Angeryx B - instructions for use, dose, side effects, contraindications

Component	Content in 1 ml
Active substance:
Purified surface antigen of the hepatitis B virus HBs Ag	20 μg
Excipients:
Aluminum hydroxide *	0.50 mg
Sodium chloride	9.0 mg
Sodium hydrogen phosphate dihydrate	0.98 mg
Sodium dihydrogen phosphate dihydrate	0.71 mg
Water for injections	up to 1.0 ml

* Converted to aluminum

Description:

Homogeneous, slightly opalescent suspension of whitish color, with sedimentation divided into 2 layers: upper - transparent colorless liquid; the bottom is a white precipitate that breaks easily when shaken.

Pharmacotherapeutic group:Recombinant hepatitis B vaccine.

ATX: & nbsp

J.07.B.C.01 Hepatitis B virus - purified antigen

Pharmacodynamics:

IMMUNOLOGICAL PROPERTIES

Engerix® B causes the formation of specific humoral HBs antibodies, which at a concentration> 10 MU / L have a protective effect against the infection caused by the hepatitis B virus.

Prophylactic effectiveness

In the risk groups

It ranges from 95% to 100% in newborns, children and adults.

In healthy individuals

When applying the vaccination schedule for 0-1-6 months,> 96% of the vaccinees determine the protective level of antibodies 1 month after the completion of the course. If the vaccination is carried out according to the scheme of 0-1-2-12 months, 89% of the vaccinated have a protective level of antibodies 1 month after the third dose, respectively. One month after the fourth dose, the protective titer of antibodies is determined in 95.8% of the vaccinated.

In the case when the vaccination is carried out according to the scheme 0-7-21 day, after 1 and 5 weeks after the third dose, the protective antibody titer is determined in 65.2% and 76% of the vaccinated, respectively. One month after the fourth dose, introduced one year after the completion of the vaccination course, the protective level of antibodies is determined in 98.6% of the vaccinated.

In patients with renal insufficiency, including patients on hemodialysis

The table shows the serotroceptive levels (calculated as the percentage of patients who achieved antibody titer> 10 IU / L), as determined during clinical trials.

Population	Vaccination schedule	The transgressive level
Impaired renal function, including hemodialysis	0-1-2-6 months (40 μg / 2 ml)	Month 3: 55.4% Month 7: 87.1%

Reduction in the incidence of hepatocellular carcinoma in children

As a result of universal vaccination of children aged 6 to 14 with hepatitis B in Taiwan, there was a decrease in the incidence of hepatocellular carcinoma. There was a significant decrease in the prevalence of the hepatitis B virus, the persistence of which is an important factor in the development of hepatocellular carcinoma.

Indications:

Specific prophylaxis of viral hepatitis B, caused by all known subtypes of the virus, in children, adolescents and adults.

In accordance with the National Calendar of preventive vaccinations and the calendar of preventive vaccinations for epidemic indications, hepatitis B vaccination is indicated for all population groups not vaccinated earlier.

Angeryx® B can also prevent hepatitis D in the case of co-infection with a delta agent.

The following categories of the population are classified as at risk of viral hepatitis B:

staff of medical and dental institutions, including staff of clinical and serological laboratories;
patients who undergo or are scheduled to receive blood and blood transfusions, planned surgical interventions, invasive medical and diagnostic procedures, organ transplantation;
children born to mothers who are carriers of the hepatitis B virus;
Persons with an increased risk of illness associated with their sexual behavior;
people who inject drugs;
persons going to regions endemic for hepatitis B;
people living in regions endemic for hepatitis B;
patients sickle-cell anemia;
patients with chronic liver disease, or persons at risk of developing liver disease (including patients with chronic hepatitis C and carriers of hepatitis C virus, abusing alcohol);
persons who have close contact with patients with acute or chronic hepatitis B, and also in accordance with the calendar of preventive vaccinations for epidemic indications;
children of children's homes, orphanages and boarding schools;
persons engaged in the production of immunobiological preparations from donor and placental blood;
students of medical institutes and students of secondary medical educational institutions (primarily graduates).

Contraindications:

Hypersensitivity to any component of the vaccine (and baker's yeast) or manifestations of hypersensitivity reactions, as well as a strong reaction (the presence of body temperature above 40 ° C, swelling and hyperemia more than 8 cm in diameter at the site of administration) after the previous administration of the Engerix vaccine® AT

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccination. Scheduled vaccinations are carried out 3-4 weeks after recovery or remission.

Vaccination should be delayed in persons with acute severe fever, caused, among other things, exacerbation of chronic diseases. Vaccination is carried out 1 month after recovery (onset of remission).

With mild ARVI, acute intestinal diseases and other infectious diseases occurring in mild form, vaccination is carried out immediately after the normalization of temperature.

Pregnancy and lactation:

Pregnancy

Data on the use of the vaccine, Angierix B, during pregnancy are encouraged. Experimental studies of the effect on reproductive function in animals have not been conducted. However, as with other inactivated viral vaccines, no adverse effects on the fetus are expected. During pregnancy, the vaccine, Engerix® B should only be used when there is an obvious need and in case the expected benefit exceeds the possible risk to the fetus.

Breastfeeding period

Data on the use of the Angierx * B vaccine are not available during breastfeeding. Experimental studies of the effect on reproductive function in animals have not been conducted. The period of breastfeeding ns is set as a contraindication.

Dosing and Administration:

Method of administration

Intramuscularly, in the deltoid muscle region (adults and children of older age) or in the upper-upper surface of the middle thigh (newborns and young children). As an exception, patients with thrombocytopenia or other diseases of the blood coagulation system may receive the vaccine subcutaneously.Engericks' B should not be injected into the gluteus muscle or by the womb, as this will not achieve an adequate immune response.

Angeryx® B under no circumstances should not be administered intravenously.

Before use, the vial with the vaccine should be kept at room temperature for 30 minutes. Directly before use, the Angierix * B bottle should be shaken until a uniform whitish suspension is obtained. The bottle should be inspected for foreign particles and / or changes in appearance. If any of the above changes occur, the vaccine should be destroyed. As with other vaccines, the dose of the Engerix B vaccine should be taken under strictly aseptic conditions and take precautions to prevent contamination of the contents. It is necessary to use different needles to withdraw the vaccine from the vial (through a rubber stopper) and to administer the drug to the patient. The unused vaccine and the rest of the packaging materials after use must be destroyed in accordance with applicable regulations.

Dosing regimen

Single dose is:

- for persons younger than 16 years, including newborns - 10 mkt HBsAg (form of release in 0.5 ml vials);

- for people over 16 years of age - 20 mcg HBsAg (form of release in bottles but 1.0 ml).

Vaccination schedules

Primary vaccination

In accordance with the National Calendar of preventive vaccinations in Russia, vaccination is carried out: Children under 1 year of age who are not in the Sisk group, according to the scheme 0-1-6 months (the first dose - in the first 24 hours of life, the second dose - at the age of 1 month, the third dose - at the age of 6 months); children under 1 year of pis (poured from the mother-observer HBsAg, patients with viral hepatitis 13 or who have undergone viral hepatitis B in the third trimester of pregnancy who do not have the results of testing for hepatitis B markers consuming narcotic drugs or psychotropic substances from families in which there is a carrier HBsAg or a patient with acute viral hepatitis B and chronic viral hepatitis) according to the scheme 0-1-2-12 months (the first dose in the first 24 hours of life, the second dose at the age of 1 month, the 3rd dose at the age of 2 months, the 4th dose - at the age of 12 months);

children from 1 year to 18 years, adults from 18 to 55 years old, nc grafted earlier, according to the scheme 0-1-6 months (1st dose, at the time of vaccination, 2nd dose, 1 month after the 1st vaccination, 3rd dose - 6 months after the vaccination).

- Persons aged 18 and over

In adults, in exceptional circumstances, requiring the rapid development of a preventive response to immunization, for example, going to the hyperendemic area, an emergency vaccination schedule can be applied 0-7-21 days. In applying this scheme, a fourth vaccination should be performed 12 months after the first vaccination.

- Patients with impaired renal function who are on hemodialysis (16 years and over)

The course of vaccination of patients on hemodialysis includes a fourfold administration of doubled doses (40 mcg) on the selected day, then 1-2-6 months after the first dose. The possibility of conducting serological tests after vaccination should be considered. Based on the results of serological studies, the vaccination schedule can be adjusted to provide an antibody titer equal to or greater than the protective level of 10 IU / L.

- Patients with impaired renal function who are on hemodialysis (up to 16 years, including newborns)

Can be used as a vaccination scheme 0-1-2-12 months, and according to the scheme 0-1-6 months using a dose of 10 mcg HBsAg. Based on the experience of vaccination in adults, it can be assumed that the use of doses with a higher antigen content may enhance the immune response.This should take into account the results of serological tests conducted after vaccination. Additional doses may be required to provide an antibody titer equal to or greater than the protective level of 10 IU / L.

- Persons who are accidentally at risk of infection

If a person is infected with a hepatitis B virus (eg, a prick with an infected needle), a vaccination schedule of 0-1-2-12 months is recommended. The first dose of the vaccine should be administered concomitantly with the immunoglobulin against hepatitis B, with injections being carried out in different parts of the body.

Revaccination

The need for revaccination in healthy individuals who received a full course of primary vaccination is not established.

The need for revaccination in patients with a reduced immune response and patients on hemodialysis is determined by the results of serological studies.

Side effects:

Clinical Trials Data

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: Often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100), rarely (> 1/10 000 and <1/1 000), rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug.

As with other hepatitis B vaccines, the causal relationship of reactions that occurred rarely and very rarely, including individual reports, has not been established with the introduction of the vaccine.

Frequency of occurrence of undesirable reactions:

Violations of the blood and lymphatic system

Rarely: lymphadenopathy.

Disorders from the metabolism and nutrition

Often: loss of appetite.

Disorders of the psyche

Very often: irritability.

Disturbances from the nervous system

Often: headache (very often in people younger than 16 years), drowsiness.

Infrequently: dizziness.

Rarely: paresthesia.

Disorders from the gastrointestinal tract

Often: nausea, vomiting, diarrhea, abdominal pain.

Disturbances from the skin and subcutaneous tissues

Rarely: rash, itching, hives.

Disturbances from musculoskeletal and connective tissue

Infrequently: myalgia.

Rarely: arthralgia.

General reactions

Very often: soreness and redness at the injection site, fatigue.

Often: swelling at the injection site, malaise, reactions at the injection site

(such as compaction), an increase in temperature (> 37.5 ° C).

Infrequently: flu-like syndrome.

Post-registration data

Infectious and parasitic diseases: meningitis.

Violations from the blood and lymphatic system: thrombocyte.

Immune system disorders: anaphylaxis, allergic reactions, including anaphylactoid reactions and a syndrome resembling serum sickness.

Impaired nervous system: paralysis, convulsions, hypoesthesia, encephalitis, encephalopathy, neuropathy, neuritis.

Vascular disorders: hypotension, vasculitis.

Disturbances from the skin and subcutaneous tissues: angioedema, Wilson's lichen, erythema multiforme.

Disturbances from the musculoskeletal and connective tissue: arthritis, muscle weakness.

Overdose:In the course of post-registration surveillance, cases of overdose have been reported. In this case, the nature of the undesired reactions did not differ from that observed when the recommended doses of the vaccine were administered

Interaction:

Simultaneous use of the Angierix® B vaccine and standard immunoglobulin doses against hepatitis B is not accompanied by a decrease in the titer HBs- antithesle, provided that the drugs are injected into different injection points.

Angeryx® B can be used concomitantly with other vaccines of the National Schedule of Prophylactic Vaccinations (with the exception of the vaccine against tuberculosis) and inactivated vaccines of the vaccination schedule for epidemiological indications. It is also possible to use simultaneously with the human papillomavirus (Csvarwix) vaccine, and the vaccines should be injected with different syringes into different parts of the body.

Angerix® B can be used to complete the vaccination course initiated by other hepatitis B vaccines, as well as for revaccination if necessary.

Special instructions:

Vaccination during the incubation period of viral hepatitis B may not prevent the development of the disease.

The vaccine does not prevent the development of infections caused by hepatitis A, hepatitis C and hepatitis E.

Since the development of an immune response to vaccination is associated with a variety of concomitant factors, those who are not sufficiently effective for vaccination may require an additional dose of the vaccine (see the section on "Revaccination", section "Dosing and Administration"),

HIV infection is not a contraindication for vaccination against hepatitis B.

In patients with kidney disease! deficiency, including patients on hemodialysis, in HIV-infected individuals and in those with a reduced immune status after the course of primary vaccination, an adequate titer is not always achieved HBs-antibodies, and therefore additional administration of the vaccine may be required (see section "Method of administration and dose"),

In connection with the possibility of developing an anaphylactic reaction in rare cases, the vaccinated should be under medical supervision for 30 minutes, and procedural rooms should be provided with antishock therapy.

As with any vaccine, a protective immune response can not be achieved in all vaccinated individuals (see section "Immunological properties").

The potential risk of apnea and the need to monitor respiratory function within 48-72 hours should be taken into account in the course of primary vaccination of children born prematurely (<28 weeks gestation), and especially children with an immature respiratory system in the anamnesis. Due to the need for vaccination of children in this group, vaccination can not be delayed or denied.

After vaccination, or sometimes in front of it, fainting or severe weakness is possible as a psychological reaction to injection. Before vaccination it is important to make sure that the patient does not get injured in the event of a syncope.

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

It is unlikely.

Form release / dosage:

Suspension for intramuscular injection, 20 μg / ml.

Packaging:

Dose for people younger than 16 years.

0.5 ml in a neutral glass type I (EF) bottle sealed with a plug of synthetic butyl rubber, crimped with an aluminum cap for running in, equipped with a protective snap-off plastic lid.

The dose for people starting 16 years.

By 1.0 ml in a bottle of neutral glass type I (EF), sealed with a plug of synthetic butyl rubber, crimped with an aluminum cap for running in, equipped with a protective snap-off plastic lid.

For 1, 25, 100 vials (0.5 ml or 1.0 ml) in a pack of cardboard along with instructions / instructions for use (3 instructions for packaging of 25 bottles, 10 instructions for packaging of 100 bottles).

Storage conditions:

STORAGE CONDITIONS

Store at a temperature of 2 to 8 ° C in a dark place. Do not freeze. Keep out of the reach of children.

CONDITIONS OF TRANSPORTATION

Transport at a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Short-term (up to 72 hours) transportation at a temperature of up to 34 ° C is allowed.

Shelf life:

3 years.

Do not use after the expiration date stated on the package.

Expiration date is the last day of the month indicated on the package.

Terms of leave from pharmacies:For hospitals

Registration number:П N011718 / 01

Date of registration:08.09.2006

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Biologicals, s.a. Belgium

Representation: & nbspZAO "GlaxoSmithKline Trading"ZAO "GlaxoSmithKline Trading"

Information update date: & nbsp24.02.2015

Illustrated instructions

Instructions

Angeryx® B (Engerix® B)