Label: information for the user

VAQTA 25Units/0.5ml

Pre-filled syringe suspension

inactivated, adsorbed hepatitis A vaccine

For children and adolescents

Read this label carefully before this vaccine is administered to you or your child,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed to you or your child personally 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 do not appear in this label. See section4.

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

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

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

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

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

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

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

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

Do not use VAQTA 25U/0.5ml

- If you or your child is allergic to the active ingredients or to any of the other components of this medication (listed in section6) or to neomycin or formaldehyde (see section "Advertencias and precautions").

- If you or your child has a severe infection with fever. The doctor will indicate when the vaccine can be administered.

Advertencias and precautions

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

- If you or your child has had any previous allergic reaction to a dose of VAQTA 25U/0.5ml.

- 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 causing easy bruising or prolonged bleeding from minor cuts (for example due to a bleeding disorder or treatment with anticoagulant medications).

- If you or your child has 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 in people with a healthy immune system. If possible, it is recommended to delay vaccination until the treatment or disease has ended.

This may cause severe allergic reactions because it contains latex in the packaging.

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

Please inform your doctor if you or your child has a history of jaundice or has lived in areas where hepatitisA is common. Your doctor will determine if you or your child should have a test for hepatitisA antibodies before vaccination.

Use of VAQTA 25U/0.5ml with other medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

Use with other vaccines

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

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

Use with Immunoglobulin (antibodies)

Occasionally, an injection of human immunoglobulin (antibodies) will be administered toprotect you or your child until the vaccine begins to work.VAQTA 25U/0.5mlcan be administered at the same time as the immunoglobulin using different injection sites and syringes.

Medications that affect the immune system or blood

Please see the previous section "Advertencias and precautions".

Pregnancy, breastfeeding and fertility

If you or your daughter is pregnantor breastfeeding, or thinks you or your daughter may be pregnantor intends to become pregnant, consult your doctor orpharmacistbefore using this vaccine.

Driving and operating machinery

There are no data to suggest that VAQTA25U/0.5mlproduces an effect on the ability to drive or operate machinery.

VAQTA contains sodium

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

Dosage

VAQTA 25U/0.5ml should be administered by trained medical professionals or nurses equipped to handle any rare severe allergic reactions. The vaccinated person will receive a first dose followed by a second dose (booster).

First dose

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

The first doseof vaccine should protect you or your child from hepatitisA infection within a period of 2 to 4weeks.

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

Second dose (booster)

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

Long-term protection requires a second dose of the vaccine (booster dose). It has been proven that healthy children who have received two doses have antibody levels that persist for at least 10years. It is expected that hepatitisA antibodies will persist for at least 25years after vaccination.

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

Administration

Your doctor or nurse will administerVAQTA 25U/0.5ml by 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 after injection (e.g. hemophiliacs) may receiveVAQTA 25U/0.5ml by subcutaneous injection instead of intramuscular injection to reduce the risk of bleeding.

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

Like all vaccines and medications, VAQTA 25 U/0.5 ml may cause adverse effects, although not everyone will experience them.

Like all vaccines, it may cause allergic reactions that in rare cases can lead to anaphylaxis. 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 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.

Adverse effects reported in children aged 12 to 23 months

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

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 that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

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

Do not use this vaccine if you observe an unusual appearance or if it contains any foreign particles (see section 6).

Drugs should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and unused medications. This will help protect the environment.

Composition of VAQTA25U/0.5ml

The active principles are:inactivated hepatitis A virus (produced in diploid human MRC-5 cells, adsorbed on amorphous aluminium hydroxide phosphate sulfate).

One dose (0.5ml) contains 25U of inactivated hepatitis A virus (adsorbed on amorphous aluminium hydroxide phosphate sulfate) (0.225mg of Aluminium).

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

Appearance of the product and contents of the package

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

The following package sizes are registered:

Containers with 1 or 10pre-filled syringes

Only some package sizes may be commercially available.

After vigorous agitationVAQTA 25U/0.5ml is a white opaque suspension.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Abelló Laboratories, S.A.

Josefa Valcárcel, 42

28027Madrid

Responsible for manufacturing:

Merck Sharp & Dohme B.V.

Merck Manufacturing Division

Waarderweg 39, PO Box 581

2003 PC Haarlem

Netherlands

Local Representative:

MerckSharp&Dohme de España,S.A.

C/JosefaValcárcel,42

28027Madrid

Spain

Tel.: 91 3210600

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last review of this leaflet:12/2021.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals:

Incompatibilities

In the absence of compatibility studies, this medicineshould not be mixed with other medicines.

Instructions for use and handling

The vaccine should be used as presented.

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

A thorough agitation is necessary to maintain the suspension of the vaccine.To syringe without a needle, hold the syringe body and fix the needle by turning it clockwise until it is fully seated in the syringe and administer the vaccine immediately.