Havrix 720 Junior/Havrix 1440 Adult

Havrix 720 Junior/Havrix 1440 Adult

vaccine, hepatitis a

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Inactivated hepatitis A virus vaccine.
Description
Havrix 720 Junior: Each dose is standardised to ensure a viral antigen content of not less than 720 ELISA units of viral antigens/0.5 mL.
Havrix 1440 Adult: Each dose of vaccine is standardised to ensure a viral antigen content of not less than 1440 ELISA units of viral antigens/mL.
Havrix 1440 Adult/Havrix 720 Junior, a hepatitis A virus vaccine, is a sterile suspension containing formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) adsorbed onto aluminium hydroxide.
The viral antigen content is determined by an ELISA test.
Havrix 1440 Adult/Havrix 720 Junior also contains the following excipients: Aluminium hydroxide, amino acids for injections, disodium phosphate, monopotassium phosphate, polysorbate 20, potassium chloride, sodium chloride and water for injections.
The virus is propagated in MRC5 human diploid cells. Before viral extraction, the cells are extensively washed to remove culture medium constituents. A virus suspension is then obtained by lysis of the cells followed by purification using ultrafiltration techniques and gel chromatography. The virus is inactivated with formaldehyde.
Havrix 1440 Adult/Havrix 720 Junior meets the World Health Organization requirements for the hepatitis A vaccine (inactivated).
Action
Pharmacotherapeutic Group: Hepatitis A vaccines. ATC Code: J07BC02.
Pharmacology: Pharmacodynamics: Havrix 1440 Adult/Havrix 720 Junior confers immunisation against hepatitis A virus (HAV) by stimulating specific immune responses evidenced by the induction of antibodies against HAV.
In clinical studies, 99% of vaccines seroconverted 30 days after the 1st dose. In a subset of clinical studies where the kinetics of the immune response was studied, early and rapid seroconversion was demonstrated following administration of a single dose of Havrix 1440 Adult/Havrix 720 Junior in 79% of vaccinees at day 13; 86.3% at day 15; 95.2% at day 17 and 100% at day 19, which is shorter than the average incubation period of hepatitis A (4 weeks). (See also Toxicology as follows.)
The efficacy of Havrix 1440 Adult/Havrix 720 Junior was evaluated in different community-wide outbreaks (Alaska, Slovakia, USA, UK, Israel and Italy). These studies demonstrated that vaccination with Havrix 1440 Adult/Havrix 720 Junior led to termination of the outbreaks. A vaccine coverage of 80% led to termination of the outbreaks within 4-8 weeks.
In order to ensure long-term protection, a booster dose should be given between 6 and 12 months after the primary dose of Havrix 1440 Adult or Havrix 720 Junior. In clinical trials, virtually, all vaccinees were seropositive 1 month after the booster dose.
However, if the booster dose has not been given between 6 and 12 months after the primary dose, the administration of this booster dose can be delayed up to 5 years. In a comparative trial, a booster dose given up to 5 years after the primary dose has been shown to induce similar antibody levels as a booster dose given between 6 and 12 months after the primary dose.
Long-term persistence of hepatitis A antibody titres following 2 doses of Havrix given 6-12 months apart has been evaluated. Data available after 10 years allows prediction that at least 97% of subjects will remain seropositive (>20 mIU/mL) 25 years after vaccination.
Current data do not support the need for booster vaccination among immunocompetent subjects after a 2-dose vaccination course.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
Toxicology: Preclinical Safety Data: Appropriate safety tests have been performed.
In an experiment in 8 nonhuman primates, the animals were exposed to a heterologous hepatitis A strain and vaccinated 2 days after exposure. This post-exposure vaccination resulted in protection of all animals.
Indications/Uses
Active immunisation against hepatitis A virus (HAV) infection in subjects at risk of exposure to HAV.
Havrix 1440 Adult/Havrix 720 Junior will not prevent hepatitis infection caused by other agents eg, hepatitis B virus, hepatitis C virus and hepatitis E virus or other pathogens known to infect the liver.
In areas of low to intermediate prevalence of hepatitis A, immunisation with Havrix is particularly recommended in subjects who are, or will be, at increased risk of infection eg:
Travelers: Persons traveling to areas where the prevalence of hepatitis A is high eg, Africa, Asia, Mediterranean basin, the Middle East, Central and South America.
Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor and have an increased risk of HAV infection. Active immunisation is indicated for these individuals.
Persons for Whom Hepatitis A is an Occupational Hazard or for Whom there is an Increased Risk of Transmission: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, food handlers, among others.
Persons at Increased Risk Due to Their Sexual Behavior: Homosexuals, persons with multiple sexual partners.
Hemophiliacs.
Abusers of injectable drugs.
Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunisation of close contacts is recommended.
Persons who require protection as part of hepatitis A outbreak control or because of regionally elevated morbidity.
Specific population groups known to have a higher incidence of hepatitis A eg, American Indians, Eskimos, recognised community-wide HAV epidemics.
Subjects with chronic liver disease or who are at risk of developing chronic liver disease [eg, hepatitis B (HB) and hepatitis C (HC) chronic carriers and alcohol abusers].
In areas of intermediate to high prevalence of hepatitis A (eg, Africa, Asia, Mediterranean basin, the Middle East, Central and South America), susceptible individuals may be considered for active immunisation. These include children and adolescents especially in high socio-economic groups and urban areas.
Dosage/Direction for Use
Primary Vaccination: Adults ≥19 years: Single dose of Havrix 1440 Adult (1 mL).
Children and Adolescents 1-18 years: Single dose of Havrix 720 Junior (0.5 mL).
Booster Vaccination: After primary vaccination with either Havrix 1440 Adult/Havrix 720 Junior, a booster dose is recommended in order to ensure long-term protection. This booster dose should be given at any time between 6 months and 5 years, but preferably between 6 and 12 months after the primary dose (see Pharmacology: Pharmacodynamics under Actions).
Administration: Havrix 1440 Adult/Havrix 720 Junior is for IM administration. The vaccine should be injected in the deltoid region in adults and children, in the anterolateral part of the thigh in young children.
The vaccine should not be administered in the gluteal region.
The vaccine should not be administered SC/intradermally since administration by these routes may result in a less than optimal anti-HAV antibody response.
Havrix should under no circumstances be administered intravascularly.
Havrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an IM administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least 2 min.
Overdosage
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
Contraindications
Subjects with known hypersensitivity to any component of Havrix 1440 Adult/Havrix 720 Junior (see Description for the qualitative and quantitative composition and list of excipients), or to subjects having shown signs of hypersensitivity after previous Havrix 1440 Adult/Havrix 720 Junior administration.
Special Precautions
As with other vaccines, the administration of Havrix 1440 Adult/ Havrix 720 Junior should be postponed in subjects with acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for vaccination.
It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of vaccination. It is not known whether Havrix 1440 Adult/Havrix 720 Junior will prevent hepatitis A in such cases.
In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after a single dose of Havrix 1440 Adult/Havrix 720 Junior and such patients may therefore require administration of additional doses of vaccine.
Havrix 1440 Adult/Havrix 720 Junior contains traces of neomycin. Havrix 1440 Adult/Havrix 720 Junior should be used with caution in patients with known hypersensitivity to this antibiotic.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available for treatment in case of rare anaphylactic event following the administration of Havrix 1440 Adult/Havrix 720 Junior.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints. Havrix 1440 Adult/Havrix 720 Junior can be given to HIV-infected persons. Seropositivity against hepatitis A is not a contraindication.
Effects on the Ability to Drive or Operate Machinery: Havrix 1440 Adult/Havrix 720 Junior is unlikely to produce an effect on the ability to drive and use machines.
Use in pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. However, as with all inactivated viral vaccines, the risks to the fetus are considered to be negligible. Havrix 1440 Adult/Havrix 720 Junior should be used during pregnancy only when clearly needed.
Use in lactation: Adequate human data on use during lactation and adequate animal reproduction studies are not available. Although the risk can be considered as negligible, Havrix 1440 Adult/Havrix 720 Junior should be used during lactation only when clearly needed.
Use In Pregnancy & Lactation
Use in pregnancy: Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. However, as with all inactivated viral vaccines, the risks to the fetus are considered to be negligible. Havrix 1440 Adult/Havrix 720 Junior should be used during pregnancy only when clearly needed.
Use in lactation: Adequate human data on use during lactation and adequate animal reproduction studies are not available. Although the risk can be considered as negligible, Havrix 1440 Adult/Havrix 720 Junior should be used during lactation only when clearly needed.
Adverse Reactions
Clinical Trials: The safety profile presented as follows is based on data from >5300 subjects.
Frequencies per dose are defined as follows: Very Common: ≥10%, common: ≥1% and <10%, uncommon: ≥0.1% and <1%, rare: ≥0.01% and <0.1%, very rare: <0.01%.
Infections and Infestations: Uncommon: Upper respiratory tract infection, rhinitis.
Metabolism and Nutrition Disorders: Common: Loss of appetite.
Psychiatric Disorders: Very Common: Irritability.
Nervous System Disorders: Very Common: Headache. Common: Drowsiness. Uncommon: Dizziness. Rare: Hypoaesthesia, paraesthesia.
Gastrointestinal Disorders: Common: Gastrointestinal symptoms (eg, diarrhoea, nausea, vomiting).
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash. Rare: Pruritus.
Musculoskeletal and Connective Tissue Disorders: Uncommon: Myalgia, musculoskeletal stiffness.
General Disorders and Administration Site Conditions: Very Common: Pain and redness at the injection site, fatigue. Common: Swelling, malaise, fever (≥37.5°C), injection site reaction (eg, induration). Uncommon: Influenza-like illness. Rare: Chills.
Post-Marketing Surveillance: Immune System Disorders: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness.
Nervous System Disorders: Convulsions.
Vascular Disorders: Vasculitis.
Skin and Subcutaneous Tissue Disorders: Angioneurotic oedema, urticaria, erythema multiforme.
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Drug Interactions
Since Havrix 1440 Adult/Havrix 720 Junior is an inactivated vaccine, its concomitant use with other inactivated vaccines is unlikely to result in interference with immune responses.
Concomitant administration of typhoid, yellow fever, cholera (injectable) or tetanus does not interfere with Havrix 1440 Adult/Havrix 720 Junior immune response.
Concomitant administration of immunoglobulins does not impact the protective effect of the vaccine.
When concomitant administration of other vaccines or of immunoglobulins is considered necessary, the products must be given with different syringes and needles and at different injection sites.
Incompatibilities: Havrix 1440 Adult/Havrix 720 Junior should not be mixed with other vaccines or immunoglobulins in the same syringe.
Caution For Usage
Instructions for Use/Handling: The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. Before use of Havrix 1440 Adult/Havrix 720 Junior, the vial/syringe should be well shaken to obtain a slightly opaque white suspension. Discard the vaccine if the content appears otherwise.
Storage
Store at +2 to +8°C. Do not freeze; discard if vaccine has been frozen.
Havrix 1440 Adult/Havrix 720 Junior has been kept at +37°C for 3 weeks without a significant loss of potency.
ATC Classification
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Havrix 720 Junior: Monodose syringe 720 ELISA units/0.5 mL (slightly opaque, white, sterile susp for inj) x 0.5 mL x 1's.
Havrix 1440 Adult: Monodose syringe 1440 ELISA units/mL (slightly opaque, white, sterile susp for for inj) x 1 mL x 1's.
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