FSME-Immune Junior - instructions for use, dose, side effects, contraindications

1 dose (0.25 ml) contains:
Antigen of tick-borne encephalitis virus (TBE) (active ingredient)	1.19 μg
The aluminum hydroxide gel (adjuvant)	0.5 mg (from 0.14 to 0.21 mg in terms of aluminum)
Human blood albumin (stabilizer)	0.25 mg
Formaldehyde (inactivator)	not more than 0.0025 mg
Sucrose	not more than 7.5 mg
Protamine sulfate	not more than 0.0025 mg
Neomycin	footprints
Gentamicin	footprints
Sodium chloride	1.725 mg
Sodium hydrogen phosphate dihydrate	0.11 mg
Potassium dihydrogen phosphate	0.0225 mg
Water for injections	before 0.25 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 FSME-IMMUN vaccine^® is a purified concentrated sterile suspension of tick-borne encephalitis virus (strain "Neudorf") 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 children and adolescents aged 1 year and up to 16 years after the triple vaccination and lasts for three years or more.

Indications:

Prevention of tick-borne encephalitis (TBE) in children and adolescents aged 1 to 16 years in a dose of 0.25 ml.

The contingent of persons subject to specific prevention includes:

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

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

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, gentamycin;

- Pa cross-allergy to aminoglycosides other than gentamicin and neomycin;

- andAn important severe hypersensitivity to egg and chicken proteins (for example, anaphylactic reaction / anaphylaxis after oral intake of egg / chicken proteins) and latex (eg, allergic reactions) can cause a severe allergic reaction in sensitized individuals (see section "Special instructions and precautions" ");

- aboutacute 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). With non-severe acute respiratory infections, acute intestinal diseases, etc.vaccinations are carried out immediately after the temperature is normalized.

Carefully:

There is no information.

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.

Children under 18 months, or depending on the degree of development and nutritional status, the vaccine is injected into the outer surface of the middle third of the thigh (vastus lateralis muscle). Avoid accidental intravascular administration of the vaccine (see section "Special instructions and precautions").

1. Primary vaccination course

The primary course of vaccination is the same for children from 1 to 16 years and 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 vaccination course should be completed with a third dose at the end of the current season of mite activity or, at least, before the start of the next season.

Vaccination	Dose	Routine vaccination	Emergency vaccination
First Inoculation	0.25 ml	0 day	0 day
Second Inoculation	0.25 ml	1-3 months after the first vaccination	14 days after the first vaccination
Third Inoculation	0.25 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 0.25 ml of the FSME-IMMUN® Junior vaccine is given after 3 years. It is recommended to conduct before the season of activity of ticks.

Revaccination	Dose	Time
All vaccinations	0.25 ml	Every 3 years

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

Patients with weakened immune system (include children who have undergone treatment with immunosuppressors)

There are no clinical data describing the dosing regimen for immunocompromised children. However, if there is no clear seroconversion for 4 weeks after the second vaccination, 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 vaccine 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 present in the suspension or if the appearance does not correspond to the description, the use of the vaccine is prohibited.

Side effects:

Unwanted reactions observed during clinical trials

Data on frequency in children are based on a generalized analysis of adverse reactions observed after the first vaccination (3,088 patients) in 8 clinical studies conducted with the use of FSOME-IMMUN^® Junior in children aged 1-15 years. The frequency of systemic adverse reactions observed after the second and third vaccinations was lower than after the first vaccination. After the first, second and third vaccinations, a similar reaction rate at the injection site was observed.

Classes and systems of organs (CSR)	Unwanted reaction	Frequency
Violations of the blood and lymphatic system	Lymphadenopathy	Infrequent
Disorders of metabolism and nutritional status	Decreased appetite	Frequent
Mental disorders	Sleep disorders	Frequent
	Anxiety¹	Frequent
Disturbances from the nervous system	Headache	Frequent
	Sensory disorders	Rare
	Dizziness	Rare
Hearing disorders	Vertigo	Rare
Classes and systems of organs (CSR)	Unwanted reaction	Frequency
Disorders from the gastrointestinal tract tract	Nausea	Frequent
	Vomiting	Frequent
	Diarrhea	Rare
	Abdominal pain	Infrequent
	Dyspepsia	Rare
Disturbances from the skin and subcutaneous tissues	Hives	Rare
Disorders of the musculoskeletal apparatus and connective tissue	Myalgia	Frequent
	Arthralgia	Infrequent
General disorders and reactions at the site of administration	Reactions at the injection site²	Very Frequent
	Pain at the injection site	Very Frequent
	Redness at the injection site	Frequent
	Sealing at the injection site	Frequent
	Swelling at the injection site	Frequent
	Itching at the injection site	Rare
	Fever³	Frequent
	Fatigability	Frequent
	Malaise⁴	Frequent
	Chills	Infrequent

The frequency of adverse reactions according to WHO is classified as follows: very frequent (≥1/10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100), rare (≥1 / 10 000, <1/1000), very rare (<1/10000).

¹The frequency is estimated on the basis of data in children 1-5 years old.

²More than one phenomenon could have been noted in the subject.

³ Fever was observed more often in children of an earlier age compared with older children (that is, very often or often, respectively). The frequency of fever after the second and third vaccinations is usually lower than after the first vaccination.

⁴The frequency is estimated on the basis of data in children 6-16 years old.

Body temperature in children under 3 years old was measured rectally, in children older than 3 years - oral.

The increase in body temperature depends on age and decreases with subsequent vaccination.

In safety studies and dose selection, the degree of increase in body temperature after the first vaccination was as follows:

Children from 1 to 2 years: average (38-39 ° C) in 27.9%; Increased (39,1-40,0 ° С) in 3,4%; a high temperature (more than 40.0 ° C) was not observed.

In children from 3 to 15 years (n= 2519): an average of 6.8%; high in 0.6%; high temperature was not observed.

The increase in body temperature after the second vaccination is usually lower compared to the increase in temperature after the first vaccination: 15.6% (41/263) for children 1 to 2 years and 1.9% (49/2522) for children from 3 up to 15 years.

Undesirable reactions observed in the post-marketing period

The following additional unwanted reactions were registered in the post-marketing period in children receiving FSEM-IMMUN^® Junior and classified as rare (≥1/10 000, <1/1000):

Immune system disorders: anaphylactic reaction, hypersensitivity.

Disturbances from the nervous system: encephalitis, convulsions (including febrile), meningism, polyneuropathy, impaired motor function (hemiparesis / hemiplegia, paralysis / paresis of the facial nerve, paralysis, paresis, neuritis).

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

Hearing disorders: tinnitus.

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

Disturbances from the skin and subcutaneous tissues: fromyip (erythematous, spotty-papular, vesicular), erythema, pruritus, hyperhidrosis.

Disorders from the musculoskeletal system and connective tissue: pain in the neck, stiffness in the musculoskeletal system (including stiff neck), pain in the limbs.

General disorders and reactions at the site of administration: gait disturbance, flu-like syndrome, asthenia, edema.

Class-specific reactions:

It was reported about the occurrence of the syndrome Hyena-Bare possible with the use of vaccines against tick-borne encephalitis in children.

Overdose:

Adult cases (0.5 ml / dose) of vaccine for children were reported. In such cases, the risk of adverse reactions is likely to increase.

Interaction:

Simultaneous administration of PCME-IMMUN® vaccination is possible with the introduction of other inactivated or live vaccines (other than rabies vaccines) with individual syringes in different parts of the body 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 injected, allergic reactions can occur after administration, including severe anaphylactic reactions (eg, anaphylactic shock). Emergency aids should be available for anaphylaxis.

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

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

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

After the first immunization, children may develop fever, especially in children at a very early age (see "Side Effects" section). Most fever subsides within 24 hours. After the second vaccination, the heat intensity is generally lower in compared with the first vaccination. In children with fibrillar convulsions or high fever after a previous history of vaccination, the use of antipyretics may be considered.

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

In order to determine the need for additional doses, serological testing 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.

Care should be taken when assessing the need for vaccination in individuals with existing cerebral disorders, such as active forms of demyelinating diseases or poorly controlled epilepsy.

Like all vaccines, FSME-IMMUM^® The junior can not fully ensure the protection of all vaccinated patients from the corresponding infections.

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

Influence on motor functions in children (for example, playing outdoors or riding a bicycle), the ability to drive vehicles and work with mechanisms is unlikely. However, it is necessary to take into account the possibility of reducing vision or dizziness, which may affect the ability to drive vehicles and work with mechanisms.

Form release / dosage:A suspension for intramuscular administration, 0.25 ml / dose.

Packaging:

0.25 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 5 syringes each with a needle, together with instructions for use in a cardboard pack.

0.25 ml (1 dose) into a disposable syringe made of transparent glass (Type I) with a protective cap. 1 or 5 syringes in the 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.

Shelf life:

30 months.

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

Terms of leave from pharmacies:For hospitals

Registration number:LSR-003210/07

Date of registration:15.10.2007

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

Manufacturer: & nbsp

EKATERINBURG FARM FACTORY, OJSC Russia

PFIZER CORPORATION AUSTRIA, GmbH Austria

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp15.12.2015

Illustrated instructions

Instructions

FSME-Immun® Junior (FSME-Immun® Junior)