Vaqta 25

Package Leaflet: Information for the User

VAQTA 25, 25 U/0.5 ml, Suspension for Injection

Hepatitis A Vaccine, Inactivated, Adsorbed
Hepatitis A vaccine, inactivated, adsorbed. For children and adolescents.

Read the package leaflet carefully before using the vaccine because it contains important information for the patient.

• Keep this package 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 a specific person. Do not pass it on to others. The vaccine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is VAQTA 25 and what is it used for
• 2. Important information before using VAQTA 25
• 3. How to use VAQTA 25
• 4. Possible side effects
• 5. How to store VAQTA 25
• 6. Contents of the pack and other information

1. What is VAQTA 25 and what is it used for

The vaccine is indicated for active immunization against infections caused by hepatitis A virus. The vaccine is recommended for healthy children from 12 months of age and adolescents up to 17 years of age who are at risk of infection or transmission and for whom infection may be life-threatening (e.g., individuals with diagnosed hepatitis C).
VAQTA 25 should be used in accordance with official recommendations.
To achieve the best protection, the first dose of the vaccine should be given at least 2 weeks (preferably 4) before expected exposure to hepatitis A virus.
The vaccine does not protect against hepatitis A caused by other types of viruses than type A.

2. Important information before using VAQTA 25

When not to use VAQTA 25

• if the child is allergic to the active substance or any of the other ingredients of the vaccine (listed in section 6),
• in case of severe illness with fever, vaccination should be postponed.

Warnings and precautions

Tell your doctor about:

• past and current illnesses and allergies,
• allergic reactions after the first dose,
• pregnancy or planned pregnancy.

The vaccine may contain trace amounts of neomycin and formaldehyde used in the manufacturing process.
In individuals with cancer, undergoing cancer treatment, or with impaired immunity for other reasons, VAQTA 25 may not provide the same level of protection as in healthy individuals.
Since hepatitis A can develop without symptoms for a long time, it is possible that the vaccinated person may already be infected with the virus. In such cases, the vaccine may not prevent the disease.
The packaging contains latex. It can cause severe allergic reactions.
Like other vaccines, VAQTA 25 may not protect all individuals who receive it.

VAQTA 25 and other medicines

VAQTA 25 can be used at the same time as vaccines against measles, mumps, rubella, chickenpox, 7-valent conjugated pneumococcal vaccine, inactivated poliovirus vaccine, diphtheria, tetanus, acellular pertussis vaccine, and against Haemophilus influenzae type b (Hib).
Although data on use in individuals from 12 months to 17 years of age are not available, studies in adults from 18 to 54 years of age have shown that VAQTA 25 can be given at the same time as yellow fever vaccine and typhoid vaccine.
Data on concomitant use with other vaccines are limited.
VAQTA 25 should not be mixed in the same syringe with other vaccines. If concomitant administration is necessary, different injection sites and separate syringes should be used.
VAQTA 25 can also be given at the same time as immunoglobulin. In such cases, separate syringes and different injection sites should be used.

Pregnancy and breastfeeding

Pregnancy:

It is not known whether VAQTA 25 given to a pregnant woman can cause harm to the fetus. VAQTA 25 should be given to pregnant women only in necessary cases, when the doctor believes that the benefits of vaccination outweigh the potential risk to the fetus.

Breastfeeding:

Tell your doctor if you are breastfeeding. VAQTA 25 should be given to breastfeeding women only in necessary cases.

Driving and using machines

There is no information suggesting an impact of the vaccine on the ability to drive and use machines.

VAQTA 25 contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is essentially 'sodium-free'.

3. How to use VAQTA 25

Primary dose
Children and adolescents from 12 months to 17 years of age should receive one dose of 0.5 ml (25 U) of the vaccine at the chosen time.
The safety and efficacy of the vaccine in children under 12 months of age have not been established.
Booster dose
Children and adolescents who received the primary dose between 12 months and 17 years of age should receive a booster dose of the vaccine, also 0.5 ml (25 U), between 6 and 18 months after the first dose.
Antibodies against hepatitis A virus (HAV) persist for at least 10 years after the second dose (i.e., the booster dose). It is expected that the duration of antibody persistence is at least 25 years.
VAQTA 25 can be given as a booster dose 6-12 months after primary vaccination with another inactivated hepatitis A vaccine.
If the booster dose of the vaccine is not given at the recommended time, the decision on further action should be made by the doctor.
The vaccine should be given INTRAMUSCULARLYin the deltoid muscle.
In individuals with bleeding disorders, for whom intramuscular injection of the vaccine may cause bleeding (e.g., individuals with hemophilia), the vaccine can be given intramuscularly after taking preventive measures, such as using medications indicated for the treatment of hemophilia or similar therapy, or applying a pressure bandage. In such individuals, the vaccine may be given subcutaneously.
The vaccine should not be given subcutaneously or intradermally, as this may cause a lower immune response than expected.

VAQTA 25 must not be administered intravenously.

4. Possible side effects

Like all medicines, VAQTA 25 can cause side effects, although not everybody gets them.
The vaccine is generally well tolerated.

Side effects reported in children from 12 to 23 months of age

Very common (occurring in 1 or more in 10 vaccinated individuals):

• pain/tenderness at the injection site, redness at the injection site

Common (occurring in 1 or more in 100 and less than 1 in 10 vaccinated individuals):

• swelling at the injection site, warmth at the injection site, bruising at the injection site
• fever
• irritability
• diarrhea

Uncommon (occurring in 1 or more in 1,000 and less than 1 in 100 vaccinated individuals):

• decreased or loss of appetite
• sleep problems, sleepiness, feeling tired - lethargy, lack of energy, restlessness
• tearfulness
• runny nose, cough, stuffy nose
• vomiting
• rash, diaper rash
• feeling unwell
• thickening at the injection site, rash at the injection site

Rare (occurring in 1 or more in 10,000 and less than 1 in 1,000 vaccinated individuals):

• various allergies
• dehydration
• agitation, nervousness, feeling anxious, crying
• dizziness, headaches, balance disorders
• styes on the eyelids
• asthma, respiratory tract obstruction, sneezing, runny or itchy nose, sore mouth and throat
• nausea, abdominal pain/discomfort, gas in the stomach or intestines (bloating), frequent bowel movements, regurgitation, vomiting, constipation, change in stool color
• rash, itching, and redness of the skin, blisters, feeling of moisture or heat on the skin, sweating
• joint inflammation
• at the injection site: bleeding, itching, discoloration, thickening or itchy rash, pain, discomfort
• weakness/fatigue, gait disturbances, feeling of heat

Side effects reported in children and adolescents from 2 to 17 years of age

Very common (occurring in 1 or more in 10 vaccinated individuals):

• pain and tenderness at the injection site

Common (occurring in 1 or more in 100 and less than 1 in 10 vaccinated individuals):

• headache
• warmth at the injection site, redness, and swelling, fever, bruising at the injection site

Uncommon (occurring in 1 or more in 1,000 and less than 1 in 100 vaccinated individuals):

• irritability
• dizziness
• abdominal pain, vomiting, diarrhea, nausea
• rash, itching
• arm pain (the limb into which the injection was given), joint pain, muscle pain
• fatigue, itching at the injection site, and pain/discomfort

Rare (occurring in 1 or more in 10,000 and less than 1 in 1,000 vaccinated individuals):

• loss of appetite
• nervousness
• sleepiness, unusual sensations such as tingling
• ear pain
• hot flashes with redness
• stuffy nose, runny nose, cough
• hives, sweating
• stiffness
• thickening at the injection site, flu-like symptoms, chest pain, pain, feeling of heat, blister at the injection site, stiffness/tension, and pricking

Side effects reported after marketing authorization:

Very rare (occurring in less than 1 in 10,000 vaccinated individuals, including single cases):

• Guillain-Barré syndrome (muscle weakness, abnormal sensation, tingling sensation in the arms, legs, and upper body)
• decreased platelet count

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store VAQTA 25

Store in a refrigerator (2°C – 8°C).

DO NOT FREEZE.

Keep the medicine out of the sight and reach of children.
Do not use VAQTA 25 after the expiry date stated on the packaging after EXP.
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. Contents of the pack and other information

What VAQTA 25 contains

1 dose of the vaccine (0.5 ml) contains:

• The active substance of the vaccine is:hepatitis A virus, strain CR326F (inactivated) ……………25 U

Grown in a culture of human diploid fibroblast cells (MRC-5).
Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.225 mg Al).
Units determined according to the manufacturer's internal method - Merck Sharp & Dohme LLC.

• The excipients are:sodium tetraborate, sodium chloride, water for injections.

What VAQTA 25 looks like and contents of the pack

Available packs:
1 vial of 0.5 ml, in a cardboard box.
10 vials of 0.5 ml, in a cardboard box.
1 pre-filled syringe of 0.5 ml, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:MSD Polska Sp. z o.o., ul. Chłodna 51, 00-867 Warsaw, tel. 22 549 51 00, e-mail: [email protected].
Manufacturer:Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands.
Date of last revision of the leaflet:05/2022