Euvax B

Package Leaflet: Information for the User

EUVAX B, 20 micrograms, suspension for injection

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

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

• Keep this 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 their 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 Leaflet:

• 1. What is EUVAX B vaccine and what is it 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 IS EUVAX B VACCINE AND WHAT IS IT USED FOR

EUVAX B (20 micrograms in 1 ml) is a suspension for injection that contains the surface antigen of 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 subtypes of hepatitis B virus.
The vaccine induces the production of specific antibodies against the surface antigen of 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 hepatitis B virus, there is a possibility of unrecognized infection and vaccination 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 20 micrograms (adult dose) is intended for use in adolescents (from 16 years of age) and adults.

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 illness with high fever. In these cases, vaccination should be postponed.

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When to use EUVAX B vaccine with caution

If the patient has experienced the side effects described in section 4 or any other concerning reactions after a 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 disease exacerbation. As with all injectable vaccines, appropriate treatment should always be available in case of rare anaphylactic reactions following 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 previous vaccination.

EUVAX B vaccine and other medicines

Tell your doctor about all medicines you are taking or have recently taken, including those that are available without a prescription and vaccinations.
The vaccine can be administered simultaneously with vaccines against tuberculosis, diphtheria, tetanus, pertussis, measles, mumps, rubella, and poliomyelitis. When administering different vaccines at the same time, they should be injected into different parts of the body using different syringes and needles.
EUVAX B vaccine can be administered simultaneously with hepatitis B immune globulin, but in different parts of the body.

Pregnancy, breastfeeding, and fertility

Before using any medicine, consult your doctor. The effect of HBsAg on fetal development has not been studied. As with other inactivated vaccines, the risk is considered negligible. EUVAX B 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 only be administered intramuscularly, into the deltoid muscle.
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 must not be administered intravenously.
Primary vaccination consists of 3 doses:

• First dose: at the chosen date
• Second dose: 1 month after the first dose

© 2024 LG Chem, Ltd. All rights reserved.

• Third dose: 6 months after the first dose.

Booster vaccination
The World Health Organization (WHO) does not recommend booster doses for 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 immune memory.

Follow the officially recommended guidelines for booster vaccination.

In special cases, to achieve an optimal immune response quickly, 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, antibody titers should be determined.
In cases of confirmed or suspected exposure to hepatitis B virus infection (e.g., infection through damaged skin or mucous membrane; in newborns born to mothers who are HBsAg carriers), the first dose of EUVAX B should be administered simultaneously with hepatitis B immune globulin (HBIg). These injections must be given in two different locations.
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, redness at the injection site, resolving within 2 days, fever, crying without apparent reason, abdominal pain, decreased appetite, diarrhea, vomiting, insomnia, irritability, fussiness, rash, erythema
Uncommon:
jaundice in newborns, oral thrush, rhinitis, rash, urticaria, erythema multiforme
Rare:
malaise, fatigue, headache, dizziness, transient increase in liver enzymes, muscle pain, arthritis
Very rare:
optic neuritis, facial palsy, Guillain-Barré syndrome, exacerbation of multiple sclerosis
Side effects reported after the vaccine was placed on the market include:

• Abscess at the injection site, pharyngitis, rhinitis
• Lymphadenopathy, thrombocytopenia
• Hypersensitivity reactions, anaphylactic reactions
• Decreased appetite, anorexia
• Restlessness, insomnia
• Seizures, hypotonia, somnolence, 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, arthritis
• Reactions at the injection site (erythema, swelling, pain, inflammation, induration, warmth, itching, 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 side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather more information on the safety of the vaccine.
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. This 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)* - 20 micrograms, adsorbed on hydrated aluminum hydroxide - 0,5 mg Al
*produced by recombinant DNA technology in yeast cells ( Saccharomyces cerevisiae)
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 1 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, importers, or distributors

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 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 particles 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.