VAQTA 50 Units/1ml Injectable Suspension in Prefilled Syringe

Introduction

Package Leaflet: Information for the User

VAQTA 50Units/1ml

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed to you personally and you should not pass it on to others.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think the side effects are not serious. See section 4.

Contents of the package leaflet

1. What is VAQTA 50 Units/1 ml and what is it used for
2. What you need to know before you are given VAQTA 50 Units/1 ml
3. How to use VAQTA 50 Units/1 ml
4. Possible side effects
5. Storage of VAQTA 50 Units/1 ml
6. Package contents and further information

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

VAQTA 50 U/1 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 directed against.

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 that contains the virus. Symptoms can 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 start to produce protection (antibodies) against the hepatitis A virus. However, it usually takes between 2 and 4 weeks from the time you receive the injection until you are protected.

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

Additionally, 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 it cannot cause a hepatitis A infection.

2. What you need to know before you are given VAQTA 50 Units/1 ml

It is important to inform your doctor or nurse if any of the following points apply to you. If there is anything you do not understand, 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 components 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 tell you when the vaccine can be given.

Warnings and precautions

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

• If you have had any previous 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 in the manufacturing process of the vaccine and may be present in trace amounts in the vaccine.
• If you have had bleeding problems causing easy bruising or prolonged bleeding from minor injuries (e.g., due to a coagulation disorder or treatment with anticoagulant medications).
• If you 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 50 U/1 ml may not completely protect all vaccinated people.

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 if you should have an antibody test for hepatitis A before vaccination.

Using VAQTA 50U/1ml with other medicines

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

Use with other vaccines

Since VAQTA 50U/1ml does not contain live bacteria or viruses, it can usually be given 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 given at the same time in different injection sites with the yellow fever vaccine and the typhoid polysaccharide vaccine.

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

Use with Immunoglobulin (antibodies)

Sometimes, an injection of human immunoglobulin (antibodies) will be given to try to protect you until the vaccine starts to work. VAQTA 50U/1ml 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 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

There are no data to suggest that VAQTA 50 U/1 ml affects the ability to drive or use machines.

VAQTA contains sodium

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

3. How to use VAQTA 50 Units/1 ml

Dosage

VAQTA 50 U/1 ml should be administered by doctors or nurses who are trained in the administration of vaccines and equipped to handle any severe allergic reaction that may occur. The person being vaccinated will receive a first dose followed by a second dose (booster).

First dose

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

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

Second dose (booster)

People who received the first dose should receive a second booster dose of 1 ml (50 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 adults who have received two doses have antibody levels that persist for at least 6 years. It is expected that hepatitis A antibodies will persist for at least 25 years after vaccination.

Use in children and adolescents

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

Method of administration

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

People at risk of bleeding after injection (e.g., hemophiliacs) may receive VAQTA 50 U/1 ml by subcutaneous injection instead of into the muscle to reduce the risk of bleeding.

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

4. Possible side effects

As with all vaccines and medicines, VAQTA 50 U/1 ml can cause side effects, although not everybody gets them.

As with all vaccines, it can cause severe allergic reactions that rarely 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 are still in 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think the side effects are not serious. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, 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 expiration date that appears on the packaging after CAD or EXP. The expiration date is 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 you notice an unusual appearance 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 the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of VAQTA 50U/1ml

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

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

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

Appearance of the product and package contents

VAQTA 50 U/1 ml is presented in a pre-filled syringe with or without a needle containing a 1 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.

Packaging with 1 or 10 pre-filled syringes.

Not all 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

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 medicine is authorized in the Member States of the European Economic Area under the following names:

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

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

This information is intended only for healthcare professionals:

Incompatibilities

In the absence of compatibility studies, this medicine should 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 an abnormal physical appearance. Discard the product if it contains particles 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.