FSME-Immun - instructions for use, doses, side effects, contraindications

Antigen of tick-borne encephalitis virus (TBE) (active ingredient)	2.38 μg
The aluminum hydroxide gel (adjuvant)	1.0 mg (0.28 to 0.41 mg in terms of aluminum)
Human blood albumin (stabilizer)	0.5 mg
Formaldehyde (inactivator)	not more than 0.005 mg
Sucrose	not more than 20.0 mg
Protamine sulfate	not more than 0.005 mg
Neomycin	footprints
Gentamicin	footprints
Sodium chloride	3.45 mg
Sodium hydrogen phosphate dihydrate	0, 22 mg
Potassium dihydrogen phosphate	0, 045 mg
Water for injections	up to 0.5 ml

Does not contain preservatives.

Description:

Opaque, whitish color suspension 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:The PCME-IMMUN® vaccine is a purified, concentrated, sterile suspension of tick-borne encephalitis virus (strain Neidorf), inactivated by formaldehyde, obtained by reproducing it in a culture of chick embryo cells "SPF", sorbed on aluminum hydroxide gel.

The level of seroconversion and protection is achieved in 97-100% of vaccinated patients after a triple vaccination and remains for three or more beds.

Indications:

Specific prophylaxis of tick-borne encephalitis in persons aged 16 years and older.

Contingents subject to specific prevention:

1. Population living on enzootic by tick-borne viral encephalitis territories.

2. Persons arriving on these territories who perform the following works:

- agricultural, irrigation and drainage, construction, excavation and transfer of soil, harvesting, fishing, geological, prospecting, expedition, deratization and disinsection,

- logging, clearing and improvement of the forest, recreation and recreation areas of the population.

3. Persons visiting endemic for tick-borne encephalitis territory for the purpose of tourism, recreation, work in the country and garden areas.

4. Persons working with live cultures of the causative agent of tick-borne viral encephalitis.

Contraindications:

- Hypersensitivity to the active component of the drug, any of the excipients or to the components used in the preparation: formaldehyde, protamine sulfate, neomycin, gentamicin.

- cross-allergy to aminoglycosides, other than gentamicin and neomycin.

- known severe hypersensitivity to egg and chicken proteins (eg, anaphylactic reaction / anaphylaxis after oral ingestion of egg / chicken proteins) and latex (eg, allergic reactions) can cause severe allergic reaction in sensitized individuals (see.See "Special instructions and precautions");

- acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Vaccination is performed no earlier than 2 weeks after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature is normalized.

Pregnancy and lactation:

There are no reliable data on the use of the drug FSME-IMMUN® in pregnant or lactating women. It is not known whether the drug is excreted into breast milk.

The doctor should carefully evaluate the possibility of using the drug on the basis of the ratio of the likely risk to the expected benefit and only on urgent indications.

The use of the drug FSME-IMMUN® during pregnancy or during lactation is allowed only if it is necessary to urgently initiate an immune defense against tick-borne encephalitis infection.

Dosing and Administration:

The vaccine is injected intramuscularly into the deltoid muscle.

Avoid accidental intravascular administration of the vaccine (see section "Special instructions and precautions").

1. Primary vaccination course

The primary vaccination course consists of three vaccinations.

The interval between the first and second vaccination is from 1 to 3 months.

If it is necessary to achieve a rapid immune response, the second vaccination is carried out at an interval of two weeks after the first vaccination.

After the first two vaccinations, protection sufficient for the current season of mite activity is expected.

The third inoculation should be administered in the range of 5 to 12 months after the second vaccination. After the third vaccination, protection is expected for 3 years.

To obtain immunity before the season of activity of mites that occurs in the spring, the first and second vaccinations should preferably be administered in the winter months. Ideally, the course of vaccination should be completed with a third vaccination at the end of the current season of tick activity or at least until the beginning of the next season.

Vaccination	Dose	Routine vaccination	Emergency vaccination
First Inoculation	0.5 ml	0 day	0 day
Second Inoculation	0.5 ml	1-3 months after the first vaccination	Across 14 days after the first vaccination
Third Inoculation	0.5 ml	5-12 months after the second vaccination	5-12 months after the second vaccination

2. Revaccination

After a course of primary vaccination, a single injection of 0.5 ml of the FSME-IMMUN® vaccine is given every 3 years. It is recommended to conduct before the season of activity of ticks.

Revaccination for persons from 16 to 60 years old	Dose	Time
Weight of vaccination	0.5 ml	Every 3 years

The increase in the interval between vaccinations in primary vaccination or revaccination can lead to inadequate protection against infection during the transition period.

Patients with weakened immune system (including individuals, treated with immunosuppressors)

There are no clinical data describing the vaccination regimen for immunocompromised patients. However, if there is no clear seroconversion for 4 weeks after the second vaccination, an additional vaccination may be considered. This method is applicable to subsequent vaccinations.

Before use, the vaccine should be brought to room temperature. Before use, the vaccine should be shaken well to completely mix the suspension. After mixing, the vaccine is an opaque suspension of whitish color.Before use, the vaccine should be examined for foreign particles and / or changes in appearance.

If foreign particles are found in the suspension, or if its appearance does not correspond to the description, the use of the drug is prohibited.

Side effects:

Undesirable reactions, observed during clinical trials

The table below shows the incidence of adverse reactions attributable to one vaccination, calculated on the basis of a combined analysis of adverse events observed in 7 clinical studies conducted with the use of FSOME-IMMUN® in patients aged 16-65 years who received 3 vaccinations (3512 patients after the first vaccination, 3,477 patients after the second vaccination and 3,274 patients after the third vaccination).

Classes and systems of organon (CSR)	Unwanted reaction	Frequency
Violations of the blood and lymphatic system	Lymphadenopathy	Infrequent
Immune system disorders	Hypersensitivity	Rare
Disorders of metabolism and nutritional status	Decreased appetite	Frequent
Disturbances from the nervous system	Headache	Frequent
Disturbances from the nervous system	Drowsiness	Rare
Hearing disorders	Vertigo	Rare
Disorders from the gastrointestinal tract tract	Nausea	Frequent
	Vomiting	Infrequent
	Diarrhea	Rare
	Abdominal pain	Rare
Disorders of the musculoskeletal apparatus and connective tissue	Myalgia	Frequent
	Arthralgia	Frequent
Common disorders and reactions at the site of administration	Pain at the injection site	Very Frequent
	Redness at the injection site	Rare
	Sealing at the injection site	Rare
	Swelling at the injection site	Rare
	Itching at the injection site	Rare
	Paresthesia at the injection site	Rare
	Increase in temperature at the injection site	Rare
	Fever	Frequent
	Fatigability	Frequent
	Malaise	Frequent
	Chills	Infrequent

The incidence of adverse reactions is classified by WHO as follows: very frequent (≥1/10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1,000, <1/100), rare (> 1 / 10 000, <1/1 000), very rare (< 1/10 000).

Undesirable reactions observed in the post-marketing period

The following undesirable reactions were recorded in the post-marketing period and are classified as rare (≥1 / 10,000, <1 / 1,000).

Infections and infestations: herpes zoster (occurs in patients who have been exposed to the virus beforehand).

Immune system disorders: anaphylactic reactions, provocation or exacerbation of autoimmune diseases (eg, multiple sclerosis).

Impaired nervous system: demyelinating diseases (acute disseminated encephalomyelitis, Guillain-Barre syndrome, myelitis, transverse myelitis), encephalitis, seizures, aseptic meningitis, meningism, sensory disorders and motor disorders (paralysis / paresis of the facial nerve, paralysis, paresis, neuritis), neuralgia, optic neuritis , dizziness.

Disorders from the side of the organ of vision: visual impairment, photophobia, pain in the eyes.

Hearing disorders: tinnitus.

Heart Disease: tachycardia.

Disturbances from the respiratory system, chest and mediastinal organs: dyspnea.

Disturbances from the skin and subcutaneous tissues: urticaria, rash (erythematous, spotty-papular), itching, dermatitis, erythema, hyperhidrosis.

Disorders from the musculoskeletal system and connective tissue: back pain, swelling of the joints, neck pain, stiffness in the musculoskeletal system (including the neck), pain in the limbs.

General disorders and reactions at the site of administration: violation of gait, chills, flu-like syndrome, asthenia, edema, joint disorders in the injection area, joint pain in the injection area, nodule at the injection site, inflammation at the injection site.

Overdose:

No cases of overdose have been reported.

With this form of vaccine, an accidental overdose (introduction of excess volume) is unlikely.

Interaction:

Simultaneous administration of FSKE-IMMUN® vaccination and the introduction of other inactivated or live vaccines (other than rabies and BCG) by individual syringes in different parts of the body are allowed in accordance with the vaccination calendar.

After the introduction of immunoglobulin against tick-borne encephalitis, the FSXE-IMMUN vaccine^® can be administered no earlier than 4 weeks, otherwise the level of specific antibodies can be reduced.

Special instructions:

As with all vaccines that are administered by injection, allergic reactions, including severe anaphylactic reactions (for example, anaphylactic shock), may occur after the administration of FSOME-IMMUN®. When carrying out vaccination for such persons, emergency care should be available for anaphylaxis.

The package contains latex, which can cause severe allergic reactions in people who are allergic to latex.

It is necessary to avoid accidental intravascular injection of the vaccine, which can lead to severe allergic reactions and shock.

The concentration of sodium and calcium in the preparation is less than 1 mmol / dose, i.е. the drug is practically free of sodium and calcium.

A protective immune response may not occur in persons with a weakened immune system or in persons receiving immunosuppressive therapy.

In order to determine the need for additional doses of the vaccine, a serological study is necessary. The study should be conducted in an accredited laboratory, as false positive results can be observed due to cross reactivity with pre-existing antibodies due to natural exposure or previous vaccination against other flaviviruses (eg Japanese encephalitis, yellow fever, Dengue virus).

If the recipient has or is suspected of an autoimmune disease, the risk of infection with CE should be correlated with the risk of adverse effects of vaccination on the course of an autoimmune disease.

Caution should be exercised in assessing the need for vaccination in individuals with existing cerebral disorders, such as active forms of demyelinating disease or poorly controlled epilepsy.

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

Information on the effect of FSOME-IMMUN® on the ability to drive a car or complex equipment is missing. There may be visual impairment and dizziness, which may affect the ability to drive vehicles and work with mechanisms.

Form release / dosage:

Suspension for intramuscular injection, 0.5 ml / dose.

Packaging:

0,5 ml (1 dose) into a disposable syringe made of transparent glass (Type I) with a needle. 1 or 5 syringes per blister.

1 blister containing 1 syringe with a needle, or

2 blisters containing each 5 syringes each with a needle, together with instructions for use in a cardboard pack.

0.5 ml (1 dose) into a disposable syringe made of transparent glass (Type 1) with a protective cap. 1 or 5 syringes per blister.

1 Blister containing 1 syringe with protective cap, or

2 blisters containing 5 syringes each with a protective cap each, together with instructions for use in a cardboard box,

1 Blister containing 1 syringe with protective cap, complete with 1 sterile disposable needle (normal or safe), or

2 blisters containing 5 syringes each with a protective cap each, complete with 10 sterile disposable needles (conventional or safe) along with instructions for use in a cardboard pack.

Storage conditions:

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

Keep out of the reach of children.

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

Shelf life:

30 months.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014361 / 01

Date of registration:30.05.2007

The owner of the registration certificate: Pfizer Inc. Pfizer Inc. USA

Manufacturer: & nbsp