Engerix-B Junior 10 micrograms/0.5 ml, suspension for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Engerix-B Junior 10 micrograms/0.5 ml, injectable suspension in a pre-filled syringe

Hepatitis B vaccine (rDNA, adsorbed) (HBV)

Read all of this leaflet carefully before you/your child starts receiving this vaccine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed only for you/your child; do not pass it on to others.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Throughout this leaflet, any reference to "you" may also mean "your child".

Contents of this leaflet

1. What Engerix-B Junior is and what it is used for

2. What you need to know before you receive Engerix-B Junior

3. How Engerix-B Junior is administered

4. Possible side effects

5. How to store Engerix-B Junior

6. Contents of the pack and other information

1. What Engerix-B Junior is and what it is used for

Engerix-B Junior is a vaccine used to protect against hepatitis B infection. It may also help protect against hepatitis D infection.

This vaccine can be given to newborns, children, and adolescents up to and including 15 years of age.

Hepatitis B is an infectious liver disease caused by a virus. Some people carry the hepatitis B virus in their body but cannot eliminate it. These individuals can continue to infect others and are known as carriers. The disease spreads when the virus enters the body through contact with bodily fluids, most often blood, from an infected person.

If a mother is a carrier of the virus, she may transmit it to her child during childbirth. In addition, it is possible to contract the virus from a carrier through, for example, unprotected sexual intercourse, sharing of injectable syringes, or medical treatment with equipment that has not been properly sterilized.

Main signs of the disease include: headache, fever, malaise (nausea), and jaundice (yellowing of the skin and eyes), although approximately three out of every 10 patients show no symptoms. Among those infected with hepatitis B, one in every 10 adults and up to nine out of every 10 children will become carriers of the virus and are likely to develop severe liver damage and, in some cases, liver cancer.

How Engerix-B Junior works

Engerix-B Junior contains a small amount of the outer coat of the hepatitis B virus. This outer coat is non-infectious and cannot cause the disease.

• When the vaccine is administered, it will stimulate the body's immune system to prepare it to protect against this virus in the future.
• Engerix-B Junior will not protect you if you are already infected with the hepatitis B virus.
• Engerix-B Junior can only help protect you against infection by the hepatitis B virus.

2. What you need to know before you receive Engerix-B Junior

Do not administer Engerix-B Junior:

• If you are allergic (hypersensitive) to Engerix-B Junior or to any of the other components of this vaccine (listed in section 6).
• If you have a fever (high body temperature).

Engerix-B Junior must not be given if any of the above conditions apply to you. If you are unsure, speak with your doctor or pharmacist before receiving Engerix-B Junior. Inform your doctor or pharmacist if you have any allergies or if you have ever experienced health problems after receiving a vaccine.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Engerix-B Junior if you:

• Are on dialysis due to kidney problems or if you have a disease that may affect your immune system.

Patients requiring dialysis, those with chronic liver disease, hepatitis C carriers, or those who are HIV positive may also receive Engerix-B Junior. This is because hepatitis B infections can be severe in these patients. More information about kidney problems and dialysis can be found in section 3.

If you are unsure whether any of the above conditions apply to you, consult your doctor before receiving Engerix-B Junior.

Fainting (especially in adolescents) may occur before or after any injection; therefore, inform your doctor or nurse if you have previously fainted after receiving an injection.

Like other vaccines, Engerix-B Junior may not fully protect you against hepatitis B. A combination of factors such as advanced age, sex, overweight, smoking, and certain chronic conditions may reduce the immune response to the vaccine. If any of these apply to you, your doctor may decide to perform a blood test or administer additional doses of Engerix-B Junior to ensure you are protected.

Use of Engerix-B Junior with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Engerix-B Junior can be administered at the same time as most routine vaccines. Your doctor will ensure that the vaccines are injected separately and at different sites on the body.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Engerix-B Junior will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you do not feel well.

Engerix-B Junior contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially "sodium-free".

3. How Engerix-B Junior is administered

How your vaccine is administered

Your doctor will administer the recommended dose of Engerix-B Junior.

Engerix-B Junior will be given:

• as an injection into the muscle of the upper arm in children and adolescents
• as an injection into the thigh muscle in newborns and young children
• as an injection under the skin if you bruise easily or have bleeding disorders.

How much is administered

You will receive a series of Engerix-B Junior injections. Once you have completed the injection schedule, long-term protection against hepatitis B can be expected.

• Newborns, children, and adolescents up to and including 15 years of age normally receive the 10 microgram/0.5 ml vaccine.

There are several alternative administration schedules for Engerix-B Junior. Your doctor will choose the most appropriate schedule for you.

Schedule 1 – for newborns, children, and adolescents up to and including 15 years of age

First injection – now
Second injection – 1 month after the first injection
Third injection – 6 months after the first injection

Schedule 2 – for newborns, children, and adolescents up to and including 15 years of age

First injection – now
Second injection – 1 month after the first injection
Third injection – 2 months after the first injection
Fourth injection – 12 months after the first injection

• Schedule 2 allows Engerix-B Junior to be administered at the same time as other routine childhood vaccines in newborns.
• This schedule may also be used if vaccination is due to recent exposure to hepatitis B, as it will provide faster protection.

It is very important that you attend your appointments to receive your injections according to the recommended schedule. If you have any questions about the amount of vaccine to be administered, consult your doctor.

Vaccination and childbirth

If you have hepatitis B and have just given birth, either Schedule 1 or Schedule 2 may be used to vaccinate your child.

• Your doctor will also decide whether to administer hepatitis B immunoglobulins (human antibodies) to your child at the time of the first injection. This will help protect your child from hepatitis B. These will be given at a different injection site.

Kidney problems and dialysis

If your child has a kidney problem or is undergoing dialysis, your doctor may decide to perform a blood test or administer additional doses of the vaccine to ensure your child is protected.

4. Possible adverse effects

Like all vaccines, this vaccine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this vaccine:

Allergic reactions

If you have an allergic reaction, seek medical attention immediately. Signs may include:

• swelling of the face
• low blood pressure
• difficulty breathing
• skin turning blue
• loss of consciousness.

These signs usually begin shortly after the injection is administered. Seek immediate medical attention if they occur after you have left the clinic.

Other adverse effects include:

Very common (may occur in more than 1 in 10 doses of the vaccine): headache, pain and redness at the injection site, feeling tired, irritability.

Common (may occur in up to 1 in 10 doses of the vaccine): numbness, nausea or vomiting, diarrhoea or abdominal pain, loss of appetite, fever (high body temperature), feeling generally unwell, swelling at the injection site, reactions at the injection site such as induration.

Uncommon (may occur in up to 1 in 100 doses of the vaccine): dizziness, muscle pain, flu-like symptoms.

Rare (may occur in up to 1 in 1,000 doses of the vaccine): swollen glands, hives, skin rash and itching, joint pain, tingling.

Adverse effects reported during the marketing of Engerix-B Junior include: easy bruising and inability to stop bleeding if cut, low blood pressure, inflammation of blood vessels, sudden swelling of the face around the mouth and throat area (angioneurotic oedema), inability to move muscles (paralysis), inflammation of nerves (neuritis) which may cause loss of sensation or numbness, including temporary inflammation of nerves causing pain, weakness and paralysis in the limbs, often progressing to the chest and face (Guillain-Barré syndrome), a nerve disease of the eye (optic neuritis), multiple sclerosis, difficulty moving arms or legs (neuropathy), inflammation of the brain (encephalitis), degenerative brain disease (encephalopathy), infection around the brain (meningitis), seizures, loss of skin sensitivity to pain or touch (hypoesthesia), purple or purplish-red spots on the skin (lichen planus), red or purple spots on the skin, joint pain and stiffness (arthritis), muscle weakness.

In very premature newborns (at 28 weeks of gestation or earlier), periods between breaths may be longer than normal during the 2–3 days following vaccination.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Engerix-B Junior

• Keep this vaccine out of the sight and reach of children.
• Do not use this vaccine after the expiry date stated on the label and packaging, after EXP. The expiry date is the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C).
• Do not freeze.
• Keep in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Engerix-B Junior

• The active substance is the outer coat protein of the hepatitis B virus. Each dose contains 10 micrograms/0.5 mL of protein composed of this outer coat adsorbed onto aluminium hydroxide hydrate.
• The other components are sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate, and water for injections.

Appearance of the product and contents of the pack

Engerix-B Junior is a white, turbid injectable liquid.

Engerix-B Junior (10 micrograms/0.5 mL) is available in a 1-dose pre-filled syringe with or without separate needles; pack sizes of 1 and 10.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel.: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1330 Rixensart, Belgium

or

SmithKline Beecham, S.A., Carretera de Ajalvir, Km. 2.5, 28806 Alcalá de Henares, Madrid, Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Austria, Denmark, Finland, Iceland, Norway, Sweden: Engerix-B

Belgium, Luxembourg: Engerix B Junior

France, Ireland, Italy: Engerix B-10

Germany: Engerix-B Kinder

Greece: Engerix

Spain, Netherlands: Engerix-B Junior

Portugal: Engerix B

Date of the most recent revision of this leaflet: 02/2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

After storage, the product may appear as a fine white deposit with a clear, colourless supernatant. After shaking, the vaccine is slightly opalescent.

The vaccine should be inspected visually for particulate matter and/or abnormal appearance before administration. Do not administer the vaccine if either is observed.

The entire contents of the single-dose container should be withdrawn and used immediately after withdrawal.

Instructions for the pre-filled syringe

Disposal of waste

The disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.