Inactivated hepatitis A vaccine, adsorbed.
The active ingredient is: Hepatitis A virus (GBM strain)*, inactivated** 80U*** For one 0.5 ml dose.
* cultured on MRC-5 human diploid cells.
** adsorbed on aluminium hydroxide (quantity equivalent to 0.15 mg of aluminium).
*** antigen units expressed using an in-house reference.
Excipients/Inactive Ingredients: The other ingredients are phenoxyethanol, formaldehyde, Hanks medium 199 which is a complex mixture of amino acids, mineral salts, vitamins, hydrochloric acid or sodium hydroxide for pH adjustment and water for injections.
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 child receives an injection of AVAXIM 80 U PEDIATRIC, the natural defences of his/her 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 U PEDIATRIC is a vaccine.
Vaccines are used to protect the patient against infectious diseases.
The vaccine helps protect the child aged from 12 months to 15 years inclusive against the infection caused by the hepatitis A virus.
Dosage: The recommended dose is 0.5 mL for each injection.
The vaccination schedule includes a single primary vaccination dose. A booster injection is recommended 6 to 36 months later in order to obtain long-term protection. This booster will protect the child against hepatitis A beyond 10 years.
Method and/or routes 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 he/she bruises or bleeds easily, the vaccine can exceptionally be administered under his/her 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 patient forgets to use AVAXIM 80U PEDIATRIC: The doctor will decide when to administer this missing dose.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use AVAXIM 80U 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 he/she has recovered.
If the child has a weakened immune system due to: Corticosteroids, cytotoxic drugs, radiotherapy or other treatments likely to weaken his/her immune system. The doctor may wait until treatment is over.
HIV (Human immunodeficiency virus) infection or any other diseases that weaken his/her immune system. Vaccine administration is recommended although it may not protect him/her 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.
List of excipients with recognised effect: Not applicable.
Driving or 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 the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine. Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicines, AVAXIM 80 U PEDIATRIC can cause side effects, although not everybody gets them.
Common reactions (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; local injection site reactions such as pain, redness, swelling or induration; fever, fatigue.
Uncommon reactions (reported by less than 1 in 100 people but more than 1 in 1000 people): Skin eruptions (rash) with inching (urticaria).
Very rare reactions (reported by less than 1 in 10,000 people): fainting in response to injection.
All undesirable effects were moderate and confined to the first few days following vaccination, with spontaneous recovery.
Reporting of side effects: If the child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.
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.
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.
If the child is taking or has recently taken any other medicines, even one obtained without a prescription, please tell the doctor or pharmacist.
The vaccine should not be used in case of colouring or presence of foreign particles. 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.
This vaccine must not be mixed with other vaccines in the same syringe.
Store in a refrigerator 2°C - 8°C and protect from light.
Do not freeze.
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Vaccine inj (pre-filled syringe) 80 u/0.5 mL (turbid and whitish suspension) x 1's.