Avaxim 80 U Pediatric/Avaxim Adult

Inactivated adsorbed hepatitis A virus.

Avaxim 80 U Pediatric: The active ingredient is inactivated^** hepatitis A virus (GBM strain)^* 80 ELISA units^*** For one 0.5 mL dose.
^* Cultured on MRC-5 human diploid cells.
^** Adsorbed on hydrated aluminium hydroxide (quantity equivalent to 0.15 mg of Al³⁺).
^*** Antigenic units measured according to the manufacturer's internal method.
Excipient with known effect (see Precautions): Phenylalanine: 10 micrograms per 0.5 mL dose.
Avaxim Adult: Each 0.5 mL dose contains: Inactivated Adsorbed^** Hepatitis A virus^* 160 ELISA units^***, Aluminium hydroxide (expressed as aluminium) 0.3 mg, 2-phenoxyethanol 2.5 μL, Ethanol 2.5 μL, Formaldehyde 12.5 μg, Hanks 199 medium^**** up to 0.5 mL, Water for injections, Polysorbate 80, Hydrochloric acid and sodium hydroxide for pH adjustment, Less than 1 mmol of sodium and less than 1 mmol of potassium per dose.
^* GBM strain cultured on MRC-5 human diploid cells.
^** Adsorbed on hydrated aluminium hydroxide (0.3 milligrams of Al).
^*** In the absence of an international standardised reference, the antigen content is expressed using an in-house reference.
^**** Hanks 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamin and other components, including potassium.
Excipient with known effect: Formaldehyde.
Excipients/Inactive Ingredients: Avaxim 80 U Pediatric: 2-Phenoxyethanol, ethanol, formaldehyde and Hanks Medium 199*, 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; Vaccine against Hepatitis A. ATC code: J07BC02.
Pharmacology: Pharmacodynamics: Avaxim 80 U Pediatric: This vaccine is prepared from hepatitis A virus cultured, harvested, purified and then inactivated by formaldehyde.
It confers immunity against hepatitis A virus (HAV) by inducing anti-HAV antibody titres longer lasting and higher than those obtained after passive immunisation with immunoglobulins. This vaccine has been demonstrated to elicit protective anti-HAV antibody titres (≥20 mIU/mL) within two weeks following the injection in over 95% of individuals and in 100% of individuals before the booster dose administered 6 months after the first dose.
A study conducted in Argentina (an area of intermediate endemicity for hepatis A) enabled the evaluation of long-term persistence of anti-HAV antibodies in children aged 12 months to 47 months vaccinated with 2 doses of AVAXIM 80 U PEDIATRIC 6 months apart. The results show a persistence of the antibodies until 14-15 years at levels considered as protective and do not suggest the need for new administration of the vaccine.
A mathematical model using the available data from this study until 14-15 years after administration of the 2 doses of AVAXIM 80 U PEDIATRIC predicts a persistence of the protective anti-HAV antibodies for at least 30 years in 87.5% (CI 95%: 74.1; 94.8) of these children.
Avaxim Adult: This vaccine is prepared from hepatitis A virus cultured, purified and then inactivated by formaldehyde. It confers immunity against hepatitis A virus by inducing a higher antibody response than that obtained after passive immunisation with immunoglobulins. The antibodies appear soon after the first injection, and 14 days after vaccination, more than 90% of immunocompetent subjects are seroprotected (titres above 20 mIU/mL).
One month after the first injection, almost 100% of subjects have titres higher than 20 mIU/mL. Immunity may persist up to the 36^th month. In a study with 103 healthy subjects whose serology levels were monitored for 3 years after the first injection of AVAXIM 160 U, 99% still had, by the 36^th month, antibody titres of at least 20 mIU/mL against the hepatitis A virus.
Long-term persistence of a protective antibody level against the hepatitis A virus after a second dose (booster) of AVAXIM 160 U is not currently established. However, the available data suggest that the antibodies against the hepatitis A virus persist beyond 10 years after the second dose in healthy people.

Avaxim 80 U Pediatric: Avaxim 80 U Pediatric comes in the form of a suspension for injection in a prefilled syringe (0.5 mL). This vaccine is recommended in the prevention of infection induced by hepatitis A virus in children 12 months to 15 years inclusive.
This vaccine should be administered in accordance with official recommendations.
Avaxim Adult: This medicinal product is a VACCINE.
This medicinal product is recommended in the prevention of infection caused by hepatitis A virus in adults over the age of 16 years.
Vaccination against hepatitis A is recommended for subjects exposed to hepatitis A virus risks such as: Non-immunized adults traveling in an endemic area (region where the hepatitis A virus is commonly found).
* Adults professionally exposed to a risk of contamination: nursery personnel, boarders and staff of establishments and services for handicapped infants and children, sewage and water treatment personnel, food industry and catering personnel).
* Adults in particular risk categories (haemophilia, multiple transfusion, IV drug dependency, homosexual practices).
It does not protect against infection due to other types of hepatitis virus or to other known pathogens of the liver.

Avaxim 80 U Pediatric: Posology: Primary-vaccination: Primary vaccination is achieved with one vaccine dose of 0.5 mL.
Booster: One booster dose of 0.5 mL is recommended in order to provide long-term protection. This booster will preferably be administered 6 to 36 months following the primary vaccination dose, but administration will be possible until 7 years after this primary vaccination.
Available data on vaccination with AVAXIM 80 U PEDIATRIC show that after the two doses of the initial vaccination schedule, no other booster vaccination is necessary in immunocompetent individuals, which is in agreement with the official recommendations.
It is estimated that anti-HAV antibodies persist several years (beyond 10 years) after the second dose (booster).
Avaxim Adult: Posology: The recommended dose is 0.5 mL for each injection. The primary vaccination is performed with single dose of vaccine followed by a booster injection: 6 to 12 months later for adults over 16 years of age and can be administered up to 36 months after the first vaccination. This vaccine can also be administered as a booster dose of the hepatitis A vaccination in subjects from 16 years of age who received a first injection with the combined typhoid fever (Vi purified polysaccharide) and hepatitis A (inactivated) vaccine between 6 and 36 months earlier.
Method of administration: Avaxim 80 U Pediatric: This vaccine must be administered by the intramuscular route.
The recommended injection site is the deltoid region. The vaccine should not be administered into the buttocks because of the varying amount of fat tissue in this region, that may contribute to variability in effectiveness of the vaccine.
Shake before use until you obtain a homogeneous suspension.
Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel. Do not inject by the intradermal route.
Avaxim Adult: It is recommended that this vaccine be administered by the intramuscular route (IM) in order to minimize local reactions.
The recommended injection site is: the deltoid region (upper arm muscle) in adults.
Do not inject via the intravascular route: insure that the needle does not penetrate a blood vessel.
The vaccine should not be administered into the gluteal muscle of the buttocks (due to the presence of varying amounts of adipose tissue) nor intradermally, since these modes of administration may induce a lesser degree of immune response.
In exceptional cases, vaccine may be administered subcutaneously in patients with thrombocytopenia (inadequate amount of platelets, a specific blood component with an important role in blood clotting) or in patients subject to haemorrhages.
This vaccine should not be mixed together with other vaccines in the same syringe.
Do not inject by the intradermal route.

Avaxim Adult: A few cases of overdose have been reported with AVAXIM 160 U, with no specific undesirable effects.

Avaxim 80 U Pediatric: Hypersensitivity to the active substance, to one of the excipients, to neomycin (that may be present as traces in each dose due to its use during the manufacturing process).
Hypersensitivity following a previous injection of this vaccine.
Suffering from febrile disease, acute disease, progressive chronic disease (it is preferable to postpone vaccination).
Avaxim Adult: This medicinal product must not be used in the following cases: In the event of fever, acute illness, chronic progressive disease (it is preferable to postpone vaccination).
Hypersensitivity to one of its components, to neomycin (that may be present as traces in each dose due to its use during manufacturing process), or following a previous injection.
If there is any doubt, it is essential to consult the doctor or pharmacist.

As with all injectable vaccines, available appropriate medical treatment and subject monitoring are recommended in case of an anaphylactic reaction after vaccine administration.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection, especially in adolescents. This may be accompanied by several neurological signs such as transient visual disturbance/sight disorders, paraesthesia and tonic-clonic limb movements during the recovery phase. It is important that procedures are in place to avoid any injury from faints.
Avaxim 80 U Pediatric/Avaxim Adult has not been studied in patients with impaired immunity.
Avaxim 80 U Pediatric: Inform the doctor if the child is immunocompromised.
The immune response to this vaccine may be impaired by immunosuppressive treatment or immunodeficiency states. In such cases it is recommended to wait for the end of treatment before vaccination or to make sure the subject is well protected. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even though the antibody response might be limited.
Because of the incubation period of hepatitis A, infection may already be present, although asymptomatic, at the time of vaccination. The effect of administering Avaxim 80 U Pediatric during the incubation period of hepatitis A has not been documented. In such a case, vaccination may have no effect on the development of hepatitis A. The use of this vaccine in subjects with liver disease should be considered with caution, as no studies have been performed in such subjects.
As with all vaccines, vaccination may not induce a protective response in all susceptible vaccines. Avaxim 80 U Pediatric does not protect against infection caused by hepatitis B virus, hepatitis C virus, hepatitis E virus or by other known liver pathogens.
AVAXIM 80 U PEDIATRIC, suspension for injection in prefilled syringe 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".
Avaxim Adult: Do not inject by the intravascular route: ensure that the needle does not penetrate a blood vessel.
This vaccine is not to be injected into the buttocks (due to the presence of varying amounts of adipose tissue) nor administered intradermally, since these routes of administration may induce a reduced degree of immune response.
Immunosuppressant treatment or a state of immune deficiency may lead to a diminished immune response to the vaccine.
It is then recommended to wait until the end of treatment before vaccinating or to make sure the subject is well protected. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even though the antibody response might be limited.
Vaccination may have no effect on the development of hepatitis A if administered during the incubation period of the disease.
The use of this vaccine in subjects with liver disease should be considered with caution, as no studies have been performed in such subjects.
As with all vaccines, a protective immune response may not be obtained in all vaccines.
The vaccine does not protect against infection caused by hepatitis B, hepatitis C or hepatitis E viruses, or by other known liver pathogens.
AVAXIM 160 U contains ethanol, phenylalanine, potassium and sodium: AVAXIM 160 U contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicinal product will not have any noticeable effects.
AVAXIM 160 U contains 10 micrograms phenylalanine in each 0.5 mL dose, which is equivalent to 0.17 micrograms/kg for a 60 kg person. Phenylalanine may be harmful to people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
AVAXIM 160 U contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'potassium-free' and 'sodium-free'.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: The effects on the ability to drive and use machines have not been studied.

Pregnancy: As a precautionary measure, it is preferable not to use this vaccine during pregnancy, except in case of a major contamination risk.
Avaxim 80 U Pediatric: No sufficient teratogenic data on animal are available.
In humans, up to now, the data is inadequate to assess teratogenic or foetotoxic risk of the vaccine against Hepatitis A when administered during pregnancy.
Avaxim Adult: No reliable data are available on teratogenesis in animals.
To date, there are no sufficiently relevant clinical data available to assess a potential vaccine-related malformation or foetoxic effect of the hepatitis A vaccine, when it is administered during pregnancy.
Breastfeeding: Avaxim 80 U Pediatric: It is not known whether this vaccine is excreted in human milk. Caution must be exercised when AVAXIM 80 U Pediatric is administered to a nursing mother. Ask the doctor or pharmacist for advice before taking any medicinal product.
Avaxim Adult: The effect of administering this vaccine during breast feeding has not been studied and its use during feeding is therefore not recommended.

Avaxim 80 U Pediatric: Summary of the safety profile: More than 6200 children aged from 12 months to 15 years (around 7000 administered doses) were vaccinated with AVAXIM 80 U PEDIATRIC during clinical trials.
Most undesirable effects were moderate and limited to the first few days following vaccination with spontaneous recovery.
Reactions were more rarely reported after the booster dose than after the first dose.
However, as with all pharmaceuticals, expanded commercial use of the vaccine might reveal rarer undesirable effects.
Tabulated list of adverse reactions: The undesirable effects are derived from clinical studies and worldwide post-marketing experience. In each System Organ Class, the undesirable effects are ranked under headings of frequency, the most common reactions coming first, using the following convention: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000), Very rare (<1/10000), Not known: cannot be estimated from the available data.
The table as follows summarize the frequencies of the adverse reactions that were recorded after the first dose, after the booster dose or after any dose of AVAXIM 80 U PEDIATRIC. (See table.)


Click on icon to see table/diagram/image


Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Avaxim Adult: The undesirable effects are derived from clinical studies and worldwide post-marketing experience. The undesirable effects are ranked under headings of frequency using the following convention: Very common (≥ 1/10), Common (≥ 1/100 and < 1/10), Uncommon (≥ 1/1,000 and < 1/100), Rare (≥ 1/10,000 and < 1/1,000), Very rare (< 1/10,000) including isolated cases. Not known: cannot be estimated from available data.
Immune system disorders: Not known: anaphylactic reaction.
Nervous system disorders: Common: cephalalgia.
Not known: vasovagal syncope in response to injection.
Gastrointestinal disorders: Common: nausea, vomiting, appetite decrease, diarrhoea, abdominal pain.
Skin and subcutaneous tissue disorders: Not known: urticaria, rash associated or not with pruritus.
Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia.
General disorders and administration site conditions: Very common: asthenia, mild injection site pain.
Common: mild fever.
Uncommon: injection site erythema.
Rare: injection site nodule.
Investigations: Rare: increase in serum transaminases (mild and transient).
The reactions were less frequently reported after the booster injection than after the first dose.
In subjects seropositive against hepatitis A virus, this vaccine was as well tolerated as in seronegative subjects.

Avaxim 80 U Pediatric: The immunological response may be diminished in the event of immunosuppressive treatment.
The simultaneous administration of immunoglobulins with this vaccine in two different injection sites may be performed. The seroprotection rates are not modified, but the antibody titers may be lower than those obtained when the vaccine is administered alone.
In case of simultaneous administration, this vaccine must not be mixed with other vaccines in the same syringe. The vaccine may be administered simultaneously, in two different injection sites, with the routine booster vaccine of the child during the second year of life, i.e. various vaccines containing one or more of following valences: diphtheria, tetanus, pertussis (acellular or whole cells), Haemophilus influenzae of type b and inactivated or oral poliomyelitis.
This vaccine can be administered simultaneously, but at two different injection sites, with a vaccine against measles, mumps and rubella.
This vaccine can be used as a booster in subjects previously vaccinated with another inactivated Hepatitis A vaccine.
Inform the doctor or the pharmacist if the patient has recently taken any other medicinal product, even without prescription.
Avaxim Adult: The vaccine may be administered simultaneously with immunoglobulins provided two different injection site are used.
Since this vaccine is inactivated, it can be given at the same time as other inactivated vaccines using a different injection site, without in general causing interference.
This vaccine can be administered at the same time as a recombinant hepatitis B vaccine, a typhoid polysaccharide vaccine (Typhim Vi) or yellow fever vaccine but two separate injection site should be used.
This vaccine can be used as a booster dose in subjects who have received primary vaccination with another inactivated hepatitis A vaccine.

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep in the original packaging, protected from light.
Avaxim Adult: If frozen, the vaccine should be discarded.
Shelf life: 36 months.

Vaccines, Antisera & Immunologicals

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

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