Patient Information Leaflet for Engerix B® 20 micrograms/1 ml vaccine Suspension for injection

Hepatitis B recombinant vaccine, adsorbed

This leaflet tells you about hepatitis B vaccine. Please read it carefully. If there is anything you do not understand, or if you want to know more about this vaccine, ask your doctor, nurse or pharmacist (chemist). Please keep this leaflet. You may want to read it again.

What is in Engerix B vaccine?

The name of your vaccine is ‘Engerix B 20 micrograms/1 ml’ but will be referred to as ‘Engerix B’ throughout the remainder of the leaflet. This vaccine contains the outer coat of the hepatitis B virus. Each 1 ml contains 20 micrograms of protein, made up of at least 95% of this outer coat.

This vaccine also contains inactive ingredients. These are aluminium oxide hydrated, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate and water for injections.

The vaccine is available in vials or pre-filled syringes.

The 20 micrograms/1 ml vaccine is available as single dose vials (in packs of one and ten) and single dose syringes (in packs of one and ten). The 10 micrograms/0.5 ml vaccine is available in packs containing one single dose vial or syringe.

What is Engerix B and how does it work?

Engerix B vaccine is a suspension for injection which contains a part (the outer coat) of the hepatitis B virus. When you are given the vaccine your body will make antibodies (your body’s natural defence system) against the hepatitis B virus. This will protect you against hepatitis B infection. This vaccine will not, however, protect you from hepatitis B if you are already incubating the infection, nor will it protect you against other types of liver infection. This vaccine can also protect against hepatitis D, as hepatitis D does not occur in the absence of hepatitis B infection.

Before having this vaccine

Engerix B must not be given if the person who is to have the vaccine answers YES to any of the following questions:

• Do you think that you may be allergic to Engerix B or any of the ingredients listed?
  • Thiomersal is present (in trace amounts) in this vaccine, and it is possible that you may experience an allergic reaction. Please tell your doctor if you have any known allergies or if you have experienced any health problems after previous administration of a vaccine.
• Are you suffering from a fever or infection?
  • Administration of the vaccine should be postponed if you are suffering from a fever or infection.

Please tell your doctor or nurse if the answer to any of the following questions is YES for the person who is to have the vaccine (as the vaccine may have to be delayed, or the vaccination schedule varied):

• Are you on dialysis for kidney disease or do you have an illness which may affect your immune system? Even if you have a chronic liver disease, are HIV positive or are a carrier of hepatitis C, vaccination with Engerix B may be recommended since hepatitis B infections can be severe in patients with these conditions.
• Are you pregnant or do you think you may be?
• Have you experienced any health problems after previous administration of a vaccine?
• Were you diagnosed as being a carrier of Hepatitis B when you gave birth to your baby?
• Are you being vaccinated because of a possible recent exposure to hepatitis B infection?

No vaccine is totally effective in all individuals who are vaccinated. A number of factors, for example older age, gender, being overweight, smoking and some chronic diseases, have been observed to reduce the immune response to hepatitis B vaccines. If they apply to the person who is to have the vaccine, the doctor or nurse may decide to do blood tests or give that person an additional dose of vaccine to ensure protection.

 

Effects on ability to drive and use machinery . May cause partial or complete loss of vision, dizziness, drowsiness, or fainting. If affected do not drive or operate machinery.

Your doctor or nurse will shake the vaccine well before it is used and it should not be used if it appears discoloured or clumped.

Having the vaccine

Engerix B is injected into the muscle of the upper arm in adults and children. In babies and young children, it is normally injected into the thigh muscle. However, this vaccine may be injected under the skin for patients with blood disorders.

This vaccine must NOT be injected into the buttocks, into the skin or into a vein.

Adults and children 16 years of age and over are given the 20 µg/1 ml vaccine and new-born babies and children 15 years of age and under are usually given the 10 µg/0.5 ml vaccine.

However, the 20 µg/1 ml vaccine may be given to children aged 11-15 years of age if it is thought unlikely that the child will receive the third injection in the vaccination schedule. This will provide a higher level of protection than two doses of the 10 µg/0.5 ml vaccine.

Your doctor will tell you when to receive the vaccine. The person who is to have the vaccine may receive it at the same time as another vaccine, but the vaccines should always be given at different injection sites.

You will need to receive a series of injections of Engerix B. Once you have completed the course of injections you will have long term protection against hepatitis B. Your doctor or nurse will choose the most appropriate schedule for your circumstances. There are several options as shown in the following table:

• Schedule 1
  • 1st injection now
  • 2nd injection in one month
  • 3rd injection 6 months after first injection
• 
   
• Schedule 2*
  • 1st injection now
  • 2nd injection in one month
  • 3rd injection 2 months after first injection
• 
   
• Schedule 3* (18 years and over only)
  • 1st injection now
  • 2nd injection in one week
  • 3rd injection 3 weeks after first injection
• 
   
• Schedule 4**
  • 1st injection now
  • 2nd injection in six months
  • 3rd injection see footnote

*If either of these schedules is used, it is recommended that you receive a fourth injection (booster injection) 12 months after the first injection.

After having the vaccine – possible side effects

Like all vaccines, Engerix B can have unwanted effects.

Very rarely, some people can have a serious allergic reaction to the vaccine. Tell the doctor or nurse if you get a rash, have tightness in the throat or shortness of breath or any other unwanted effects.

The following side effects have been reported following Engerix B vaccination:

Common (less than 1 in 10 but more than 1 in 100 doses of vaccine):

• Pain, redness or hardness at the site of injection.

Rare (less than 1 in 1,000 but more than 1 in 10,000 doses of vaccine):

• Dizziness, headache, numbness, pins and needles
• Nausea, vomiting, diarrhoea, stomach pains
• Abnormal liver function
• Rash, itching and hives
• Painful joints, muscle pain
• Fever, tiredness, general body discomfort, flu-like symptoms

Very Rare (less than 1 in 10,000 doses of vaccine):

• A blood disorder which may cause bruising or bleeding
• Hypersensitivity reactions, swollen glands
• Fainting, paralysis, inflammation of the nerves, disturbance of nerve function – e.g. Guillian Barre Syndrome, multiple sclerosis, and optic neuritis (which may cause partial or complete loss of vision)
• inflammation of the brain, degenerative disease of the brain,meningitis, seizures
• Low blood pressure, inflammation of the blood vessels
• Difficulty in breathing or wheezing
• Sudden swelling of the face, erythema multiforme (allergic rash)
• Arthritis

Storage of this vaccine

This vaccine should be stored in a refrigerator at 2°- 8°C until it is given to you. The doctor or nurse should check that the expiry date on the label has not passed. The vaccine must not be frozen.

Discard any unused portion. Unused vaccine or partly used syringes should be disposed of safely, preferably by heat inactivation or incineration.

If your doctor has given you a prescription for Engerix B to collect from your pharmacy (chemist) instead of giving it to you straight away, you should store the vaccine carefully. Keep it in your fridge (between 2° and 8°C).

Disease information on hepatitis B

Hepatitis B is an infectious illness of the liver caused by a virus. Some people have the hepatitis B virus in their body but cannot get rid of it. They can still infect other people and are known as carriers. The disease is spread by the virus entering the body following contact with body fluids, most often blood, from an infected person.

If the mother is a carrier of the virus she can pass the virus to her baby at birth. It is also possible to catch the virus from a carrier through, for example, unprotected sex, shared injection needles or treatment with medical equipment which has not been properly sterilised.

The main signs of the illness include headache, fever, sickness and jaundice (yellowing of the skin and eyes) but in about three out of 10 patients there are no signs of illness.

In those infected with hepatitis B one out of 10 adults and up to nine out of 10 babies will become carriers of the virus and are likely to go on to develop serious liver damage and in some cases cancer of the liver.