Havrix 720 Iunior

Patient Information Leaflet: User Information

Havrix 720 Junior, Suspension for Injection

This vaccine is a hepatitis A virus inactivated, adsorbed vaccine.

Read the leaflet carefully before the vaccine is given, as it contains important information for the patient.

It contains information that is important for the patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This vaccine has been prescribed for a specific person. It should not be given to others.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

The content of this leaflet has been written in a way that assumes it will be read by the person receiving the vaccine. However, since this vaccine may be given to adolescents and children, it is possible that the content of the leaflet will be read by a parent or guardian.

Table of Contents of the Leaflet:

• 1. What is Havrix 720 Junior vaccine and what is it used for
• 2. Important information before receiving Havrix 720 Junior vaccine
• 3. How to use Havrix 720 Junior vaccine
• 4. Possible side effects
• 5. How to store Havrix 720 Junior vaccine
• 6. Contents of the pack and other information

1. What is Havrix 720 Junior vaccine and what is it used for

What is Havrix 720 Junior vaccine used for

Havrix 720 Junior vaccine is used to prevent hepatitis A virus infection (HAV) in individuals from 1 year of age to 15 years inclusive. If necessary, Havrix 720 Junior vaccine may also be given to adolescents from 16 to 18 years of age.

What is hepatitis A virus infection:

‐
Hepatitis A is a liver disease caused by the hepatitis A virus (HAV).
‐
The HAV virus is spread from person to person or through contact with contaminated water, food, and drinks.
‐
The symptoms of hepatitis A infection range from mild to severe and may include fever, malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark urine, and jaundice (yellowing of the eyes and skin). Most patients recover completely, but sometimes the disease can be severe and require hospitalization, and in rare cases, it can lead to acute liver failure.

How Havrix 720 Junior vaccine works

‐
Havrix 720 Junior vaccine helps the body produce its own protection (antibodies) against the virus. These antibodies help protect the body against the disease.
‐
Like all vaccines, Havrix 720 Junior vaccine may not fully protect all vaccinated individuals.

2. Important information before receiving Havrix 720 Junior vaccine

When not to use Havrix 720 Junior vaccine

‐
If the patient is allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6) or to neomycin or formaldehyde,
‐
If the patient has ever had an allergic reaction to any hepatitis A vaccine.
Symptoms of an allergic reaction may include itchy skin rash, difficulty breathing, swelling of the face or tongue.
Havrix 720 Junior vaccine should not be given if any of the above applies to the patient. In case of doubt, the doctor, pharmacist, or nurse should be consulted before administering Havrix 720 Junior vaccine.

Warnings and precautions

Before administering Havrix 720 Junior vaccine, the doctor, pharmacist, or nurse should be consulted if:
‐
The patient has a severe infection with high fever. In this case, vaccination will be postponed. Mild infections, such as a cold, should not be a contraindication to vaccination, but the doctor should be informed first,
‐
The patient has a weakened immune system due to disease and/or medication. The doctor will decide if additional doses are needed,
‐
The patient experiences bleeding problems or easy bruising.
After or even before each injection, fainting may occur. Therefore, the doctor, pharmacist, or nurse should be informed if the patient has ever fainted during an injection.

Havrix 720 Junior vaccine and other medicines

The doctor, pharmacist, or nurse should be informed about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take and any vaccines recently received.
Havrix 720 Junior vaccine can be given at the same time as some other vaccines and immunoglobulins, but the injection sites must be different.

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, pharmacist, or nurse before using this vaccine.

Driving and using machines

Havrix 720 Junior vaccine has no or negligible influence on the ability to drive and use machines.

Havrix 720 Junior vaccine contains phenylalanine, sodium, and potassium

This vaccine contains 0.083 mg of phenylalanine per dose.
Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose and less than 1 mmol (39 mg) of potassium per dose, i.e., the vaccine is considered "sodium and potassium-free".

3. How to use Havrix 720 Junior vaccine

How Havrix 720 Junior vaccine is given

‐
Havrix 720 Junior vaccine is given by injection into the muscle, usually in the upper arm in children and adolescents.
‐
In small children, the vaccine may be given in the thigh muscle.
‐
In patients with low platelet count or severe bleeding disorders, Havrix 720 Junior vaccine may be given under the skin as an exception.

Dosage

‐
The patient will receive 1 dose of Havrix 720 Junior vaccine (0.5 ml suspension) on the day agreed with the doctor or nurse.
‐
A second dose (booster dose) is recommended to be given between 6 and 12 months after the first dose, but it can be given up to 5 years after the first dose to ensure long-term protection.

Overdose of Havrix 720 Junior vaccine

Overdose is very unlikely because the vaccine is supplied in a single-dose vial or syringe and is administered by a doctor or nurse. A few cases of accidental overdose have been reported, and the adverse reactions reported were similar to those reported with normal vaccination (listed in section 4).

If the next dose of Havrix 720 Junior vaccine is missed

The doctor should be contacted, who will decide if another dose is needed.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Severe side effects

The doctor should be informed immediately if any of the following severe side effects occur - urgent treatment may be needed:

‐
Allergic reactions - symptoms may include local or widespread rash, which may be itchy or blistering, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness.
These reactions may occur before leaving the doctor's office.
If any of the above severe side effects occur, the doctor should be informed immediately.

During clinical trials, the following side effects were reported with Havrix 720 Junior vaccine:

Very common(may affect more than 1 in 10 doses of the vaccine):

• Irritability
• Pain and redness at the injection site

Common(may affect up to 1 in 10 doses of the vaccine):

• Decreased appetite
• Headache
• Dizziness
• Nausea (vomiting)
• General malaise
• Fever ≥ 37.5°C
• Swelling at the injection site

Uncommon(may affect up to 1 in 100 doses of the vaccine):

• Stuffy nose or runny nose
• Vomiting
• Diarrhea
• Rash
• Hardening at the injection site

The following side effects have been reported with Havrix 720 Junior vaccine since it has been marketed:

‐
Seizures
‐
Vasculitis leading to narrowing or blockage of blood vessels (vasculitis)
‐
Severe allergic reaction causing swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing
‐
Hives, red, often itchy patches that start on the limbs and sometimes on the face and rest of the body
‐
Joint pain

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 this vaccine.

5. How to store Havrix 720 Junior vaccine

The vaccine should be kept out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original package to protect from light.
Do not use this vaccine after the expiry date stated on the package after "EXP". The expiry date refers to the last day of the month.
The "Lot" abbreviation means the batch number of the product.

6. Contents of the pack and other information

What Havrix 720 Junior vaccine contains

• The active substance of Havrix 720 Junior vaccine is:

Hepatitis A virus, strain HM175 (inactivated) not less than 720 ELISA units, grown in human diploid cell culture MRC-5, adsorbed on aluminum hydroxide, hydrated, 0.25 mg Al

• The other ingredients are: polysorbate 20, amino acids for injection (including phenylalanine), sodium phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, water for injection.

What Havrix 720 Junior vaccine looks like and contents of the pack

Havrix 720 Junior is a slightly opaque, white suspension in a vial or pre-filled syringe.
Pack sizes:
1 vial of 0.5 ml in a cardboard box
1 pre-filled syringe with needle of 0.5 ml in a cardboard box
1 pre-filled syringe of 0.5 ml with attached needle in a cardboard box

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals S.A.
Rue de l’Institut 89
1330 Rixensart, Belgium
For further information, please contact the local representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Tel. +48 (22) 576 90 00

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

Date of last revision of the leaflet:

08/2024
Information intended for healthcare professionals or healthcare workers only:
During storage, a white deposit and a clear, colorless liquid may appear at the bottom of the vial or pre-filled syringe. Before administration, the vaccine should be inspected for any foreign particles or physical changes.
Before use, the vial or pre-filled syringe should be shaken to obtain a slightly opaque, white suspension.
If any changes in the appearance of the vaccine are observed, it should not be administered.

Instructions for the pre-filled syringe
The pre-filled syringe should be held by the body, not by the plunger.
The cap of the pre-filled syringe should be removed by twisting it in the opposite direction to the clockwise direction.

Luer Lock adapter
Plunger
Body
Cap
The needle should be attached to the pre-filled syringe by connecting the needle cap to the Luer Lock adapter (Luer Lock Adaptor, LLA) and twisting it a quarter turn in the clockwise direction until the needle is locked.
The plunger should not be pulled out of the body of the pre-filled syringe. If this happens, the vaccine should not be administered.
Disposal
Any unused product or waste material should be disposed of in accordance with local regulations.

Needle cap