Vaccine for the prevention of diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Included in the formulation

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

АТХ:

J.07.C.A Combination of vaccines for the prevention of viral and bacterial infections

Pharmacodynamics:

Provides immunostimulating act. Forms specific immunity against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.

Pharmacokinetics:

No data.

Indications:

Primary vaccination and revaccination of children against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.

ICD-10

XXI.Z20-Z29.Z24.6 The need for immunization against viral hepatitis

XXI.Z20-Z29.Z27.3 The need for immunization against diphtheria-tetanus-pertussis and poliomyelitis

Contraindications:

- hypersensitivity to the active ingredients of the vaccine or to any of the components of the vaccine, as well as to neomycin and polymyxin;

- hypersensitivity after previous administration of diphtheria, tetanus, pertussis vaccines, hepatitis B vaccines and poliomyelitis;

- Encephalopathy of unclear etiology, developed within 7 days after the previous administration of a vaccine containing a pertussis component.In this case, the administration of pertussis vaccine should be discontinued and vaccination continued with diphtheria-tetanus vaccine alone, as well as vaccines against hepatitis B and polio;

- acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 2-4 weeks after recovery or during the period of convalescence or remission. With mild ARVI, acute intestinal diseases and other vaccinations are carried out immediately after the normalization of temperature.

Carefully:

It should be used with caution in patients with thrombocytopenia or with blood coagulation disorders, since intramuscular injection can cause bleeding in such patients.

Pregnancy and lactation:

Since the vaccine is used in accordance with the National Calendar of preventive vaccinations of the Russian Federation in children, there is no evidence of the effect of the drug on the course of pregnancy and lactation.

Dosing and Administration:

Vaccination schedule

A single dose of the vaccine is 0.5 ml.

Primary vaccination:

According to the National calendar of preventive vaccinations of the Russian Federation, the course of primary vaccination consists of three doses of the vaccine administered at 3; 4,5 and 6 months.

However, other three-dose primary vaccination schedules (for example, 2-3-4 months, 3-4-5 months, 2-4-6 months) and a two-dose (eg 3-5 months) can also be used on a doctor's recommendation. It is necessary to observe the interval between doses not less than 1 month.

Revaccination:

According to the National calendar of preventive vaccinations of the Russian Federation, revaccination is performed once in 18 months of life.

Nevertheless, on the recommendation of a doctor, a revaccination can be performed at another time if the interval is observed not less than 6 months after the last inoculation of the primary course. So, after a two-dose primary vaccination (for example, 3-5 months), the revaccinating dose is preferably administered between 11 and 13 months of life, after a three-dose course of primary immunization, a revaccinating dose can be administered up to 18 months.

In all cases of violation of the vaccination schedule, the physician should be guided by the instruction for the use of the drug and the recommendations of the National calendar of preventive vaccinations of the Russian Federation.

Mode of administration:

The recommended place of injection is the anterolateral surface of the middle part of the thigh. The vaccine should be administered intramuscularly, alternating sides with subsequent injections.

The syringe should be shaken to obtain a homogenous homogeneous suspension of whitish color and visually checked for mechanical inclusions and / or change in appearance. If they are detected, the use of the vaccine should be discarded.

Before administration, the vaccine may be at room temperature (21 ° C) for up to 8 hours.

Unused vaccine should be disposed of according to local requirements. The vaccine is not used in children older than 36 months.

Side effects:

General reactions

Very often: anxiety, unusual crying, irritability, loss of appetite, fever ≥ 38 ° C, fatigue.

Often: fever> 39.5 ° C.

Infrequently: drowsiness, excitability.

From the respiratory system

Infrequent: infections of the upper respiratory tract, bronchitis, cough.

From the gastrointestinal tract

Often: vomiting, diarrhea.

From the skin and subcutaneous fat

Often: itching.

Infrequent: rash.

Rarely: dermatitis.

Very rarely: urticaria.

Reactions at the site of administration

Very often: soreness, redness, swelling at the injection site (≤ 50 mm).

Often: edema at the injection site (> 50 mm), seal at the injection site.

Infrequent: diffuse swelling of the extremity into which the injection was made, sometimes involving the adjacent joint.

Overdose:

Cases of overdose are not described.

Interaction:

Clinical studies have shown that the vaccine can be used concomitantly with the vaccine to prevent infection caused by Haemophilus influenzae type b. In the course of these studies, vaccines were injected into different parts of the body.

As with other vaccines, it can be expected that in patients receiving immunosuppressive therapy, an adequate immune response may not be achieved.

The vaccine should not be mixed with other vaccines in the same syringe.

Special instructions:

Under no circumstances should the vaccine be administered intravenously or intradermally.

Before vaccination, the history of the child should be studied, paying attention to the previous administration of vaccines and the associated occurrence of adverse reactions, as well as to conduct an examination.

As with the introduction of any other vaccine, you should have ready everything you need to stop a possible anaphylactic reaction to the vaccine.The vaccinated should be under medical supervision for 30 minutes after immunization.

The occurrence of the following reactions after vaccine administration is not a contraindication for subsequent vaccinations, but the benefit / risk ratio should be taken into account:

- temperature ≥ 40 ° C, which occurred within 48 hours;

- a collapse or shock-like condition that developed within 48 hours after the introduction of the vaccine;

- a shrill scream lasting 3 hours or more, which occurred within 48 hours after the introduction of the vaccine;

- febrile or afefrilnye convulsions that occurred within 3 days after vaccination.

As with any other vaccination, in some cases, a protective immune response may not be achieved.

The vaccine does not prevent the development of diseases caused by any other pathogens, with the exception of Corynebacterium diphtherial, Clostridium tetani, Bordelella pertussis, hepatitis B virus, poliovirus 1, 2, 3 types. However, a prophylactic effect is expected for hepatitis D, which can be prevented by vaccination, since hepatitis D (caused by the hepatitis virus delta virus) does not occur in the absence of hepatitis B virus.

HIV infection is not a contraindication to vaccination.However, after immunization of patients with immunodeficiency, the expected immunological response may not be achieved.

In children with progressive neurological disorders, including infantile spasms, epilepsy or uncontrolled progressive encephalopathy, pertussis vaccine (both whole cell and acellular vaccines) should be postponed until stabilization. The decision to prescribe a vaccine with a pertussis component should be taken individually after a thorough assessment of the benefits and risks.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 48-72 hours with primary vaccination of children born prematurely (<28 weeks gestation), and especially children with respiratory distress syndrome. In view of the need to vaccinate children of this group, the primary vaccination should not be postponed or refused.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

The presence of febrile seizures in the anamnesis, as well as seizures in the family history or the syndrome of sudden child death is not a contraindication, but requires special attention. Such vaccinated should be observed within 2-3 days, since during this period an undesirable phenomenon may occur.

Instructions

Vaccine for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (Vaccinum ad prophylaxim diphtheriae, tetani, pertussis, hepatitidis epidemicae B, poliomyelitidis)