VaqtA 25 units/0.5 ml injectable suspension in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

VAQTA 25 Units/0.5 ml

Injectable suspension in a pre-filled syringe

inactivated adsorbed hepatitis A vaccine

For children and adolescents

Please read all of this leaflet carefully before this vaccine is administered to you or your child, 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 specifically for you or your child and must not be given to other people.
• If you or your child experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

1. What VAQTA 25 Units/0.5 ml is and what it is used for
2. What you need to know before VAQTA 25 Units/0.5 ml is administered
3. How to use VAQTA 25 Units/0.5 ml
4. Possible side effects
5. How to store VAQTA 25 Units/0.5 ml
6. Contents of the pack and other information

1. What VAQTA 25 Units/0.5 ml is and what it is used for

VAQTA 25 U/0.5 ml is a vaccine. Vaccines are used to protect against infectious diseases by causing the body to produce its own protection against the disease they target.

VAQTA 25 U/0.5 ml helps protect children from 12 months up to 17 years of age against disease caused by the hepatitis A virus.

Hepatitis A is an infection caused by a virus that attacks the liver. It can be acquired through food or drink contaminated with the virus. Symptoms may include jaundice (yellowing of the skin and eyes) and general malaise.

When you or your child receive an injection of VAQTA 25 U/0.5 ml, the immune system (the body's natural defenses) will begin to generate protection (antibodies) against the hepatitis A virus. However, it generally takes between 2 and 4 weeks after you or your child receives the injection before protection is established.

VAQTA 25 U/0.5 ml does not prevent hepatitis caused by infectious agents other than the hepatitis A virus.

In addition, if you or your child are already infected with the hepatitis A virus at the time VAQTA 25 U/0.5 ml is administered, the vaccine may not prevent the disease.

VAQTA 25 U/0.5 ml protects against hepatitis A, but cannot cause hepatitis A infection.

2. What you need to know before VAQTA 25 Units/0.5 ml is administered to you

It is important to inform your doctor or nurse if any of the following apply to you. If there is anything you do not understand, ask your doctor or nurse.

Do not use VAQTA 25U/0.5ml

• If you or your child are allergic to the active substances or to any of the other components of this medicine (listed in section 6) or to neomycin or formaldehyde (see section "Warnings and precautions").

-If you or your child have a severe infection with fever. Your doctor will advise when the vaccine can be administered.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before VAQTA 25U/0.5ml is administered to you:

• If you or your child have previously had an allergic reaction to a dose of VAQTA 25 U/0.5 ml.

• This vaccine may contain traces of an antibiotic called neomycin and a substance called formaldehyde, which are used in the manufacturing process of the vaccine and may be present in trace amounts in the final product.

• If you or your child have blood clotting disorders leading to easy bruising or prolonged bleeding from minor injuries (for example, due to a coagulation disorder or treatment with anticoagulant medicines).

• If you or your child have a weakened immune system due to cancer, treatments affecting the immune system, or any other illness. The vaccine may not provide as strong protection as in people with a healthy immune system. If possible, vaccination should be delayed until after completion of treatment or recovery from the illness.

As with other vaccines, VAQTA 25 U/0.5 ml may not fully protect all vaccinated individuals.

Please inform your doctor if you or your child have a history of jaundice or have lived in areas where hepatitis A is common. Your doctor will determine whether you or your child should be tested for hepatitis A antibodies before vaccination.

Use of VAQTA 25U/0.5ml with other medicines

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

Use with other vaccines

Since VAQTA 25U/0.5ml does not contain live bacteria or viruses, it can generally be administered at the same time as other vaccines, but at different injection sites (another part of the body, for example, the other arm or leg). VAQTA 25U/0.5ml must not be mixed with any other vaccine in the same syringe. Studies have shown that VAQTA 25U/0.5ml can be administered simultaneously with vaccines against measles, mumps, rubella, varicella, heptavalent conjugate pneumococcal vaccine, inactivated poliomyelitis, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b.

In adults, VAQTA 25 U/0.5 ml can be administered at the same time as yellow fever vaccine and typhoid polysaccharide vaccine.

Use with Immunoglobulin (antibodies)

Sometimes, an injection of human immunoglobulin (antibodies) may be given to help protect you or your child until the vaccine starts to work. VAQTA 25 U/0.5 ml can be administered at the same time as immunoglobulin, using different injection sites and separate syringes.

Medicines that affect the immune system or blood

Please refer to the section above "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

There are no data suggesting that VAQTA 25 U/0.5 ml has an effect on the ability to drive or operate machinery.

VAQTA contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; i.e., essentially "sodium-free".

3. How to use VAQTA 25 Units/0.5 ml

Dosage

VAQTA 25 U/0.5 ml must be administered by injection by doctors or nurses trained in vaccine administration and equipped to manage any rare severe allergic reactions. The vaccinated person will receive a first dose followed by a second dose (booster).

First dose

Children between 12 months and 17 years of age should receive a single dose of 0.5 ml of vaccine (25 Units) on the scheduled date.

The first vaccine dose will protect you or your child against infection with hepatitis A virus within 2 to 4 weeks.

Safety and effectiveness have not been established in children under 12 months of age.

Second dose (booster)

Individuals who received the first dose should receive a second booster dose of 0.5 ml (25 Units) 6 to 18 months after the first dose.

Long-term protection requires a second dose of the vaccine (booster dose). Healthy children who have received two doses have been shown to maintain antibody levels for at least 10 years. Hepatitis A antibodies are expected to persist for at least 25 years after vaccination.

VAQTA 25 U/0.5 ml is not recommended for individuals over 18 years of age.

Method of administration

Your doctor or nurse will administer VAQTA 25 U/0.5 ml to you or your child as an injection into the muscle of the upper arm (deltoid muscle). The muscle in the outer region of the thigh may be used in children if the deltoid muscle is not sufficiently developed.

Individuals at risk of excessive bleeding following injection (e.g., hemophiliacs) may receive VAQTA 25 U/0.5 ml as a subcutaneous injection instead of intramuscular to reduce the risk of bleeding.

VAQTA 25 U/0.5 ml must not be administered into a blood vessel.

4. Possible adverse effects

Like all vaccines and medicines, VAQTA 25 U/0.5 ml can cause adverse effects, although not everyone experiences them.

As with all vaccines, it may cause allergic reactions, which rarely lead to shock. These reactions may include:

• hives
• difficulty breathing
• swelling of the face, tongue, and throat
• dizziness
• collapse

When these signs or symptoms occur, they usually develop very rapidly after the injection, while you or your child is still at the clinic or medical office. If you or your child experience any of these symptoms after leaving the place where the injection was given, contact your doctor IMMEDIATELY.

Adverse effects reported in children aged between 12 and 23 months

Adverse reactions reported in children and adolescents, aged between 2 and 17 years

Reporting of adverse reactions

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

5. Storage of VAQTA 25 Units/0.5 ml

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

Do not use this vaccine after the expiry date stated on the container after CAD or EXP. 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.

Do not use this vaccine if it looks abnormal or contains any foreign particles (see section 6).

Medicines should not be disposed of via wastewater or household waste. 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 VAQTA 25 U/0.5 ml

The active substance is: inactivated hepatitis A virus (produced on human diploid MRC-5 cells, adsorbed onto amorphous aluminium hydroxyphosphate sulfate).

One dose (0.5 ml) contains 25 U of inactivated hepatitis A virus adsorbed onto amorphous aluminium hydroxyphosphate sulfate (0.225 mg of aluminium).

The other excipients are: sodium borate, sodium chloride and water for injections.

Appearance of the product and contents of the container

VAQTA 25 U/0.5 ml is supplied as a pre-filled syringe with or without needle, containing a 0.5 ml dose of injectable suspension. The presentation with the pre-filled syringe without fixed needle may include 1 or 2 separate needles in the secondary packaging.

Packs containing 1, 2, 5 or 10 pre-filled syringes.

Only certain pack sizes may be marketed.

After vigorous shaking, VAQTA 25 U/0.5 ml is an opaque white suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Abelló, S.A.

Josefa Valcárcel, 42

28027 Madrid

Spain

Manufacturer:

Merck Sharp & Dohme B.V.

Merck Manufacturing Division

Waarderweg 39, PO Box 581

2003 PC Haarlem

The Netherlands

Local Representative:

Merck Sharp & Dohme de España, S.A.

C/ Josefa Valcárcel, 42

28027 Madrid

Spain

Tel.: 91 3210600

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

Date of the most recent review of this leaflet: 09/2025.

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:

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Instructions for use and handling

The vaccine should be used as supplied.

Before administration, the vaccine should be inspected visually for the presence of foreign particles and/or abnormal physical appearance. Discard the product if particles are present or if discoloration occurs. The syringe must be shaken well until a slightly opaque white suspension is obtained.

Thorough shaking is necessary to maintain the vaccine suspension. For needle-free syringes, hold the syringe body and attach the needle by turning it clockwise until fully secured to the syringe, then administer the vaccine immediately.