ADULT ENTSEPUR
Active material: tick-borne encephalitis virus antigen
When ATH: J07BA01
CCF: A vaccine for the prevention of tick-borne encephalitis
ICD-10 codes (testimony): Z24.1
When CSF: 14.03.01.27
Manufacturer: NOVARTIS VACCINES AND DIAGNOSTICS GmbH & Co.KG (Germany)
Pharmaceutical form, composition and packaging
Suspension for the / m opaque, whitish, without foreign impurities.
| 0.5 ml (1 dose) | |
| tick-borne encephalitis virus antigen (strain K 23), propagated on chick embryo cell culture, purified inactivated | 1.5 g |
Excipients: trisgidroksimetilaminometan, sodium chloride, sucrose, aluminum hydroxide, water d / and.
0.5 ml – glass syringes with needles (1) – blisters (1) – packs cardboard.
Pharmacological action
A vaccine against tick-borne encephalitis. Antibody titers to the virus encephalitis detected in all vaccinated after a full course of primary immunization.
When immunization scheme A:
4 weeks after the first vaccination (28 day) – in 50% Vaccinated;
2 weeks after the second vaccination (42 day) – in 98% Vaccinated;
2 weeks after the third vaccination (314 day) – in 99% Vaccinated.
When using Scheme B – Emergency vaccination, protective antibody levels reached after 14 days:
after the second vaccination (21 day) – in 90% Vaccinated;
after the third vaccination (35 day) – in 99% Vaccinated.
Pharmacokinetics
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Testimony
- Active prevention of tick-borne encephalitis in adults and adolescents with 12 years.
Vaccination is indicated for individuals, residing permanently or temporarily in the territories, endemic tick-borne encephalitis. Vaccinations can be carried out year round.
Dosage regimen
The primary course of vaccination
Primary vaccination is carried out, A scheme using.
| Vaccination | Dose | Scheme A |
| The first vaccination | 0.5 ml | 0 day |
| The second vaccination | 0.5 ml | Through 1-3 Months |
| A third vaccination | 0.5 ml | Through 9-12 months after the second vaccination |
The second dose can be administered through 14 days after the first dose.
The traditional scheme is preferred for people, located in endemic areas.
After completion of the vaccination, Protective titers of antibodies persists for, at least, 3 years, then it is recommended to revaccination.
Seroconversion develops no earlier, than 14 days after the second vaccination.
If you want fast (Emergency) vaccination, The scheme is applied.
| Vaccination | Dose | Scheme B |
| The first vaccination | 0.5 ml | 0 day |
| The second vaccination | 0.5 ml | On the 7th day |
| A third vaccination | 0.5 ml | 21 day |
Seroconversion develops no earlier, than 14 days after the second vaccination, ie of 21 day. After completion of the vaccination, Protective titers of antibodies persists for 12-18 Months, then it is recommended to revaccination.
In patients with immune deficiencies and those aged 59 years of age and older should check the level of antibodies in the period from 30 to 60 days after the second vaccination scheme A and the third vaccination by the scheme B and, if necessary, should conduct additional vaccination.
Revakcinaciâ
After the primary vaccination course, carried out according to one of the two circuits, one injection 0.5 ml of vaccine Entsepur adult is sufficient to maintain the intensity of immunity. Based on the results of clinical trials, Use the following intervals for revaccination.
For persons receiving primary vaccination routine vaccination scheme (Scheme A), We recommend the following intervals.
| Scheme A (Traditional) | The first revaccination | Subsequent revaccination |
| Age from 12 to 49 years | 3 year | Every 5 years |
| Age more 49 years | 3 year | Every 3 year |
For persons receiving primary vaccination scheme for emergency (Scheme B), We recommend the following intervals.
| Scheme B (Emergency) | The first revaccination | Subsequent revaccination |
| Age from 12 to 49 years | Through 12-18 Months | Every 5 years |
| Age more 49 years | Through 12-18 Months | Every 3 year |
Rules of administration
Immediately prior to the introduction of the vaccine in the syringe must be shaken well.
Inject / m, preferably in the region of the upper third of the shoulder (deltoid). If necessary, (eg, patients with hemorrhagic diathesis) the vaccine can be administered s / c.
The vaccine should not be administered in /!
Faulty I / O vaccine can cause allergic reactions up to shock. In such cases, you should immediately conduct antishock therapy.
On the day of vaccination doctor (or paramedic) conducting a survey and inspection of the graft with obligatory thermometry, studying medical records graft. For the correct destination vaccination responsible physician.
Vaccination register in the established registration form indicating the date of vaccination, dose, the name of the vaccine, manufacturer, batch number, shelf life, reactions to the vaccine.
Only the full course of vaccination provides protection.
Side effect
When evaluating the adverse effects of the drug based on the following basis in the frequency data: Often – ≥ 10%; often – from 1% to 10%; sometimes – from 0.1% to 1%, rarely – from 0.01% to 0.1%, rarely – < 0.01%, including isolated cases.
Based on, from clinical studies and clinical use of the vaccine, The following information was obtained on the frequency of adverse events occurring:
Local reactions: Often – passing pain; often – redness, edema; rarely – granuloma at the site of injection, as an exception to form seroma.
Systemic reactions: Often – general malaise; often – flu-like symptoms (Sweating, chills), often after the first vaccination, rise in body temperature ≥ 38 ° C..
From the digestive system: often – nausea; rarely – vomiting; rarely – diarrhea.
On the part of the musculoskeletal system: often – arthralgia and myalgia; rarely – arthralgia and myalgia in the neck.
On the part of the immune system: rarely – lymphadenopathy.
From the central and peripheral nervous system: Often – headache; rarely – paraesthesia (eg, itch, numbness).
Allergic reactions: rarely – generalized allergic rash, swelling of the mucous, laryngeal edema, dyspnoea, bronchospasm, gipotenziya, kratkovremennaya thrombocytopenia.
Flu-like symptoms occur most often after the first vaccination, and are usually in 72 no. If necessary, it is recommended to apply anti-inflammatory therapeutic agents.
Arthralgia and myalgia in the neck may be pattern meningism. Such symptoms are rare and disappear within a few days without consequences.
There were reports, that in a few cases, after vaccination against tick-borne encephalitis have been diseases of the central and peripheral nervous system, including ascending paralysis (Guillain Barre syndrome).
Contraindications
- Acute febrile illness of any etiology or exacerbation of chronic infectious diseases. Vaccination is carried out not earlier, than 2 weeks after the disappearance of symptoms of acute illness (normalization of body temperature);
- The presence of allergic reactions to the vaccine components.
If complications occurred after vaccination, it should be considered, a contraindication for further immunization of the same vaccine until, until you have established the cause complications. This is especially important with respect to adverse reactions, are not limited to the injection site.
Pregnancy and lactation
Clinical studies of the safety of the vaccine Entsepur adult in pregnant and lactating women have not been conducted.
Vaccination of pregnant and lactating women may be carried out only after careful determination of the risk of possible virus infection encephalitis.
Cautions
Usually, there is no increased risk when immunization Entsepur adults, having an allergic reaction to chicken protein or positive skin reaction to ovalbumin.
In those extremely rare cases, When these patients showed clinical symptoms, such as rashes, swelling of the lips and epiglottis, laringo- or bronchospasm, hypotension, or shock, the vaccine should be administered only under careful clinical observation and indoors, unfunded antishock therapy.
The need for vaccination of persons with brain lesions in history to be determined very carefully.
Individuals, The following have the disease, Vaccination can be carried out simultaneously with the purpose of medical treatment of the disease present:
- A family history of seizures;
- Febrile convulsions (persons, subject to vaccination, it is desirable in this case to appoint antipyretics immediately prior to administration of the vaccine, and through 4 and h 8 h after inoculation);
- Eczema and other skin disorders, localized skin lesions;
- During treatment with antibiotics or corticosteroids, incl. small doses, as well as the topical application of drugs, containing steroids;
- Nonprogressive CNS;
- Congenital or acquired immunodeficiencies;
- Chronic diseases of internal organs, systemic chronic diseases.
Overdose
Data on overdose Entsepur adult vaccines are not given.
Drug Interactions
Allowed the simultaneous administration of the vaccine Entsepur adult and other vaccines individual syringes in different parts of the body.
Patients, receiving immunosuppressive therapy, vaccination may be less effective.
After administration of immunoglobulin against tick-borne encephalitis vaccine Entsepur adult should be no earlier than 4 of the week, otherwise the level of specific antibodies can be reduced.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The vaccine should be stored and transported at a temperature of 2 ° to 8 ° C; Do not freeze. Keep out of the reach of children.
Shelf life – 24 Months. Do not use after the expiry date, on the package.
