Pandemrix- new strain identified on April 24, 2009.

Contains a unique combination of gene segments that have not been reported previously among swine or human influenza viruses in the US or elsewhere.

Reassortant of 4 influenza A virus subtype H1N1 strains. Analysis at the CDC identified 4 components:
one endemic in humans
one endemic in birds
2 endemic in pigs (swine)

1. 1 strain widespread in USA
2. 1 strain widespread in Europe/Asia

Vaccines:
"Vaccination and the use of antiviral drugs are two of the most important response measures for reducing morbidity and mortality during a pandemic."

Anti-virals are likely to play a key role in preventing and treating influenza during the early stages of an influenza pandermic prior to the availability of a vaccine for the pandermic strain

Only the neuraminidase inhibitors zanamivir (Relenza) and oseltamivir (Tamiflu) are being considered for use in a pandemic.

Posology:
Adults aged 18-60 years.
One dose of 0.5 ml at an elected date. A second dose of vaccine should preferably be given.
Interval of at least 3 weeks between 1st and 2nd dose.
Preliminary immunogenicity data in healthy adults aged 18-60 years suggest that a sungle dose may be sufficient in this age group.

Children and adolescents aged 10-17 years.
The choice of dose for this age group should thake into account available data on safety and immunogenicity in adults amd in children aged from 3-9 years.

Children aged 3-9 years.
If vaccination is considered necessary, available data suggest that half of the adult dose at an elected date and a second dose administered at least 3 weeks later may be sufficient.

Children aged from 6 months to 3 years.
If vaccination is considered to be necessary, consideration may be given to dosing in accordance with the recommendation in children aged 3-9 years.

Contraindication:
History of anaphylactic reaction (life-threatening) to the vaccine

Known allergy (hypersensitivity) to the active substance or any of the ingredients or trace residues contained in pandemrix-ovalbumin, formaldehyde, gentamycin sulphate.

Special warnings and Precautions:
Known hypersensitivity to eggs or chicken protein
Individuals with acute infection with high grade temperature (over 38C)
Individuals who are immunosupressed-endogenous/iatrogenic

Interaction with other medicinal products:
No data on co-administration with other vaccines
If co-administration with other vaccine is considered, administration should be on separate limbs. Adverse reactions may be intensified.

Pregnancy and lactation:
Currently no data available.
Data from pregnant women vaccinated with different inactivated non-adjuvenated seasonal vaccines do not suggest malfprmation of fetal or neonatal toxicity.
May be considered during pregnancy if necessary, taking into account official recommendations.
Pandemrix may be used in lactating women.

Shelf life and stability:
2 years
After mixing, the vaccine should be used within 24 hours.
Chemical and physical in-use stability has been demonstrated 24 hours at 25C.


1. What Pandemrix is and what it is used for
Pandemrix is a vaccine against a pandemic influenza (flu).

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms (signs) of pandemic flu are similar to those of ordinary flu but are usually more severe.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. None of the vaccine can cause flu.

2. How Pandemrix is given
Your doctor or nurse will administer the vaccine.

A dose (0.5 ml for adult/0.25 ml for paed) of the vaccine will be injected into the muscle (usually the upper arm). It must never be administered in a vein (intravascularly).
A second dose of vaccine should be given after an interval of at least 3 weeks.

If you are older than 80 years, you may receive 2 double injections of Pandemrix. Tjhe first 2 injections should be given at the elected date and the 2 other injections should preferably be given 3 weeks after.
The double injections will bw given in opposite arms.

3. Possible side effects
like all medicines, Pandemrix can cause side effects, although not everybody gets them.

Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

The frequency of possible side effects listed below is defined using the following convention.
Very common (these may occur with more than 1 nin 10 doses of the vaccine).

Common (these may occur with up to 1 in 10 doses of the vaccine).
Uncommon (these may occur with up to 1 in 10 doses0 doses of the vaccine).

Very common:
Headache
Tiredness
pain, redness, swelling or a hard lump at the injection site
Fever
Arching muscles, joint pain

Common:
Warmth, itching or bruising at the injection site
Increased sweating, shivering, flu-like symptoms
Swollen glands in the neck, armpit or groin

Uncommon:
Tingling or numbness of the hands or feet
Sleepiness
Dizziness
Diarrhoea, vomiting, stomach pain, feeling sick
Itching, rash
Generally feeling unwell
Sleeplessness

These side effects usually disappear within 1-2 days without treatment they persist, consult your doctor.

GSK Biologicals s.a.