Label: information for the user

VAQTA 50Units/1ml

Pre-filled syringe suspension

inactivated, adsorbed anti-hepatitis A vaccine

For adults

Read this label carefully before this vaccine is administered to you, as 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 for you personally and should not be given to other people.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, evenifthey do not appear in this label. See section4.

VAQTA 50U/1mlis 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 50U/1ml helps to protect adults (18years of age and older) against the disease caused by the hepatitisA virus.

HepatitisA 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 (yellow discoloration of the skin and eyes) and general discomfort.

When you receive an injection of VAQTA 50U/1ml,your immune system (natural defenses of the body) will begin to generate protection (antibodies) againstthe hepatitisA virus. However, it usually takes between 2 and 4weeks from the time you receive the injection until you are protected.

VAQTA50U/1mldoes not prevent hepatitis caused by other infectious agents other than the hepatitisA virus.

Additionally, if you are already infected with the hepatitisA virus at the time you are administered VAQTA 50U/1ml, the vaccine may not prevent the disease.

VAQTA 50U/1ml protects against hepatitisA, but it cannot cause a hepatitisA infection.

It is essential 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 50U/1ml

- If you are allergic to the active ingredients or any of the other components of this medication (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 indicate when you can administer the vaccine.

Warnings and Precautions

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

- If you have had any previous allergic reaction to a dose of VAQTA 50U/1ml.

- 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 have had bleeding or bruising problems caused by easy formation of petechiae or prolonged bleeding from minor injuries (for example, due to a coagulation disorder or treatment with anticoagulant medications).

- If you have a weakened immune system, due to cancer, treatments affecting 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.

You may experience severe allergic reactions because it contains latex in the packaging.

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

Please inform your doctor if you have a history of jaundice or have resided in areas where hepatitis A is common. Your doctor will determine if you should undergo a hepatitis A antibody test before vaccination.

Use of VAQTA 50U/1ml with other medications

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

Use with other vaccines

Since VAQTA 50U/1ml does not contain live bacteria or viruses, it can usually be administered at the same time as other vaccines, but in different injection sites (another part of your body, for example, the other arm or leg). VAQTA 50U/1ml should not be mixed with any other vaccine in the same syringe. Studies have shown that VAQTA 50U/1ml can be administered at the same time in different injection sites with the yellow fever vaccine and the polysaccharide typhoid vaccine.

Studies in children with the pediatric presentation (VAQTA 25U/0.5ml) have shown that the vaccine can be administered at the same time as vaccines against measles, mumps, rubella, varicella, pneumococcal conjugate heptavalent, and with the inactivated poliomyelitis vaccine.

Use with Immunoglobulin (antibodies)

On occasion, an injection of human immunoglobulin (antibodies) will be administered to protect you until the vaccine begins to act. VAQTA 50U/1ml can be administered at the same time as immunoglobulin using different injection sites and syringes.

Medications affecting the immune system or blood

Please see the previous section "Warnings and Precautions".

Pregnancy, lactation, and fertility

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

Driving and operating machinery

There are no data to suggest that VAQTA 50U/1mlaffects your ability to drive or operate machinery.

VAQTA contains sodium

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

Dosage

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

First dose

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

The first doseofvaccineshouldprotectagainstinfection bythe hepatitisA virusin a period of 2 to4weeks.

Second dose (booster)

People who received the first dose must receive the second dose of booster 1ml (50Units) 6 to 18months after the first dose.

Long-term protection requires a second dose of the vaccine (booster dose). It has been proven thathealthy adults who have received two doses have antibody levels that persist for at least 6years. It is expected that hepatitisA antibodies will persist for at least 25years after vaccination.

Use in children and adolescents

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

Administration

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

People with a risk of excessive bleeding after injection (e.g. hemophiliacs) may receive VAQTA 50U/1ml by subcutaneous injection instead of intramuscular to reduce the risk of bleeding.

VAQTA50U/1mlmust not be administered into a blood vessel.

Like all vaccines and medications, VAQTA 50U/1ml 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 are still at the clinic or doctor's office.If you experience any of these symptoms after leaving the place where you received the injection, contact your doctor IMMEDIATELY.

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 theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis vaccineout of sight and reach of children.

Do not usethis vaccineafter 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 refrigerator (between 2°C and 8°C). Do not freeze.

Do not use this vaccineif you observe a strange appearance or contains any foreign particle (see section6).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

VAQTA 50 CompositionU/1ml

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

One dose (1ml) contains 50U of inactivated hepatitis A virus (adsorbed on amorphous aluminium hydroxide phosphate sulfate) (0.45mg of Aluminium).

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

Appearance of the product and contents of the package

VAQTA50U/1mlis presented in a pre-filled syringe with or without a needle containing a dose of 1ml 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.

Packaging with 1 or 10pre-filled syringes.

Only some package sizes may be commercially available.

After vigorous agitation, VAQTA50U/1mlis 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 medicinal product is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:12/2021.

Detailed information about this medicinal product 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 medicinal productshould 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 visually inspected for the presence of particulate matter and/or any change in 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.For syringe without needle, hold the syringe body and fix the needle by rotating it in the direction of the clock until it is fully seated in the syringe and administer the vaccine immediately.