Proquad

This leaflet answers some common questions about ProQuad. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of your child being given ProQuad against the benefits they expect it will have for your child.

You may need to read it again.

ProQuad is a vaccine used to help protect people from getting measles, mumps, rubella (German measles) and chicken pox (varicella). It can be given to children aged 12 months to 12 years of age.

Protection against these infections is important as they can cause serious problems in some people.

Measles is a serious disease that causes a high fever (temperature), runny nose, cough, conjunctivitis and a rash. It usually lasts for about 1 to 2 weeks. It is very easily passed from one person to another in the tiny droplets of moisture which are expelled during coughing or sneezing. One out of every 10 children who catch measles will also have an ear infection or pneumonia. On rare occasions, measles can also cause an infection of the brain that could lead to seizures, hearing loss, mental retardation, and even death. Babies and adults who catch measles are often much sicker for a longer time or are more likely to die than school children and teenagers who catch measles.

Mumps causes fever, headache, and swollen, painful glands under the jaw (salivary glands) and usually lasts several days. It is easily passed from one person to another by the tiny droplets of moisture expelled during coughing or sneezing. Mumps can sometimes be a very serious disease, causing a mild inflammation of the coverings of the brain and spinal cord (meningitis) in about one person in every 10 who catch it. About one out of every 4 teenage or adult males with mumps will have a painful swelling of the testicles for several days. This does not usually affect their ability to father children, but can cause sterility in rare cases. Teenagers and adults, especially males, who catch mumps are often much sicker and more likely to suffer longer than children do.

Rubella is usually a mild disease that causes a mild fever, swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for 2 or 3 days. Rubella is very dangerous if a pregnant woman catches it. Pregnant women who catch rubella can have babies who are stillborn, or have heart disease, blindness, deafness, or problems with learning. Rubella is also spread to others in the tiny droplets of moisture expelled during coughing or sneezing.

Chickenpox is an infectious disease caused by the varicella-zoster virus, or otherwise known as varicella virus. It occurs in millions of people around the world each year, most often in children 5 to 9 years of age. Chickenpox is easily passed from one person to another. It is commonly spread from person to person through the air by sneezing or coughing. Once a person is infected, it usually takes about 2 to 3 weeks before symptoms of the infection start.

Symptoms of chickenpox include mild headache, moderate fever and general discomfort. These are followed by a rash of itchy, little red spots which usually start on the chest, stomach or back, but can appear anywhere on the body. There may be only a few spots or groups of spots, or even hundreds of spots that develop over the next 3 to 5 days. The spots will change into clear blisters filled with fluid which then become cloudy, break open, dry, scab and heal, usually within 5 to 20 days.

Although chickenpox is generally a fairly harmless infection, it may be associated with serious complications and/or rarely death. In children, the most common complications are bacterial skin infections. Less frequent but very serious complications include pneumonia, inflammation of the brain (encephalitis), Reye Syndrome (which causes brain and liver damage), and death. Severe disease and serious complications are more likely to occur in teenagers and adults.

ProQuad contains weakened strains of living measles, mumps, rubella and varicella viruses. These strains of live viruses cause either mild or no symptoms of infection.

When injected the vaccine causes the body to produce its own protection by making disease-fighting substances (antibodies) against these infections.

If a vaccinated child comes into contact with measles, mumps, rubella or varicella virus, the body is usually ready, and produces antibodies to destroy the virus. However, as with all vaccines, 100% protection against measles, mumps, rubella and chickenpox cannot be guaranteed. Also it may take up to 4-6 weeks for maximum protection to develop, so occasionally infections may occur during this time.

It is not known whether ProQuad will prevent measles, mumps, rubella or chickenpox if it is given after you have been exposed to the natural measles, mumps, rubella or varicella virus. Therefore, vaccination before exposure is the best way to help protect against infection and possible serious complications.

Only one injection of ProQuad is needed to help protect against chickenpox in children aged 12 months through 12 years.

The chance of a severe reaction from ProQuad is very small, but the risks from not being vaccinated are very serious.

Symptoms of a serious allergic reaction include swelling of the face, lips, tongue, throat, difficulty in breathing, or hives.

The safety and effectiveness of ProQuad in children below the age of 12 months have not been established.

The vaccine should not be given if the recipient is breast-feeding or intends to breast-feed.

Your doctor will advise you whether your child is receiving any of these medicines.

ProQuad can be given at the same time as Haemophilus b conjugate, hepatitis B, pneumococcal 7-valent conjugate, and hepatitis A (inactivated) vaccines. The injections should be given at different places on the body and using separate syringes. At least one month should elapse between a dose of ProQuad and all other vaccines. Your doctor will decide if ProQuad should be given with other vaccines.

The entire contents of the vial.

ProQuad is usually injected just under the skin (subcutaneously) of the upper arm or the upper thigh by a doctor or trained nurse.

ProQuad is given by injection to persons aged 12 months through 12 years of age. The appropriate time and number of injections will be determined by your doctor.

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

These people may be at risk of catching chickenpox from your child.

A serious condition called Reye Syndrome has been reported following the use of aspirin or other salicylate medicines during a natural chickenpox infection.

ProQuad helps protect most people from measles, mumps, rubella and varicella, but it may have unwanted side effects in a few children. 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.

These are the more common side effects of ProQuad. For the most part these have been mild. They usually improve or disappear within a few days.

Other less common side effects have been reported with ProQuad, and some of these were serious. These included:

Other adverse events have been reported with at least one of the following: ProQuad, M-M-R II, the monovalent components of M-M-R II or VARIVAX. These adverse events include:

†Can be from naturally occurring chickenpox or the vaccine in healthy individuals or individuals with lowered immunity in those given VARIVAX.

Tell your doctor immediately if you notice any of the above or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

These are serious side effects. Your child may need urgent medical attention. Serious side effects are rare.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

As with all vaccines given by injection, there is a very small risk of a serious allergic reaction.

If your child has these, your child may have had a serious allergic reaction to ProQuad. Your child may need urgent medical attention or hospitalisation. Most of these side effects occur within 15-30 minutes of vaccination, before your child leave the doctor's surgery or clinic.

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

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

ProQuad comes as white to pale yellow powder in glass vials. It is reconstituted with a special diluent to make a solution suitable for injection.

The active ingredients of ProQuad are weakened strains of measles, mumps, rubella (German measles) and varicella viruses.

Inactive ingredients:

This product also contains residual components of recombinant human albumin, bovine serum albumin and other buffer and media ingredients.

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.