, the decision should be made based on a benefit-risk assessment, such as whether primary vaccination has been completed. Typically, the decision to vaccinate is made if the primary vaccination has not been completed (i.e., less than 3 doses of vaccine have been administered). The immunogenicity of the vaccine may be reduced by immunosuppressive therapy or immunodeficiency. It is recommended to delay vaccination until after treatment. However, in persons with chronic immunodeficiency, such as HIV infection, vaccination is recommended, although the immune response may be reduced. There are no data on the use of the vaccine in premature infants. However, a reduced immune response may occur and a clinically significant level of protection is unknown. The immune response has not been studied in relation to genetic polymorphisms. In patients with chronic renal failure, there may be a reduced immune response to the hepatitis B vaccine and it is necessary to conclude that an additional dose of the hepatitis B vaccine is necessary. It is prohibited to administer this vaccine into the vascular bed, subcutaneously or intradermally. In patients with bleeding disorders (hemophilia, thrombocytopenia, anticoagulant therapy), caution should be exercised and measures taken to prevent the risk of hematoma formation after injection. After primary immunization of premature infants (less than 28 weeks) and in infants with a history of respiratory failure, continuous monitoring of respiratory activity is necessary due to the possibility of apnea occurring within 48-72 hours. In several cases, antigenuria has been identified after injection of a vaccine containing the antigen Haemophilus influenzae type b. However, it has no diagnostic value for 2 weeks after immunization. Pregnancy and lactation Not applicable because This vaccine is only intended for use in children. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Not applicable, because This vaccine is only intended for use in children. Overdose No data available. Release form and packaging 0.5 ml (1 dose) of suspension in bottles made of neutral glass type I, sealed with stoppers (chlorobutyl) and sealed with silicone caps. 10 bottles along with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions At a temperature of 2 ºС to 8 ºС in the refrigerator. Do not freeze! Keep out of the reach of children. Shelf life: 3 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription (for specialized institutions). Manufacturer Sanofi Pasteur S.A., 2, avenue PontPasteur F-69007 Lyon France Registration certificate holder Sanofi Pasteur S.A., France

Contraindications for use

It is prohibited to vaccinate children with the following conditions:

• any acute infectious diseases;
• exacerbation of chronic pathologies;
• anaphylactic reactions to previous administration of the drug Hexaxim;
• individual intolerance to vaccination components (including auxiliary ones);
• cases of hypersensitivity to previous administration of the pertussis component of any vaccines;
• epilepsy or other neurological disorders of a progressive type;
• encephalopathy that developed after the administration of the pertussis component of any vaccinations;
• thermometry readings are 37 degrees and above.

It is allowed to vaccinate children with Hexaxim simultaneously with other vaccines, but clinical trials and studies of the characteristics of the formation of an immune response in such conditions have not been carried out. If the child is taking any medications, the doctor must be informed about this. Immunosuppressive therapy may affect the expected effectiveness of vaccination.

Contraindications

History of anaphylactic reactions to previous administration of the Hexaxim® vaccine.

Hypersensitivity to the active substances, to any of the excipients listed in the "Composition" section, to residual substances that may be present in the drug in trace quantities (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any vaccine against pertussis or to previous administration of the Hexaxim® vaccine or a vaccine containing the same active ingredients or components.

Immunization should be delayed in persons with moderate or severe acute febrile illness or infection. The presence of mild infections and/or slight fever should not be a reason to delay vaccination.

Vaccination with the Hexaxim® vaccine is contraindicated in persons who have developed encephalopathy of unknown etiology within 7 days after a previous vaccination with a vaccine containing a pertussis component (whole cell or acellular). Under such conditions, vaccination against pertussis should be stopped and the course of vaccination should be continued with vaccine against diphtheria, tetanus, hepatitis B, polio and Hib infection.

Pertussis vaccine should not be administered to persons with an uncontrolled neurological disorder or uncontrolled epilepsy until the condition has been adequately treated, the patient's condition has improved, and the benefits clearly outweigh the risks.

Possible side effects and complications

After administration of the drug, the following reactions may develop:

• hypersensitivity from the immune system;
• loss of appetite;
• irritability, prolonged crying (up to 3 hours);
• drowsiness;
• vomiting, diarrhea;
• rash;
• low-grade fever;
• local manifestations: swelling, pain, swelling in the injection area.

The listed reactions resolve on their own within 3-5 days and do not require specialist intervention.

After administration of vaccinations containing the same components as Hexaxim, the risk of developing the following undesirable post-vaccination reactions remains:

• Guillain-Barre syndrome;
• neuritis of the brachial or optic nerve;
• encephalopathy, encephalitis;
• convulsions;
• peripheral neuropathy;
• apnea (in premature infants);
• extensive swelling of the limb;
• progressive sclerosis of the nervous system.

The frequency of reactions, according to the manufacturer, does not exceed 1%.

Price and analogues of the vaccine Hexaxim

The cost of the multicomponent vaccine Hexaxim in Russian pharmacies is difficult to estimate, due to its lack of free sale. In the Russian Federation, other foreign DTP vaccinations are more popular.

The average price in Ukraine is 1000 UAH per dose (the drug is available here).

Analogues:

1. Pentaxim (France). Cost: from 1.2 to 2.5 thousand rubles.
2. Infanrix Hexa (Belgium). Price: 2-3 thousand rubles.
3. Tetraxim. Cost: 1.3-1.5 thousand rubles.

The price does not include the services of paid medical centers.

Interactions with other medicinal drugs and other types of interactions

Data from the one-hour administration of the Hexaxim® vaccine with pneumococcal polysaccharide conjugate vaccine indicate the presence of any clinically significant influx of antibodies to the skin of the administered antigens.

Data from a one-hour administration of a booster dose of the Hexaxim® vaccine with vaccines for the prevention of measles, mumps and rubella did not reveal any clinically significant influx in the type of antibodies to the skin after injection of antigens. A clinically significant influx of antibodies may be avoided when the Hexaxim® vaccine and the chickenpox vaccine are ingested, so the vaccines should not be administered at the same time.

Data from the one-hour stagnation of rotavirus vaccines do not indicate a clinically significant influx of antibodies to the skin from the administered antigens.

Data from the one-hour administration of the Hexaxim® vaccine with a conjugate vaccine against meningococcus With or with a conjugate vaccine against meningococcus group A, C, W-135 and Y indicate the presence of any clinically significant influx on vidoids go antibodies to the skin with the introduction of antigens .

As it turns out, the treatment for immediate administration of a different vaccine, the use of these vaccines may affect different parts of the body.

Hexaxim® cannot be mixed with any other vaccines or other medications intended for parenteral administration.

There were no recent reports of clinically significant interactions with other medications or biological products due to immunosuppressive therapy (section “Peculiarities of treatment”).

Influx on the results of laboratory tests: div. section “Peculiarities of stagnation”.

Before surgery, you must tell your doctor about taking any medications (including
over-the-counter ones).

Reviews about vaccination

Reviews from parents who vaccinated their children with an immunodrug called Hexaxim are mostly positive.

The benefits of vaccination, according to experts and parents:

• good tolerability, no side effects;
• products of a famous French company;
• the ability to protect a child from six infections with just one injection.

The most frequently cited disadvantages: high price, problems with availability in pharmacies and paid medical centers in the country.

Reactions, in those who did experience them, were minimal: a slight increase in body temperature, moodiness, lethargy, crying, soreness and thickening at the injection site. An increasing number of parents prefer paid vaccinations, refusing domestic analogues. This fact has a simple explanation: due to the lower content of harmful components and a higher degree of purification, vaccines produced in Europe and the USA are easier to tolerate, with the same degree of effectiveness.