Euvax B

Package Leaflet: Information for the User

EUVAX B, 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)
Hepatitis B vaccine (recombinant DNA)
Single-dose vaccine for children

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for you, do not pass it on to others.
• If the adult or child experiences any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What EUVAX B vaccine is and what it is used for
• 2. Important information before using EUVAX B vaccine
• 3. How to use EUVAX B vaccine
• 4. Possible side effects
• 5. How to store EUVAX B vaccine
• 6. Contents of the pack and other information

1. WHAT EUVAX B VACCINE IS AND WHAT IT IS USED FOR

EUVAX B (10 micrograms in 0.5 ml) is a suspension for injection that contains the surface antigen of the hepatitis B virus (HBsAg) produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae).
The vaccine is intended for active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of the hepatitis B virus.
The vaccine induces the production of specific antibodies against the surface antigen of the hepatitis B virus (anti-HBs). It is considered that an anti-HBs antibody level of 10 mIU/ml or higher is protective against hepatitis B virus infection.
Vaccination of patients with latent or chronic hepatitis B virus infection may not affect the course of the disease.
Due to the long incubation period of the hepatitis B virus, there is a possibility that the infection may not be recognized and the vaccine may be administered during the incubation period of the disease. In such cases, the vaccine may not prevent the disease.
The vaccine does not prevent infections caused by other types of viruses, such as hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis E virus (HEV), and other microorganisms that cause liver disease.
EUVAX B 10 micrograms (pediatric dose) is indicated for use in newborns, infants, children up to 15 years of age.

2. IMPORTANT INFORMATION BEFORE USING EUVAX B VACCINE

When not to use EUVAX B vaccine

• If the patient is hypersensitive (allergic) to the active substance or any of the other ingredients of EUVAX B vaccine.
• In case of acute disease with high fever. In these cases, vaccination should be postponed.

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When to use EUVAX B vaccine with caution

If the side effects described in section 4 or any other disturbing reactions occurred after the previous dose of the vaccine.
In patients with multiple sclerosis, as any stimulation of the immune system may exacerbate the disease. In these patients, the benefit of vaccination should be weighed against the risk of exacerbating the disease. As with all injectable vaccines, appropriate treatment should always be available in case of rare anaphylactic reactions after vaccination.
The vaccine should not be injected into the buttock or subcutaneously, as this method of administration does not guarantee an optimal immune response.
Thiomersal is present (in trace amounts) in this product and it is possible that the patient may experience an allergic reaction. The doctor should be informed if the child has had any known allergic reactions. The doctor should also be informed if there have been any health problems after the previous vaccination.

EUVAX B vaccine and other medicines

Tell your doctor about all medicines you are taking or have recently taken, including those prescribed by your doctor and any purchased without a prescription, as well as any vaccinations.
The vaccine can be administered at the same time as vaccines against tuberculosis, diphtheria, tetanus, pertussis, measles, mumps, rubella, and poliomyelitis. When administering different vaccines at the same time, they should be administered at different injection sites using different syringes and needles.
EUVAX B vaccine can be administered at the same time as hepatitis B immune globulin, but at different injection sites.

Pregnancy, breastfeeding, and fertility

Before using any medicine, consult your doctor. The effect of the HBsAg antigen on fetal development has not been studied. As with other inactivated vaccines, the risk is considered negligible. EUVAX B vaccine can be used during pregnancy only when there is a clear indication for immunization and the benefits to the mother outweigh the potential risk to the fetus.
Before using any medicine, consult your doctor.
The effect of EUVAX B vaccine administered to mothers on breastfed infants has not been studied in clinical trials. There are no contraindications to vaccinating breastfeeding women.

Driving and using machines

There are no data on the effects of the vaccine on driving and using machines.

3. HOW TO USE EUVAX B VACCINE

EUVAX B vaccine should be administered only intramuscularly, in the deltoid muscle in children or in the anterolateral thigh in newborns, infants, and younger children.
The vaccine should not be injected into the buttock or subcutaneously, as this method of administration does not guarantee an optimal immune response. The vaccine should not be administered intravenously.
Primary vaccination consists of 3 doses:

• First dose: at the chosen date

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• Second dose: 1 month after the first dose
• Third dose: 6 months after the first dose.

Booster vaccination
The World Health Organization (WHO) does not recommend the use of booster doses in individuals who have responded properly to 3 doses of the vaccine, as they are protected against the disease for 15 years. Despite the decrease in antibody titers, the vaccinated person is protected against hepatitis B virus infection due to the immune memory.

Follow the official recommendations for booster vaccination.

In special cases, to achieve an optimal immune response as quickly as possible, e.g., in newborns born to mothers who are HBsAg carriers, in individuals exposed to hepatitis B virus infection (e.g., needlestick injury), or in individuals traveling to areas with high risk of infection, the following (alternative) vaccination schedule can be used: - first dose: at the chosen date - second dose: 1 month after the first dose - third dose: 2 months after the first dose.
A fourth dose should be administered 12 months after the first dose to ensure long-term protection.
Additional doses of the vaccine may be required for patients undergoing hemodialysis or with immune system disorders, as they may not produce a protective level of antibodies (≥10 mIU/ml) after primary vaccination. In these patients, it is recommended to determine the antibody titer.
In cases of suspected or confirmed exposure to hepatitis B virus infection (e.g., infection through damaged skin or mucous membranes; in newborns born to mothers who are HBsAg carriers), the first dose of EUVAX B vaccine should be administered simultaneously with hepatitis B immune globulin (HBIg). These injections must be administered at two different sites.
There are no data on the adverse effects of overdosing with EUVAX B vaccine.

4. POSSIBLE SIDE EFFECTS

Like all medicines, EUVAX B vaccine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows: very common (affects more than 1 in 10 doses of the vaccine), common (affects more than 1 in 100 but less than 1 in 10 doses), uncommon (affects more than 1 in 1,000 but less than 1 in 100 doses), rare (affects more than 1 in 10,000 but less than 1 in 1,000 doses), very rare (affects less than 1 in 10,000 doses, including isolated cases).
Very common:
pain at the injection site, resolving within 2 days
Common:
hematoma, induration, swelling, tenderness, inflammation at the injection site, resolving within 2 days, fever, unexplained crying, abdominal pain, decreased appetite, diarrhea, vomiting, insomnia, irritability, drowsiness, rash, erythema
Uncommon:
jaundice in newborns, oral thrush, rhinitis, rash, urticaria, erythema multiforme
Rare:
malaise, fatigue, headache, dizziness, transient increase in liver enzyme activity, muscle pain, arthritis
Very rare:
optic neuritis, facial palsy, Guillain-Barré syndrome, exacerbation of multiple sclerosis

• Abscess at the injection site, pharyngitis, rhinitis
• Lymphadenopathy, thrombocytopenia
• Hypersensitivity reactions, anaphylactic reactions
• Decreased appetite, anorexia
• Restlessness, insomnia
• Seizures, hypotonia, drowsiness, headache, dizziness, syncope
• Tachycardia
• Hypotension
• Cough
• Vomiting, diarrhea, nausea, abdominal pain
• Erythema, urticaria, rash, pruritus, petechiae
• Muscle pain, limb pain, muscle spasms, muscle stiffness and joint stiffness, arthralgia
• Reactions at the injection site (erythema, swelling, pain, inflammation, induration, warmth, pruritus, hematoma, induration), fever, irritability, malaise, weakness, fatigue, chills

In premature infants (born at 28 weeks of gestation or earlier), within 2-3 days after vaccination, longer pauses between breaths may occur.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE EUVAX B VACCINE

Keep out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Do not use EUVAX B vaccine after the expiry date stated on the carton and vial.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. OTHER INFORMATION

What EUVAX B vaccine contains
The active substance of the vaccine is:
Hepatitis B surface antigen (HBsAg)* - 10 micrograms, adsorbed on aluminum hydroxide - 0,25 milligrams Al
*produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)
© 2024 LG Chem, Ltd. All rights reserved.
The vaccine also contains: potassium dihydrogen phosphate, disodium phosphate heptahydrate, sodium chloride, water for injections.

What EUVAX B vaccine looks like and contents of the pack

Vial of 0.5 ml (1 dose)
Available packs:
Pack: 1, 10 or 20 vials.

Marketing authorization holder

LG Chem Life Sciences Poland Sp. z o. o.
Grzybowska Street 80/82
00-844 Warsaw
phone: 0 781 111 100

Name and address of the manufacturer responsible for batch release

LG Chem Life Sciences Poland Sp. z o. o.
Grzybowska Street 80/82
00-844 Warsaw
phone: 0 781 111 100
Polypharm S.A.
Julianowska Street 41
05-500 Piaseczno
phone: 22 832 34 78
e-mail: polypharm@polypharm.com.pl

Date of revision of the package leaflet:

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Information intended for healthcare professionals only:
During storage, a white precipitate and a clear colorless liquid may form above.
Before administration, the vaccine should be shaken thoroughly and inspected for any visible foreign particles and/or physical changes. If any abnormalities are observed in the appearance of the vaccine, the vaccine should not be administered and the marketing authorization holder should be contacted directly.
© 2024 LG Chem, Ltd. All rights reserved.