AWACIM 80 - instructions for using the medicine, structure, Contraindications
Hepatitis A vaccine.
Active substance – hepatitis A virus inactivated whole.
AWACIM 80: composition and form of release
One dose (0,5 ml) in a glass syringe with a capacity 1 ml, placed in a closed transparent cell package; one closed cell package is placed in a cardboard box with instructions for use.
Composition of 1 dose (0,5 ml):
Active ingredient: hepatitis A virus(1)(2) inactivated - 80 antigen units(3)
(1) strain GBM, cultured in human diploid cell culture MRC-5,
(2) formaldehyde inactivated and adsorbed on aluminum hydroxide,
(3) antigen content is expressed using the manufacturer's internal reference standard.
Excipients: aluminum hydroxide (in terms of aluminum) – 0,15 mg, 2-phenoxyethanol - 2,5 l, formaldehyde - 12,5 g, Wednesday Hanks 199(4) - To 0,5 ml, hydrochloric acid or sodium hydroxide to adjust the pH value. Neomycin (production admixture) - No more 5 ug / ml.
(4) Wednesday Hanks 199 (no phenol red) is a mixture of amino acids (D,L-alanine, L-arginine hydrochloride, D,L-aspartic acid, L-cysteine hydrochloride monohydrate, L-cystine dihydrochloride, D,L-glutamic acid monohydrate, L-glutamine, glycine, L-histidine hydrochloride monohydrate, D,L-isoleucine, L-hydroxyproline, D,L-leucine, L-lysine hydrochloride, D,L-methionine, D,L-phenylalanine, L-proline, D,L-serine, D,L-threonine, D,L-tryptophan, L-tyrosine disodium, D,L-valine), Mineral salts (calcium chloride anhydrous, iron nitrate nonahydrate, potassium chloride, magnesium sulfate heptahydrate, sodium chloride, Potassium dihydrogen phosphate, sodium hydrogen phosphate, anhydrous), vitamins (vitamin C, D-biotin, ergocalciferol, calcium pantothenate, choline chloride, folic acid, Inositol, manager, a nicotinic acid, nicotinamide, para-aminobenzoic acid, pyridoxal hydrochloride, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, retinol acetate, alpha-tocopherol sodium phosphate) and other components (adenine sulfate, triphosadenine disodium, adenosine phosphate, cholesterol, deoxyribose, dextrose, reduced glutathione, guanine hydrochloride, hypoxanthine disodium, ribose, sodium acetate, thyme, polysorbate 80, uracil, xanthine disodium), dissolved in water for injection.
AWACIM 80: pharmachologic effect
Avaxim vaccine 80 made from hepatitis A viruses – cultured, purified and then inactivated with formaldehyde. It forms protection against the hepatitis A virus by inducing the formation of antibodies in titers, exceeding those, obtained by passive immunization with immunoglobulin. In the conducted clinical trials of the Avaxim vaccine 80 seroconversion was defined as the presence of antibodies to the hepatitis A virus (VGA) at concentrations, exceeding 20 mIU / ml. Through 14 days after the first dose of vaccine, the proportion of individuals with a protective antibody titer (>20 mIU / ml) was 93,6%. Within one month after the first injection, almost 100% patients reached a protective level of antibodies.
Immunity is preserved for at least 36 months and can be enhanced by revaccination. Data on the duration of the preservation of antibodies after immunization with the Avaxim vaccine 80 currently missing. At the same time, available data suggest, that antibodies to HAV persist for at least 10 years after revaccination.
AWACIM 80: indications and dosage
Specific prophylaxis of viral hepatitis A in children aged from 12 Months before 15 years inclusive.
Before vaccination, the syringe is shaken well until a homogeneous suspension is obtained.. The vaccine is administered intramuscularly, in the deltoid muscle of the shoulder in a single dose 0,5 ml.
For children under 2 years of age, the vaccine is administered in the upper outer thigh area..
The vaccine should not be injected into the buttocks (due to varying thickness of subcutaneous adipose tissue), nor intradermally, since these routes of administration may impair the immune response.
Do not enter into the vascular bed! Before the introduction, make sure, that the needle did not enter the blood vessel.
Do not mix this vaccine with other vaccines in the same syringe.
To ensure long-term immunity, revaccination is carried out with the same dose through 6 Months, or before 36 months after the first dose.
Existing recommendations indicate that there is no need for revaccination after 2 vaccinations in immunocompetent individuals..
Before use, you must carefully read the instructions for medical use.
Do not use the vaccine if it is discolored or has foreign particles..
Remaining unused vaccine or medical waste must be destroyed (disposed of) according to national requirements.
AWACIM 80: overdose
Cases of overdose have been reported. There were no adverse events as a result of overdose..
AWACIM 80: side effects
To indicate the frequency of development of unwanted side reactions (MATCH) uses the NDP classification of the World Health Organization: very common ≥10 %; frequent ≥1 % and <10 %; infrequent ≥0.1 % and <1 %; rare ≥0.01 % and <0,1 %; very rare <0,01 %, unknown frequency (when, according to the available data, it is not possible to estimate the incidence of ADR).
Data, obtained in the course of clinical trials.
All adverse reactions were mild, transient and disappear on their own without treatment.
Metabolic and nutritional disorders.
Frequent: decreased appetite.
Mental Disorders.
Frequent: irritability, insomnia.
From the nervous system.
Frequent: headache.
From the gastrointestinal tract.
Frequent: abdominal pain, diarrhea, nausea, vomiting.
Skin and subcutaneous tissue.
infrequent: rash, hives.
From the musculoskeletal and connective tissues.
Frequent: arthralgia, myalgia.
General disorders and disorders at the injection site.
Frequent: mild soreness at the injection site, redness at the injection site, hardening and swelling at the injection site, moderate increase in body temperature, weakness.
Adverse reactions were recorded less frequently after revaccination., than after primary vaccination.
Hepatitis A seropositive individuals were also well tolerated., as in seronegative individuals.
Reaction, noted in children with hemophilia, were similar to the reactions, observed in adults.
Data, obtained during post-marketing observations.
Below is information about adverse events., received from spontaneous reports after the registration of the vaccine in various countries of the world. Adverse events observed were very rare. (< 0,01 %), however, it is impossible to accurately calculate the frequency of their occurrence., therefore their frequency was determined as "unknown".
Nervous System Disorders.
Vasovagal syncope.
The patient and / or his parents should be informed of the need to inform the doctor about all cases of unwanted adverse reactions., including those not listed in this Instructions for Use.
AWACIM 80: Contraindications
- allergy to the active ingredient or to one of the excipients, included in the vaccine;
- systemic hypersensitivity reaction or life-threatening reaction to previous administration of Avaxim vaccine 80 or vaccines, containing similar components;
- disease, febrile, acute or chronic infectious disease in the acute stage. Vaccination is carried out through 2-4 weeks after recovery or during convalescence or remission. For mild SARS, acute intestinal infections, etc.. vaccinations are carried out immediately after normalization of temperature.
AWACIM 80: interactions with other drugs and alcohol
Avaxim vaccine 80 can be administered simultaneously to different parts of the body with vaccines, included in the National Immunization Schedule and containing one or more of the following components: toxoids diphtheria, tetanus; hepatitis B vaccines, whooping cough (acellular or whole cell), hemophilic type b, polio (live or inactivated), Measles, endemic mumps and rubella.
Since this vaccine is inactivated, its combination with other inactivated vaccines usually does not affect the effectiveness of vaccination, provided that the vaccines are administered in different parts of the body.
Avaxim vaccine 80 may be used as a booster dose in case of, if another inactivated hepatitis A vaccine was used for primary vaccination.
Avaxim vaccine 80 can be administered simultaneously with hepatitis A immunoglobulin, to different parts of the body. It does not affect the seroconversion rate, but may result in lower antibody titers.
AWACIM 80: precautions for taking
Avaxim vaccine 80 should be used with caution in individuals with thrombocytopenia or coagulation disorders due to the possibility of bleeding after intramuscular injection. After the injection, such patients should apply a pressure bandage to at least 2 m.
Exceptionally in patients with thrombocytopenia, or in patients at risk of bleeding, the vaccine may be given subcutaneously.
In persons with hypersensitivity to formaldehyde or neomycin (or another antibiotic of the same class) vaccination should be done with caution.
Before vaccination, the healthcare professional must take all necessary measures to prevent the development of anaphylactic or anaphylactoid reactions at the time of vaccination, to do this, he must have access to the necessary medicines, including adrenaline.
Immunosuppressive therapy or immunodeficiency conditions may be the cause of a weak immune response to the vaccine. In these cases, it is recommended to postpone vaccination until the end of treatment or until recovery..
Nonetheless, vaccination of people with chronic immunodeficiencies, such as HIV infection, recommended even if, if the immune response to the vaccine may be reduced due to the underlying disease.
Insertion of a needle during vaccination may cause psychogenic syncope (weakness, loss of consciousness). Vaccination should be carried out in places with the possibility of medical care for fainting and in conditions, to avoid injury in the event of a fall.
AWACIM 80: use during pregnancy and during breastfeeding
Due to limited data on the use of the vaccine in pregnant women, its use during pregnancy is not recommended.. The decision to vaccinate women during pregnancy should only be made if there is a clear indication based on an assessment of the balance of benefit and risk..
Unknown, is the vaccine excreted in breast milk. The vaccine should be used with caution in breastfeeding women..
Immunization with Avaxim vaccine 80 especially recommended in regions, disadvantaged in the incidence of hepatitis A, as well as persons, traveling to disadvantaged countries (regions), Where is hepatitis A outbreak reported?, and contact persons in the foci of hepatitis A.
Children can also be vaccinated, without an increased risk of infection, if their legal representatives (guardians) want to protect them from getting hepatitis A.
Avaxim vaccine 80 does not provide protection against hepatitis, caused by other pathogens, such as hepatitis B virus, hepatitis C virus, hepatitis E virus, as well as other known pathogens, affecting the liver.
Immunization may not be effective in infected individuals, vaccinated during the incubation period of hepatitis A.
Hepatitis A seropositivity is not a contraindication to vaccination.
The physician must be informed of the recent or concurrent vaccination of the child with any other medicinal product., including non-prescription.
Studies on the effect of the vaccine on the ability to drive cars and other mechanisms have not been conducted.
AWACIM 80: storage conditions
In a place protected from light, at a temperature of 2-8 ° C (Do not freeze).
Transportation conditions:
Transport at temperatures from 2 to 8 ° C. Do not freeze.
AWACIM 80: general information
- Sales form: on prescription
- Current in-about: Hepatitis A virus inactivated whole
- Manufacturer: Sanofi Pasteur
- Farm. Group: Drugs, stimulating immune processes
