Inactivated, adsorbed, hepatitis A (GBM strain) vaccine.
The active substance is: Hepatitis A virus GBM strain* (inactivated)** 80 U*** or 160 unit*** 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 Al, respectively).
*** In the absence of an international standardized reference, the antigen content is expressed using an in-house reference.
Excipients/Inactive Ingredients: 2-Phenoxyethanol, formaldehyde, Hanks Medium 199 without phenol red (a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components) supplemented with polysorbate 80 and diluted in water for injections with a pH adjusted with hydrochloric acid or sodium hydroxide.
AVAXIM 80/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 defenses of the patient's 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 protect the child aged from 12 months to 15 years inclusive against the 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: Recommended dosage 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 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 bruises or bleeds easily, the vaccine can exceptionally be administered under the skin.
This vaccine must never be administered into a blood vessel.
Do not inject the vaccine into the skin.
The vaccine must not be administered into the buttock.
Shake the syringe immediately before the injection and make sure the liquid is turbid and whitish and there are no foreign particles.
If the patient forgets to use AVAXIM 80 U Pediatric: The doctor will decide when to administer this missing dose.
If the patient has any further questions on the use of this medicine, 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 has any further questions on the use of this medicine, ask the doctor or pharmacist.
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 AVAXIM 80 U Pediatric/AVAXIM 160 U (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.
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 wish to wait until treatment is over.
Human immunodeficiency virus (HIV) infection or any other diseases that weaken the immune system. Vaccine administration will be possible but it may not protect the patient as well as it protects people whose immune system functions normally.
If the patient has a liver disease.
If the patient has haemophilia or if easily subjected to bruises or bleeding.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell 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.
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/AVAXIM 160 U Pediatric can cause side effects, although not everybody gets them.
Avaxim 80: 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 itching (urticaria).
Very rare reactions (reported by less than 1 in 10000 people): fainting in response to injection.
All undesirable effects were moderate and confined to the first few days following vaccination with spontaneous recovery.
Avaxim 160: Serious allergic reactions: Serious allergic reactions are always a very rare possibility after vaccine injection. These reactions may include: difficulty in breathing; bluish colouration of the tongue or lips; skin rash; swelling of the face or throat; low blood pressure which causes dizziness or fainting.
These signs or symptoms generally appear very soon after the injection, while the patient is still at the clinic or the medical practice.
If any of these symptoms appear after the patient left the place where injection was received, IMMEDIATELY consult a doctor.
Very common reactions (reported by more than 1 in 10 people): mild injection site pain; fatigue.
Common reactions (reported by less 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 less than 1 in 100 people but by more than 1 in 1,000 people): injection site redness.
Rare reactions (reported by less than 1 in 1,000 people but by more than 1 in 10,000 people): injection site bump; transient modifications of blood tests measuring liver activity.
Not known (frequency cannot be estimated from the available data): fainting in response to injection; skin rash with or without itching.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed previously.
By reporting side effects, the patient can help provide more information on the safety of this medicine.
Avaxim 80: 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.
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/AVAXIM 160 U may not work so well if it is given at the same time as the immunoglobulins. However the patient 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 patient is taking or has recently taken any other medicines, even one obtained without a prescription, please tell the doctor or pharmacist.
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.
Avaxim 160: 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.
This vaccine must not be mixed with other vaccines in the same syringe.
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.
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.
Store in a refrigerator (2°C - 8°C) and protect from light.
Do not freeze.
If frozen, the vaccine should be discarded.
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Avaxim 80: P1S1S3, Avaxim 160: P1S1S3, A
Avaxim 80: Susp for inj (pre-filled syringe) (turbid and whitish suspension) 80 u x 0.5 mL/dose.
Avaxim 160: Susp for inj (pre-filled syringe) (turbid and whitish suspension) 160 u x 0.5 mL/dose.