Avaxim 80

The hepatitis A vaccine (inactivated, adsorbed) is a turbid and whitish suspension.
AVAXIM 80 U PEDIATRIC contains: The active substance is: Hepatitis A virus GBM strain* (inactivated)** 80 ELISA units*** for one dose of 0.5 mL.
* Cultured on MRC-5 human diploid cells.
** Adsorbed on hydrated aluminium hydroxide (0.15 milligrams of Al³⁺).
*** Antigen units expressed using an in-house reference.
Excipients/Inactive Ingredients: The other components are: 2-Phenoxyethanol, ethanol, formaldehyde, Hanks Medium 199*, water for injections, polysorbate 80, hydrochloric acid and sodium hydroxide for pH adjustment.
* Hanks Medium 199 (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components, including potassium.

AVAXIM 80 U PEDIATRIC is a vaccine.
Vaccines are used to protect patients against infectious diseases.
This vaccine helps protect children aged from 12 months to 15 years inclusive against the infection caused by the hepatitis A virus.
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 a child receives an injection of AVAXIM 80 U PEDIATRIC, 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.

Dosage: Primary vaccination (first dose): Primary vaccination is ensured with a 0.5 mL dose of vaccine.
Booster: After 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 must be administered into a muscle (in order to minimise local reactions), in the outer upper part of the child's arm.
If the child has haemophilia or if bruises or bleeds easily, the vaccine can exceptionally be administered under the skin.
This vaccine must never be administered into a blood vessel.
The doctor or the nurse must not inject the vaccine into the skin.
The vaccine will not be administered into the buttock.
The doctor or the nurse will shake the syringe immediately before the injection and will make sure the liquid is turbid and whitish and there are no foreign particles.
If the child forgets to use AVAXIM 80 U PEDIATRIC: The doctor will decide when to administer this missing dose.
If there are any further questions on the use of this medicine, ask a doctor or pharmacist.

Do not use AVAXIM 80 U PEDIATRIC: If the child is allergic to the active substance or any of the other ingredients of AVAXIM 80 U PEDIATRIC (listed in Description).
If the child 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 child is allergic to AVAXIM 80 U PEDIATRIC.
If the child has a disease with a high temperature. Vaccination should be postponed until the child has recovered.

Talk to a doctor, pharmacist or nurse before using AVAXIM 80 U PEDIATRIC.
If the child 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.
HIV (Human immunodeficiency virus) infection or any other diseases that weaken the immune system. Vaccine administration is recommended although it may not protect the child as well as it protects people with a normal immune system.
If the child has a liver disease.
If the child has haemophilia or is easily subject to bruises or bleeding.
Fainting can occur (especially in adolescents) following, or even before, any needle injection. Therefore, tell the doctor or nurse if the child fainted with a previous injection.
This vaccine will not protect the child against other viruses that infect the liver (such as hepatitis B, hepatitis C or hepatitis E viruses).
If the child is already infected by the hepatitis A virus at the time of the administration of AVAXIM 80 U PEDIATRIC, 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 will definitely be protected against hepatitis A.
AVAXIM 80 U PEDIATRIC contains phenylalanine, ethanol, potassium and sodium: AVAXIM 80 U PEDIATRIC 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 for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
AVAXIM 80 U PEDIATRIC contains 2 mg of alcohol (ethanol) per dose of 0.5 mL. The quantity for 1 dose of this medicinal product is equivalent to less than 0.1 mL of beer or less than 0.1 mL of wine. The small quantity of alcohol contained in this medicinal product is not likely to cause any notable effects.
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 essentially "potassium-free" and "sodium-free".
Driving and using machines: The vaccine is unlikely to have any effects on the ability to drive or to use machines. However no studies on this were performed.

As a precautionary measure, it is preferable not to use this vaccine during pregnancy, except in case of a major contamination risk.
The use of this vaccine is possible during breast-feeding.
If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask a doctor or pharmacist for advice before receiving this vaccine.
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.
Serious allergic reactions: Serious allergic reactions (anaphylactic reaction, including shock), though very rare, may occur after vaccination.
Contact the doctor or a healthcare professional immediately, or go to the emergency department of the nearest hospital immediately in case of allergic reactions that could be life-threatening. These signs or symptoms will generally appear very quickly after the injection and may include: difficulty breathing, blue colouring of the tongue or lips; vertigo (low blood pressure) and possible fainting; fast heart rate and weak pulse, cold skin; swelling of the face or neck; itching and skin rash.
Other side effects: Side effects have been reported after the first dose (primary vaccination) and the second dose (booster dose) with the following frequencies: Very common side effects (reported in more than 1 in 10 people): pain at the injection site ⁽¹⁾; abnormal crying ⁽¹⁾.
Common side effects (reported by less than 1 in 10 people but more than 1 in 100 people): appetite decrease; irritability, insomnia; headache; belly pain, diarrhoea, nausea, vomiting; muscle and joint pain ⁽¹⁾; local injection site reactions such as pain ⁽²⁾, redness, swelling or induration, haematoma ⁽¹⁾; malaise, fever, fatigue or somnolence.
Uncommon side effects (reported in less than 1 in 100 people but more than 1 in 1000 people): abnormal crying ⁽²⁾; skin eruptions ⁽²⁾, itching (urticaria) ⁽¹⁾; joint pain ⁽²⁾; haematoma at the injection site ⁽²⁾.
Side effects with a not known frequency (cannot be estimated based on the available data): fainting in response to injection; seizures with or without fever.
⁽¹⁾ Frequency after the first dose.
⁽²⁾ Frequency after the second dose.
Overall, side effects were reported less frequently after the second dose than after the first dose.
All undesirable effects were moderate and limited to the first few days following vaccination with spontaneous recovery.
Reporting of side effects: If the child gets any side effects, talk to a 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.

The immunological response may be diminished in case of immunosuppressive treatment.
The vaccine may be administered at the same time as routine booster vaccines of the child during the second year of life, i.e. the various vaccines against diphtheria, tetanus, pertussis, Haemophilus influenzae of type b and poliomyelitis.
This vaccine can also be administered at the same time as a vaccine against measles, mumps and rubella.
All injections must be performed in separate injection sites, i.e. in another part of the body such as another arm or another leg, and the vaccines must not be mixed in the same syringe.
This vaccine can be administered at the same time as immunoglobulins (antibodies obtained from blood donation) but in two separate injection sites.
AVAXIM 80 U PEDIATRIC may not work so well if it is given at the same time as the immunoglobulins. However the child will probably be protected against the 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.
Tell the doctor or pharmacist if the child is taking, has recently taken or might take any other medicines.

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep in the original packaging, protected from light.
Do not use this medicine if there is a colouration or the presence of foreign particles.
Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer in use. These measures will help protect the environment.

Vaccines, Antisera & Immunologicals

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

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