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

Clinical and pharmacological group: & nbsp

Included in the formulation

Adasel [Vaccine for the prevention of diphtheria (with a reduced content of antigen), stamens and pertussis (acellular), combined, adsorbed]

suspension w / m

Sanofi Pasteur S.A. France

Vaccine pertussis-diphtheria-tetanus adsorbed liquid (DTP vaccine)

suspension w / m

BIOMED them. I.I.Mechnikova, OJSC Russia

Infanrix®

suspension w / m

GlaxoSmithKline Trading, ZAO Russia

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.02 Vaccine against diphtheria-pertussis-tetanus

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

Pharmacodynamics:

Vaccine against diphtheria, tetanus and pertussis.

Immune response to primary immunization

One month after the three-year course of primary vaccination in the first 6 months of life, more than 99% of children immunized with the vaccine titers of antibodies to diphtheria and tetanus toxoid are more than 0.1 IU / ml. Antibodies to pertussis antigens (pertussis toxoid (CA), filamentous hemagglutinin / PHA / and pertactin) are produced in more than 95% of the vaccinated.

Immune Response to Revaccination

After a vaccine revaccination at 2 years of life (13 to 24 months) in all children who were initially immunized with the vaccine, titers of antibodies to diphtheria and tetanus toxoid are more than 0.1 IU / ml. A secondary immune response to pertussis antigens is observed in more than 96% of children.

Protective efficiency The vaccine reaches an average of 88%.

Pharmacokinetics:

No data.

Indications:

Primary vaccination against diphtheria, tetanus and pertussis in children from 3 months; revaccination of children who had previously been immunized with 3 doses of acellular pertussis-diphtheria-tetanus or whole-cell pertussis-diphtheria-tetanus vaccine.

At the beginning of the course of vaccination with the whole-cell pertussis-diphtheria-tetanus vaccine, it is possible to administer subsequent doses of acellular pertussis-diphtheria-tetanus vaccine and vice versa.

ICD-10

XXI.Z20-Z29.Z27.1 The need for immunization against diphtheria-tetanus-pertussis [CDS]

Contraindications:

- known hypersensitivity to any component of the present vaccine, as well as if the patient has had hypersensitivity symptoms after the previous administration of the vaccine;

- a pronounced reaction (temperature over 40 ° C, hyperemia or swelling more than 8 cm in diameter) or a complication (collapse or shock-like condition that developed within 48 hours after the administration of the vaccine, continuous crying lasting 3 hours or more that occurred within 48 hours after the introduction of the vaccine, convulsions accompanied or not accompanied by a febrile condition that occurred within 3 days after vaccination) for the previous administration of the vaccine;

- encephalopathy, developed within 7 days after the previous administration of a vaccine containing a pertussis component. In this case, the vaccination course should continue with a diphtheria-tetanus vaccine.

Carefully:

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

It should be used with caution in patients with thrombocytopenia or with blood coagulation disorders, since intramuscular injection can cause bleeding in such patients.To prevent bleeding, press the injection site without rubbing it for at least 2 minutes.

Pregnancy and lactation:

Not intended for use in adults.

Dosing and Administration:

A single dose of the vaccine is 0.5 ml.

The course of primary vaccination consists of 3 doses of the vaccine administered according to the National Schedule of Prophylactic Inoculations of Russia at 3; 4,5 and 6 months of life; revaccination is carried out at 18 months.

Before administration, the vaccine is shaken well until a homogeneous turbid suspension is formed and carefully examined. In case of detection of foreign particles, undiluted flakes or change in appearance, the vaccine is not used.

Vaccine injected intramuscularly and alternate injection sites during the course of vaccination.

Vaccine under no circumstances is not administered intravenously.

Side effects:

The safety profile presented below is based on data from more than 11,400 patients.

With the introduction of a vaccine revaccination dose in 18 months there was an increase in the incidence of local reactions and fever.

In children who have been vaccinated with acellular pertussis vaccine,there is a high likelihood of developing edema at the injection site after the administration of the revaccinating dose, compared with children who received the primary vaccination with the whole-cell vaccine. These reactions are resolved on their own within 4 days.

Determination of the frequency of adverse reactions: very often (≥ 10%), often (≥ 1%, <10%), sometimes (≥ 0.1%, <1%), rarely (≥ 0.01%, <0.1% ), very rarely (<0.01%).

From the side of the lymphatic system: very rarely - lymphadenopathy.

From the nervous system and psyche: very often - irritability, drowsiness; often worry, unusual crying; sometimes - a headache.

From the respiratory system: sometimes - cough, bronchitis, rhinitis, pharyngitis.

From the digestive system: often - loss of appetite, diarrhea, vomiting.

Dermatological reactions: often itching; sometimes - a rash; rarely - hives, dermatitis.

General and local reactions: very often - redness, swelling at the injection site (≤ 50 mm), fever ≥ 38 ° C; often - tenderness, swelling at the injection site (> 50 mm); sometimes - a seal at the injection site, a feeling of fatigue, fever ≥ 39,1 ° C, diffuse edema at the injection site, in some cases including nearby tissues.

Postmarketing observations

On the part of the hematopoiesis system: thrombocytopenia.

Allergic reactions: hypersensitivity reactions, angioedema, anaphylactic and anaphylactoid reactions.

From the nervous system: collapse or shock-like state (hypotensive-hypo-sporadic episode), convulsions (with or without fever) within 2-3 days after the administration of the vaccine.

From the respiratory system: apnea.

Local reactions: swelling at the injection site.

Other: very rarely - otitis media.

Overdose:

Data on vaccine overdose not provided.

Interaction:

In accordance with the rules adopted in Russia, can be administered simultaneously (on the same day) with other vaccines of the National Calendar of Prophylactic Inoculations and inactivated vaccines of the preventive vaccination calendar for epidemic indications. In this case, other vaccines should be injected into other parts of the body.

It is allowed to mix the vaccine with the vaccine against Haemophilus influenzae type b.

Special instructions:

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, and to carry out osmosistr.

The introduction of the vaccine should be postponed if the child has an acute illness accompanied by fever. With an infectious disease in mild form, vaccination can be carried out after the temperature is normalized.

HIV infection is not a contraindication to vaccination.

When the vaccine is administered to patients undergoing immunosuppressive therapy or to patients with immunodeficient conditions, an adequate immune response may not be achieved.

The following conditions are contraindications to the introduction of whole-cell DTP vaccines and can be attributed to general precautions when administering the vaccine:

- temperature 40.5 ° C and higher for 48 hours after vaccination, not related to other causes, except for the introduction of the vaccine;

- a collapse or shock-like state (hypotonic hypo-spontaneous episode) that developed within 48 hours after the introduction of the vaccine;

- continuous crying, lasting 3 hours or more, occurred within 48 hours after the introduction of the vaccine;

- convulsions, accompanied or unaccompanied by a febrile condition that occurred within three days after vaccination.

In children with progressive neurological disorders, including infantile spasms,uncontrolled epilepsy or progressive encephalopathy, the introduction of a vaccine with a pertussis component (whole-cell or acellular) must be postponed until the condition is stabilized. The decision to prescribe a vaccine with a pertussis component should be taken on an individual basis after a thorough assessment of the benefits and risks.

The presence of febrile seizures in the anamnesis, as well as convulsions in the family history is not a contraindication, but requires special attention.

It is necessary to take into account the potential risk of apnea and the need to monitor respiratory function for 48-72 hours during the course of 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, vaccination can not be postponed or denied.

Instructions

Vaccine for the prevention of diphtheria, pertussis and tetanus (Vaccinum ad prophylaxim diphtheriae, pertussis et tetani)