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

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of diphtheria, pertussis and tetanusVaccine for the prevention of diphtheria, pertussis and tetanus
Dosage form: & nbspsuspension for intramuscular injection
Composition:

1 dose of vaccine (0.5 ml) contains:

Active substances:

Tetanus toxoid, adsorbed - 5 Lf (more than 20 ME)

Diphtheria toxoid, adsorbed - 2 Lf (more than 2 ME)

An acellular pertussis vaccine comprising:

- Pertussis anatoxin (CA), adsorbed - 2.5 μg

- filamentous hemagglutinin (PHA), adsorbed - 5 μg

- Agglutinogens of fimbria types 2 and 3 (FIM), adsorbed - 5 μg

- pertactin (PRI), adsorbed - 3 μg

Excipients1:

Aluminum phosphate (at recalculated on aluminum) - 1.5 mg (0.33 mg)

2-phenoxyethanol 0.6% (v / v) (3.33 mg)

Water for injection - up to 0.5 ml.

1 - residual products of the production process, present in 1 dose of vaccine (0.5 ml) in trace amounts (their calculated amount is indicated): formaldehyde (not more than 0.5 μg) and glutaraldehyde (less than 50 ng).

Description:

A whitish, cloudy, homogeneous suspension.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

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:

The Adasel vaccine is a sterile isotonic suspension that contains a diphtheria toxoid (derived from a toxin produced Corynebacterium diphtheriae), in a reduced amount, tetanus toxoid (derived from a toxin produced Clostridium tetani), and five acellular pertussis components that are derived from cultures Bordetella pertussis: Pertussis anatoxin (CA), filamentous hemagglutinin (PHA) and pertactin (PRN); Fimbria types 2 and 3 (FIM).

Diphtheria, tetanus and acellular pertussis components are adsorbed on aluminum phosphate, combined with a preservative - 2-phenoxyethanol - and diluted with water for injection.

Efficiency

Tetanus: protection from tetanus is achieved by the development of neutralizing antibodies to tetanus toxin. The minimum protective concentration of tetanus antitoxic antibodies in serum, determined by the neutralization method, should be at least 0.01 IU / ml. In clinical studies of the Adasel vaccine, the protective concentration of tetanus antitoxic antibodies measured by the ELISA method was determined to be 0.1 IU / ml, and an increase in the concentration of antitoxic antibodies to 1.0 IU / ml was associated with prolonged protection. The immune response to tetanus toxin after administration of Adasel reaches a level previously defined as protective (≥ 0.1 IU / ml), which confirms the immunological efficacy of the tetanus toxoid used in the Adasel vaccine.

Diphtheria: Protection from diphtheria is provided by neutralizing diphtheria toxin antibody. The minimum concentration of antidiphtheria antitoxic antibodies in the serum that protects against the disease is 0.01 IU / ml. The concentration of antidiphtheria antibodies equal to or greater than 0.1 IU / ml is considered protective and the level of antibodies equal to or greater than 1.0 IU / ml is associated with prolonged protection.The immune response to diphtheria toxin after administration of Adasel reaches a level previously defined as protective (≥ 0.1 IU / ml), which confirms the immunological efficacy of the diphtheria toxoid used in the Adasel vaccine.

Whooping cough: the effectiveness of pertussis antigens included in the Adasel vaccine was confirmed by comparing the concentration of antibodies to these antigens achieved in a single dose vaccinated with Adasel with the concentration of antibodies to the same antigens achieved in children under 1 year who received a triple immunization with the vaccine for children up to 12 months containing tetanus anatoxin, diphtheria toxoid and a similar acellular pertussis component (ABCDC) in the study of the epidemiological effectiveness of this vaccine, in Sweden in 1992-1995Sweden I). Epidemiological efficacy of AbDBC was 84.9% against confirmed pertussis (a disease with seizures of convulsive cough for at least 21 days, with the excreta B. pertussis or established epidemiological connection with a laboratory-confirmed case of the disease), and in relation to whooping cough (at least 1 day with coughing attacks, with discharge B. pertussis) The epidemiological efficiency of the vaccine was 77.9%.

Acellular pertussis components included in the vaccine composition Adasel AbKDS and differ only in the number KA (2.5 g vaccine Adasel, compared with 10 ug vaccine AbKDS). In clinical studies of humoral response to pertussis antigens in children, adolescents and adults, it was shown that Adasel revaccination with one dose of the vaccine results in significant formation of antibodies to all pertussis antigens included in the vaccine, with the formation of post-vaccination antibody levels 2-5 times higher than the the protective level observed in the study Sweden I.

The effectiveness of vaccines for the prevention of diphtheria (with a reduced antigen content), tetanus and pertussis (acellular) [AdSbk] Adasel including vaccines for the prevention of whooping cough was confirmed in many studies. In adolescents immunized against pertussis in infancy and early childhood, the whole-cell vaccine efficacy AdSbk vaccines during outbreaks of whooping cough ranged from 66 to 75%. Similarly, adolescents who received a primary course of immunization with an acellular pertussis vaccine efficacy AdSbk vaccines during outbreaks of whooping cough was 73-75% in the first year following vaccination.

Immunogenicity in children, adolescents and adults

Comparative studies were conducted in children (4-6 years), adolescents (11-17 years) and adults (18-64 years). In these studies, the concentration of antibodies was determined after 1 month (28-35 days) after immunization with the Adasel vaccine.

In clinical studies, in 100% of children, adolescents and adults, a protective concentration of antibodies against tetanus toxoid was achieved ≥ 0.1 U / ml 1 month after the introduction of the Adasel vaccine. The protective concentration of antibodies (≥ 0.1 U / ml) against diphtheria toxoid was achieved 1 month after administration of Adasel vaccine in 100% of children, 99.8% of adolescents and 94.1% of adults.

An evaluation of the level of immune response to pertussis antigens in all clinical studies in children, adolescents and adults showed that revaccination results in a marked increase in the level of antitoxic antibodies against pertussis toxin, which was 2-5 times higher than the protective level observed in the study Sweden I (antitoxic antibody level against pertussis toxin> 86.6 U / ml, anti-PHA antibody level> 40.0 U / ml, antibody level to PRN> 108 U / ml and antibody level to FIM> 341 U / ml in the Sweden study I).

Duration of protective action

A prolonged (for 10 years) observation of the persistence of the level of antibodies to vaccine antigens in adolescents and adults who were vaccinated in early childhood against diphtheria, tetanus and pertussis (a vaccine containing the whole-cell pertussis component) and once revaccinated with Adasel showed preservation of protective parameters for tetanus (≥ 0.01 IU / ml) and diphtheria (≥ 0.01 IU / ml) of toxoids 10 years after vaccination (99.2% and 92.6%, respectively). The concentration of pertussis antibodies remained 2-9 times higher than the baseline level for 5 years. Ten years after vaccination, the concentration of pertussis antibodies decreased to the baseline level (before vaccination).

Studies on the duration of postvaccinal immunity and data from the study of repeated administration of the Adasel vaccine confirm the possibility of using it at an interval of 10 years instead of vaccines containing only tetanus and diphtheria toxoins.

Preclinical toxicology

The study of the carcinogenic or mutagenic potential of the Adasel vaccine, as well as its effect on fertility, has not been conducted.

Pharmacokinetics:

No pharmacokinetics studies have been conducted.

Indications:Revaccination against tetanus, diphtheria and whooping cough in persons aged 4 to 64 years.
Contraindications:

- Anaphylactic reactions in a history of drugs containing diphtheria, tetanus toxoid and pertussis vaccine.

- Encephalopathy (eg, coma, impaired consciousness, recurrent convulsions) within 7 days after the administration of the vaccine containing the pertussis component, unless another reason is established.

- Progressive neurological diseases, uncontrolled epilepsy or progressive encephalopathy.

- Acute infectious and non-infectious diseases, exacerbations of chronic diseases are temporary contraindications (in such cases, the vaccination is performed after recovery or during remission). With mild ARVI, acute intestinal diseases and other conditions, the vaccination is carried out immediately after the temperature normalization.

Pregnancy and lactation:

Reproductive toxicity of Adasel vaccine, as well as its impact on the development of the embryo and fetus, have not been studied.

Vaccination during pregnancy is not recommended, except in cases of obvious risk of pertussis infection. Due to the fact that the vaccine is inactivated, the risk for the embryo or fetus is unlikely. The doctor should carefully evaluate the ratio of the benefits and risks of using the vaccine during pregnancy individually in each case if there is a high probability of infection from a sick family member or in case of an outbreak of infection in the team.

Effect of the appointment of the vaccine Adasel during lactation not studied. Since the vaccine is inactivated, the risk of adverse effects on the mother and infant is unlikely. Nevertheless, the impact of the Adasel vaccine on infants of nursing mothers vaccinated with this vaccine has not been studied. The doctor should carefully evaluate the relationship between the benefits and risks of using Adasel vaccine in nursing mothers individually in each case.

Dosing and Administration:

Revaccination is carried out once in a dose of 0.5 ml.

The vaccine should be injected intramuscularly into the deltoid muscle of the shoulder.

Vaccine Adasel can not be injected into the gluteus muscle.

Intravascular administration of the Adasel vaccine is prohibited..

Do not administer the vaccine intradermally or subcutaneously.

If necessary, according to national guidelines, the Adasel vaccine may be used in place of the vaccine against diphtheria and tetanus for revaccination against diphtheria, tetanus and pertussis in older children and adults.

Precautions for use

The treatment room in which immunization is performed should be equipped with the necessary anti-shock therapy (epinephrine hydrochloride solution for injection 1: 1000, glucocorticosteroids and other appropriate drugs). Patients should be supervised by a medical professional for at least 30 minutes after vaccination.

Preparing for and conducting an injection

Before introduction, evaluate the contents of the vial for the presence of foreign inclusions and / or discoloration (see section "Description"). If any deviations are observed, the drug can not be administered.

Shake the bottle until a homogeneous, cloudy suspension is obtained.

Before taking a dose of the vaccine, disinfect the vial with an antiseptic.

Do not remove the plug and the metal cap holding the plug from the bottle. It is necessary to follow the rules of asepsis.

Enter the total inoculation dose (0.5 ml of the drug) intramuscularly. Preferred place of administration is deltoid muscle.

Side effects:

In clinical studies of Adasel vaccine in persons aged 4-64 years, the pain at the injection site was the most frequent local reaction due to the injection method of vaccine administration. Most of the local reactions associated with the introduction of the vaccine, was observed within 3 days from the time of vaccination, and their average duration was less than 3 days. Three days after the vaccination with the Adasel erythema preparation, 11.7% of children, 5.9% of adolescents and 4.8% of adults received an ≥35 mm injection site; edema at the injection site of ≥35 mm was noted in 10.1% of children, 6.2% of adolescents, and 5.2% of adults.

The most common common reactions were increased fatigue in children and a headache in adolescents and adults. An increase in body temperature above 38 ° C was noted in less than 10% of vaccinated persons. The listed disorders were short-term and weak or moderately intense. Three days after vaccination with Adasel, an increase in body temperature> 39.5 ° C was observed in 0.3% of children, 0.1% of adolescents, and was not observed in adults.

Adverse reactions are grouped according to the classification of organs and systems of organs indicated in the medical dictionary for regulatory activities MedDRA, as the frequency of occurrence decreases. The following categories of reaction frequency are used:

- Very often: ≥ 10%

- Frequently: ≥ 1% and <10%

- Infrequently: ≥ 0.1% and <1%

- Rarely: ≥0.01% and <0.1%

- Very rarely: <0.01%

- The frequency is not set: it can not be determined according to the available data.

Reactions at the injection site

Often: pain, swelling, redness.

Systemic reactions

Often: headache, nausea2, diarrhea, anorexia1, myalgia2,3, muscle pain or muscle weakness2 3, edema in the joint area2,3, general malaise, chills2.

Often: fever, nausea1, vomiting, skin rash, myalgia1, muscle pain or muscle weakness1, edema in the joint area1, chills1,3, an increase in axillary lymph nodes.

Note: was observed in the following age groups: 1 -children,2- teenagers,3- adults.

Post-registration data

Information on the following adverse events was obtained in the form of spontaneous reports during the period of post-marketing use of the Adasel vaccine.Since these unwanted phenomena are sent voluntarily and are obtained in a population that is difficult to determine, it is not always possible to assess their frequency and cause-and-effect relationship with the use of the vaccine. The decision to include information on these adverse events in the instructions for use is based on the following factors: 1) the severity of the undesirable phenomenon, 2) the frequency of the reports, and 3) the alleged possibility of having a cause-and-effect relationship with the Adasel vaccine.

Immune system disorders

Hypersensitivity reaction (anaphylactic): angioedema, edema, rash, hypotension.

Disturbances from the nervous system

Paresthesia, hypoesthesia, Guillain-Barre syndrome, neuritis of the brachial nerve, paralysis of the facial nerve, convulsions, fainting, myelitis.

Heart Disease

Myocarditis.

Disturbances from the skin and subcutaneous tissue

Itching, rashes.

Disorders from the musculoskeletal system and connective tissues

Myositis, muscle cramps.

General reactions and reactions at the site of administration

Common reactions in the injection area (more than 50 mm), extensive swelling of the limb,spreading from the injection site beyond one or two joints; hematoma at the injection site, aseptic abscess.

Overdose:

Not applicable.

Interaction:

Simultaneous administration of vaccines

The Adasel vaccine can be administered concomitantly with a trivalent inactivated influenza vaccine and hepatitis B vaccine.

As with the simultaneous administration of the Adasel vaccine and the trivalent inactivated influenza vaccine, and when these vaccines were administered at 1 month intervals, comparable results were obtained with respect to safety and immunogenicity in adults.

Teenagers compared the safety and immunogenicity of the Adasel vaccine and vaccines for the prevention of hepatitis B, which were administered both concomitantly and at intervals of 1 month. During the formation of the immune response, no mutual effect was observed on any of the antigens, regardless of whether the Adasel vaccine and the vaccine were administered to prevent hepatitis B at the same time or at different times.

When administered simultaneously with other vaccines, each vaccine should be injected with different syringes, into different parts of the body, preferably in different limbs.

Interactions of vaccine and medicines

Immunosuppressive agents with simultaneous application with the vaccine can influence the formation of an immune response. Immunosuppressive therapy, including radiation therapy, the use of antimetabolites, alkylating agents, cytotoxic drugs and glucocorticosteroids (at doses above therapeutic levels), may reduce the immune response to the vaccine.

Vaccine Adasel it is forbidden to mix in one syringe with any preparations intended for parenteral administration.

Special instructions:

Like any other vaccine, Adasel may not provide 100% protection to all vaccinated people.

Hematologic disorders

Since any intramuscular injection can lead to the formation of a hematoma at the site of administration in individuals who have coagulation disorders, for example, in patients with hemophilia or thrombocytopenia, as well as in persons receiving anticoagulant therapy, intramuscular injections should not be given to such patients unless The benefits of administering the Adasel vaccine exceed the risk.

If a decision is made on intramuscular injection of the drug to these individuals, vaccination should be carried out with caution,taking measures to prevent the formation of hematoma after injection.

Immune system disorders

Hypersensitivity reactions to any component of the vaccine may occur after administration of the Adasel vaccine, even in persons who have no history of hypersensitivity reactions to the components of this vaccine.

In patients who have decreased immunity (due to disease or as a result of immunosuppressive therapy), an immune response may not form. If possible, vaccination should be postponed until the end of immunosuppressive therapy. However, vaccination of patients with chronic immunodeficiency states, in particular in patients with HIV infection, should be carried out even in the case of a reduced immune response.

Neurological disorders

Vaccine Adasel should not be administered to people with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen is established, stabilization is achieved, and the benefit of administering the drug will convincingly exceed the risk.

If Guillain-Barre syndrome develops within 6 weeks following the administration of a vaccine containing tetanus toxoid, the decision to administer the Adasel vaccine or another vaccine containing tetanus toxoid should be taken based on a thorough assessment of the potential benefit versus the possible risk.

Effect on the ability to drive transp. cf. and fur:

Studies to study the effect of the vaccine on the ability to drive and other mechanisms were not conducted.

Form release / dosage:

Suspension for intramuscular injection, 0.5 ml / dose.

Packaging:

For 0.5 ml (one dose) of the drug in a bottle of transparent colorless glass type I (Hebrew F.), with a capacity of 2 ml, with a rubber stopper (halobutyl elastomer) and an aluminum cap for running in with a detachable plastic lid of the "flip-off’.

For 1 or 5 bottles in a cardboard box with instructions for use.

Storage conditions:

At a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

The drug, which has been frozen, is not subject to application.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:LP-003707
Date of registration:28.06.2016
Expiration Date:28.06.2021
The owner of the registration certificate:Sanofi Pasteur S.A.Sanofi Pasteur S.A. France
Manufacturer: & nbsp
Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
Information update date: & nbsp23.01.2017
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