EnceVir^® Neo for children (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

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)

Dosage Form

EnceVir® Neo for children

Intramuscular suspension 0.25 ml/1 dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration white in color, homogeneous, without foreign particles.

Excipients : aluminum hydroxide (adjuvant) – 0.15-0.25 mg, sucrose (stabilizer) – 10-15 mg, human albumin (stabilizer) – 0.1-0.125 mg; buffer system salts: sodium chloride – 1.97 mg, disodium hydrogen phosphate dodecahydrate – 3.56 mg, sodium dihydrogen phosphate dihydrate – 0.21 mg.

Does not contain antibiotics or preservatives.

0.25 ml (1 dose) – glass ampoules with a capacity of 1 ml (5) – contour cassette packs (2) – cardboard boxes.
0.25 ml (1 dose) – glass ampoules with a capacity of 1 ml (10) – cardboard boxes.

Clinical-Pharmacological Group

Vaccine for the prevention of tick-borne encephalitis

Pharmacotherapeutic Group

Vaccines; viral vaccines; vaccines against viral encephalitides

Pharmacological Action

It is an encephalitis virus inactivated with formaldehyde.

The vaccine induces immunity to the tick-borne encephalitis virus.

Indications

Routine preventive immunization in foci with a high risk of infection, as well as selective vaccination of persons visiting tick-borne encephalitis foci.

Emergency care in case of suspected tick bite in regions endemic for tick-borne encephalitis.

ICD codes

Dosage Regimen

Administer the vaccine via intramuscular injection into the deltoid muscle.

For primary immunization in children aged 1 to 15 years, administer two doses of 0.25 ml each.

Schedule the second dose 1 to 7 months after the first dose.

For rapid immunization, administer the second dose as early as 2 weeks after the first.

Perform the first revaccination with a single 0.25 ml dose 12 months after the primary immunization course is completed.

Perform subsequent revaccinations every 3 years with a single 0.25 ml dose.

For emergency prophylaxis following a tick bite in endemic areas, administer a single 0.25 ml dose to previously vaccinated individuals.

For unvaccinated individuals, initiate the standard primary immunization schedule.

Do not administer the vaccine intravenously.

Shake the ampoule thoroughly before use to obtain a homogeneous suspension.

Inspect the suspension visually for any foreign particulate matter or discoloration prior to administration; do not use if present.

Adverse Reactions

Very rarely: increased body temperature, headache within the first 2 days.

Local reactions: short-term burning sensation at the injection site, rarely – redness, tenderness, development of an infiltrate.

Contraindications

Febrile conditions (of infectious and non-infectious origin), hereditary, progressive diseases of the nervous system, epilepsy with frequent seizures, food allergy (especially to eggs), bronchial asthma, collagenoses, chronic diseases of the liver and kidneys, chronic heart failure, cerebrovascular accident, diabetes mellitus, thyrotoxicosis, malignant neoplasms, blood diseases, pregnancy.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use in Hepatic Impairment

Contraindicated in chronic liver diseases.

Use in Renal Impairment

Contraindicated in chronic kidney diseases.

Pediatric Use

Use in children under 1 year of age is recommended only in case of a real risk of infection.

Special Precautions

After febrile conditions, vaccinations are permissible no earlier than 1 month after recovery, and for persons who have had viral hepatitis and meningococcal infection, no earlier than 6 months after recovery.

Vaccinations are permissible 2 weeks after childbirth.

Avoid intravascular administration.

Drug Interactions

Can be used simultaneously with live and inactivated vaccines.

The interval between the use of tick-borne encephalitis immunoglobulin and the vaccine should be at least 4 weeks.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.