AWACIM 160 - instructions for using the medicine, structure, Contraindications

AWACIM 160 is a vaccine for the prevention of viral hepatitis A.

Active substance – hepatitis A virus inactivated whole.

AWACIM 160: indications and dosage

AWACIM 160 designed to prevent infectious diseases, caused by the hepatitis A virus in adults older than 16 years.

Hepatitis A - liver infection, caused by hepatitis A virus. This disease can develop in anyone., especially in hot countries with low hygienic culture.

The source of the viral infection is directly sick with hepatitis A, with the feces of which viral particles are released into the environment. The virus enters the body through contaminated food. (especially with seafood) or water.

Usually, symptoms of hepatitis A:

• increased body temperature (lasts 4-10 days),
• weakness,
• malaise,
• nausea,
• myalgia,
• loss of appetite.

When the liver is involved in the infectious process, noted:

• dark urine,
• jaundice (yellowing of the skin and whites of the eyes),
• chair brightens.

At this stage of the disease, nausea and fever disappear., however, the patient may be disturbed by itching and pain in the abdomen.

Prevention of hepatitis A with the AVAXIM vaccine 160 required for the following risk groups:

• unvaccinated patients older than 16 years, who are going to stay in the regions, where epidemiological foci of hepatitis A are recorded (Africa, Latin America, some Asian countries and others).
• Patients, who are at risk of infection at work or whose profession involves contact with a focus of the virus (medical service workers, sewer cleaners and water workers, catering and industrial personnel, Fire Department, police, etc.)
• patients aged from 16 years, who live in orphanages, hospices, nursing homes.
• special risk groups of adult patients: hemophiliacs; people, who frequently undergo blood transfusions or donations; drug addicted patients, who take intravenous drugs; gay men.
• adult patients, suffering from chronic hepatitis B virus.

AVAXIMA injections 160 do not guarantee protection against other forms of hepatitis, except type A, as well as similar diseases, caused by viral pathogens.

Dosage of AVAXIM 160

The first vaccination procedure is done once in a dose 0,5 ml. re-vaccination is done in the same amount after six months to a year.

AVAXIM injection 160 injected intramuscularly into the deltoid muscle of the shoulder. Before vaccination, shake the vial until the drug liquid becomes a homogeneous suspension..

Do not administer intravenously! Honey. the employee must make sure, that the needle did not enter one of the blood vessels.

Also, injections should not be injected into the buttocks.. Because in this area the thickness of the fat layer can vary.

Besides, injections are not carried out intradermally, due to the possibility of inducing a reduced immune response.

In non-standard cases (if the patient has thrombocytopenia or poor blood clotting due to injuries) AVAXIMA vaccine 160 allowed to enter subcutaneously.

AWACIM 160: overdose

About cases of overdose of AVAXIM 160 no information found.

AWACIM 160: side effects

Introduction AWAXIM 160 may lead to the following side effects of varying severity.

All adverse reactions were moderate., did not require special treatment and spontaneously resolved within a few days.

It is necessary to inform the treating doctor about any unusual reactions of the body during the period of the vaccine., even those, which are not described in this manual.

The doctor must report all confirmed symptoms, associated with the action of AVAXIMA 160 to the National Authorities for the Control of Medical Immunobiological Products and report to the manufacturing company.

AWACIM 160: Contraindications

Suspension AVAXIM 160 contraindicated for use with the following factors:

Disease, accompanied by fever:

• acute infections (SARS) is a general term for a group of respiratory diseases, with viral etiology. All acute respiratory viral infections have similar clinical manifestations and are characterized by damage to the respiratory tract in varying degrees of severity.. Due to the similarity of symptoms in everyday life, ARVI is called a cold.
• chronic infections (eg, cholecystitis - inflammation of the gallbladder, that is one of the most frequent complications of cholelithiasis; uretrit - inflammation of the urethra (urethra), caused by various pathogenic microorganisms (bacteria or viruses; prostatitis - inflammation of the prostate gland; cystitis – inflammatory diseases of the bladder and urinary tract; pyelonephritis - non-specific inflammation of the renal pelvis, calyx and renal parenchyma.)
• tuberculosis - infection, caused by different types of mycobacteria (most commonly Koch's wand). The disease usually affects lung tissue, less frequently affecting other organs.
• toxoplasmosis - parasitic disease of humans and animals, caused by the parasitic protist Toxoplasma gondii.
• HIV (AIDS virus) belongs to the retrovirus family. HIV infects various systems of the human body (eg, nervous, digestive), but predominantly affects the immune system.
• cancer diseases - group of diseases, that start with a mutation, when a cell (somatic cells, ie. not sexual) begin to divide and grow uncontrollably.
• viral hepatitis - group of infectious diseases, that primarily affect the human liver, causing an inflammatory process. Hepatitis viruses are very different, Therefore, with this or that hepatitis (A, IN, FROM, D and others) symptoms may vary.
• thyroid disease - group of diseases, that occur against the background of unchanged, reduced (gipotireoz) or increased (hyperthyroidism, thyrotoxicosis) endocrine function.
• parasitic worms (helminths), that cause different (depending on the type of worm) helminthiasis, or helminthic invasion.
• zhelezodefitsitnaya anemia – polyetiological hematological syndrome complex, associated with iron deficiency due to impaired intake, assimilation and increased loss, what is manifested by hypochromic anemia and sideropenia.

And there are additional contraindications:

• hypersensitivity to any component of the vaccine,
• hypersensitivity to any neomycin,
• allergic reaction, observed as a result of a previous vaccination against hepatitis A.

In these cases, vaccination should be delayed until recovery..

AWACIM 160: interactions with other drugs and alcohol

The vaccine can be administered simultaneously with immunoglobulins, provided that the vaccine and immunoglobulins are injected into different parts of the body.

• Immunoglobuliny are special proteins, which are produced by lymphocytes and are involved in the formation of our immunity. Immunoglobulins respond to the invasion of foreign substances and microorganisms into the body, neutralizing them and preventing their spread. Against bacteria, viruses or other harmful agents form their own "personal" antibodies.

AVAXIM suspension 160 not compatible with all types of vaccines. Important, that those vaccines, that were carried to other parts of the body did not reduce the effect of this drug. In particular, the vaccine can be used simultaneously with other types of vaccines such as:

Recombinant hepatitis B vaccine - medicinal product, hepatitis B vaccine group, from different manufacturers. Although vaccination is only one of several ways to prevent disease, caused by the hepatitis B virus from its giant reservoir of infection in the world, This method has recently received significant development., primarily due to genetic engineering technologies.

Typhoid vaccine – is the first killed vaccine, included in the arsenal of means of specific prevention of infectious diseases. It is a vaccine for the prevention of typhoid fever for the population, living in a territory with a high incidence of typhoid fever and other risk groups for this disease.

Typhoid fever is an acute infectious anthroponotic disease with fecal-oral transmission, caused by salmonella typhoid fever and characterized by a fever of a predominantly constant type, general intoxication with the development of lethargy of the nervous system up to typhoid status, skin rash, hepatosplenomegaly and lesions of the lymphatic apparatus of the small intestine.

Live vaccine to prevent yellow fever - this vaccine stimulates the formation of immunity to the yellow fever virus for a duration of 10-15 years.

Yellow fever - viral disease, characterized by high body temperature, severe general condition, and bleeding in the mouth, intestine, stomach. There is also damage to the kidneys and liver.. The causative agent of the disease is the Viscerophilus tropicus virus., which is carried by insects (eg, mosquitoes).

But the AVAXIM vaccine 160 never mix with other vaccines in the same syringe.

Before vaccination, it is necessary to warn the doctor about a recent vaccine or about taking drugs in this

AWACIM 160 can be used for revaccination in those cases, when the previous vaccination was carried out with other inactivated vaccines for the prevention of hepatitis A.

AWACIM 160: precautions for taking

Immunosuppressive therapy or an immunodeficiency state may cause a weak immune response to the vaccine.

Vaccination, carried out during the incubation period of hepatitis A, may be ineffective. The incubation period for hepatitis A can range from 15 to 50 days

Use with caution in patients with liver disease.

AWACIM 160: use of the drug during pregnancy and lactation

Clinical studies of the effects of the drug AVAXIM 160 on the embryo or fetus during fetal development has not been carried out. Therefore, the vaccine should not be used during pregnancy.. Vaccination can only be carried out if there is a real threat of infection of a woman with hepatitis A. Vaccination is allowed during lactation.

AWACIM 160: pharmachologic effect

Prevention of infectious diseases, caused by the hepatitis A virus. The drug exhibits protective properties and produces antibody titers (no less 20 mIU / ml), which reduce the activity of the hepatitis A virus for 2 weeks after vaccine administration in more than 90% patients, vaccinated. The effect of immunization lasts for six months to a year. After a second dose of AVAXIM 160 immunity develops in 100% grafted.

AWACIM 160: composition and form of release

Suspension 1 dose (0,5 ml) in a filled syringe for intramuscular injection.

One vaccination dose of vaccine (0,5 ml) It contains:

Active material: hepatitis A virus * formaldehyde-inactivated 160 antigen units**,

Excipients:

• aluminum hydroxide (for aluminum) 0,3 mg,
• 2-phenoxyethanol 2,5 l,
• formaldehyde 12,5 g,
• Wednesday Hanks 199*** to 0,5 ml,
• hydrochloric acid or sodium hydroxide to adjust the pH value.

*strain GBM, cultured on human diploid cells (MRC5). **in the absence of an international reference standard, the antigen content is expressed using the internal reference standard and the company's ELISA test system. ***Wednesday Hanks 199 is a mixture of amino acids, Mineral salts, vitamins and other ingredients, dissolved in water for injection; pH value is adjusted with hydrochloric acid or sodium hydroxide.

AWACIM 160: storage conditions

Store at temperatures from +2 ^o From to +8 ^o FROM (in a refrigerator).
Do not freeze
Keep out of the reach of children!

AWACIM 160: general information

• Sales form: on prescription
• Current in-about: Hepatitis A virus inactivated whole
• Manufacturer: Sanofi Pasteur
• Farm. Group: Drugs, stimulating immune processes