Vaqta 50

Package Leaflet: Information for the User

VAQTA 50, 50 U of Hepatitis A Virus, Strain CR326F/1 ml, Suspension for

injection
Hepatitis A Vaccine, Inactivated, Adsorbed
Vaccine against viral hepatitis A, inactivated, adsorbed.
For adults.

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 the patient experiences any side effects, including any not listed in this package leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is VAQTA 50 and what is it used for
• 2. Important information before using VAQTA 50
• 3. How to use VAQTA 50
• 4. Possible side effects
• 5. How to store VAQTA 50
• 6. Package contents and other information

1. What is VAQTA 50 and what is it used for

The vaccine is indicated for active immunization against infections caused by the hepatitis A virus. The vaccine is recommended for healthy adults aged 18 years and older who are at risk of infection or transmission, and for whom infection may be life-threatening (e.g., individuals infected with the human immunodeficiency virus (HIV) and individuals with diagnosed viral hepatitis C).

2. Important information before using VAQTA 50

When not to use VAQTA 50

• if the patient is allergic to the active substance or any of the other ingredients of the vaccine (listed in section 6).

Warnings and precautions

Tell your doctor about any past or present illnesses and allergies.
Tell your doctor if you are pregnant or planning to become pregnant.
Because 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 vaccine packaging contains latex. It may cause severe allergic reactions.

VAQTA 50 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
VAQTA 50 can be used at the same time as the yellow fever vaccine and the typhoid vaccine.
Although data on use in individuals aged 18 and older are not available, studies in children aged 12 to 23 months have shown that VAQTA may be given at the same time as vaccines against measles, mumps, rubella, chickenpox, 7-valent pneumococcal conjugate vaccine, and inactivated poliovirus vaccine. Immunogenicity data are insufficient to confirm the possibility of simultaneous administration of VAQTA 50 with DTaP (diphtheria, tetanus, and pertussis; acellular).
Studies on interactions with other vaccines than yellow fever and typhoid vaccines are not yet available; however, when vaccines are administered at different injection sites, interactions with other vaccines are not expected.
If co-administration is necessary, VAQTA 50 should not be mixed in the same syringe with other vaccines, and other vaccines should be administered at different sites.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this vaccine.
Pregnancy
It is not known whether VAQTA 50 given to a pregnant woman can cause harm to the fetus. VAQTA 50 should only be given to pregnant women if, in the doctor's opinion, the potential benefits outweigh the potential risks to the fetus.
Breastfeeding
Tell your doctor if you are breastfeeding. VAQTA 50 should only be given to breastfeeding women if necessary.

Driving and using machines

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

VAQTA 50 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 50

VAQTA 50 should always be used as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Primary dose
Adults aged 18 years and older should receive one dose of 1 ml (50 U) of the vaccine at the chosen time.
Booster dose
Adults who received the primary dose at 18 years of age or older should receive a booster dose of the vaccine, also 1 ml (50 U), between 6 and 18 months after the first dose.
Antibodies against hepatitis A virus (HAV) persist for at least 6 years after the second dose (i.e., the booster dose). It is expected that the duration of antibody persistence is at least 25 years.
The vaccine may be given as a booster dose 6-12 months after primary vaccination with another inactivated hepatitis A vaccine.

Missing a dose of VAQTA 50

If a booster dose of the vaccine is not given at the recommended time, the decision on further action should be made by the doctor.
Adults infected with the human immunodeficiency virus (HIV)
Adults infected with HIV should receive one dose of 1 ml (50 U) of the vaccine at the designated time, and then a booster dose, also 1 ml (50 U), 6 months after the first dose.
The vaccine should be administered INTRAMUSCULARLYin the deltoid muscle.
In individuals with bleeding disorders, for whom intramuscular administration of the vaccine may cause bleeding (e.g., individuals with hemophilia), the vaccine can be administered subcutaneously.
The vaccine should not be administered intradermally, as this may result in a lower immune response than expected.

VAQTA 50 must not be administered intravenously.

4. Possible side effects

Like all medicines, VAQTA 50 can cause side effects, although not everybody gets them.
The vaccine is generally well tolerated.
The frequency of side effects is classified as follows:

• Very common (affecting 1 or more in 10 vaccinated individuals);
• Common (affecting 1 or more in 100 and less than 1 in 10 vaccinated individuals);
• Uncommon (affecting 1 or more in 1000 and less than 1 in 100 vaccinated individuals);
• Rare (affecting 1 or more in 10,000 and less than 1 in 1000 vaccinated individuals);
• Very rare (affecting less than 1 in 10,000 vaccinated individuals, including single cases).

Clinical trial data

Infections and infestations:
Uncommon:pharyngitis, upper respiratory tract infections.
Rare:bronchitis, infectious gastroenteritis.
Blood and lymphatic system disorders:
Uncommon:generalized lymph node enlargement.
Metabolism and nutrition disorders:
Rare:anorexia.
Psychiatric disorders:
Rare:apathy, insomnia.
Nervous system disorders:
Common:headache.
Uncommon:dizziness of central origin, paresthesia (spontaneous sensory phenomena).
Rare:somnolence, migraine, tremor.
Eye disorders:
Rare:eye itching, photophobia, lacrimation.
Ear and labyrinth disorders:
Uncommon:ear pain.
Rare:dizziness of labyrinthine origin.
Vascular disorders:
Rare:flushing.
Respiratory, thoracic, and mediastinal disorders:
Uncommon:nasal congestion, cough.
Rare:pharyngeal edema, sinusitis.
Gastrointestinal disorders:
Uncommon:nausea, diarrhea, flatulence, vomiting.
Rare:dry mouth, oral ulcers.
Skin and subcutaneous tissue disorders:
Uncommon:itching, urticaria, erythema.
Rare:nocturnal sweating, rash, skin changes.
Musculoskeletal and connective tissue disorders:
Common:pain in the arm where the injection was given.
Uncommon:muscle pain, stiffness, shoulder pain, musculoskeletal pain, back pain, joint pain, leg pain, neck pain, muscle weakness.
Rare:muscle cramps, elbow pain, hip pain, jaw pain, cramp.
Reproductive system and breast disorders:
Rare:menstrual disorders.
General disorders and administration site conditions:
Very common:tenderness at the injection site, pain, feeling of warmth, swelling, erythema.
Common:weakness/fatigue, fever (38.3°C or higher measured orally), hematoma at the injection site, pain/tenderness.
Uncommon:itching at the injection site, stiffness/tension, pain, bruising at the injection site, chills, abdominal pain, malaise, induration and numbness at the injection site, feeling of cold, flu-like symptoms.
Rare:burning at the injection site, induration (≤2.5 cm), muscle twitching, rash, abdominal distension, chest pain, side pain, irritability.
As with any vaccine, allergic reactions may occur, which in rare cases can lead to anaphylaxis.

Side effects reported after marketing authorization

Nervous system disorders:
Very rare:Guillain-Barré syndrome (muscle weakness, abnormal sensation, tingling sensation in the arms, legs, and upper body).
Blood and lymphatic system disorders:
Very rare:decreased platelet count.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, you should 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VAQTA 50

Store in a refrigerator (2°C - 8°C).

DO NOT FREEZE.

Medicines should be kept out of the sight and reach of children.
Do not use VAQTA 50 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. These measures will help protect the environment.

6. Package contents and other information

What VAQTA 50 contains

1 dose of the vaccine (1 ml) contains:

• The active substance of the vaccine is: hepatitis A virus, strain CR326F (inactivated) ……………50 U

Propagated in a culture of human diploid fibroblast cells (MRC-5).
Adsorbed on amorphous aluminum hydroxyphosphate sulfate (0.45 mg Al).
Units determined according to the manufacturer's internal method - Merck Sharp & Dohme LLC.

• Other ingredients are: sodium tetraborate, sodium chloride, water for injections.

What VAQTA 50 looks like and contents of the pack

Available packs:
1 vial of 1 ml, in a cardboard box.
10 vials of 1 ml, in a cardboard box.
1 pre-filled syringe of 1 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 package leaflet: 05/2022