Encepur^® (Suspension) Instructions for Use

ATC Code

J07BA01 (Inactivated whole tick-borne encephalitis virus)

Active Substance

Tick-borne encephalitis vaccine (inactivated)

Tick-borne encephalitis vaccine (inactivated) (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Vaccine for the prevention of tick-borne encephalitis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Tick-borne encephalitis vaccine. Antibody titers to the tick-borne encephalitis virus are detected in all vaccinated individuals after a full course of primary immunization.

When immunized according to Schedule A:

4 weeks after the first vaccination (day 28) – in 50% of vaccinated individuals,

2 weeks after the second vaccination (day 42) – in 98% of vaccinated individuals,

2 weeks after the third vaccination (day 314) – in 99% of vaccinated individuals.

When using Schedule B – emergency vaccination, the protective level of antibodies is achieved 14 days after the second vaccination (day 21) – in 90% of vaccinated individuals, after the third vaccination (day 35) – in 99% of vaccinated individuals.

Indications

• Active prevention of tick-borne encephalitis in children aged from 1 year to 11 years inclusive.

From the age of 12, the use of the vaccine for adults is indicated.

Vaccination is indicated for individuals permanently residing or temporarily staying in areas endemic for tick-borne encephalitis. Vaccination can be carried out year-round, including during the tick-borne encephalitis epidemic season.

ICD codes

Dosage Regimen

Suspension

Primary vaccination course

Primary vaccination is carried out using Schedule A (traditional schedule).

The second dose can be administered 14 days after the first dose.

The traditional schedule is preferable for individuals in endemic areas.

After completion of vaccination, the protective antibody titer persists for at least 3 years, after which a booster vaccination is recommended.

Seroconversion develops no earlier than 14 days after the second vaccination.

If rapid (emergency) vaccination is required, Schedule B is used.

Seroconversion develops no earlier than 14 days after the second vaccination, i.e., on day 21. After completion of vaccination, the protective antibody titer persists for 12-18 months, after which a booster vaccination is recommended.

In individuals with immunodeficiencies and individuals aged 59 years and older, the antibody level should be checked between 30 and 60 days after the second vaccination according to Schedule A and the third vaccination according to Schedule B and, if necessary, an additional vaccination should be administered.

Booster vaccination

After the primary vaccination course conducted according to one of the two schedules, one injection of 0.5 ml of Encepur^® adults vaccine is sufficient to maintain a strong immune response. Based on the results of clinical studies, the following intervals for booster vaccination should be used.

For individuals who received primary vaccination according to the planned vaccination schedule (Schedule A), the following intervals are recommended.

For individuals who received primary vaccination according to the emergency schedule (Schedule B), the following intervals are recommended.

Administration Instructions

Immediately before administration, the vaccine in the syringe must be shaken well.

The vaccine is administered intramuscularly, preferably into the upper third of the arm (deltoid muscle). If necessary (for example, in patients with hemorrhagic diathesis), the vaccine can be administered subcutaneously.

The vaccine must not be administered intravenously!

Erroneous intravenous administration of the vaccine can cause allergic reactions up to shock. In such cases, anti-shock therapy must be carried out immediately.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinee with mandatory temperature measurement and reviews the vaccinee’s medical record. The doctor is responsible for the correct prescription of the vaccination.

The vaccination performed is registered in the established accounting forms, indicating the date of vaccination, dose, name of the vaccine, manufacturer, batch number, expiration date, and reaction to the vaccination.

Only a full course of vaccination provides reliable protection.

Adverse Reactions

When assessing the adverse effects of the drug, the following frequency data were used: very common – ≥ 10%; common – from 1% to 10%; uncommon – from 0.1% to 1%; rare – from 0.01% to 0.1%; very rare – < 0.01%, including isolated cases.

Based on data obtained during clinical studies and results of clinical use of the vaccine, the following information on the frequency of occurring adverse events was obtained.

Local reactions at the injection site very common – transient pain at the injection site; common – redness, swelling; very rare – granuloma at the injection site, in exceptional cases with the formation of a tumor-like accumulation of blood serum in the tissues.

Systemic reactions very common (in children from 1 to 2 years) – increased body temperature ≥ 38°C (100.4°F); common – general malaise, flu-like symptoms (sweating, chills), increased body temperature ≥ 38°C (100.4°F) (most often after the first vaccination in children from 3 to 11 years).

From the digestive system common – nausea; rare – vomiting, diarrhea.

From the musculoskeletal system common – arthralgia and myalgia; very rare – arthralgia and myalgia in the occipital region. Arthralgia and myalgia in the neck area may present a picture of meningism. Such symptoms are rare and disappear within a few days without consequences.

From the immune system very rare – lymphadenopathy (involvement/enlargement of lymph nodes).

From the central and peripheral nervous system very common – drowsiness in children under 3 years; common – headache in children over 3 years; very rare – paresthesia (e.g., itching, numbness of extremities), seizures with increased body temperature.

Allergic reactions: very rare – generalized allergic rash, swelling of mucous membranes, laryngeal edema, dyspnea, bronchospasm, hypotension, short-term thrombocytopenia.

Flu-like symptoms occur most often after the first vaccination and usually resolve within 72 hours. If necessary, the use of anti-inflammatory and antipyretic agents is recommended.

There have been reports that in isolated cases, after vaccination against tick-borne encephalitis, diseases of the central and peripheral nervous system have occurred, including ascending paralysis (Guillain-Barré syndrome).

Contraindications

• Acute febrile conditions of any etiology or exacerbation of chronic infectious diseases. Vaccination is carried out no earlier than 2 weeks after the symptoms of the acute illness have disappeared (normalization of body temperature);
• Presence of allergic reactions to the components of the vaccine.

If a complication occurs after vaccination, it should be considered a contraindication for further vaccination with the same vaccine until the cause of the complication is established. This is especially important for adverse reactions that are not limited to the injection site.

Pediatric Use

The drug is intended for active prevention of tick-borne encephalitis in children aged from 1 year to 11 years inclusive. From the age of 12, the use of the vaccine for adults is indicated.

Special Precautions

As a rule, there is no increased risk when immunizing children with Encepur^® children’s vaccine who have allergic reactions to chicken protein or a positive skin reaction to ovalbumin.

In extremely rare cases where such patients have experienced clinical symptoms such as rash, swelling of the lips and epiglottis, laryngo- or bronchospasm, hypotension, or shock, the vaccine should be administered only under careful clinical supervision and in a room equipped with means for anti-shock therapy.

The need for vaccination of individuals with a history of brain lesions should be determined after consultation with a neurologist.

Vaccination of individuals with a history of the following diseases or conditions should be carried out strictly as prescribed by a doctor:

• Common infection, especially if there is an increase in body temperature above 38°C (100.4°F);
• Seizures in family history;
• Febrile seizures (in this case, individuals to be vaccinated are advised to be prescribed antipyretics immediately before vaccine administration, as well as 4 hours and 8 hours after vaccination);
• Eczema and other skin diseases, localized infectious skin lesions;
• During treatment with antibiotics or corticosteroids, including low doses, as well as with topical application of drugs containing steroids;
• Non-progressive lesions of the central nervous system;
• Congenital or acquired immunodeficiencies;
• Chronic diseases of internal organs, systemic chronic diseases.

If necessary, these patients may be prescribed therapy appropriate to the underlying disease.

Overdose

Data on overdose of Encepur^® children’s vaccine are not available.

Drug Interactions

Simultaneous administration of Encepur^® children’s vaccine and other vaccines with separate syringes into different parts of the body is allowed.

In patients receiving immunosuppressive therapy, vaccination may be less effective.

After administration of tick-borne encephalitis immunoglobulin, vaccination with Encepur^® children’s vaccine should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

Storage Conditions

The vaccine should be stored and transported at a temperature from 2°C (35.6°F) to 8°C (46.4°F); do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 24 months. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.