Inactivated hepatitis A vaccine, adsorbed.
The active substance is: The hepatitis A virus GBM strain* (inactivated) ** (160 units*** for one 0.5-ml dose).
*Cultured on MRC-5 human diploid cells.
**Adsorbed on hydrated aluminium hydroxide (0.3 milligrams of Al).
***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, formaldehyde, and Hanks 199 medium 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 that adjusted with hydrochloric acid or sodium hydroxide.
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 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 160 U is a vaccine.
Vaccines are used to protect against infectious diseases.
This vaccine helps protect against the infection caused by the hepatitis A virus in people aged 16 years or more.
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, a second injection (booster) of hepatitis A vaccine will be needed. 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 between 6 and 36 months earlier.
Method of administration: The doctor or nurse will 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 bleeding problems or if he/she bruises easily, the vaccine can be administered under the skin.
AVAXIM 160 U must be administered into a muscle in the outer upper part of the arm.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not use 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 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 is easily subject 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 160 U, the vaccination may not work properly.
This vaccine cannot cause the infections against which it protects.
As with all vaccines, not all people who receive 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.
Like any medicines, this medicine can cause side effects in certain subjects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions are only very rarely possible 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 has left the place where he/ she received the injection, 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 1000 people): injection site redness.
Rare reactions (reported by less than 1 in 1000 people but by more than 1 in 10 000 people): injection site bump; slight and transient modifications 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.
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.
By reporting side effects, the patient can help provide more information on the safety of this medicine.
As the 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 can be administered at the same time as any of the following vaccines but in separate injection sites, i.e. in 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) in two separate injection sites.
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.
If frozen, the vaccine should be discarded.
The vaccine should not be used if it contains foreign particles.
Store in a refrigerator (2-8°C).
Do not freeze.
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.
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Vaccine inj (pre-filled syringe w/ or w/o needle, turbid and whitish suspension) 160 units/0.5 mL x 1's.