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Th1229 details
Primary information
ID10868
Therapeutic IDTh1229
Protein NameHepatitis A Vaccine
SequenceNA
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeEvaluation of pharmacokinetic properties is not required for vaccines.
DescriptionTwo types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects.
Indication/DiseaseHepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the 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 have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers.
PharmacodynamicsElevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection.
Mechanism of ActionThe hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
ToxicityLD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338]
MetabolismNA
AbsorptionNA
NA
ClearanceNA
CategoriesActively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetB-lymphocytes
Brand NameAvaxim
CompanySanofi Pasteur Limited
Brand DescriptionSanofi Pasteur Limited
Prescribed ForAVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above.
Chemical NameNA
FormulationEach 0.5 mL dose of sterile, whitish, cloudy suspension, contains 80 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.15 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to: 0.5 mL; neomycin: trace amounts.
Physical Appearance Suspension
Route of AdministrationIntramuscular
Recommended DosageNA
ContraindicationHypersensitivity to the active substance(s) or to any of the excipients.
Side Effectsdiarrhea, drowsiness, fatigue, fever, generally feeling unwell, headache, irritability, loss of appetite, muscle or joint achiness, nausea or vomiting, pain and redness at the injection site, swelling or hard lump at the injection site, weakness might occur as side reaction
Useful Link 1Link
Useful Link 2NA
RemarksNA


Primary information
ID10869
Therapeutic IDTh1229
Protein NameHepatitis A Vaccine
SequenceNA
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting pointNA
Half-lifeEvaluation of pharmacokinetic properties is not required for vaccines.
DescriptionTwo types of HAV vaccines are currently available internationally: 1. Formaldehyde-inactivated vaccines: Inactivated HAV vaccines are used in most countries. Monovalent inactivated HAV vaccines are available in paediatric dose (0.5 ml) for children aged 1 year to 15 years, and in adult dose (1 ml). 2. Live attenuated vaccines (based on H2 or LA-1 HAV strains): These vaccines are manufactured and used mainly in China and India. Inactivated hepatitis A vaccines are safe and highly effective. Traditionally, a two-dose schedule is recommended, particularly in travellers at substantial risk of contracting hepatitis A and in immunocompromised individuals. However, in healthy individuals, comparable effectiveness has been achieved with a single dose. The Chinese live attenuated hepatitis A vaccines have been shown to be safe and highly protective (95%) against clinical infection for at least 3 years. Among the adverse effects from Hepatitis A vaccine injection are fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site and malaise. Anorexia and nausea could be possible side effects.
Indication/DiseaseHepatitis A vaccine is indicated for active immunization against disease caused by hepatitis A virus (HAV). It is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV. HAVRIX® will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with HAVRIX® is particularly recommended in subjects who are, or will be, at increased risk of infection such as: * Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the 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 have an increased risk of HAV infection. Active immunization is indicated for these individuals. * Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. * Persons for whom there is an Increased Risk of Transmission of Hepatitis A: e.g. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, hemophiliac patients. * Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization of close contacts is recommended. * Specific Population Groups known to have Higher Incidence of Hepatitis A: e.g. North American Indians, Inuits, recognized community-wide HAV epidemics. * Subjects with chronic liver disease or who are at risk of developing chronic liver disease e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers.
PharmacodynamicsElevation of Anti-Hepatitis A antibodies which gives protection against Hepatitis A infection.
Mechanism of ActionThe hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.
ToxicityLD50 information for the hepatitis A vaccine is not readily available in the literature. The prescribing information for the inactivated Hepatitis A vaccine indicates that postmarketing reports of adverse effects following an overdose with the vaccine that were similar to those that are normally expected. This may include pain or redness at the injection site, headache, irritability, appetite loss, and other symptoms. Prescribing information also advises contacting the local poison control center in the case of an overdose.[L338]
MetabolismNA
AbsorptionNA
NA
ClearanceNA
CategoriesActively Acquired Immunity,Inactivated Hepatitis A Virus Vaccine,Vaccines
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetB-lymphocytes
Brand NameHavrix
CompanyDispensing Solutions, Inc.
Brand DescriptionDispensing Solutions, Inc.
Prescribed ForHAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV)
Chemical NameNA
FormulationEach 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. It contains few excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL).
Physical Appearance Suspension
Route of AdministrationIntramuscular
Recommended DosagePrimary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later.
ContraindicationSevere allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX
Side EffectsInjection site hematoma, upper respiratory tract infections, Insomnia etc
Useful Link 1Link
Useful Link 2NA
RemarksNA