Generic Name: H1N1 Pandemic influenza vaccine (split virion, inactivated)
Product Name: Panvax H1N1 Vaccine Junior (Child Swine Flu Vaccine)
Panvax Junior is a vaccine used to protect children aged over six months from influenza type H1N1, which is commonly referred to as swine flu.
Panvax Junior contains particles of the H1N1 virus which have been grown in chicken eggs. The virus particles are inactivated (no longer alive) and do not cause illness when injected into the body. However, the immune system responds to an injection of the virus particles in the same way it would if live H1N1 virus entered the body. It produces antibodies to fight against H1N1 virus, which will protect against future infection with the disease.
- Those aged 6-35 months need to be injected on two separate occasions, at least four weeks apart. They will be injected with 0.25ml of Panvax which contains 7.5 micrograms of particles containing an inactivated form of the H1N1 virus;
- Those aged 36 months- <10 years also need to receive two injections, four weeks apart. Children in this age group receive a higher dose of 0.5ml of Panvax, containing 15 micrograms of inactive H1N1 virus;
- Those aged 10-18 years only require a single 0.5ml injection of Panvax Junior.
If you have any queries about the correct way to Panvax Junior is administered, please ask your doctor.
Panvax Junior should not be used under certain conditions. Tell your doctor if you or your children have:
- A high fever;
- An infection;
- History of allergic reaction to any of the following:
- Previous influenza vaccination;
- Thiomersal (multi dose, thiomersal containing vaccine only);
- Polymixin B sulfate.
Special care needs to be taken when using Panvax Junior under certain conditions. Tell your doctor if you or your children:
- Have a condition affecting your immune system or are using immunosuppressant medications (medications which suppress the immune system);
- Are using medications containing corticosteroids;
- Have a history of Guiilian-Barr syndrome within six weeks of a previous influenza vaccination.
Use in pregnancy
Panvax Junior is a Pregnancy Category B2 medication. No studies have been conducted in pregnant women to determine whether or not the vaccine has adverse affects for them or their unborn child. However, studies conducted with animals have not produced evidence of maternal or foetal damage. The doctor will assess the risks and benefits of giving a Panvax Junior vaccination on a case by case basis.
No studies have been conducted to determine whether or not Panvax Junior is safe for use by breastfeeding adolescent women. The doctor will assess the risks and benefits of administering Panvax Junior to these women on a case by case basis.
Use in children
Panvax Junior is safe for use in children aged >6 months.
Panvax Junior is Schedule 4.1
Common side effects
All medicines have side effects. Most commonly the side effects are minor; however, some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before giving an injection of Panvax Junior.
The side effects of Panvax Junior in children aged >6 months 9 years are typically mild and transient. There are no data regarding side effects in children and adolescents aged 10-<18 years.
Very common side effects
Very common side effects are those that occur in more than 10% of people given Panvax Junior. These include:
- Pain at the injection site (30.1% children aged >6 months- <3 years; 34.3% children aged ≥3-<9 years);
- Erythema (skin redness) at the injection site (27.2% children aged >6 months- <3 years; 24.1% children aged ≥3-<9 years);
- Induration (formation of hard tissue) at the injection site (17.5% children aged >6 months- <3 years; 13.9% children aged ≥3-<9 years);
- Fever (21.4% children aged >6 months- <3 years; 16.7% children aged ≥3-<9 years);
- Irritability (40.8% children aged >6 months- <3 years);
- Diarrhoea (24.3% children aged >6 months-<3 years);
- Loss of appetite (12.6% children aged >6 months- <3 years);
- Malaise (general weakness) (16.7% children aged ≥3-<9 years);
- Myalgia (muscle pain) (16.7% children aged ≥3-<9 years).
Common side effects
Common side effects are those that occur in 110% of people given Panvax Junior. These include:
- Diarrhoea (7.4% children aged ≥3-<9 years);
- Nausea/vomiting (5.8% children aged >6 months- <3 years).
Based on the results of larger research studies of similar vaccines, it is expected that the following adverse events will also occur in children administered Panvax Junior:
Very common side effects (occurrence >10% of users):
- Influenza type illness (for multi-dose, thiomersal-containing vaccine).
Common side effects (occurrence 1-10% of users):
- Influenza type illness (for single-dose thiomersal free vaccine).
Uncommon side effects
As research about the effects of Panvax Junior have to date involved a limited number of children (<500) they have not necessarily identified all the uncommon, rare or very rare side effects (which only occur in <1 in 100, <1 in 1000 or < 1 in 10,000 people respectively). However much larger research studies of similar vaccines, which have involved larger numbers of people have been conducted.
Based on the results of these research studies, it is expected that the following adverse events will also occur in children administered Panvax Junior. People do not necessarily experience any of these side effects, so do not become alarmed by this list:
Uncommon side effects (occurrence 0.11% of users):
Rare side effects (occurrence 0.010.1% of users):
- Transient thrombocytopenia (reduced concentration of platelets which regulate blood clotting);
- Allergic reactions including anaphylactic shock (a severe allergic reaction which can be fatal);
- Paraesthesia (pins and needles);
- Neuralgia (sharp, stabbing pains);
Very rare side effects (occurrence < 0.01% of users):
- Encephalitis (inflammation of the brain);
- Neuritis (nerve inflammation);
- Neuropathy (progressive deterioration of the nerves);
- Guillain-Barre syndrome (a condition in which the muscles of the respiratory system become weak or paralysed);
- Vasculitis (inflammation of a blood vessel) with kidney involvement.
If you experience any of the listed side effects, or any other symptoms that appear abnormal or unusual, please tell your doctor.
|For more information on the common cold and influenza, types of influenza and treatments and tips for preventing influenza, see Cold and Flu.|
- Panvax Product Information. Parkville, Vic: CSL Limited; December 2009.
For further information talk to your doctor.