Wakta - instructions for use, doses, side effects, contraindications

One dose for adults in 1.0 ml contains: aluminum (in the form of aluminum hydroxyphosphate sulfate amorphous) 0.45 mg, sodium borate decahydrate 0.07 mg, sodium chloride 9.0 mg, water for injection up to 1 ml.

One dose for children and adolescents in 0.5 ml contains: aluminum (in the form of aluminum hydroxyphosphate sulfate amorphous) 0.225 mg, sodium borate decahydrate 0.035 mg, sodium chloride 4.5 mg, water for injection up to 0.5 ml.

Description:

Lightly opalescent suspension. Upon settling, it is separated into a clear, colorless liquid and a white precipitate without flakes and foreign inclusions, which easily breaks when shaken.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.B.C.02 Hepatitis A virus - purified antigen

Pharmacodynamics:

Characteristics of the preparation

Vaccine BACTA® is a highly purified suspension of formaldehyde inactivated hepatitis A virions (strain CR 326F) grown in the culture of human diploid fibroblast cells MRC 5. The strain to which the inactivated virus contained in the vaccine belongs was initially obtained after a series of passages of the attenuated strain. The virus was grown, cultivated and purified using a combination of technologies based on physical methods and high performance liquid chromatography and developed in the research laboratories of Merck Sharp and Dome (Merck Research Laboratories). Further, the virus was adsorbed on aluminum hydroxylphosphate sulfate amorphous. One milliliter of vaccine contains 50 units of high-purity hepatitis A antigen, less than 0.1 μg of non-viral proteins, less than 4 × 10^-6μg of residual DNA and less than 1x10^-4 μg of bovine albumin, less than 0.8 μg of formaldehyde, less than 10 ng of neomycin, the proportion of other residual derivatives is less than 10 ng.

Does not contain preservatives.

Immunological properties

Immunogenicity and efficacy

Vaccine BACTA® provides protection against hepatitis A virus (HAV) by inducing the production of anti-HAV antibodies, as well as by the presence of an anamnestic immune response.

Vaccine VAKTA® has a high profile of efficacy, safety and immunogenicity.

Application in pediatric practice

It was shown that the vaccine BAKTA^® is well tolerated and is highly immunogenic for children over the age of 12 months. The safety and efficacy of the vaccine VAKTA® in children under 12 months of age has not been established.

Children aged 12-23 months

4 weeks after the administration second doses of vaccine VAKTA^® children at the age of 15 months, the protective level of anti-HAV antibodies (titer more than 10 mIU / ml) was observed in 100% of children who received only the vaccine VAKTA^®, and in 100% of children who received the vaccine VAKTA® concomitantly with other vaccines.

Children and adolescents aged 2-16 years

In clinical studies conducted in areas where hepatitis A outbreaks occurred from time to time, initially seronegative participants 4 weeks after vaccination with a single dose of the vaccine VACTA^® seroconversion exceeded 99%.Initiation of seroconversion after administration single dose Vaccine vaccine^® coincided with the emergence of protection against the hepatitis A virus.

Due to the long incubation period of the disease (approximately 20-50 days, for children longer), the clinical efficacy was assessed by the number of clinically confirmed cases of hepatitis A during ≥50 days after vaccination to exclude children who had the disease at the time of vaccination in the incubation period. In initially seronegative children, protective efficacy single dose Vaccine vaccine^® was 100%: in the vaccine group VAKTA^® no clinically confirmed case of hepatitis A was recorded, while 25 cases of hepatitis A were recorded in the placebo group. ≥30 days after vaccination, 28 clinically confirmed cases of hepatitis A were recorded in the placebo group and not a single case in the vaccine group BACTA^®.

Adults aged 18 years and over

In clinical trials, 1428 adults took part. In 95% of them within 4 weeks after intramuscular administration of one dose, 50 units of the vaccine of BACTA^®seroconversion occurred.

Persistence

Based on the results of long-term studies of the persistence of anti-HAV antibodies in healthy, immunocompetent volunteers under the age of 41, it can be predicted that after the administration of two doses of the vaccine, at least 99% of the vaccines will be seropositive (> 10mU / ml anti-HAV antibody) in for at least 25 years after vaccination.

Clinical studies and modeling results have demonstrated that the persistence of anti-HAV antibodies can last for 30 years and longer.

Introduction to an HIV-infected adult

In HIV-positive patients who received the vaccine VAKTA®, the incidence of seropositivity was 100% for those in whom the number of cells Cd4⁺ was ≥300 cells / mm³. However, with the number of cells Cd4⁺ <300 cl / mm³ the seropositivity rate was 87%. In the HIV-positive group, the kinetics of the immune response was slower than in the HIV-negative group. In HIV-positive adults, the administration of the vaccine BAKTA® did not adversely affect the number of cells Cd4⁺ and HIV RNA.

Indications:Prevention of viral hepatitis A in adults and children from 12 months.

Contraindications:Allergic reactions or hypersensitivity reactions (eg, anaphylaxis) in an anamnesis for the previous administration of any of the vaccine components, including neomycin.

Pregnancy and lactation:

Tests of vaccine VAKTA® on animals to study its effect on the reproductive sphere were not carried out. There is also no data on the effect of vaccine VAKTA^® the ability to procreate or to the fetus. There are no data on the penetration of the vaccine into breast milk. The use of the drug is possible if the intended use for the mother exceeds the potential risk to the fetus. Since many drugs penetrate into breast milk, caution should be exercised when administering the vaccine, VACTA^® nursing women.

Dosing and Administration:

Do not administer intravenously and intradermally!

Vaccine VAKTA® is administered intramuscularly.

The preferred place for the administration of the vaccine is the deltoid muscle (for children over 2 years, adolescents and adults). Children aged 12-23 months are advised to use the vaccine VACTA ® in the anterolateral femoral surface.

To prevent transmission of infection for each injection, a separate sterile syringe and needle should be used.

The vaccine is produced in ready-to-use form and does not need additional dilution.

Prior to the dose in the syringe, the vial of the vaccine should be vigorously shaken.Thorough shaking is necessary to form a slurry. The preparation is not used if the suspension is not homogeneous. Before administration, the drug is examined for foreign particles and color. Suspension must be translucent, white, without foreign suspended particles.

The course of immunization consists of 2 vaccinations - vaccination and re-vaccination, which are carried out according to the following schemes:

Children and teens

For children and adolescents aged 12 months - 17 years on the selected day, the vaccine is administered once in a dose of 0.5 ml (~ 25 U); re-vaccination in a dose of 0.5 ml (~ 25 U) is carried out after 6-18 months.

Adults

Persons aged 18 years and over on the selected day should be given a single dose of 1.0 ml (~ 50 U); repeated vaccination is carried out after 6-18 months at a dose of 1.0 ml (~ 50 U).

HIV-infected adults

HIV-infected adults should receive the first dose of the vaccine 1.0 ml (~ 50 U) on the selected day; re-vaccination at a dose of 1.0 ml (~ 50 U) is carried out 6 months later.

Use with other vaccines

With the simultaneous administration of different vaccines, different syringes should be used. Different vaccines should be injected into different parts of the body.

The interchangeability of vaccines against viral hepatitis A with a second vaccination

Repeated vaccination with the drug VAKTA® can be performed 6-12 months after vaccination with other inactivated hepatitis A vaccines. In 537 healthy adults aged 18 to 83 years, the administration of the vaccine BAKTA® 6 or 12 months after the administration of the vaccine HAVRIX (inactivated vaccine against hepatitis A). Vaccine VAKTA® was well tolerated and caused a sufficient immune response.

Side effects:

Clinical researches

Children aged 12-23 months

In 5 combined clinical trials, 4374 children aged 12-23 months received one or two doses of the vaccine VACTA® (~ 25 U). Within 5 days after vaccination, the temperature of the children's body was monitored and unwanted reactions at the site of administration. Systemic adverse events were evaluated within 14 days.

The most frequent local adverse reactions after the administration of one or two doses of the vaccine BACTA^® there was increased sensitivity / pain / tenderness at the injection site. The most frequent systemic adverse events in people who were given only the vaccine VAKTA® or the vaccine VACTA together with other vaccines were an increase in body temperature (> 37 ° C or fever) and increased excitability.The incidence of all systemic adverse events was comparable in those receiving only the vaccine BACTA^® or the vaccine BAKTA® together with other vaccines.

Below, in order of decreasing frequency according to the classes of organ systems and regardless of the causal relationship with the drug, there are undesirable phenomena that have been registered in at least 1% of participants who received only the vaccine VAKTA® or the vaccine BAKTA^® in combination with measles, mumps, rubella, chicken pox, pneumococcal 7-valent conjugate vaccine, oral or inactivated polio vaccine, diphtheria, tetanus toxoid, acellular pertussis vaccine and a vaccine to prevent infection caused by vaccines. Haemophilus influenzae a type b.

Classification of undesirable phenomena in frequency was the following: very frequent (≥1 / 10), frequent (≥1 / 100, <1/10).

Adverse events in children aged 12-23 months with the introduction of only the vaccine VAKTA® (two doses)

Infectious and parasitic diseases

Frequent: upper respiratory tract infections, otitis media, nasopharyngitis, rhinitis, viral infections, croup, gastroenteritis.

Disturbances on the part of the organ of sight

Frequent: conjunctivitis.

Disturbances from the respiratory system, chest and mediastinal organs

Frequent: rhinorrhea, cough, nasal congestion.

Disorders from the gastrointestinal tract

Frequent: diarrhea, vomiting, teething.

Disturbances from the skin and subcutaneous tissues

Frequent: diarrhea, rash.

General disorders and disorders at the site of administration

Very frequent: pain / tenderness / sensitivity at the injection site, erythema at the injection site, fever (> 37 ° C or fever, 1-14 days), edema at the injection site, increased excitability.

Frequent: fever (> 39 ° С in the oral cavity, 1-5 days), bruising at the injection site, bruising at the injection site.

Adverse events that occurred in children aged 12-23 months with the introduction of the vaccine VAKTA® in combination with vaccines against measles, mumps, rubella, varicella zoster, pneumococcal 7-valent conjugate vaccine, oral or inactivated polio vaccine, diphtheria, tetanus toxoid, acellular pertussis vaccine and a vaccine to prevent infection caused by Haemophilus influenzae a type b (at least one dose)

Infectious and parasitic diseases

Frequent: upper respiratory tract infections, otitis media, nasopharyngitis, viral infections, otitis media, rhinitis, laryngotraheobronchitis.

Disorders from the metabolism and nutrition

Frequent: decreased appetite.

Disturbances from the nervous system

Frequent: crying.

Disturbances on the part of the organ of sight

Frequent: conjunctivitis.

Disturbances from the respiratory system, chest and mediastinal organs

Frequent: rhinorrhea, cough, nasal congestion, obstruction of the respiratory tract.

Disorders from the gastrointestinal tract

Frequent: diarrhea, vomiting.

Disturbances from the skin and subcutaneous tissues

Frequent: rash, diarrhea and rash, reminding measles / rubella.

General disorders and disorders at the site of administration

Very frequent: pain / soreness / sensitivity at the injection site, fever (> 37 ° C or fever, 1-14 days), erythema at the injection site, edema at the injection site, increased excitability.

Frequent: temperature (> 39 ° C in the oral cavity, 1-5 days), bruising at the injection site.

Children and adolescents aged 2-17 years

In clinical studies, 2,595 healthy children older than 2 years and adolescents,received one (~ 25 U) or a course of two doses of the hepatitis A vaccine, complaints of temperature reactions and unpleasant sensations at the injection site were recorded during the first 5 days after vaccination, and for 14 days - systemic complaints. The most frequent complaints were reactions to the site of vaccine administration, which were usually weak and short-lived.

The following are information on undesirable events that were reported in ≥1% of vaccinated, regardless of the cause of their occurrence, in order of decreasing frequency and in accordance with the classification of organ systems.

Infringements in an injection site (usually weak and short-term)

Pain (18,7%), sensitivity (16,8%), feeling of heat (8,6%), erythema (7,5%), edema (7,3%), subcutaneous hemorrhage (1,3%).

General disorders

Fever (fever in the mouth ≥38.8 ° C) (3.1%), abdominal pain (1.6%).

Disorders from the gastrointestinal tract

Diarrhea (1.0%), vomiting (1.0%).

Disturbances from the nervous system

Headache (2.3%).

Disturbances from the respiratory system, chest and mediastinal organs

Pharyngitis (1.5%), upper respiratory tract infection (1.1%), cough (1.0%).

Laboratory and instrumental data

Deviations in laboratory indicators were reported very rarely.These included single cases of increased activity of hepatic enzymes, eosinophilia and proteinuria.

Adults aged 18 years and over

In clinical trials, 1,529 healthy adults who received a single dose (~ 50 U) or a course of two doses of the hepatitis A vaccine registered complaints of temperature reactions and unpleasant feelings at the injection site within the first 5 days after the administration of the vaccine, and for 14 days - systemic complaints. The most frequent complaints were reactions to the site of vaccine administration, which were usually weak and short-lived.

The following are information on undesirable phenomena registered with ≥1% of vaccinated, regardless of the cause of their occurrence, in order of decreasing frequency and in accordance with the classification of organ systems.

Infringements in an injection site (usually weak and short-term)

Sensitivity (52.6%), pain (51.1%), a feeling of heat (17.3%), edema (13.6%), erythema (12.9%), subcutaneous hemorrhage (1.5%), pain / burning (1,2%).

General disorders

Weakness / fatigue (3.9%), fever (temperature in the oral cavity ≥38.8 ° C) (2.6%), abdominal pain (1.3%).

Disorders from the gastrointestinal tract

Diarrhea (2.4%), nausea (2.3%).

Disturbances from musculoskeletal and connective tissue

Myalgia (2.0%), pain in the shoulder and forearm (1.3%), back pain (1.1%), muscle stiffness (1.0%).

Disturbances from the nervous system

Headache (16.1%).

Disturbances from the respiratory system, chest and mediastinal organs

Pharyngitis (2.7%), upper respiratory tract infection (2.8%), nasal congestion (1,1%).

Violations of the genitals and mammary gland

Violation of menstruation (1.1%).

During the clinical trials, the following local and / or systemic hypersensitivity reactions were recorded, regardless of the cause of their occurrence in less than 1% of cases in children, adolescents and adults: pruritus, urticaria, and rash.

As with any vaccine, it is likely that when applying the vaccine to ACTA® in a very large population, adverse reactions can be identified that were not observed in clinical trials.

Post-marketing research

As part of a post-registration safety study, 42110 patients aged ≥2 years who received one or two doses of the vaccine BAKTA^®, there were no serious adverse events associated with the vaccine. There was not a single non-serious associated with the vaccine unwanted phenomenon, which would entail an additional visit to the doctor,except for diarrhea / gastroenteritis in adults (the incidence rate was 0.5%).

Experience of application

The following undesirable reactions were additionally noted during the use of the vaccine BAKTA®. These reactions were received voluntarily from a population of unknown quantitative composition, so it is impossible to accurately assess their frequency and establish a causal relationship with vaccination.

Classification of undesirable reactions by frequency is the following: very rare <1/10000.

Disturbances from the nervous system

Very rare: Guillain-Barre syndrome, cerebellar ataxia, encephalitis.

Violations of the blood and lymphatic system

Very rare: thrombocytopenia.

Overdose:There are no data on cases of drug overdose.

Interaction:

Use with other vaccines

VAKTA® vaccine can be administered simultaneously with other vaccines for children from 1 year to 17 years: live viral vaccine against measles, rubella, mumps, chicken pox, conjugated 7-valent pneumococcal vaccine, oral or inactivated polio vaccine, diphtheria, tetanus toxoids and acellular vaccine against whooping cough, a vaccine to prevent infection caused by Haemophilus influenzae a type b. Data on use with other vaccines are limited.

With simultaneous use of vaccines, they must be injected into different parts of the body and use different syringes.

For adults over the age of 18, there is limited research data, where the vaccine was used concurrently with antidiphtheria, poliomyelitis (oral and inactivated), tetanus vaccines, oral typhoid vaccine, cholera vaccine, Japanese encephalitis vaccine, rabies vaccine and yellow fever vaccine . In this case, the immune response to none of the vaccines did not decrease, the incidence of adverse events did not increase.

In studies, it was shown that simultaneously with the vaccine, HACC vaccine can be administered, while the immunogenicity and incidence of adverse events also do not change.

Use with human immunoglobulin

In the case of hepatitis A prophylaxis after contact with the causative agent of the disease or, if necessary, rapid and long-term prevention, for example, in persons urgently leaving for endemic areas,Vaccine VAKTA® can be administered concomitantly with immunoglobulin (the immunoglobulin dose should be specified in the manufacturer's instructions for use) with separate syringes in different parts of the body.

Special instructions:

Patients who develop symptoms suggestive of hypersensitivity after the first administration of the vaccine WACTA® should not receive a subsequent injection of the vaccine (see CONTRAINDICATIONS section).

To prevent the development of anaphylactic or anaphylactoid reactions at the time of vaccination, the necessary medicines should be available, including epinephrine.

In patients with latex allergy, vaccine VACTA® should be used with caution (vial plug and plunger in the syringe contain natural latex).

When using the vaccine VAKTA^® in patients with malignant neoplasms, immunodeficiencies or in patients undergoing immunosuppressant therapy, the immune response can be reduced.

Vaccine BACTA ® prevents the development of only viral hepatitis A.

In the case of human infection with the hepatitis A virus (incubation period is 20 to 50 days) at the time of vaccination, the use of the vaccine VAKTA® does not guarantee the prevention of the development of the disease.

As with any other vaccine, vaccination with VACTA® may not provide protection against the disease in all vaccinees.

In the presence of clinical indications, vaccine VAKTA® can be administered subcutaneously (in particular, to patients with impaired coagulation or risk of bleeding). However, subcutaneous administration of the first dose compared with intramuscular administration of the first dose leads to a slowing of the kinetics of seroconversion.

In case of any acute infection or disease accompanied by fever, vaccination should be postponed unless, in the opinion of the doctor, the delay in vaccination poses a greater risk to health.

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

Studies of the effect of the vaccine VAKTA® on the ability to drive a car and work with mechanisms have not been carried out. It should be noted that there are reports of asthenia / weakness and headache, observed after the introduction of the vaccine VAKTA®.

Form release / dosage:Suspension for intramuscular administration, 25 U / 0.5 ml and 50 U / 1.0 ml.

Packaging:

Bottles

Suspension for intramuscular injection of 25 U / 0.5 ml (1 infant dose) or suspension for intramuscular injection 50 U / 1.0 ml (1 adult dose) in a 3 ml bottle of colorless glass type I.The bottle is sealed with a butyl plug, it is crimped with an aluminum cap and is equipped with a protective plastic cover.

For 1, 10, 25 or 100 vials in a cardboard pack together with instructions (instructions) for use.

Disposable syringe

Suspension for intramuscular injection, 25 units / 0.5 ml (1 infant dose) or suspension for intramuscular injection of 5 OED / 1.0 ml (1 adult dose) in a disposable syringe of 1.5 ml capacity from borosilicate glass type I, equipped with a polycarbonate adapter, device for safe introduction (or without it), a protective chlorobutyl cap and a piston with a plug of chlorobutyl.

1 disposable syringe with 1 or 2 sterile needles (or without needles), placed in a contour mesh package.

1 contour mesh package in a cardboard bundle together with instructions for use.

Storage conditions:

At a temperature of 2 to 8 ° C.

Do not freeze, as freezing leads to a loss of effectiveness of the vaccine.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:For hospitals

Registration number:П N012585 / 01

Date of registration:01.07.2008 / 21.05.2014

Expiration Date:Unlimited

The owner of the registration certificate:Merck Sharp and Doum B.V.Merck Sharp and Doum B.V. Netherlands

Manufacturer: & nbsp

MERCK SHARP & DOHME, Corp. USA

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp06.02.2017

Illustrated instructions

Instructions

Vakta® (Vaqta)