Microgen NPO, Russia
Active substance: from 0.3 to 1.5 .mu.g of inactivated virus antigen borne encephalitis (TBE)
Excipients: aluminum hydroxide (adjuvant), sucrose (stabilizer), human albumin (stabilizer) *, ** salt buffer system: sodium chloride, sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate. The vaccine does not contain antibiotics and preservatives.
The specific prevention of tick-borne encephalitis in children from 3 to 17 years (inclusive).
The preventive vaccination shall be:
• persons residing in endemic areas for tick-borne encephalitis;
• persons visiting endemic tick-borne encephalitis territory for the purpose of recreation, tourism, work on the cottage and garden plots.
Increased sensitivity to the protein of chicken embryo in history is not an absolute contraindication, excluding anaphylaxis. However, such persons should be vaccinated with caution.
The vaccine is used with caution in patients with cerebral disorders in history.
Application of pregnancy and during breastfeeding. The use of the vaccine during pregnancy is contraindicated. Vaccinating women during breast-feeding is conducted by the decision of a doctor, taking into account the risk of TBE infection.
According to the data obtained in the course of clinical studies, following administration of the vaccine may develop local and general reactions that occurred predominantly in the first vaccine administration and were independently without assigning specific therapy in the period from several hours to several days (2 – 4 days ).
Local reactions are expressed as redness, swelling, pain at the injection site.
Common reactions occur in the form of malaise, drowsiness, fatigue, headache, dizziness, nausea, abdominal pain, myalgia, fever up to 38.5 ° C.
May develop allergic reactions.
When a bad patient tolerability of high temperature (up to 38.5 ° C), being symptomatic therapy.
Based on the data obtained from the clinical vaccine studies, was obtained the following information on the frequency of adverse reactions occurring:
Very often (≥1 / 10) – pain at the injection
Most (1/10 – 1/100) – redness at the injection site, swelling at the injection site, fever up to 38.5 ° C (especially at first vaccination), passing within 1 – 4 days, headache, weakness , malaise, fatigue, drowsiness, abdominal pain, myalgia.
Sometimes (1/100 – 1/1000) – nausea, dizziness
Occasionally (1/1000 – 1/10000) – immediate allergic reactions and delayed-type
It is very rare (< 1/10 000) – severe neurological symptoms.
The permissible frequency for the general reactions with a temperature above 37.5 ° C – not more than 4%
How to accept, acceptance rate and dosage
The vaccine is administered in the deltoid muscle of the hands (preferably the left) at a dose of 0.25 ml. For younger children, the introduction of vaccines in verhnenaruzhnogo surface of the middle part of the thigh. Before opening the vial is necessary to make it a visual inspection.
Immediately prior to injection of the vaccine in the ampoule was warmed to room temperature and shaken until a homogeneous suspension. Ampoule neck treated with an alcohol. For each of the grafting should be used separate disposable syringe. The drug is administered immediately after opening of the ampoule. vaccination procedure should be carried out in strict compliance with the rules of aseptic and antiseptic.
Of vaccination register established in the registration form with the name of the drug, date of vaccination, dose, batch number, expiry date, the manufacturer of the vaccine enterprise, the grafting reaction to vaccination.
vaccination schemes. Routine vaccination. course of vaccination includes injection of two doses of 1 (0.25 ml) at intervals of 1-7 months (preferably 2 months).
The first and second injection is preferably carried out during the autumn and spring. If necessary, the vaccination can be performed at any time of the year, including during the summer period (epidemiological season). Visiting the natural focus of TBE is allowed no earlier than 2 weeks after the second vaccination.
Emergency vaccination. If necessary emergency prophylaxis (primarily, if appropriate vaccination saving time) interval between the first and second vaccine can be shortened to 2 weeks. Visiting the natural focus of TBE is recommended not earlier than 2 weeks after the second vaccination.
Revaccination. The first revaccination with both schemes is carried out once in 12 months after the primary vaccination course, the subsequent re-vaccination is carried out distant once every 3 years.
The vaccine must be stored at a temperature of from 2 ° to 8 ° C; do not freeze
Vaccine tick-borne encephalitis