Combined inactivated hepatitis A (720 ELISA units) and rDNA hepatitis B (20 mcg) vaccine
Only Twinrix Adult provides dual protection against hepatitis A and B
Twinrix Adult means fewer injections for greater efficiency and compliance
Dosage: Three intramuscular dosesadministered in a 0,1,6 month schedule.
Twinrix Adult Prescribing Information
Combined Inactivated hepatitis A (720 ELISA units) and rDNA hepatitIs B (20 mcg) vaccine.
Qualitative and quantitative composition
Twinnx Adult is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed on to aluminium hydroxide and aluminium phosphate. The HA virus is propagated in MRC5 human diploid cells. HBsAg is produced by culture, in a selective medium, of genetically engineered yeast cells. Each 1.0 ml dose of vaccine contains not less than 720 ELISA units of inactivated HA virus and 20 mcg of recombinant HBsAg protein. Pack of 1(1m) prefilled syringe £27.14; pack of 10(1m) prefilled syringes £271.40.
Twinrix Adult is indicated for use in non-immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Posology and method of administration
A dose of 1,0 ml is recommended for adults and adolescents 16 years of age and above.
Primary vaccination schedule
The standard primary course of vaccination with Twinrix Adult, consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose. Once initiated, the primary course of vaccination should be completed with the same vaccine.
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A and/or B vaccination(s) will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory. The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with Twinnx Adult are in the range of what is seen following vaccination with hepatitis A and hepatitis B vaccines. Based on the assumption that a minimal antibody level is required for protection; protective levels (10 mIU/ml) of anti-HBs will persist in the majority of subjects for 5 years, with anti-HAV to persist for at least 10 years. Booster vaccination with the combined vaccine can be recommended 5 years after initiation of the primary course. If the monovalent vaccines (hepatitis A and hepatitis B) are used as boosters, they can be administered 5 years after initiation of the primary course for hepatitis B and 10 years after initiation of the primary course for hepatitis A.
Method of administration
For intramuscular use only in the deltoid region.
Hypersensitivity to any constituent of the vaccine or to any constituent of the monovalent hepatitis A or hepatitis B vaccine. Acute severe febrile illness.
Special warnings and special precautions for use
If hepatitis A or B Infection is present at the time of vaccination it is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases. In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs may not be obtained after the primary immunisation course, therefore, additional dose of vaccine may be required. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphytactic event. Twinrix Adult should under no circumstances be administered intravascularly.
Pregnancy and lactation
Not recommended in pregnancy unless definite risk of hepatitis A and hepatitis B. Use with caution in breast-feeding women.
The most common reactions were those at the site of injection. They included transient pain, redness and swelling. Systemic adverse events rarely seen were transient and mild, these included fever, headache, malaise, fatigue, nausea and vomiting. Following widespread use of the monovalent hepatitis A and/or hepatitis vaccines, the following undesirable events have been reported in temporal association after vaccination. In many instances, a causal relationship has not been established. Flu-like symptoms (such as fever chills, headache, myalgia, arthralgia), fatigue, dizziness. Rarely reported: paraesthesia, nausea, vomiting, decreased appetite, diarrhoea, abdominal pain, abnormal liver function tests, rash, pruritus, urticaria. very rarely reported: allergic reactions mimicking serum sickness, vasculitis, syncope, hypotension, lymphadenopathy, cases of peripheral and/or central neurological disorders, and may include multiple sclerosis, optic neuritis, myelitis, Bells palsy, polyneuritis such as Gullain-Barré syndrome (with ascending paralysis), meningitis, encephalitis, encephalopathy, thrombocytopenic purpura, erythema exsudativum multiforme.
Legal category POM. 17.12.96
Marketing Authorisation Number EU 1/96/020/001 pack of 1 prefilled syringe and EU 1/96/020/002 packs 10 prefilled syringes are held by held by SmithKline Beecham, Bioiogicals SA, Rixensart, Belgium.
Further information is available from the address below:
Smithkline Beecham Pharmaceuticals, Welwyn Garden City, Hertfordshire AL7 1EY
1. Kane M. Wal Hepatitis Prevention Board Nol:4.
2. Department of Health Welsh Office. Scottish Home and Health Department. Imnunisation against infectious disease. London HMSO 1992: 104-9.
3. Kane MA Gut 1993.34 (2): S10-S12.
4. Steffen R: Risk of hepatitis A in travellers. Vaccine 1992:10 (suppl 1): S69-S72.
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