Avaxim 160 U

Package Leaflet: Information for the User

AVAXIM 160 U, suspension for injection in a pre-filled syringe
Hepatitis A (inactivated, adsorbed) vaccine

Read the package leaflet carefully before using the vaccine, as 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 specifically for you. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What AVAXIM 160 U is and what it is used for
• 2. Important information before using AVAXIM 160 U
• 3. How to use AVAXIM 160 U
• 4. Possible side effects
• 5. How to store AVAXIM 160 U
• 6. Package contents and other information

1. What AVAXIM 160 U is and what it is used for

This medicinal product is a vaccine in the form of a suspension for injection in a pre-filled syringe of 0.5 ml, in a box of 1.
AVAXIM 160 U is indicated for active immunization against hepatitis A (HAV) in individuals from 16 years of age and older.
It does not protect against infection caused by other types of hepatitis virus or other known microorganisms that cause liver disease.
The vaccine should be used in accordance with official recommendations.

2. Important information before using AVAXIM 160 U

When not to use AVAXIM 160 U:

• if the patient has a fever, acute infection, or chronic disease during an exacerbation (it is best to postpone vaccination);
• if the patient is allergic to the active substance or any of the other ingredients of the vaccine (listed in section 6) or if the patient has experienced hypersensitivity after previous administration of the vaccine.

Warnings and precautions

• do not inject intravascularly. Before injection, make sure the needle is not in a blood vessel;
• the vaccine should not be administered into the buttock muscle due to the presence of varying amounts of fatty tissue, nor subcutaneously, as these routes of administration may affect the immune response;
• immunosuppressive treatment or a state of reduced immunity may lead to a reduced immune response to the vaccine;
• if the vaccine is administered during the incubation period of hepatitis A, it may not affect the development of hepatitis A;
• in patients with liver disease;
• in patients allergic to neomycin (each dose of the vaccine contains trace amounts of neomycin).

Fainting can occur (especially in adolescents) after, or even before, any needle injection.
Therefore, inform your doctor or nurse if you or your child have experienced fainting during previous injections.

Pregnancy and breastfeeding

The effect of the vaccine on the fetus is not known. As with other inactivated viral vaccines, no adverse effects on the fetus are expected. However, the vaccine is not recommended for pregnant women.
As with other medicines, when deciding whether to vaccinate a pregnant or breastfeeding woman, the risk-benefit ratio should be considered.
The vaccine is not recommended during breastfeeding, as no studies have been conducted on its administration to breastfeeding women.

Driving and using machines

It is unlikely that the vaccine will affect the ability to drive and use machines.
However, no studies have been conducted on this.

AVAXIM 160 U contains ethanol, phenylalanine, potassium, and sodium

AVAXIM 160 U contains 2 mg of alcohol (ethanol) per 0.5 ml dose.
The small amount of alcohol in this vaccine will not cause noticeable effects.
AVAXIM 160 U contains 10 micrograms of phenylalanine per 0.5 ml dose, which corresponds to 0.17 micrograms/kg for a person with a body weight of 60 kg. Phenylalanine may be harmful in patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
AVAXIM 160 U contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, meaning the product is essentially "potassium-free" and "sodium-free".

Important information about some vaccine components:

Excipients that may affect the patient:
formaldehyde.

AVAXIM 160 U and other medicines

The vaccine can be administered simultaneously with immunoglobulins if injected into two different parts of the body.
AVAXIM 160 U is inactivated and can be administered simultaneously with other inactivated vaccines at different sites without causing interactions.
This vaccine can be administered simultaneously, but at a different site, with a recombinant hepatitis B vaccine (rHBV) or a polysaccharide typhoid vaccine.
AVAXIM 160 U can also be used simultaneously with a live yellow fever vaccine, but at a different site.
AVAXIM 160 U can be used as a booster dose in individuals who have received primary vaccination with another inactivated hepatitis A vaccine (HAV).
Inform your doctor about all medicines you have taken recently, even those that are available without a prescription.

3. How to use AVAXIM 160 U

Dosage

Recommended dosage: 0.5 ml for individuals from 16 years of age.
Primary protection is achieved after a single dose of the vaccine.
Immunity to hepatitis A is achieved approximately 14 days after the first dose.
To achieve long-term protection, a second dose (booster) should be administered ideally between 6 and 12 months after the first vaccination, but can be administered up to 36 months after the first vaccination. This booster dose will provide protection against hepatitis A for more than 10 years.
This vaccine can also be administered as a booster dose for hepatitis A vaccination in individuals who received their first vaccination with a combined typhoid and hepatitis A vaccine (inactivated) 6 to 36 months earlier.

Method of administration

The vaccine should be administered intramuscularly (im) to minimize local side effects.
The recommended site for vaccine administration is the deltoid muscle.
Do not inject AVAXIM 160 U intravascularly. Before injection, make sure the needle is not in a blood vessel.
AVAXIM 160 U should not be administered into the buttock muscle due to the presence of varying amounts of fatty tissue, nor subcutaneously, as these routes of administration may affect the immune response.
In exceptional cases, the vaccine may be administered subcutaneously in patients with thrombocytopenia (insufficient platelets, which are essential for blood clotting) or in patients at risk of bleeding.
AVAXIM 160 U should not be mixed in the same syringe with other vaccines.
Shake before use until a homogeneous suspension is obtained.
Any unused vaccine or waste material should be disposed of in accordance with local regulations.

Overdose of AVAXIM 160 U

Not applicable.

Missed dose of AVAXIM 160 U

Not applicable.

4. Possible side effects

Like all medicines, AVAXIM 160 U can cause side effects, although not everybody gets them.

Severe allergic reactions

Severe or even life-threatening allergic reactions (anaphylactic reactions, including shock) can occur, although they are very rare.
In the event of an allergic reaction, seek immediate medical attention or go to the nearest hospital emergency room.
Allergic reactions can occur immediately or within a few days of vaccination, and symptoms may include:

• difficulty breathing, blue discoloration of the tongue or lips
• dizziness (low blood pressure) and possible fainting
• rapid heartbeat and weak pulse, cold skin
• swelling of the face and neck
• itching and skin rash

Other side effects

Very common reactions (reported by more than 1 in 10 people):

• mild pain at the injection site
• general weakness (asthenia)

Common reactions (reported by less than 1 in 10 but more than 1 in 100 people):

• headache
• nausea or vomiting
• loss of appetite
• diarrhea and (or) abdominal pain
• muscle and joint pain
• mild fever

Uncommon reactions (reported by less than 1 in 100 but more than 1 in 1,000 people):

• redness (erythema) at the injection site

Rare reactions (reported by less than 1 in 1,000 but more than 1 in 10,000 people):

• appearance of a lump at the injection site (injection site nodule)
• mild and transient changes in blood tests that measure liver function (elevated transaminase activity)

Reactions with unknown frequency (cannot be estimated from available data):

• fainting in response to injection
• rashes, which were sometimes lumpy and itchy (including urticaria)

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 AVAXIM 160 U

AVAXIM 160 U should be stored out of sight and reach of children.
Do not use this vaccine after the expiration date stated on the outer carton and on the label of the syringe: Expiration Date (EXP). The expiration date refers to the last day of the month stated.
Do not use this vaccine if there are particles present.
Store in a refrigerator (2°C - 8°C). Do not freeze. Discard the vaccine if it has been frozen.
Store in the original package to protect from light.
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. Package contents and other information

What AVAXIM 160 U contains

The active substance of the vaccine is:
hepatitis A virus, GBM strain (inactivated) ………….. 160 ELISA antigen units
* grown in human diploid MRC-5 cells
** adsorbed onto hydrated aluminum hydroxide 0.3 mg Al
*** antigen units determined based on in-house standard.
The excipients are:

• 2-phenoxyethanol
• anhydrous ethanol
• formaldehyde
• Hanks' 199 medium*
• water for injections
• polysorbate 80
• hydrochloric acid and sodium hydroxide for pH adjustment * Hanks' 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components.

What AVAXIM 160 U looks like and contents of the pack

Suspension for injection in a pre-filled syringe.
Packaging:
1 pre-filled syringe of 0.5 ml with a needle attached in a cardboard box.

Marketing authorization holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France
Sanofi Winthrop Industrie, Voie de l’Institut - Parc Industriel d’Incarville, B.P 101, 27100 Val de
Reuil, France
Sanofi-Aventis Zrt., Building DC5, Campona Utca 1., Budapest XXII 1225, Hungary
Date of last revision of the leaflet: December 2024