Hepatitis A Pediatric Vaccine (Havrix Pediatric)

Reviewed: December 14, 2021

Hepatitis is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A pediatric vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A pediatric vaccine is recommended for all children who are 12 months of age or older. This vaccine is also recommended in children who travel to certain areas of the world where hepatitis A is a common disease.

Like any vaccine, the hepatitis A pediatric vaccine may not provide protection from disease in every person.

uses

What is Hepatitis A Pediatric Vaccine (Havrix Pediatric) used for?

• Hepatitis A Prophylaxis

warnings

What is the most important information I should know about Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

Hepatitis A vaccine will not protect against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if your child is already infected with the virus, even without showing symptoms.

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if the child is allergic to neomycin.

Tell your doctor if you have ever had:

• an allergy to latex rubber; or
• a weak immune system (caused by disease or by using certain medicine.

Hepatitis A pediatric vaccine is not approved for use by anyone younger than 12 months old.

Side Effects

What are the side effects of Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Call your child’s doctor at once if the child has:

• extreme drowsiness, fainting;
• fussiness, irritability, crying for an hour or longer;
• a seizure; or
• high fever (within a few hours or a few days after the vaccine).

Common side effects may include:

• fever;
• irritability, drowsiness;
• loss of appetite;
• headache; or
• swelling, tenderness, redness, or warmth where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Pregnancy & Breastfeeding

Can I take Hepatitis A Pediatric Vaccine (Havrix Pediatric) if I’m pregnant or breastfeeding?

C

Risk cannot be ruled out

Based on FDA pregnancy categories

Interactions

What drugs and food should I avoid while taking Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Dosage Guidelines & Tips

How to take Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

Use Hepatitis A Pediatric Vaccine (Havrix Pediatric) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

Contact your doctor if your child will miss a booster dose or if he or she gets behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine, or the child may not be fully protected against disease.

Overdose Signs

What happens if I overdose on Hepatitis A Pediatric Vaccine (Havrix Pediatric)?

An overdose of this vaccine is unlikely to occur.

If you think you or someone else may have overdosed on: Hepatitis A Pediatric Vaccine (Havrix Pediatric),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Hepatitis A Pediatric Vaccine (Havrix Pediatric), call 911

911

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Your Child’s Immunizations: Hepatitis A Vaccine (HepA) (for Parents)

en español: Las vacunas de su hijo: Vacuna contra la hepatitis A

Reviewed by: Elana Pearl Ben-Joseph, MD

What Is Hepatitis A?

Hepatitis A is an infection of the liver caused by the hepatitis A virus (HAV) virus. People with hepatitis A can have no symptoms or they can feel very sick with fever, nausea, vomiting, and
jaundice.

HepA Immunization Schedule

The HepA vaccine is recommended for children 12–23 months old, followed by a second dose at least 6 months later.

HepA can be given as early as 6 months of age if a baby will travel to a place where hepatitis A is common. The baby will still need routine vaccination after their first birthday. It’s also recommended for older kids (2–18 years old) who haven’t already gotten it.

Why Is HepA Recommended?

The HepA vaccine not only protects the kids who get it. It also can help prevent outbreaks. An outbreak is when a disease happens in greater numbers than expected in a particular area.

Childcare centers are a common site of hepatitis A outbreaks. Some kids can be infected and not have symptoms. But they can still spread the virus to others. Having many young kids vaccinated against hepatitis A can stop it from spreading in a community.

Possible Risks of the HepA Vaccine

Side effects usually are mild, and can include a mild fever and soreness or redness at the injection site. Allergic reactions to the vaccine are rare.

The HepA vaccine contains a killed (inactivated) virus, so it cannot cause hepatitis.

When to Delay or Avoid HAV Immunization

The HepA vaccine is not recommended if your child:

• is currently sick, although simple colds or other minor illnesses should not prevent immunization
• had a serious allergic reaction to the first dose of hepatitis A vaccine or has a latex allergy

Caring for Your Child After HAV Immunization

Your child may have fever, soreness, and some swelling and redness at the shot site. For pain and fever, check with your doctor to see if you can give either acetaminophen or ibuprofen, and to find out the right dose.

When Should I Call the Doctor?

Call your doctor if:

• You aren’t sure if the vaccine should be postponed or avoided.
• There are problems after the immunization.

Reviewed by: Elana Pearl Ben-Joseph, MD

Date reviewed: February 2022

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Hepatitis B vaccine “Regevac” recombinant yeast liquid – City Hospital No.

40

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CJSC MTX, Russia

Release form: 1 ampoule/1 dose/1 ml No.years), 1apule / 1 dose / 0.5 ml No. 10 (for children and adolescents up to 19 years of age inclusive).

Vaccination schedule: 0 day – 1 month – 6 months.

INSTRUCTIONS FOR USE
Regevak B

hepatitis B vaccine, recombinant yeast liquid, suspension for intramuscular injection

Reg evak B is a preparation based on the surface antigen of the hepatitis B virus (serotype ayw)f obtained by the method recombination of DNA in a culture of yeast transformed by incorporating into their genome a gene encoding the surface antigen of the hepatitis B virus.

One milliliter of the preparation contains 20 µg of HBsAg, 0.5 mg of aluminum hydroxide (sorbent) and 50 µg of merthiolate (preservative).
Suspension of white with a grayish tint, without visible foreign particles, which separates after settling into a clear supernatant and a white precipitate with a grayish tint, easily resuspendable on shaking.

IMMUNOBIOLOGICAL PROPERTIES
The course of vaccination leads to the formation of specific antibodies to the hepatitis B virus in more than 90% vaccinated in protective titer.

INTENDED USE
Prevention of hepatitis B in children as part of the national immunization schedule and in individuals at increased risk of infection with the hepatitis B virus: children and adults whose families have an HBsAg carrier or a patient with chronic hepatitis B, children of orphanages, orphanages homes and boarding schools, children and adults who regularly receive blood and its preparations, as well as those on hemodialysis and oncohematological patients. Persons who have had contact with material infected with the hepatitis B virus. Health workers who have contact with the blood of patients. Persons involved in the production of immunobiological preparations from donor and placental blood. Students of medical institutes and students of secondary medical schools (primarily graduates). Persons who inject drugs.
In addition to the above categories, all other population groups should be vaccinated.

DOSAGE AND ADMINISTRATION
The vaccine is administered intramuscularly into the deltoid muscle,
in newborns and young children in the anterior-lateral
thigh: administration elsewhere reduces the effectiveness of
vaccination. Shake the ampoule before administration.
A single dose for newborns and persons under 19 years of age is
0.5 ml (10 μg HBsAg). Single dose from 19years is 1 ml (20 mcg
HBsAg).
Patients on hemodialysis units are given a double dose of 2 ml (40 µg HBsAg).
The vaccination course consists of three intramuscular injections of the vaccine according to the scheme: 0-1-6 months. If the interval between vaccinations is extended, the next vaccination should be carried out as soon as possible, determined by the state of health of the vaccinated. Children from the age of 13 who have not been vaccinated before are vaccinated according to the standard scheme.
Children born to mothers carrying the hepatitis B virus, or suffering from hepatitis B in the third trimester of pregnancy, are vaccinated against hepatitis B according to the scheme 0 (on the day of birth) -1-2-12 months.
Vaccinations in previously unvaccinated persons who have had contact with material infected with the hepatitis B virus are carried out according to the scheme 0 -1 – 2 months.
Patients in hemodialysis units are given the vaccine four times with a monthly interval between vaccinations.
Vaccination against hepatitis B can be carried out simultaneously (on the same day) with the vaccines of the national immunization schedule and inactivated vaccines of the immunization schedule according to epidemic indications. The introduction is carried out with different syringes in different parts of the body.
Only a disposable syringe is used for injection.
The injection site is treated with 70% alcohol before and after the injection. The opening of the ampoules and the vaccination procedure are carried out with strict observance of the rules of asepsis and antisepsis.
Do not use ampoules that have a physical defect that leads to a violation of their tightness.
Do not administer intravenously.
The drug in the opened ampoule is not subject to storage,

REACTION TO INTRODUCTION
Side effects with the use of the vaccine are rare. In 5-10% of cases, pain, erythema, and induration at the injection site may occur. The administration of the drug is occasionally possible: a slight increase in temperature, complaints of malaise, weakness, joint pain, muscle pain, headache, dizziness, nausea, vomiting, pain in the abdomen.
All injection reactions are mild and usually resolve within 2-3 days after injection.
Due to the possibility of developing immediate allergic reactions in particularly sensitive individuals, medical supervision should be provided for vaccinated within 30 minutes after vaccination. Vaccination sites must be provided with anti-shock therapy.

CONTRAINDICATIONS FOR USE
Hypersensitivity to yeast and other components of the vaccine. A pronounced reaction (temperature above 40 ° C, edema, hyperemia of more than 8 cm in diameter at the injection site) or a complication to the previous administration of the hepatitis B vaccine. Acute infectious and non-infectious diseases, chronic diseases in the acute stage – immunization is carried out no earlier than after 1 month after recovery (remission). In mild forms of SARS and acute intestinal infections, vaccinations can be carried out after the temperature has returned to normal.
Use during pregnancy. The effect of the vaccine on the fetus has not been studied.

FORM
1 ml (1 adult dose) and 0. 5 ml (1 child dose) in ampoules.
5 ampoules in a blister pack, 1 or 2 blister packs in a carton pack.
The pack includes instructions for use and an ampoule knife or scarifier.

HOLIDAY CONDITIONS
For healthcare facilities (pack of 10 ampoules). By prescription (pack of 5 ampoules).

EXPIRY DATE, TRANSPORTATION AND STORAGE CONDITIONS
Shelf life 3 years
Store and transport in accordance with SP 3.3.2.1248-03 at a temperature of 2°C to 8°C out of the reach of children. Short-term (no more than 72 hours) transportation is allowed at temperatures from 9°С to 30°С.
A product that has been frozen or has expired should not be used.
Claims for the specific and physical properties of the drug should be sent to the State Research Institute for Standardization and Control of Medical Immunobiological Preparations named after L.A. Tarasevich (119002, Moscow, per. Sivtsev Vrazhek, 41 ″, tel. (095) 241 39 22, fax (095) 241 12 38) and to the address of the manufacturer: CJSC Medico-technological holding “MTX” (124460 , Moscow-Zelenograd, 4th Western passage, 3, building 1, tel/fax (095) 536 85 42).
The increased reactogenicity of the drug and complications after its administration should be reported by telephone or telegraph to the Federal Service for Supervision of Consumer Rights Protection and Human Welfare and to the State Research Institute for Standardization and Control of Medical Immunobiological Preparations. L.A. Tarasevich.

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Make an appointment

Registration with a passport and policy is carried out:

• in person through the terminal of polyclinic No. 68;
• by phone +7 (812) 246-73-33;
• on the site gorzdrav.spb.ru.

An immunologist also provides consultations to the heads of medical and preventive institutions of the district on legal issues of organization of immunoprophylaxis for employees.

Vaccination against COVID-19

Vaccination under the compulsory medical insurance policy is carried out in polyclinic No. 68 (Borisova St. 9)
for all interested citizens of the Russian Federation over 18 years old, vaccination is carried out for foreign citizens on a paid basis.

Pre-registration required
By phone +7 (812) 246-73-33, on the Gorzdrav website in the section Sign up for vaccination against COVID-19
and on the website of the State Services

Will we allow polio and diphtheria to return?

Over the past ten years, the vaccination of children against dangerous infectious diseases has been steadily decreasing in Estonia. Thus, we have reached a situation where we are in real danger of the return of serious infectious diseases.

Irina Filippova, Chief Specialist of the Infectious Diseases Epidemiology Department, from the Health Board, stated that state borders do not in any way limit the spread of infectious diseases. “In today’s globalized world, an infection can spread from any part of the world to another within a day. According to the World Health Organization, in recent years, the prevalence of vaccine-preventable diseases in Europe has increased. Such a high incidence rate has not been observed for decades. For example, in 2022, 331 cases of diphtheria were registered in Europe, one of which ended in death, a year earlier there was an outbreak of polio in Tajikistan, and in 2018 an unvaccinated child died of whooping cough in Latvia. In 2017‒2019gg. there was a measles outbreak in Europe, more than 200 thousand people fell ill,” Filippova gave examples from statistics from other countries. But Estonia did not stand aside either – remember, for example, the measles outbreak in Saaremaa in 2018. In the 21st century, we have not been spared by any rubella or mumps

Vaccination is safer than the disease

Irina Filippova explained that the task of the immune system is to recognize, remember and quickly begin the fight against pathogens with which the human body may come into contact during its life. “, is a less burdensome and safer way to achieve immunity than contracting an infectious disease. It is impossible to predict how severe the disease will be and what the consequences may be. Immune cells acquired through a vaccine recognize the causative agent of the disease and in most cases prevent the disease,” Filippova told

However, the myth persists that vaccination weakens the immune system. In fact, the opposite is true – vaccination activates and trains the immune system, allowing you to protect the body from infectious agents that we have not encountered before. “Vaccines cannot cause disease because they contain weakened or killed pathogens or their particles,” Filippova explained.

Disinformation influences people’s decisions

Irina Filippova stated that a lot of conflicting information about vaccination is being circulated on the Internet and in the media. “Vaccine opponents do a lot of harm by actively spreading disinformation through various media channels. The Estonian healthcare system is based on evidence-based medicine and science, which has sufficiently proven the effectiveness and safety of modern vaccines. When deciding whether to vaccinate your child, you should only rely on information from official sources of information (e.g. https://ta.vaktsineeri.ee) and, if necessary, seek advice from a specialist – especially your family doctor or nurse or your doctor . With specific questions, you can also seek advice from infectious disease doctors, the Health Board or the Drug Board,” Filippova recommended.

Why is it necessary to be vaccinated against infectious diseases in infancy or childhood? Irina Filippova explained that the purpose of such vaccination is to develop an optimal immune response. “The level of antibodies obtained from the mother decreases in the infant within a few months, so it is important to start vaccinating the child on time according to the vaccination schedule. It should be remembered that some infectious diseases are especially dangerous for infants and young children, for example, rotavirus enteritis (viral intestinal infection) can be very difficult for an infant to tolerate. For this age group, whooping cough is especially dangerous, most deaths are among babies under three months old, ”said Filippova.

Children whose parents refused to be vaccinated will soon become adults. This will allow them to make their own vaccination decisions, but can vaccinations missed in childhood still be made in adulthood? Irina Filippova: “If in childhood a person was not vaccinated against whooping cough, polio, measles, mumps, rubella, hepatitis B and HPV, in adulthood, vaccination against these diseases is possible, but at your own expense. The immunization plan provides adults with free vaccinations for diphtheria and tetanus. ” It should also be taken into account that vaccines may differ from childhood vaccines and their effectiveness may be lower, and the vaccination schedule may also be different. Adults are generally not vaccinated against Haemophilus influenzae type b, nor are they vaccinated with rotavirus and TB vaccines because they are indicated for children.

Why are we afraid of vaccinations?

MYTH Vaccines are not safe and their side effects are life-threatening.

REALITY Vaccines are biological drugs. The use of drugs is never completely safe, so the benefit must be weighed against the possible risk. The benefit of vaccines is to prevent infectious diseases and their complications, including death. A possible risk is the side effects caused by the vaccine. They are generally light and pass quickly. Serious side effects are very rare.

MYTH Vaccines contain hazardous substances.

REALITY Vaccines – consist of active ingredients and excipients. The active substances are killed or weakened bacteria or viruses or particles of their proteins. The active substances provide the development of immunity in the human body. Excipients enhance the effect of the vaccine and ensure the preservation of the properties of the vaccine and its stability. One such excipient is sorbitol, a natural component of fruits such as apples and pears.

MYTH Giving multiple vaccines at the same time or using multiple vaccines is harmful to humans.

REALITY Different vaccines can be administered at the same time, but in different areas of the body, because the dendritic cells activated by the virus or bacteria contained in the vaccine get from different injection sites to the lymph nodes in different parts of the body, i.e. the development of an immune response starts in different lymph nodes.

MYTH Vaccines are ineffective.

REALITY In Estonia, many infectious diseases, such as polio, have disappeared due to the fact that we had a high vaccination coverage for a long time.