Composition, form of production and packaging
Suspension for the / m introduction for children is homogeneous, white; when standing, a colorless supernatant is formed and a slowly precipitating white precipitate that breaks easily when shaken.
0.5 ml
antigen of hepatitis A virus (strain HM 175) 720 units ELISA
Auxiliary substances: aluminum hydroxide 0.5 mg (sorbent), 2-phenoxyethanol 5 mg (preservative), amino acids (mixture), sodium hydrogen phosphate, potassium dihydrogen phosphate, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (traces), water d / and .
The preparation contains formaldehyde inactivated hepatitis A virions (strain HM 175) grown in diploid human MRC5 culture, concentrated and adsorbed on aluminum hydroxide.
1 dose (0.5 ml) - disposable syringes (1) - cardboard packs.
1 dose (0.5 ml) - bottles of colorless glass (1) - packs of cardboard.
1 dose (0.5 ml) - bottles of colorless glass (10) - cardboard boxes.
1 dose (0.5 ml) - bottles of colorless glass (25) - cardboard boxes.
1 dose (0.5 ml) - bottles of colorless glass (100) - cardboard boxes.
Suspension for the / m introduction for adults is homogeneous, white; when standing, a colorless supernatant is formed and a slowly precipitating white precipitate that breaks easily when shaken.
1 ml
antigen of hepatitis A virus (strain HM 175) 1440 units. ELISA
Auxiliary substances: aluminum hydroxide 0.5 mg (sorbent), 2-phenoxyethanol 5 mg (preservative), amino acids (mixture), sodium hydrogen phosphate, potassium dihydrogen phosphate, polysorbate 20, potassium chloride, sodium chloride, neomycin sulfate (traces), water d / and .
The preparation contains formaldehyde inactivated hepatitis A virions (strain HM 175) grown in diploid human MRC5 culture, concentrated and adsorbed on aluminum hydroxide.
1 dose (1 ml) - disposable syringes (1) - cardboard packs.
1 dose (1 ml) - vials of colorless glass (1) - packs of cardboard.
1 dose (1 ml) - bottles of colorless glass (10) - cardboard boxes.
1 dose (1 ml) - bottles of colorless glass (25) - cardboard boxes.
1 dose (1 ml) - bottles of colorless glass (100) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Vaccine for the prevention of hepatitis A. Provides protection against hepatitis A, forming specific immunity by inducing the production of antibodies against hepatitis A virus (HAV), as well as by activating the cellular mechanisms of immunity. Double vaccination with an interval of 6-12 months provides a long-term preservation of immunity.
When studying the kinetics of the immune response, in special studies it was found that after the administration of a single dose of HavrixВ®, early and rapid seroconversion is achieved. At the same time, after 13 days after the introduction of the vaccine, the number of persons with a protective titer of antibodies (> 20 mMe / ml) was 79%. With the increase in the period since the introduction of the drug, this indicator has increased significantly.
To provide long-term protection, a second (revaccinating) dose is administered between 6-12 months after the administration of the 1st dose. Repeated inoculation, conducted in 12-60 months to persons previously grafted once, provides an adequate immune response.
Based on the available data, it can be concluded that persons with unchanged immune status after a vaccination course consisting of the administration of a vaccine and a booster dose do not need to be re-vaccinated.
PHARMACOKINETICS
Data on the pharmacokinetics of HavrixВ® are not available.
INDICATIONS
- prevention of hepatitis A from 12 months of age.
DOSING MODE
HavrixВ® can not be administered IV. The vaccine Havriks В® is intended for the / m introduction.
Before administration, the vaccine should be visually inspected for foreign matter and changes in appearance. Immediately before the introduction of the vaccine, the vial or syringe should be vigorously shaken until a slightly cloudy white suspension is obtained. If any deviations from the norm are found in the vaccine, then such a package with the vaccine must be destroyed.
For adults and older children, the vaccine should be administered to the deltoid muscle region, and children 12-24 months of age should be injected into the anterolateral region of the thigh. The vaccine should not be injected into the gluteus muscle, as well as the SC, because in such ways of administration, the formation of antibodies to the hepatitis A virus may not reach the optimal level.
Vaccination schedule
A single dose for primary vaccination for adults and adolescents over the age of 16 is 1 ml, for children and adolescents under the age of 16, 0.5 ml. The optimal time for the introduction of the revaccinating dose is 6-12 months after the administration of the vaccination dose, which ensures a long-term protection of the vaccinated.
If the booster vaccination is not carried out within 6 to 12 months, if necessary, protection from infection with hepatitis A, the booster is given within 60 months after the first dose.
SIDE EFFECT
The safety profile presented below is based on data collected from the observation of more than 5,300 patients.
Frequency of occurrence of undesirable phenomena is determined as follows: very often (? 10%), often (? 1% and <10%), sometimes (? 0.1% and <1%), rarely (? 0.01% and <0.1%), very rarely (<0.01%).
Clinical Trials Data
Infections and invasions: sometimes - upper respiratory tract infections, rhinitis.
From the side of metabolism and nutrition: often - loss of appetite.
From the nervous system: very often - irritability, headache; often - drowsiness; sometimes - dizziness; rarely - reduced sensitivity, paresthesia.
From the digestive system: often - diarrhea, nausea, vomiting.
Dermatological reactions: sometimes - a rash; rarely - itching.
From the bone-muscle system: sometimes - myalgia, musculoskeletal tension.
General and local reactions: very often - pain and redness at the injection site, fatigue; often - malaise, fever (> 37.5 В° C), swelling and compaction at the injection site; sometimes - influenza-like symptoms; rarely - chills.
Post-registration data
On the part of the immune system: anaphylaxis, allergic reactions, including anaphylactoid reactions and symptoms of an allergic condition, reminiscent of those with serum sickness.
From the nervous system: convulsions.
From the cardiovascular system: vasculitis.
Allergic reactions: angioedema, urticaria, erythema multiforme.
From the musculoskeletal system: arthralgia.
CONTRAINDICATIONS
- hypersensitivity to any component of the vaccine;
- symptoms of hypersensitivity to previous administration of the HavrixВ® vaccine.
Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination; with non-severe acute respiratory viral infections, acute intestinal diseases, vaccinations are carried out immediately after the temperature normalization.
PREGNANCY AND LACTATION
AT due to the lack of adequate data, the use of HavrixВ® during pregnancy and lactation is not recommended, despite the minimal risk of exposure to inactivated vaccines on the fetus and the baby.
SPECIAL INSTRUCTIONS
HavrixВ® does not provide protection against hepatitis caused by other pathogens, such as hepatitis B virus, hepatitis C virus, hepatitis E virus, and other known pathogens that affect the liver.
HavrixВ® should be administered with caution to patients with thrombocytopenia or with abnormalities from the blood coagulation system, since after an intravenous injection, such patients may experience bleeding. After the injection, such patients should apply a pressure bandage (but not rub off) for at least 2 minutes. Patients with thrombocytopenia or with disorders of the blood coagulation system are allowed a s / s introduction of the vaccine Havriks В® .
In patients who are on hemodialysis, as well as patients with impairments from the immune system after a single dose of the HavrixВ® vaccine, an adequate titer of antibodies against the hepatitis A virus may not be achieved. Such patients may require additional doses of the vaccine.
As with parenteral administration of any other vaccine, the vaccine room should have everything necessary to stop a possible anaphylactic reaction to the HavrixВ® vaccine. The vaccinated should be under medical supervision for 30 minutes after immunization.
Immunization with HavrixВ® is especially recommended for people at increased risk of infection, as well as for people who have hepatitis A and who have severe illness, or who, because of their professional status, can cause outbreaks. These include:
- persons living in areas with a high incidence of hepatitis A;
- Persons traveling to regions with a high incidence of hepatitis A (military personnel, travelers, etc.);
- persons contact in the hearths. Postexposure prophylaxis of HavrixВ® does not guarantee 100% effectiveness and depends on the time, the moment of contact with the hepatitis A virus, the infectious dose and the predicted state of health of the vaccinated person;
- Persons at risk of occupational exposure: medical personnel and nursing staff (especially in infectious, gastroenterological and pediatric units); personnel of preschool institutions; employees of sewerage and water supply services; personnel of the food industry and public catering establishments;
- Individuals at special risk groups (patients with chronic liver disease or an increased risk of liver disease, hemophiliacs, patients with multiple blood transfusions, drug addicts, homosexuals, people with promiscuity).
Vaccination of HavrixВ® is also shown to all other population groups.
Impact on the ability to drive vehicles and manage mechanisms
Influence on ability to concentration of attention is improbable.
OVERDOSE
Overdose cases have been documented during post-registration. The adverse events that occurred as a result of an overdose were similar to those observed with the recommended dose of the vaccine.
DRUG INTERACTION
The HavrixВ® vaccine can be administered concomitantly with inactivated vaccines of the National Schedule of Prophylactic Inoculations of the Russian Federation and the vaccination schedule according to the epidemiological indications of the Russian Federation.
With simultaneous administration with inactivated vaccines against typhoid fever, cholera, tetanus, and yellow fever, there was no decrease in the immune response to the HavrixВ® vaccine. Since the HavrixВ® vaccine is inactivated, it is unlikely that its simultaneous administration with other inactivated vaccines will lead to a disruption in the formation of an immune response. With the simultaneous administration of immunoglobulins, the protective effect of the vaccine is not reduced.
If it becomes necessary to administer HavrixВ® with other vaccines or with immunoglobulins, the drugs are administered using different syringes and needles to different parts of the body.
TERMS OF RELEASE FROM PHARMACY
A vaccine in a package containing 1 vial or syringe is dispensed on prescription.
The vaccine in a package containing 10, 25 and 100 bottles, is intended for medical and preventive institutions.
TERMS AND CONDITIONS OF STORAGE
The vaccine should be stored and transported at a temperature of 2 В° to 8 В° C; Do not freeze. Shelf life - 3 years. Do not use after the expiration date printed on the package.
