Engerix b

Patient Information Leaflet

Engerix B 10 micrograms – suspension for injection
Hepatitis B vaccine (rDNA)
Vaccinum hepatitidis B (ADNr)
Please read all of this leaflet carefully before you are given the vaccine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.

Table of contents:

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

1. What Engerix B vaccine is and what it is used for

Engerix B is a vaccine used to prevent hepatitis B virus infection (HBV).
Engerix B 10 micrograms (paediatric dose) is indicated for use in newborns, infants, children and adolescents up to and including 15 years of age.
In children aged 11 to 15 years inclusive, Engerix B 20 micrograms (adult dose) may also be used provided that the risk of hepatitis B virus infection during the vaccination course is low and there is certainty that the 2-dose vaccination schedule will be completed. If these conditions cannot be met (e.g. haemodialysis patients, individuals travelling to regions where hepatitis B is prevalent, or individuals in close contact with infected persons), the standard Engerix B 10 microgram (paediatric dose) vaccination should be used. For further details, refer to the Engerix B 20 micrograms patient information leaflet.
The vaccine stimulates the body to produce its own immunity by generating antibodies against the hepatitis B virus.
Hepatitis B virus infection (HBV): This disease is caused by the hepatitis B virus, which causes inflammation of the liver. The virus is present in body fluids such as blood, semen, vaginal secretions and saliva (sputum) of infected individuals. The disease may be asymptomatic for a period of 6 weeks to 6 months after infection. Some infected individuals may have no symptoms or only mild flu-like symptoms. Typically, infected individuals experience general malaise and fatigue. They may have nausea, vomiting, dark-coloured urine, pale skin, jaundice (yellowing of the skin and/or sclera (whites of the eyes)) and other symptoms, which may require hospital treatment.
Most adults fully recover, but some individuals, especially children, may remain infected despite having no symptoms. These individuals become carriers of the hepatitis B virus. Carriers can transmit the infection to others and are at risk of developing serious liver diseases such as cirrhosis and liver cancer.
Vaccination is the best way to prevent the disease. None of the components of the vaccine are infectious.

2. Important information before using the Engerix B vaccine

When not to use Engerix B

• if the patient is allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6). Symptoms of allergy may include itchy rash, difficulty breathing, swelling of the face or tongue;
• if the patient has a high fever (body temperature above 38.0°C). A mild infection, such as a cold, should not prevent vaccination, but the doctor should be informed about it.

Warnings and precautions
Inform the doctor if the patient:

• has previously experienced health problems after vaccinations, especially after hepatitis B virus vaccines (including allergic reactions);
• has bleeding problems or bruises easily.

Fainting may occur after or even before any injectable vaccine is given (particularly
in adolescents). Therefore, inform the doctor or nurse if the child has ever fainted during an injection.
Use of Engerix B vaccine in patients with chronic liver disease or reduced
immunity:
Patients with chronic liver disease, including hepatitis C virus carriers, may be vaccinated against hepatitis B virus.
Engerix B can also be used in individuals with reduced immunity, including those infected with HIV and those with kidney failure, including those on haemodialysis. It should be noted that they may not develop sufficient protection after a complete vaccination course and may require additional vaccine doses.
It has also been observed that several factors may reduce the effectiveness of hepatitis B vaccination. These include: male sex, obesity, smoking, route of vaccine administration, and certain chronic diseases.
In such cases, additional vaccine doses may also be necessary.
In all these cases, the doctor will decide whether additional blood tests are needed and determine the appropriate timing and method of vaccination.
As with other vaccines, it is possible that not all vaccinated individuals will develop a protective immune response.

Engerix B and other medicines
Inform the doctor about all medicines recently taken and any other vaccines administered.
Engerix B may be given simultaneously with vaccines against tuberculosis, Haemophilus influenzae type b (Hib), hepatitis A, polio, measles, mumps, rubella, diphtheria, tetanus, and pertussis, provided that the injection sites are different.
Simultaneous administration of Engerix B vaccine and standard dose of hepatitis B immunoglobulin at different body sites does not affect the level of antibodies produced.
Engerix B vaccine may be administered at the same time as the human papillomavirus (HPV) vaccine.
Concomitant administration of Engerix B and Cervarix (HPV vaccine) showed no clinically significant impact on antibody production against HPV antigens.

Pregnancy, breastfeeding and fertility
Consult a doctor before using any medicine during pregnancy or breastfeeding.
The effect of the vaccine on fetal development has not been evaluated. It is believed that, like other inactivated viral vaccines, Engerix B does not pose a significant risk to the fetus.
Engerix B may be administered to a pregnant woman only if there are clear indications for immunization and the benefits to the mother outweigh the potential risks to the fetus.
Clinical studies have not assessed the effect of Engerix B vaccine administered to mothers on breastfed infants. There is also no information on whether the hepatitis B virus antigen contained in the vaccine is excreted in breast milk. Vaccination of breastfeeding mothers is not contraindicated.
The doctor should discuss the benefits and potential risks associated with vaccination with Engerix B during pregnancy and breastfeeding.

Driving and operating machinery
It is unlikely that the Engerix B vaccine has a significant effect on the ability to drive or operate machinery. However, if the patient feels unwell, they should not drive or operate machinery.

Other information
Due to the long incubation period of hepatitis B virus infection, vaccination may sometimes occur during the incubation phase of the disease. In such cases, the vaccine may not prevent the development of infection.
Administration of Engerix B vaccine does not protect against liver infections caused by other pathogens.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the vaccine is considered "sodium-free".

3. How to use the Engerix B vaccine

The Engerix B vaccine should be administered intramuscularly into the upper arm in children and adolescents,
or into the thigh in newborns, infants, and younger children.
The Engerix B vaccine must not be administered into the gluteal muscle or intradermally, as this may result in inadequate protection.
Exceptionally, in patients with coagulation disorders due to the risk of bleeding following intramuscular administration, subcutaneous administration of the vaccine may be considered.
Under no circumstances should the vaccine be administered intravenously.

The following primary vaccination schedules are recommended:

3-dose schedule (0, 1, 6 months):
This schedule results in a slower development of optimal immunological response but ensures a higher level of antibodies against hepatitis B virus.

• First dose: at any time
• Second dose: 1 month later
• Third dose: 6 months after the first dose

Accelerated schedule (0, 1, 2 months):
This schedule allows for rapid achievement of optimal immunological response and ensures better compliance from the vaccinated individual. A fourth dose is recommended 12 months after the first dose.

• First dose: at any time
• Second dose: 1 month later
• Third dose: 2 months after the first dose
• Fourth dose: 12 months after the first dose

In children aged 11 to 15 years inclusive, Engerix B 20 micrograms (adult dose) may also be used according to a 2-dose schedule (0, 6 months), provided that the risk of hepatitis B virus infection during the vaccination course is low and there is certainty that the vaccination series will be completed. For detailed information, see the package leaflet of Engerix B 20 micrograms.

It is important to ensure that the full vaccination course consisting of three or four doses of vaccine has been received.
If all doses are not administered, the vaccinated person may not be fully protected against the disease.
The physician should inform about the possible need for additional doses and booster doses.
If the next dose of vaccine has not been received on the scheduled date, it is essential to consult the physician to arrange another visit.

4. Possible adverse reactions

Like any medicine, the Engerix B vaccine may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported after vaccination:

♦ Very common (may occur in 1 out of 10 doses of the vaccine or more frequently):

• headache
• pain and redness at the injection site, feeling of fatigue
• irritability

♦ Common (less than 1 in 10 doses of the vaccine):

• drowsiness
• nausea, vomiting, diarrhoea, abdominal pain
• decreased appetite
• fever (37.5°C or higher), malaise, swelling at the injection site, other injection site reactions (such as induration)

♦ Uncommon (less than 1 in 100 doses of the vaccine):

• dizziness
• muscle pain
• influenza-like symptoms

♦ Rare (less than 1 in 1,000 doses of the vaccine):

• generalized lymphadenopathy
• paresthesia (tingling sensation)
• urticaria, pruritus, rash
• joint pain

♦ Very rare (less than 1 in 10,000 doses of the vaccine):
Adverse reactions reported after vaccine introduction to the market:

• thrombocytopenia (bleeding or bruising more easily than usual due to a decrease in platelet count)
• encephalitis, encephalopathy, convulsions, paralysis, neuritis, neuropathies, sensory disturbances
• erythema multiforme, angioedema, lichen planus (skin and subcutaneous tissue disorders)
• arthritis, muscle weakness
• meningitis
• vasculitis, hypotension
• in very premature infants (born at or before 28 weeks of gestation), prolonged apnoea (pauses in breathing) may occur within 2–3 days after vaccination
• allergic reactions, including anaphylactic and anaphylactoid reactions, and serum sickness-like reactions. These may present as localized or generalized rash (which may be itchy or vesicular), eyelid and facial swelling, difficulty breathing or swallowing, sudden drop in blood pressure, or loss of consciousness. These reactions may occur even before leaving the doctor's office. Immediate medical attention must be sought in all such cases.

If any of the events described above do not resolve or worsen, inform a doctor.
If any adverse effects occur that are not listed in this leaflet, inform a doctor.
Do not be alarmed by this list of possible adverse reactions. It is possible that no adverse reactions occur after vaccination.

Reporting of adverse reactions
If any adverse effects occur, including any 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.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the Engerix B vaccine

Store in a refrigerator (2ºC – 8ºC).
Do not freeze.
Keep the vaccine out of the sight and reach of children.
Store the vaccine in its original packaging to protect it from light.
Do not use this vaccine after the expiry date stated on the packaging after
"EXP". The expiry date refers to the last day of the stated month.
The abbreviation "Lot" indicates the product batch number.

6. Contents of the pack and other information

What Engerix B vaccine contains

• The active substance in Engerix B vaccine is:

Hepatitis B surface antigen (HBsAg) 10 micrograms
adsorbed on aluminium hydroxide, hydrated, total: 0.25 milligrams Al
obtained from cultures of yeast cells (Saccharomyces cerevisiae) using
recombinant DNA technology

• Other components are: sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections.

What Engerix B vaccine looks like and contents of the pack
Engerix B (10 microgram dose in 0.5 ml) is a suspension for injection in a vial or pre-filled syringe.
Available pack sizes:

• Single-dose pre-filled syringes containing 1, 10 or 25 units,
• Single-dose vials containing 1, 10 or 100 units, with or without syringe.

Not all pack types may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89
1330 Rixensart, Belgium
For further information, please contact the local representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00

Information intended exclusively for healthcare professionals:

During storage, a white sediment and a clear, colourless liquid above may form.
Immediately before administration, the vaccine should be shaken vigorously to obtain a slightly
cloudy suspension, and the vaccine should be inspected for the presence of particles and (or) any
change in appearance. If any of these abnormalities are observed, the vaccine must not be used.

Instructions for the pre-filled syringe

Luer Lock adapter
Hold the pre-filled syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it counterclockwise.
Plunger
Barrel
Cap
Needle adapter
Attach the needle to the pre-filled syringe by connecting the needle adapter to the Luer Lock adapter (LLA) and turning it one-quarter turn clockwise until a click is felt, indicating that the needle is securely locked.
The plunger must not be removed from the syringe barrel. If this occurs, the vaccine must not be administered.

Disposal
Any unused product or waste material must be disposed of in accordance with local regulations.