Avaxim 80/Avaxim 160

Hepatitis A (GBM strain) vaccine (inactivated, adsorbed).

The hepatitis A vaccine (inactivated, adsorbed) is a cloudy, whitish suspension.
The active substance is: Hepatitis A virus GBM strain* (inactivated)** 80 ELISA units*** or 160 ELISA units*** for one 0.5 ml dose.
* Cultured on MRC-5 human diploid cells.
** Adsorbed on hydrated aluminium hydroxide (0.15 milligrams or 0.3 milligrams of Al³⁺, respectively).
Avaxim 80: *** Antigenic units measured according to the manufacturer's internal method.
Avaxim 160: *** In the absence of an international standardized reference, the antigen content is expressed using an in-house reference.
Excipients/Inactive Ingredients: The other ingredients are: 2-phenoxyethanol, 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, including potassium.

Pharmacotherapeutic group: Viral vaccine. ATC code: J07B C02.
AVAXIM 80 U/AVAXIM 160 U is a vaccine.
Vaccines are used to protect against infectious diseases.
Hepatitis A infection is caused by a virus which attacks the liver. It can be transmitted by food or beverages containing the virus. Symptoms include yellowing of the skin (jaundice) and feeling generally unwell.
When the patient receives an injection of AVAXIM 80 U Pediatric/AVAXIM 160 U, the natural defences of the body develop a protection against the infection caused by the hepatitis A virus.

This vaccine should be administered in accordance with official recommendations.
Avaxim 80: This vaccine helps to protect the child aged 12 months to 15 years inclusive from infection caused by the hepatitis A virus.
Avaxim 160: This vaccine helps protect against the infection caused by the hepatitis A virus in people aged 16 years or more.

Avaxim 80: Posology: Primary vaccination (first dose): The primary vaccination is provided by a 0.5 ml vaccine dose.
Booster: After the primary vaccination, a booster dose of 0.5 ml is recommended to achieve long-term protection. This booster dose should be administered 6 months to 10 years after this first dose.
Method of administration: AVAXIM 80 U Pediatric should be administered into a muscle (to minimise local reactions), in the child's upper outer arm.
If the child suffers from haemophilia or if he/she is easily prone to bruising or bleeding, the vaccine can exceptionally be administered under the skin.
This vaccine must never be administered into a blood vessel.
The doctor or nurse should not inject the vaccine into the skin.
The vaccine must not be administered into the buttock.
The doctor or nurse will shake the syringe immediately before the injection and make sure that the liquid is cloudy and whitish and that no foreign particles are in it.
If the child forgets to use AVAXIM 80 U Pediatric suspension for injection in pre-filled syringe: The doctor will decide when to administer this missing dose.
If the child stops using AVAXIM 80 U PEDIATRIC suspension for injection in pre-filled syringe: Not applicable.
If there are any further questions on the use of this medicine, advise the patient to ask the doctor or pharmacist.
Avaxim 160: The vaccine will be administered by a health professional trained to the use of vaccines and equipped to respond to any severe allergic reaction following the injection.
Dosage: One 0.5 ml dose of AVAXIM 160 U is administered to subjects from the age of 16 years.
The patient will be protected against hepatitis A about 14 days after the first dose.
In order to obtain long-term protection against hepatitis A, the patient will need a second injection (booster) of hepatitis A vaccine. It is generally administered between 6 and 12 months after the first dose, and can be administered up to 36 months after the first dose. This booster will protect the patient against hepatitis A beyond 10 years.
AVAXIM 160 U can also be administered as a booster dose of the hepatitis A vaccination if the patient has received the first injection with the combined typhoid fever (Vi purified polysaccharide) and hepatitis A (inactivated) vaccine 6 to 36 months earlier.
Method of administration: AVAXIM 160 U must be administered into a muscle in the outer upper part of the patient's arm.
If the patient has bleeding problems or bruises easily, the vaccine can be administered under the skin.
Avoid injecting the vaccine into the skin or into a blood vessel.
This vaccine must not be administered into the buttock.
If the patient forgets to use Avaxim 160 U: Not applicable.
If the patient stops using Avaxim 160 U: Not applicable.
If there are any further questions on the use of this medicine, advise the patient to ask the doctor or pharmacist.

Not applicable.

Do not use AVAXIM 80 U Pediatric/AVAXIM 160 U: If the patient is allergic to the active substance or any of the other ingredients of this vaccine (listed in Description); If the patient is allergic to neomycin (an antibiotic used during the manufacturing process of the vaccine and which may be present in it in small amounts); If the patient is allergic to AVAXIM 80 U Pediatric/AVAXIM 160 U; If the patient has a disease with a high temperature. Vaccination should be postponed until the patient has recovered.

Advise the patient to talk to a doctor, pharmacist or nurse before using AVAXIM 80 U Pediatric/AVAXIM 160 U.
If the patient has a weakened immune system due to: Corticosteroids, cytotoxic drugs, radiotherapy, or other treatments likely to weaken the immune system. The doctor may wait until treatment is over; Human immunodeficiency virus (HIV) infection or any other diseases that weakens the immune system. It is recommended that the vaccine be administered although it may not protect the patient as well as it would in a person with a normal immune system.
If the patient has a liver disease.
If the patient has haemophilia or is easily subjected to bruises or bleeding.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore, advise the patient to inform the doctor or nurse if the patient fainted with a previous injection.
This vaccine will not protect the patient against other viruses known to infect the liver (such as hepatitis B, hepatitis C or hepatitis E viruses).
If the patient is already infected by the hepatitis A virus at the time of the administration of AVAXIM 80 U Pediatric/AVAXIM 160 U, the vaccination may not work properly.
The vaccine cannot cause the infections against which it protects.
As with all vaccines, not all people who receive AVAXIM 80 U Pediatric/AVAXIM 160 U will definitely be protected against hepatitis A.
AVAXIM 80 U Pediatric and AVAXIM 160 U contains ethanol, phenylalanine, potassium and sodium: AVAXIM 80 U Pediatric and AVAXIM 160 U contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects. AVAXIM 80 U Pediatric and AVAXIM 160 U contains 10 micrograms of phenylalanine in each 0.5 ml dose, which is equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Avaxim 80: The amount per dose of this medicine is equivalent to less than 0.1 ml of beer or less than 0.1 ml of wine.
AVAXIM 80 U PEDIATRIC contains less than 1 mmol (39 mg) of potassium and less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially "potassium free" and "sodium free".
Driving and using machines: This vaccine is unlikely to have any effects on the ability to drive or to use machines. However, no studies on this topic were performed.
Avaxim 160: Use in Children: Not applicable.

As a precautionary measure, it is preferable not to use this vaccine during pregnancy unless there is a risk of significant contamination.
This vaccine can be used while breast-feeding.
If the patient is pregnant or breast-feeding, thinking may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before receiving this vaccine.
Advise the patient to ask a doctor or pharmacist for advice before taking any medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Advise the patient to contact a doctor or healthcare professional immediately or go to the nearest hospital emergency department immediately if the patient experiences any allergic reactions that may be life-threatening. In general, these signs or symptoms appear very quickly after the injection and may include: difficulty breathing, blue colour of the tongue or lips, dizziness (low blood pressure) and possibly fainting, fast heart rate and weak pulse, cold skin, swelling of the face or neck, itching and skin rash.
Reporting of side effects: If the patient gets any side effects, advise the patient to talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph.
By reporting side effects, it can help provide more information on the safety of this medicine.
Avaxim 80: Serious allergic reactions: Severe allergic reactions (anaphylactic reaction, including shock), although very rare, may occur after the vaccination.
Other side effects: Adverse reactions have been reported after the first dose (primary vaccination) and the second dose (booster dose) with the following frequencies: Very common adverse reactions (reported in more than 1 in 10 people): pain at the injection site⁽¹⁾, abnormal crying⁽¹⁾.
Common adverse reactions (reported by fewer than 1 in 10 people but more than 1 in 100): reduced appetite; irritability, insomnia; headache; stomach aches, diarrhoea, nausea, vomiting; muscle and joint pain⁽¹⁾; local reactions at the injection site such as pain⁽²⁾, redness, swelling or induration, bruising⁽¹⁾; malaise, fever, fatigue or drowsiness.
Uncommon adverse reactions (reported by fewer than 1 in 100 people but more than 1 in 1000): abnormal crying⁽²⁾, skin rash⁽²⁾, itching (hives)⁽¹⁾, joint pain⁽²⁾, haematoma at the injection site⁽²⁾.
Not known (the frequency cannot be estimated from the available data): fainting in response to injection, convulsions with or without fever.
⁽¹⁾ Frequency after first dose.
⁽²⁾ Frequency after second dose.
Overall, adverse reactions were reported less frequently after the second dose than after the first dose.
All adverse reactions were moderate and limited to the first few days after vaccination with spontaneous regression.
Avaxim 160: Serious allergic reactions: Serious allergic reactions, which can even be fatal (anaphylactic reaction, including shock), while very rare, can still occur after the vaccine.
Other adverse reactions: Very common reactions (reported by more than 1 in 10 people): mild injection site pain, fatigue.
Common reactions (reported by fewer than 1 in 10 people but by more than 1 in 100 people): headache; nausea, vomiting; loss of appetite; diarrhoea, abdominal pain; muscle and joint pain; mild fever.
Uncommon reactions (reported by fewer than 1 in 100 people but by more than 1 in 1,000 people): injection site redness.
Rare reactions (reported by fewer than 1 in 1,000 people but by more than 1 in 10,000 people): injection site bump, slight and transient modification of blood tests measuring liver activity.
Not known (cannot be estimated from the available data): fainting in response to injection, skin rash with or without itching.

This vaccine can be administered at the same time as immunoglobulins (antibodies obtained from blood donation) in two different injection sites.
AVAXIM 80 U Pediatric/AVAXIM 160 U may not work so well if it is given at the same time as the immunoglobulins. However, it is likely that the patient will still be protected against hepatitis A infection.
This vaccine can be used as a booster dose in subjects who have received a first vaccination with another inactivated hepatitis A vaccine.
Advise the patient to inform the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Avaxim 80: The immunological response may be diminished in case of immunosuppressive therapy.
The vaccine may be administered at the same time as the child's routine booster vaccinations in his/her second year, i.e. the various vaccines against diphtheria, tetanus, whooping cough, Haemophilus influenzae type b and poliomyelitis.
This vaccine can also be administered at the same time as a measles, mumps and rubella vaccine.
All injections must be given at different injection sites, i.e. another part of the body such as another arm or leg, and the vaccines must not be mixed in the same syringe.
AVAXIM 80 U PEDIATRIC with food and drink: Not applicable.
Avaxim 160: This vaccine can be administered at the same time as any of the following vaccines but in separate injection sites, i.e. another part of the body such as another arm or another leg, and must not be mixed in the same syringe: as a polysaccharide typhoid vaccine; as a yellow fever live vaccine.
As this vaccine is inactivated (it does not contain any bacteria or live virus), association with other inactivated vaccine(s) using a separate injection site should not induce any interactions.

The following information is intended for healthcare professionals only: Do not mix with other vaccines in the same syringe.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Avaxim 80: Do not use this medicine if there is an abnormal colour or the presence of foreign particles.
Avaxim 160: The vaccine should not be used if it contains foreign particles.
Shake the syringe immediately before the injection and make sure the liquid is turbid and whitish.
Parenteral products must be visually inspected to reveal the presence of particles and/or a change in colouration before administration. In either case, the product must not be administered.

Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.

Vaccines, Antisera & Immunologicals

J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.

Avaxim 80: P₁S₁S₃, Avaxim 160: P₁S₁S₃, A