Hepatitis A/ Hepatitis B Vaccine

Registered South African indications:

• Prevention against infection caused by hepatitis A and hepatitis B viruses

Contraindications 

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Hypersensitivity to neomycin
• Acute, severe febrile illness

Cautions

• Pregnancy 
• Breastfeeding
• Post-exposure prophylaxis 
• Intravascular administration
• Congenital or acquired immunodeficiency
• Haemodialysis
• Intradermal injection
• Intramuscular injection into gluteal muscle

Forms avail. in SA and covered in this monograph: inj

Prevention of hepatitis A and hepatitis B virus infections
- Primary vaccination schedule

• IM: 1ml, given as a single dose, second dose to be given after 1 month, third dose to be given 6 months after first dose

- Accelerated vaccination schedule

• IM: 1ml, to be given at day 0, 7 and 21; Booster to be given 12 months after the first dose

Paed. forms avail. in SA and covered in this monograph: inj

Prevention of hepatitis A and hepatitis B virus infections

Less than 1 year

• Not established for use

Between 1-15 years

• IM: 1ml, given as a single dose, second dose given after 6-12 months after the first dose

Older than 15 years

• See adult dosage

Pregnancy

• Caution
• Hepatitis A/Hepatitis B vaccine can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus

Breastfeeding

• Caution
• Hepatitis A/Hepatitis B vaccine should only be used during breastfeeding when the possible advantages outweigh the potential risks

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Irritability
• Headache
• Drowsiness
• Dizziness
• Paraesthesia
• Syncope
• Localised hypoaesthesia
• Multiple sclerosis 
• Encephalitis
• Encephalopathy
• Polyneuritis
• Myelitis
• Seizures
• Paralysis
• Facial palsy
• Neuritis
• Optic neuritis
• Neuropathy

Cardiovascular Disorders

• Vasculitis
• Hypotension

Gastrointestinal Disorders

• Loss of appetite
• Diarrhoea
• Nausea and vomiting
• Abdominal pain

Hepatobiliary Disorders

• Abnormal hepatic function tests

Musculoskeletal Disorders

• Arthritis
• Muscular weakness

Skin and Subcutaneous Disorders

• Injection site reaction
• Erythema multiforme
• Lichen planus
• Pruritus
• Rash 
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Thrombocytopenic purpura 
• Thrombocytopenia

• Blood and blood products
• Immunosuppressive agents
• Combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib)
• Measles-Mumps-Rubella vaccine

Disclaimer: if different syringes and other injection sites are used, no interaction will be observed with concomitant vaccination

None routine

Booster dose

• Long-term antibody persistence data following vaccination are available up to 15 years after vaccination
• Consideration should be given to serological testing of those subjects who may be at risk (obesity, elderly, smoking, etc) of not achieving seroprotection following a complete course of vaccination (due to reduced immune response to hepatitis B vaccines). Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations

Hepatitis A/ Hepatitis B vaccine confers immunity against hepatitis A virus (HAV) and hepatitis B virus (HBV) infection by inducing specific anti-HAV and anti-HBV antibodies.

COMBINATION PREPARATIONS

Hepatitic A viral antigen/ Hepatitis B antigen

Injection (per ml) 720 elisa units/ 20μg

• Twinrix (GSK) originator