VAQTA 25 units/0.5ml Injectable Suspension in Prefilled Syringe

Introduction

Package Leaflet: Information for the User

VAQTA 25Units/0.5ml

Injectable suspension in a pre-filled syringe

inactivated, adsorbed hepatitis A vaccine

For children and adolescents

Read all of this leaflet carefully before this vaccine is given to you or your child, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child. Do not pass it on to others.
• If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think they are not serious, or if they are listed in this leaflet. See section 4.

Contents of the pack

1. What VAQTA 25 Units/0.5 ml is and what it is used for
2. What you need to know before you are given VAQTA 25 Units/0.5 ml
3. How to use VAQTA 25 Units/0.5 ml
4. Possible side effects
5. Storage of 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 making the body produce its own protection against the disease they are aimed at.

VAQTA 25 U/0.5 ml helps to protect children from 12 months 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 caught from food or drink that contains the virus. Symptoms can include jaundice (yellowing of the skin and eyes) and general feeling of being unwell.

When you or your child receive an injection of VAQTA 25 U/0.5 ml, the immune system (the body's natural defenses) will start to produce protection (antibodies) against the hepatitis A virus. However, it usually takes between 2 and 4 weeks from the time you or your child receive the injection until you are protected.

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

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

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

2. What you need to know before you are given VAQTA 25 Units/0.5 ml

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 any of the other ingredients 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 tell you when the vaccine can be given.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you are given VAQTA 25U/0.5ml:

• If you or your child have had a previous 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 vaccine.
• If you or your child have had bleeding problems that cause easy bruising or prolonged bleeding from minor injuries (e.g., due to a coagulation disorder or treatment with anticoagulant medications).
• If you or your child have a weakened immune system due to cancer, treatments that affect the immune system, or any other disease. The vaccine may not protect as well as it does people with a healthy immune system. If possible, vaccination should be delayed until treatment or the disease is completed.

It can cause severe allergic reactions because it contains latex in the packaging.

As with other vaccines, VAQTA 25 U/0.5 ml may not completely protect all people who are vaccinated.

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 decide if you or your child should have a blood test for hepatitis A antibodies before vaccination.

Using VAQTA 25U/0.5ml with other medicines

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

Using VAQTA 25U/0.5ml with other vaccines

Since VAQTA 25U/0.5ml does not contain live bacteria or viruses, it can be given at the same time as other vaccines, but in 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/0.5mlcan be given at the same time as vaccines against measles, mumps, rubella, varicella, heptavalent conjugate pneumococcal, inactivated poliovirus, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzaeb.

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

Using VAQTA 25U/0.5ml with Immunoglobulin (antibodies)

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

Medicines that affect the immune system or blood

Please refer to the previous section "".

Pregnancy, breast-feeding, and fertility

If you or your daughter are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine.

Driving and using machines

There are no data to suggest that VAQTA 25 U/0.5 ml affects the ability to drive or use machines.

VAQTA contains sodium

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

3. How to use VAQTA 25 Units/0.5 ml

Dosage

VAQTA 25 U/0.5 ml should be administered by doctors or nurses who are trained in the administration of vaccines and equipped to deal with any severe allergic reaction that may occur. The person being vaccinated 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 chosen date.

The first dose of vaccine should protect you or your child from hepatitis A virus infection within 2 to 4 weeks.

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

Second dose (booster)

People 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). It has been shown that healthy children who have received two doses have antibody levels that persist for at least 10 years. It is expected that hepatitis A antibodies will persist for at least 25 years after vaccination.

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

Method of administration

Your doctor or nurse will give you or your child VAQTA 25 U/0.5 ml by injection into the muscle of the upper arm (deltoid muscle). The muscle in the outer part of the thigh can be used in children if the deltoid muscle is not sufficiently developed.

People at risk of bleeding after injection (e.g., hemophiliacs) may receive VAQTA 25 U/0.5 ml by injection under the skin instead of into the muscle to reduce the risk of bleeding.

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

4. Possible side effects

As with all vaccines and medicines, VAQTA 25 U/0.5 ml can cause side effects, although not everybody gets them.

As with all vaccines, it can cause allergic reactions that in rare cases lead to shock. These reactions can include:

• hives
• 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 and while you or your child are still in the clinic or doctor's office. If you experience any of these symptoms after leaving the place where you or your child received the injection, contact your doctor IMMEDIATELY.

Side effects reported in children aged 12 to 23months

Side effects reported in children and adolescents, aged 2 to 17years

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think they are not serious, or if they are listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, 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 which is stated on the carton after CAD or EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Do not use this vaccine if you notice anything unusual or if it 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 no longer required. This will help protect the environment.

6. Container contents and additional information

Composition of VAQTA25U/0.5ml

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

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

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

Appearance of the product and container contents

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

The following package sizes are registered:

Packages with 1 or 10 pre-filled syringes

Only some package sizes may be marketed.

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Abelló, S.A.

Josefa Valcárcel, 42

28027 Madrid

Manufacturer:

Merck Sharp & Dohme B.V.

Merck Manufacturing Division

Waarderweg 39, PO Box 581

2003 PC Haarlem

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

Date of the last revision of this prospectus:12/2021.

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

This information is intended only 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 presented.

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

Thorough shaking is necessary to maintain the suspension of the vaccine. For a syringe without a needle, hold the syringe body and fix the needle by turning it clockwise until it is fully adjusted on the syringe, and administer the vaccine immediately.