Avaksim 80

Avaksim 80 – a vaccine for prevention of a viral hepatitis And at children.

Form of release and structure

Avaksim 80 release in the form of suspension for intramuscular introduction: muddy liquid of whitish color (on 1 dose in glass syringes of 1 type the volume of 1 ml with the fixed needle from stainless steel with a protective cap and the piston from elastomer, on 1 syringe in the transparent closed strip packaging (blister), on 1 packaging (blister) in a cardboard pack).

Is a part of 1 dose (0,5 ml) of suspension:

• Active agent: the inactivated hepatitis A virus – 80 PIECES (units, it is expressed with use of the internal referens-standard of the producer);
• Auxiliary components: aluminum hydroxide – 0,15 mg (in terms of aluminum), formaldehyde – 0,0125 mg, 2 phenoxyethanol – 0,0025 ml, Wednesday Hank 199 (mix of the amino acids, mineral salts, vitamins and other components dissolved in water for injections) – to 0,5 ml, Acidum hydrochloricum or sodium hydroxide – in the volume necessary for value adjustment рН.

Indications to use

Avaksim 80 is applied to specific prevention of a viral hepatitis And at children at the age of 1-15 years (inclusive).

Contraindications

Absolute:

• The diseases proceeding with fever, acute or chronic infectious diseases in an aggravation stage (performing vaccination is possible in 2-4 weeks after recovery or during remission or reconvalescence; at not heavy course of acute respiratory viral infections, at acute intestinal infections of an inoculation are carried out right after normalization of temperature);
• System reactions of hypersensitivity or life-threatening reactions to the previous Avaksim's introduction 80 or vaccines with the maintenance of similar components;
• Allergy to drug components.

Relative (Avaksim's use 80 is possible only with care in the presence of the following diseases / states):

• Thrombocytopenia or disturbances from coagulant system of blood (because of probability of development of bleeding after an intramuscular injection). Such patients after an injection need to apply a compressing bandage not less than for 2 minutes. In exceptional cases perhaps hypodermic administration of drug;
• Hypersensitivity to formaldehyde, Neomycinum or other antibiotic medicines of this class;
• Pregnancy and the period of a lactation (Avaksim's use 80 at pregnant women is not recommended (due to the lack of necessary data); the decision on vaccination needs to be made only in the presence of unambiguous indications after an advantage ratio with risk).

The health worker before performing vaccination has to take all measures necessary for prevention of development of anaphylactoid or anaphylactic reactions to the vaccination moment (necessary medicines, including adrenaline have to be available).

Immunodeficiency or immunosuppressive therapy can be the cause of a weak immune response on introduction of a vaccine. In these cases it is recommended to postpone vaccination until recovery or the end of treatment. Nevertheless Avaksim 80 is appointed to patients with chronic immunodeficiencies, such as HIV infection, even in cases if the immune response on its introduction can be lowered in view of the main disease.

Introduction of a needle can provoke a psychogenic syncope (in the form of weakness, a loss of consciousness); in this regard vaccination needs to be carried out in the conditions allowing to avoid traumatizing when falling and to provide necessary medical care.

Route of administration and dosage

The drug is administered intramusculary, in a deltoid muscle of a shoulder, to children 2 years – to the upper outside area of a hip are younger. Suspension should not be entered into a rump or vnutrikozhno (weakening of an immune response is possible). Introduction to a vascular bed is strictly forbidden (it is necessary to be convinced that the needle did not get to a blood vessel).

The syringe with Avaksim 80 before vaccination needs to be stirred up well before receiving homogeneous suspension.

Single dose – 0,5 ml.

Avaksim's mixing 80 in one syringe with other vaccines is forbidden!

For the purpose of ensuring long-term immunity the revaccination needs to be carried out by the same dose in 6 months or till 3 years after introduction of the first dose.

At immunocompetent persons need of carrying out a revaccination after double vaccination is absent.

It is not necessary to use a vaccine in cases of change of its color or in the presence of foreign particles. The remains of an unused vaccine utilize.

Side effects

All disturbances revealed as a result of clinical trials had slight, short-term character and took place independently without additional treatment.

Possible side reactions (> 10% – are very frequent;> 1% and <10% – is frequent;> 0,1% and <1% – infrequently;> 0,01% and <0,1% – are rare; <0,01% – are very rare; with an unknown frequency – at impossibility to estimate the frequency of development of disturbances in the available data):

• Nervous system: often – a headache;
• Skeletal and muscular and connecting fabric: often – an arthralgia, a mialgiya;
• Digestive tract: often – diarrhea, an abdominal pain, nausea, vomiting;
• Skin and hypodermic cellulose: infrequently – rash, urticaria;
• Mentality: often – irritability, sleeplessness;
• Metabolism and food: often – a loss of appetite;
• Disturbances in an injection site and the general frustration: often – easy morbidity, reddening, consolidation and hypostasis in the place of an injection, weakness, moderate fervescence.

Disturbances were registered less often after a revaccination, than after performing primary immunization. At patients, seropositive concerning a virus of hepatitis A, vaccination was transferred also well, as well as at seronegative persons.

Reactions which were noted at children with hemophilia are similar to reactions at adults.

As a result of carrying out post-marketing observations it was also established that as a result of Avaksim's use 80 development of a vazovagalny faint is possible (with an unknown frequency).

At development of any side effects (both described, and not described in the instruction) it is necessary to consult with the doctor.

Special instructions

Immunization in particular is recommended to the following groups of persons:

• Living in regions, unsuccessful on incidence of hepatitis A;
• Leaving to unsuccessful regions (countries) where flare incidence of hepatitis A is registered;
• Contacting to patients in the hepatitis A centers.

Also can carry out vaccination children who have no the increased risk of infection, in cases if their lawful representatives (trustees) want to protect them from a disease of hepatitis A.

Avaksim does not provide the 80th protection against the hepatitis caused by other activators (a virus of hepatitis B, C, E), and also other known activators which affect a liver.

The Seropozitivnost on hepatitis A a contraindication to vaccination is not.

The infected patients imparted during a hepatitis A incubation interval can have an inefficient immunization.

The doctor needs to be warned about recent or matching on time vaccination use of any other medicine, including nonprescription.

Medicinal interaction

Avaksim 80 it is possible to enter at the same time into different parts of a body with vaccines which enter the National calendar of preventive inoculations and contain the following components (one or more): anatoxins – diphtheritic, tetanic; vaccines – against a viral hepatitis In, pertussoid (tselnokletochny or acellular), against measles, hemophilic type b, poliomyelitic (inactivated or live), against local parotitis and a rubella.

As the vaccine is inactivated, its combined use with other inactivated vaccines, as a rule, on condition of introduction of vaccines to different parts of a body does not influence efficiency of vaccination.

The drug can be administered along with hepatitis A immunoglobulin (in different body parts). It does not exert impact on seroconversion frequency, but can lead to development of lower antiserum capacities.

Avaksim 80 it is possible to use as a revaktsiniruyushchy dose in cases if for performing primary immunization used other inactivated vaccine against hepatitis A.

Terms and storage conditions

To store in protected from light, the place, unavailable to children, at a temperature of 2-8 °C, not to freeze.

Period of validity – 3 years.