Comvax (Haemophilus b conjugate and Hepatitis B Vaccine) Drug / Medicine Information

Haemophilus b conjugate and Hepatitis B Vaccine

Consumer Medicine Information

What COMVAX is used for

COMVAX is a vaccine used to help prevent hepatitis B and Haemophilus b disease. It can be given to infants 6 weeks to 15 months of age.

Haemophilus b infection (HIB)

Haemophilus b disease is an infection caused by a germ called Haemophilus influenzae type b (H. influenzae type b or HIB for short). Protection against HIB is important because this germ, or bacterium, can cause serious diseases such as meningitis, which is an infection of the brain or spinal cord tissues. It can also cause infection of the blood or joints.

HIB disease occurs primarily in children under 5 years of age.

Infection from HIB bacteria usually occurs when an infant comes into contact with an infected person. The infection may be spread when an infected person coughs or sneezes near another child.

Situations that may increase your child's risk of infection include:

being around groups of other children (eg, Daycare)

living in the same household as someone who is infected

having certain medical conditions, including sickle cell disease, some immune disorders and having had the spleen removed.

Children who get HIB disease of the brain or spinal cord tissues (meningitis) often develop a cold or sore throat first. This is followed by fever, headache, stiff neck, vomiting, high-pitched crying, and/or convulsions.

Most children recover completely from HIB disease. However, about 35% of those children who recover from the infection end up with permanent brain damage including seizures, deafness and mental retardation.

COMVAX helps protect against HIB infection, not against other germs that cause meningitis.

Hepatitis B

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It can be caught by coming into contact with an infected person's blood, semen, vaginal secretions, saliva or other body fluids. For example, if these infected fluids enter your blood stream through a cut in your skin, you could become infected. Other situations that could lead to infection include being born to a mother who carries the HBV, living in the same house as someone who is infected, and travelling to areas where hepatitis B is common.

People who have hepatitis B may not look or feel sick when infected. In fact, a person could be infected by the virus six weeks to six months before symptoms occur. Some people develop mild, flu-like symptoms. Others may become very ill and extremely tired, develop yellowing of the skin and/or eyes (also called jaundice), dark urine and other symptoms that require hospitalisation.

Most people recover completely from the HBV infection. However, there are some people, particularly children, who may not have symptoms but continue to carry the virus in their blood. They are called chronic carriers. These chronic carriers are infectious and can spread the disease to others throughout their lives.

Babies who are infected with the HBV at birth, almost always go on to become chronic carriers. The infection at birth is silent, and the babies appear healthy and continue to remain healthy for many years. However, after 30, 40 or 50 years they can become unwell and develop the symptoms described above.

All chronic carriers run the risk of developing serious liver disease, such as cirrhosis (scarring of the liver) or liver cancer.

There is no specific treatment for hepatitis B. Therefore, vaccination is the best way to help protect against infection and possible serious longterm disease.

Because hepatitis B infection can go undetected for a long period of time, it is possible that an individual may already be infected at the time the vaccine is given. The vaccine may not prevent hepatitis B in these individuals.

COMVAX will not protect against hepatitis caused by other agents or viruses (such as hepatitis A, hepatitis C, hepatitis D, hepatitis E).

How COMVAX works

COMVAX works by causing your body to produce its own protection by making disease-fighting substances (antibodies) to fight the bacteria and virus causing the infections. If a vaccinated child comes into contact with the bacteria or virus, the body is usually ready, and produces antibodies to destroy them.

Your child needs to have a course of injections before full protection can develop against the bacteria and virus causing the infection.

However, as with all vaccines, even after the course, 100% protection cannot be guaranteed.

The chance of a severe reaction from COMVAX is very small, but the risks from not being vaccinated may be very serious.

Before you are given COMVAX

When your child must not be given it

Do not have COMVAX if:

your child has an allergy to COMVAX or any of the ingredients listed at the end of this leaflet

the expiry date on the pack has passed.

If the vaccine is used after the expiry date has passed, it may not work.

If you are not sure whether your child should be given COMVAX, talk to your doctor.

Do not give COMVAX to infants under 6 weeks of age.

Before your child is given it

Tell your doctor if your child:

1. has any medical conditions, especially diseases which decrease the immune system, for example, AIDS or cancer

COMVAX may not work as well as it should if your child has diseases or conditions which decrease the body's immune defence system. Your doctor will decide whether or not to give the vaccine.

2. has an infection or a high temperature

Your doctor may decide to delay the injection of COMVAX.

3. has any allergies to any other medicines or any other substances, such as foods, preservatives, latex rubber or dyes.

If you have not told your doctor about any of the above, tell them before your child is given COMVAX.

Taking other medicines

Tell your doctor if your child is taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

COMVAX may not work as well as it should if your child is taking medicines that decrease the immune system, such as corticosteroids (eg. prednisone) or cyclosporin.

Your doctor will advise you if your child is taking any of these or other medicines that decrease the immune system. Your doctor will decide whether or not to give the vaccine.

Use with other vaccines

COMVAX may be given at the same time as the series of diphtheria, tetanus and pertussis vaccine, and oral polio vaccine.

At 12 to 15 months of age, COMVAX may be given at the same time as:

oral polio vaccine

varicella virus vaccine

measles, mumps, rubella vaccine, or

a booster dose of diphtheria, tetanus and pertussis vaccine.

If COMVAX is given at the same time as other vaccine injections, the injections should be given at different places on the body and using separate syringes. Your doctor will decide if COMVAX should be given with other vaccines.

How COMVAX is given

How much is given

The usual dose of COMVAX for infants 6 weeks to 15 months of age is 0.5 mL.

How it is given

COMVAX is given as an injection, usually into the upper thigh muscle, by a doctor or trained nurse.

The vaccine should not be injected directly into veins (intravenously) or under the skin (subcutaneously).

Vaccination schedule

COMVAX is generally given as a total of three doses over ten to thirteen months. Each dose is given on a separate visit. The schedule is:

1st dose: 2 months of age

2nd dose: 4 months of age

3rd dose: 12 to 15 months of age

It may take up to one week after vaccination for protection to develop against HIB disease, so rarely HIB infections may occur during this time.

Keep a record of your child's vaccinations and update this after each injection.

Keep your child's follow-up appointment with your doctor or clinic.

It is important for your child to have the follow-up doses of COMVAX at the appropriate times to make sure the vaccine has the best chance of providing protection against hepatitis B and HIB disease.

If a dose is missed

If your child misses a scheduled dose, talk to your doctor and arrange another visit as soon as possible.

Side Effects

Tell your doctor or pharmacist as soon as possible if your child does not feel well during or after having had an injection of COMVAX.

COMVAX helps protect most infants from hepatitis B and HIB disease, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment if they get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if your child has any of the following and they are troublesome or ongoing:

local reaction around the injection site such as pain, soreness, redness, swelling or a hard lump

irritability

unusual, high-pitched crying or crying more than normal

sleepiness

fever

smaller appetite than normal

cold or flu-like symptoms such as sneezing, runny or blocked nose, cough, red or infected throat

ear infection

vomiting, diarrhoea

thrush in the mouth, which appears as creamy-yellow, raised patches

These are the more common side effects. For the most part these have been mild.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice your child has any of the following:

pinkish, itchy swellings on the skin, also called hives or nettlerash

skin rash, or other symptoms that suggest an allergic reaction

swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing

a seizure or convulsion, which may or may not be accompanied by a very high fever

Some of these may be signs of a serious allergic reaction. Your child may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above may also occur in some infants. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. Your child may not experience any of them.

Storage

COMVAX is usually stored in the doctor's surgery or clinic, or at the pharmacy. However if you need to store COMVAX:

Keep it where children cannot reach it.

Keep it in the refrigerator, but not in the door compartment.

Do not put COMVAX in the freezer, as freezing destroys the vaccine.

Keep the injection in the original pack until it is time for it to be given.

Product description

What it looks like

COMVAX comes in vials. After shaking, it appears as a slightly opaque, white suspension. Each vial contains a single dose.

Ingredients

Active ingredients:

There are 2 active ingredients:

a fragment (small section) of Haemophilus influenzae type b bacteria, linked to a protein. The scientific name is Haemophilus type b polysaccharide - conjugated to Neisseria meningitidis outer membrane protein complex.

surface protein of the hepatitis B virus, derived from genetically engineered yeast cells. This is not infectious, and will not give you the hepatitis B virus.

Inactive ingredients:

aluminium hydroxide

borax

sodium chloride

COMVAX is made without any human blood or blood products.

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

Supplier

COMVAX is supplied in Australia by:

CSL Biotherapies Pty Ltd

45 Poplar Road

PARKVILLE VIC 3052

This leaflet was prepared in June 2011.

Australian Register Number:

AUST R 70943