Euvax b
PolandTable of Contents
Package leaflet: Information for the user
EUVAX B, 20 micrograms, injection suspension
Vaccinum hepatitidis B (ADNr)
Hepatitis B vaccine (rDNA)
Single-dose vaccine for adults
Please read the entire leaflet before using the vaccine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This vaccine has been prescribed for a specific individual and must not be passed on to others.
- If any adverse reactions occur in an adult or their child, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents:
- What EUVAX B vaccine is and what it is used for
- Important information before using EUVAX B vaccine
- How to use EUVAX B vaccine
- Possible side effects
- How to store EUVAX B vaccine
- Contents of the package and other information
1. WHAT EUVAX B VACCINE IS AND WHAT IT IS USED FOR
EUVAX B (20 micrograms dose in 1 ml) is an injection suspension containing the hepatitis B surface antigen (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 the hepatitis B virus.
The vaccine induces the production of specific antibodies against the hepatitis B surface antigen (anti-HBs). A level of anti-HBs antibodies considered protective against hepatitis B infection is regarded as being equal to or greater than 10 IU/L.
Vaccination of patients with occult 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 infection may remain undiagnosed and vaccination may occur during the incubation phase of the disease. In such cases, the vaccine may not prevent the onset of disease.
The vaccine does not protect against infections caused by other viruses, such as hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis E virus (HEV), or other microorganisms causing liver disease.
EUVAX B 20 micrograms (adult dose) is intended for use in adolescents (from age 16) and adults.
2. IMPORTANT INFORMATION BEFORE ADMINISTRATION OF EUVAX B VACCINE
When not to use EUVAX B vaccine
- If the patient is allergic (hypersensitive) to the active substance or to any of the other components of EUVAX B.
- In case of acute illness with high fever. In such cases, vaccination should be postponed.
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When to exercise special caution when administering EUVAX B vaccine
If adverse reactions described in section 4 or any other concerning reactions occurred 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.
Do not inject EUVAX B vaccine into the gluteal muscle or intradermally, as this route of administration does not ensure optimal immunological response.
Thiomersal is present (in trace amounts) in this product and it is possible that the patient may experience an allergic reaction. Inform the physician if the child has had or currently has any known allergic reactions. Also inform the physician if any health disturbances occurred after previous vaccination.
EUVAx B vaccine and other medicines
Tell the physician about all medicines currently taken or recently taken, including those obtained without a prescription, as well as any vaccinations.
The vaccine may be administered simultaneously with vaccines against tuberculosis, diphtheria, tetanus, pertussis, mumps, measles, rubella, and poliomyelitis. When administering different vaccines simultaneously, they should be given at different injection sites using separate syringes and needles.
EUVAx B vaccine may be administered simultaneously with hepatitis B immunoglobulin, but at different injection sites.
Pregnancy, breastfeeding and fertility
Consult a physician before using any medicine. The effect of the HBs antigen on fetal development has not been studied. As with other inactivated vaccines, the risk is considered negligible. EUVAX B may be used during pregnancy only when there is a clear indication for immunization and when the benefits to the mother outweigh the potential risk to the fetus.
Consult a physician before using any medicine.
Clinical studies have not evaluated the effect of EUVAX B vaccine administered to mothers on breastfed infants. There are no established contraindications to vaccinating breastfeeding women.
Driving and operating machinery
There are no data available regarding the effect of the vaccine on driving and operating machinery.
3. HOW TO USE THE EUVAX B VACCINE
The Euvax B vaccine must be administered only intramuscularly, into the deltoid muscle.
The Euvax B vaccine should not be injected into the gluteal muscle or intradermally, as these routes of
administration do not guarantee an optimal immune response. The vaccine must not be administered
intravenously.
The primary vaccination schedule consists of 3 doses:
- first dose: at the chosen time
- second dose: 1 month after the first dose
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- third dose: 6 months after the first dose.
Booster vaccination
Based on study results, the World Health Organization (WHO) does not recommend booster doses for individuals who have adequately responded to the 3-dose vaccination series, as they are protected against hepatitis B for 15 years. Despite observed declines in antibody titers, vaccinated individuals remain protected against hepatitis B due to established immunological memory.
Officially valid recommendations regarding booster vaccination should be followed.
In special circumstances, to achieve a rapid and optimal immune response—for example, in newborns born to HBs antigen-positive mothers, in individuals exposed to the virus (e.g., needlestick injury), or in travelers to regions with high risk of infection—the following (alternative) vaccination schedule may be used:
- first dose: at the chosen time
- 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 vaccine doses may be required for hemodialysis patients or individuals with immune deficiencies, as they may fail to develop a protective level of antibodies (≥10 IU/L) after primary vaccination. In these patients, antibody titer measurement is recommended.
In cases of confirmed or suspected exposure to hepatitis B virus (e.g., infection through broken skin or mucous membranes; in a newborn born to an HBs antigen-positive mother), human hepatitis B immunoglobulin (HBIg) should be administered simultaneously with the first dose of Euvax B. These injections must be given at two separate sites.
Overdose of Euvax B vaccine
There are no data regarding adverse effects of the Euvax B vaccine in case of overdose.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, the EUVAX B vaccine may cause adverse reactions, although not everyone will experience them.
The frequency of occurrence within a given system is defined according to the following criteria:
very common (occurring more than 1 in 10 doses), common (occurring more than 1 in 100 but less than 1 in 10 doses),
uncommon (occurring more than 1 in 1,000 but less than 1 in 100 doses), rare (occurring more than 1 in 10,000 but less than 1 in 1,000 doses),
very rare (occurring less than 1 in 10,000 doses, including single cases).
Very common:
- Pain at the injection site, resolving within 2 days
Common:
- Bruising, induration, swelling, tenderness, inflammation at the injection site, resolving within 2 days, fever, crying without apparent cause, abdominal pain, decreased appetite, diarrhoea, vomiting, insomnia, nervousness, irritability, drowsiness, erythematous rash, erythema
Uncommon:
- Neonatal jaundice, oral candidiasis (thrush), rhinitis, erythema, maculopapular rash, pityriasis rosea
Rare:
- Malaise, fatigue, headache, dizziness, transient increase in liver enzyme activity, muscle pain, arthralgia
Very rare:
- Optic neuritis, facial nerve paralysis, Guillain-Barré syndrome, exacerbation of multiple sclerosis
Adverse reactions reported after vaccine marketing authorization include:
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- Abscess at 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, diarrhoea, nausea, abdominal pain
- Erythema, urticaria, rash, pruritus, petechiae
- Myalgia, limb pain, muscle spasms, muscle and joint stiffness, arthralgia
- Injection site reactions (erythema, swelling, pain, inflammation, oedema, pruritus, bruising, induration, warmth sensation), fever, irritability, malaise, weakness, fatigue, chills
In preterm infants (born at or before 28 weeks of gestation), prolonged breathing pauses may occur within 2–3 days after vaccination.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a doctor.
5. HOW TO STORE EUVAX B VACCINE
Keep out of the reach and sight of children.
Store at 2°C - 8°C (in a refrigerator). 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. OTHER INFORMATION
What EUVAX B vaccine contains
The active substance is:
Hepatitis B virus surface antigen (HBsAg)* – 20 micrograms, adsorbed on
aluminium hydroxide, hydrated – 0.5 milligrams Al
*Produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)
The other components are:
potassium dihydrogen phosphate, disodium phosphate heptahydrate, sodium chloride, water for injections.
What EUVAX B vaccine looks like and contents of the pack
Vial 1 ml (1 dose)
Available pack sizes:
Pack: 1, 10 or 20 vials.
Marketing Authorisation Holder
LG Chem Life Sciences Poland Sp. z o.o.
ul. Grzybowska 80/82
00-844 Warsaw
Tel. 0 781 111 100
Name and address of the holder of the import licence, where batch release takes place
LG Chem Life Sciences Poland Sp. z o.o.
ul. Grzybowska 80/82
00-844 Warsaw
Tel. 0 781 111 100
Polypharm S.A.
ul. Julianowska 41
05-500 Piaseczno
Tel. 22 832 34 78
e-mail: [email protected]
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Information intended exclusively for medical or healthcare personnel:
During storage, a white sediment and a clear, colourless liquid above may form.
Immediately before administration, the vaccine should be thoroughly mixed and inspected for the presence of foreign particles and (or) any physical changes. If abnormalities in the appearance of the vaccine are observed, it must not be administered, and direct contact with the marketing authorisation holder is recommended.
© 2024 LG Chem, Ltd. All rights reserved.