Encepur® adult (Encepur® adults)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of tick-borne encephalitisVaccine for the prevention of tick-borne encephalitis
Dosage form: & nbspsuspension for intramuscular injection
Composition:

One dose (0.5 ml) of the vaccine contains:

active components: the antigen of tick-borne encephalitis virus (strain K23) of the chick embryo reproduced on culture, inactivated, purified, 1.5 μg;

auxiliary components: tris-hydroxymethylaminomethane 2.55 mg, sodium chloride 2.4 mg, sucrose 20-30 mg, aluminum hydroxide 1 mg, water for injection up to 0.5 ml.

The vaccine does not contain preservatives.

Description:

Opaque suspension whitish color without foreign inclusions.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.A   Vaccine for the prevention of encephalitis

J.07.B.A.01   Tick-borne encephalitis virus - inactivated whole

Pharmacodynamics:

Immunobiological properties:

Titers of antibodies to the TB virus are detected in all those vaccinated after a full course of primary immunization.

For immunization according to scheme A:

4 weeks after the first vaccination (day 28): in 50% of the vaccinated;

2 weeks after the second inoculation (day 42): 98% of the vaccinated;

2 weeks after the 3rd vaccination (314 days): 99% of the vaccinated.

When using scheme B - emergency vaccination, the protective level of antibodies is reached after 14 days:

After the second vaccination (21 days): 90% of the vaccinated;

After the third vaccination (day 35): 99% of the vaccinated.

Indications:

Active prophylaxis of tick-borne encephalitis (TBE) in adults and adolescents from the age of 12

Vaccination is indicated for persons permanently residing or temporarily residing in territories endemic for tick-borne encephalitis.

Vaccination can be carried out all year round.

Contraindications:

1. Acute feverish conditions of any etiology or exacerbation of chronic infectious diseases. Vaccinations are conducted no earlier than 2 weeks after the disappearance of signs of acute illness (normalization of body temperature).

2. The presence of hypersensitivity to the active component, excipients or substances used in the manufacturing process, which may be contained in trace amounts (chlortetracycline, gentamicin, neomycin, formaldehyde).

3. A strong reaction to the previous dose of the vaccine (temperature above 40 ° C, at the injection site - swelling and hyperemia over 8 cm in diameter).

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

Carefully:

As a rule, no increased risk is observed in adult vaccination Entsepur® in individuals considered "allergic to chicken protein" or to have a positive skin reaction to ovalbumin.

In those extremely rare cases in which clinical symptoms such as rash, edema of the lips and / or epiglottis, lagging or bronchospasm, hypotension or shock have been observed in such patients, the vaccine should only be administered with careful clinical observation in a room provided with anti-shock therapy.

The need to vaccinate people with cerebral lesions in the anamnesis must be determined very carefully.

Persons with the following diseases:

- convulsions in the family history,

- febrile convulsions (persons who are to be vaccinated, it is desirable in this case to prescribe antipyretic drugs immediately before the introduction of the vaccine, and also 4 and 8 hours after vaccination),

- eczema and other skin diseases, localized skin infection,

- treatment with antibiotics or low doses of corticosteroids or topical application of preparations containing steroids,

- non-progressive lesions of the central nervous system,

- congenital or acquired immunodeficiencies,

- chronic diseases of internal organs, systemic diseases, -

vaccination can be carried out simultaneously with the appointment of drug treatment appropriate to this disease.

Pregnancy and lactation:

Clinical studies of the safety of the use of the Encepur® adult vaccine for pregnant and lactating women have not been conducted.

Vaccination of pregnant and lactating women can be carried out only after a careful assessment of the risk of their possible infection with the CE virus.

Dosing and Administration:

a) The primary course of vaccination.

Primary vaccination is performed using scheme A (the traditional scheme).

Vaccination

Dose

Scheme A

First Inoculation

0.5 ml

0 day

Second Inoculation

0.5 ml

In 1-3 months

Third Inoculation

0.5 ml

9-12 months after the second vaccination

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

A traditional scheme is preferable for people in endemic areas.

After the vaccination is completed, the protective antibody titer persists for at least 3 years, after which it is recommended that a revaccination be performed.

Seroconversion develops no earlier than 14 days after the second vaccination

If rapid (emergency) vaccination is required, scheme B.

Vaccination

Dose

Scheme B

First Inoculation

0.5 ml

0 day

Second Inoculation

0.5 ml

In 7 days

Third Inoculation

0.5 ml

After 21 days

Seroconversion develops not earlier than 14 days after the second inoculation, that is on the 21st day. After the vaccination is completed, the protective antibody titer persists for 12-18 months, after which it is recommended to conduct a booster.

In patients with immune deficiencies, and persons 59 years 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 scheme vaccinations and, if necessary, carry out additional vaccination.

b) Revaccination.

Following primary vaccination course, conducted according to one of the two circuits, one injection of 0.5 ml Entsepur® adult is sufficient to maintain stress immunity. Based on the results of clinical trials conducted, the following intervals should be used for booster vaccination.

For persons who received a primary vaccination according to the routine vaccination schedule (scheme A), the following intervals are recommended:

Scheme A (traditional)

First revaccination

Subsequent revaccinations

Age from 12 to 49 years old

3 years

Every 5 years

Age over 49 years

3 years

Every 3 years

For persons who received vaccination under the emergency scheme (Scheme B), the following intervals are recommended.

Scheme B (emergency)

First revaccination

Subsequent revaccinations

Age from 12 to 49 years old

In 12-18 months

Every 5 years

Age over 49 years

In 12-18 months

Every 3 years

Method of administration:

Immediately before administration, the syringe with the vaccine should be shaken well!

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

Do not administer intravenously!

Incorrect intravenous administration of the vaccine can cause allergic reactions up to a shock. In such cases it is necessary to immediately carry out anti-shock therapy.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examines the vaccine with mandatory thermometry, examines the medical card of the vaccinated person. The doctor is responsible for the correct administration of the vaccine.

The vaccination is recorded in the prescribed registration forms with the date of vaccination, dose, name of vaccine, manufacturer, serial number, expiration date, response to vaccination.

Only a full course of vaccination provides reliable protection.

Side effects:

In assessing the side effects of the drug, the following frequency data was the basis:

Very often - ≥10%

Often - from 1 to 10%

Occasionally, from 0.1 to 1%

Rarely, from 0.01 to 0.1%

Very rarely - <0.01%, including isolated cases

Based on data from clinical trials and clinical use of the vaccine, the following information was obtained on the incidence of side effects:

Local reactions in the field of injection

Very often: passing pain in the area of ​​injection.

Often: redness, swelling.

Very rarely: granuloma at the injection site, in exceptional cases with the formation of a tumor-like accumulation of serum in the tissues.

Systemic reactions

Very often: general malaise.

Often: influenza-like symptoms (sweating, chills), most often after the first vaccination, an increase in body temperature> 38 ° C.

Gastrointestinal tract

Often: nausea.

Rarely: vomiting.

Very rarely: diarrhea.

Muscles and Joints

Very often: myalgia.

Often: arthralgia.

Very rarely: arthralgia and myalgia in the occiput.

Circulatory and lymphatic system

Very rarely: lymphadenopathy.

Nervous system

Very often: headache.

Very rarely: paresthesia (eg, itching, numbness of the limbs).

The immune system

Very rarely: allergic reactions (generalized allergic rash, swelling of the mucous membranes, laryngeal edema, dyspnoea, bronchospasm, hypotension) and transient thrombocytopenia.

Flu-like symptoms occur more often after the first vaccination and usually go through 72 hours. If necessary, anti-inflammatory therapeutic agents are recommended.

Arthralgia and myalgia in the neck can represent a picture of meningism. Such symptoms are rare and disappear within a few days without consequences.

In clinical trials, two cases of glioblastoma emerged.

The frequency of occurrence of this phenomenon in clinical studies was higher than the expected initial generalpopulation frequency described in the literature. However, there was no increase in the incidence of these phenomena during post-marketing surveillance, and the cause-and-effect relationship with the use of the Encepur® adult vaccine was not established.

There were reports that, in isolated cases after vaccination against CE, there were diseases of the central and peripheral nervous system, including ascending paralysis (Guillain-Barre syndrome).

Interaction:

Simultaneous vaccination of Encepur® adults and the administration of other vaccines with separate syringes in different parts of the body are allowed.

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

After the administration of immunoglobulin against tick-borne encephalitis, the Encepur® adult vaccination should be given no earlier than 4 weeks, otherwise the level of specific antibodies can be reduced.

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

Research into the effects of the Encepur vaccine® adult on the ability to drive vehicles and mechanisms have not been carried out (also see the "Side effect" section). Some of the undesirable reactions described in the "Side effect" section may affect the ability to drive vehicles and mechanisms.

Form release / dosage:A suspension for intramuscular administration, 0.5 ml / dose.
Packaging:

For 0.5 ml (1 dose) in a sterile syringe made of hydrolytic class I glass (Hebrew Pharm.) With a needle covered with a rubber cap. One syringe with a needle in a blister (PVC). One blister with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Transportation

All types of indoor transport at a temperature of 2 to 8 ° C. Do not freeze.

Shelf life:

24 months.

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

Terms of leave from pharmacies:On prescription
Registration number:П N013657 / 01
Date of registration:06.03.2009
The owner of the registration certificate:Novartis Vaccines & Diagnostics GmbH & Co. KG Novartis Vaccines & Diagnostics GmbH & Co. KG Germany
Manufacturer: & nbsp
Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC
Information update date: & nbsp14.12.2015
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