Havrix 720 Junior, injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Havrix 720 Junior, injectable suspension in pre-filled syringe

Hepatitis A vaccine (inactivated, adsorbed)

Read this entire leaflet carefully before you or 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, consult your doctor, pharmacist, or nurse.

• This vaccine has been prescribed only for you or your child and must not be given to other people.

• If you or your child experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

This leaflet has been written assuming that the person receiving the vaccine is the one reading it, although it may be administered to children and adolescents, so you may need to read it on behalf of your child.

Leaflet contents

1. What Havrix 720 Junior is and what it is used for

2. What you need to know before receiving Havrix 720 Junior

3. How Havrix 720 Junior is administered

4. Possible side effects

5. How to store Havrix 720 Junior

6. Contents of the pack and other information

1. What Havrix 720 Junior is and what it is used for

What Havrix 720 Junior is used for

Havrix 720 Junior is a vaccine used to protect children and adolescents from 1 to 15 years of age inclusive against infection caused by the hepatitis A virus.

Havrix 720 Junior may also be administered to adolescents from 16 to 18 years of age inclusive, if necessary.

What is hepatitis A

• Hepatitis A is a liver disease caused by the hepatitis A virus.
• The hepatitis A virus can be transmitted from person to person or through contact with contaminated water, food, and drinks.
• Symptoms of hepatitis A range from mild to severe and may include: fever, general malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark-colored urine, and jaundice (yellowing of the eyes and skin). Most people recover completely, although sometimes the disease can be severe and require hospitalization, and in rare cases, it may lead to acute liver failure.

How Havrix 720 Junior works

• Havrix 720 Junior helps your body produce its own protection (antibodies) against the virus. These antibodies help protect you against the disease.
• As with all vaccines, Havrix 720 Junior may not fully protect all vaccinated individuals.

2. What you need to know before receiving Havrix 720 Junior

Do not administer Havrix 720 Junior if:

• you are allergic to the active substance or to any of the other components of this vaccine (listed in section 6) or to neomycin or formaldehyde,
• you have previously had an allergic reaction to any hepatitis A vaccine.

Signs of an allergic reaction may include: itchy rash, difficulty breathing, and swelling of the face or tongue.

Havrix 720 Junior must not be given if any of the above situations apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before receiving Havrix 720 Junior.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving Havrix 720 Junior if:

• you have a serious infection with a high fever. The vaccine can be given once you have recovered. A minor infection, such as a cold, should not be a problem, but check with your doctor first,
• you have a weakened immune system due to illness and/or treatments. Your doctor will determine whether additional doses are needed,
• you have bleeding problems or bruise easily.

Fainting can occur before or after any injection with a needle. Therefore, inform the doctor, pharmacist, or nurse if you have previously fainted after an injection.

Other medicines and Havrix 720 Junior

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

Havrix 720 Junior can be administered at the same time as other vaccines and immunoglobulins. A different injection site should be used for each injection.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before receiving Havrix 720 Junior.

Driving and using machines

The influence of Havrix 720 Junior on the ability to drive and operate machinery is none or negligible.

Havrix 720 Junior contains phenylalanine, polysorbate 20, sodium, and potassium

This vaccine contains 0.083 mg of phenylalanine per dose.

Phenylalanine may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This vaccine contains 0.025 mg of polysorbate 20 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.

This medicine contains potassium, less than 1 mmol (39 mg) per dose; essentially “potassium-free”.

3. How Havrix 720 Junior is administered

How the vaccine is administered

• Your doctor or nurse will administer Havrix 720 Junior as an injection into a muscle, usually into the upper arm in children and adolescents.
• In young children, the injection may be given into the muscle of the thigh.
• Havrix 720 Junior may exceptionally be injected under the skin if you have thrombocytopenia or suffer from severe bleeding disorders.

How much is administered

• You will receive 1 dose of Havrix 720 Junior (0.5 ml suspension) on the date agreed with your doctor or nurse.
• A second dose (booster) is recommended between 6 and 12 months after the first dose, although it may be given up to five years after the first dose, to ensure long-term protection.

If you receive more Havrix 720 Junior than you should

Overdose is very unlikely because the vaccine is supplied in a single-dose vial or syringe and is administered by a doctor or nurse. A few cases of accidental administration have been reported, and the adverse effects reported were similar to those reported with normal administration of the vaccine (listed in section 4).

If you forget to receive Havrix 720 Junior

Contact your doctor, who will decide whether a dose is required and when it should be administered.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone will experience them.

Serious adverse effects

Tell your doctor immediately if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• allergic reactions: signs may include localized or widespread skin rashes that can cause itching or blistering, swelling of the eyes and face, difficulty breathing or swallowing, a sudden drop in blood pressure, and loss of consciousness.

These reactions may occur before you leave the doctor's office.

Tell your doctor immediately if you notice any of the serious adverse effects listed above.

Adverse effects observed during clinical trials with Havrix 720 Junior were as follows:

Very common (may occur in more than 1 in 10 doses of the vaccine):

• irritability
• pain and redness at the injection site

Common (may occur in up to 1 in 10 doses of the vaccine):

• loss of appetite
• headache
• drowsiness
• nausea
• general feeling of malaise
• fever of 37.5°C or higher
• swelling at the injection site

Uncommon (may occur in up to 1 in 100 doses of the vaccine):

• runny or blocked nose
• vomiting
• diarrhea
• skin rash
• hardening at the injection site

Adverse effects reported following marketing of Havrix 720 Junior were the following:

• seizures or convulsions
• inflammation of blood vessels leading to narrowing or blockage (vasculitis)
• severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
• hives, red spots that often itch and typically begin on the limbs and sometimes on the face and other parts of the body
• joint pain

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Havrix 720 Junior

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the packaging. The expiry date refers to 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 a SIGRE collection 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 Havrix 720 Junior

The active substance is inactivated hepatitis A virus adsorbed onto aluminium hydroxide. Each 0.5 ml dose of vaccine contains 720 ELISA units of hepatitis A virus.

The other components are amino acids for injection (containing phenylalanine), disodium phosphate, monopotassium phosphate, polysorbate 20 (E-432), potassium chloride, sodium chloride, water for injections (see section 2).

Appearance of the product and contents of the pack

Injectable suspension.

Havrix 720 Junior is a cloudy injectable liquid.

Havrix 720 Junior is available in a 1-dose pre-filled syringe with or without needles; pack sizes of 1, 5, 10 and 25.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Spain

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 authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 03/2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Havrix 720 Junior is a cloudy liquid suspension. During storage, it may show a fine white deposit and a clear, colourless supernatant.

Before administration, the vaccine should be inspected visually for any foreign particles and/or changes in physical appearance. Prior to using Havrix 720 Junior, the prefilled syringe must be shaken thoroughly to obtain a slightly opaque white suspension. Discard the vaccine if the contents appear different.

Instructions for the prefilled syringe

Waste disposal

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.