VaqtA 50 units/1 ml injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VAQTA 50 Units/1 ml

Injectable suspension in a pre-filled syringe

inactivated adsorbed hepatitis A vaccine

For adults

Read all of this leaflet carefully before this vaccine is administered to you, 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 for you personally and must not be given to other people.
• If you 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 50 Units/1 ml is and what it is used for
2. What you need to know before VAQTA 50 Units/1 ml is administered to you
3. How to use VAQTA 50 Units/1 ml
4. Possible side effects
5. How to store VAQTA 50 Units/1 ml
6. Contents of the pack and other information

1. What VAQTA 50 Units/1 ml is and what it is used for

VAQTA 50 U/1 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 50 U/1 ml helps protect adults (18 years of age and older) 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 receive an injection of VAQTA 50 U/1 ml, your immune system (the body's natural defenses) will begin to generate protection (antibodies) against the hepatitis A virus. However, it usually takes between 2 and 4 weeks after receiving the injection before protection is established.

VAQTA 50 U/1 ml does not prevent hepatitis caused by infectious agents other than the hepatitis A virus.

In addition, if you are already infected with the hepatitis A virus at the time VAQTA 50 U/1 ml is administered, the vaccine may not prevent the disease.

VAQTA 50 U/1 ml protects against hepatitis A, but cannot cause an infection with hepatitis A.

2. What you need to know before VAQTA 50 Units/1 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, please ask your doctor or nurse.

Do not use VAQTA 50U/1ml

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6) or to neomycin or formaldehyde (see section "Warnings and precautions").
• If you have a severe infection with fever. Your doctor will advise when the vaccine can be given.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before VAQTA 50 U/1 ml is administered to you

• If you have previously had an allergic reaction to a dose of VAQTA 50 U/1 ml.

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

• If you 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 have a weakened immune system due to cancer, treatments affecting the immune system, or any other illness. The vaccine may not work as well as in people with a healthy immune system. If possible, vaccination should be delayed until treatment or illness has ended.

Like other vaccines, VAQTA 50 U/1 ml may not fully protect all vaccinated individuals.

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

Use of VAQTA 50U/1ml with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Use with other vaccines

Since VAQTA 50U/1ml 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 your body, for example, the other arm or leg). VAQTA 50U/1ml must not be mixed with any other vaccine in the same syringe. Studies have shown that VAQTA 50U/1ml can be administered simultaneously with yellow fever vaccine and typhoid polysaccharide vaccine, provided different injection sites are used.

Studies in children using the pediatric formulation (VAQTA 25 U/0.5 ml) have shown that the vaccine can be administered at the same time as measles, mumps, rubella, varicella, heptavalent conjugated pneumococcal, and inactivated polio vaccines.

Use with Immunoglobulin (antibodies)

Sometimes, an injection of human immunoglobulin (antibodies) may be given to provide temporary protection until the vaccine starts to work. VAQTA 50U/1ml may be administered at the same time as immunoglobulin, using separate injection sites and syringes.

Medicines affecting the immune system or blood

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

Pregnancy, lactation, and fertility

If you are pregnant, breastfeeding, think you 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 50 U/1 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 50 Units/1 ml

Dosage

VAQTA 50 U/1 ml must be administered by doctors or nurses trained in vaccine administration and equipped to manage any rare severe allergic reactions. The vaccinated person will receive an initial dose followed by a second dose (booster).

First dose

Adults aged 18 years and older should receive a single dose of 1 ml of vaccine (50 Units) on the chosen date.

The first vaccine dose should protect you against hepatitis A virus infection within 2 to 4 weeks.

Second dose (booster)

Individuals who received the first dose should receive the second booster dose of 1 ml (50 Units) between 6 and 18 months after the first dose.

Long-term protection requires a second dose of the vaccine (booster dose). Healthy adults who have received two doses have been shown to maintain antibody levels for at least 6 years. Hepatitis A antibodies are expected to persist for at least 25 years after vaccination.

Use in children and adolescents

VAQTA 50 U/1 ml is not recommended for individuals under 18 years of age.

Method of administration

Your doctor or nurse will administer VAQTA 50 U/1 ml as an injection into the muscle of the upper arm (deltoid muscle).

Individuals at risk of significant bleeding after injection (e.g., hemophiliacs) may receive VAQTA 50 U/1 ml as a subcutaneous injection instead of intramuscular to reduce the risk of bleeding.

VAQTA 50 U/1 ml must not be administered into a blood vessel.

4. Possible adverse reactions

Like all vaccines and medicines, VAQTA 50 U/1 ml may cause adverse reactions, although not everyone will experience them.

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

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

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

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 50 Units/1 ml

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

Do not use this vaccine after the expiry date stated on the packaging 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 unusual or contains any foreign particles (see section 6).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of VAQTA 50U/1ml

The active substances are: inactivated hepatitis A virus (produced in human diploid MRC-5 cells, adsorbed onto amorphous hydroxyphosphosphate sulfate aluminum).

One dose (1 ml) contains 50 U of inactivated hepatitis A virus adsorbed onto amorphous hydroxyphosphosphate sulfate aluminum (0.45 mg of aluminum).

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

Appearance of the product and contents of the pack

VAQTA 50 U/1 ml is supplied as a pre-filled syringe with or without a fixed needle containing one dose of 1 ml of injectable suspension. The presentation with the pre-filled syringe without a 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 50 U/1 ml is a white, opaque suspension.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the European Economic Area member states under the following names:

Date of the latest review of this leaflet: 09/2025

Detailed 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 exclusively for healthcare professionals:

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 should be shaken thoroughly until a slightly opaque white suspension is obtained.

Thorough shaking is required to maintain the vaccine suspension. For syringe without needle, hold the syringe barrel and attach the needle by rotating it clockwise until it is fully secured to the syringe, then administer the vaccine immediately.