Pandemic Influenza Vaccine H5N1 Baxter AG
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
How PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given
Possible side effects
How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Contents of the pack and other information
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals
aged 6 months adults and older. It is used to prevent influenza (flu) in an officially declared pandemic.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world. The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary’ flu but are usually more severe.
The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
if you previously had a serious allergic reaction (i.e. life-threatening) to PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine. The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, your doctor may recommend to give the vaccine.
You should tell your doctor before vaccination
if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at the end of the leaflet) or to formaldehyde, benzonase or sucrose. Allergic reactions, including sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period. Such reactions have happened both in people who have allergies and in those who do not;
if you have a poor immune response (for example because of immunosuppressive therapy,
e.g. corticosteroid treatments or chemotherapy for cancer);
if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
if you have a bleeding problem or bruise easily.
The vaccine should never be given into a blood vessel.
There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines. However, if this cannot be avoided, the other vaccine should be injected into the other limb. You should be aware that the side effects may be intensified.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins. However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
If your are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may affect your ability to drive or use machines.
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years and older:
One dose of 0.5 ml will be given. A second dose of 0.5 ml should be given after an interval of at least
three weeks.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle (usually in the upper arm or upper thigh, depending on the muscle mass).
The vaccine should never be given into a vein.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, although not everybody gets them.
In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term. The side-effects are generally similar to those related to the influenza vaccine. There were fewer side effects after the second vaccination compared with the first. The most frequently occurring side effect was injection site pain, which was usually mild.
The following side effects have been reported in clinical studies in adults and older people. Very common (may affect more than 1 in 10 vaccinees):
pain at the injection site
fatigue (feeling tired)
headache
Common (may affect up to 1 in 10 vaccinees):
runny nose and sore throat
vertigo (motion sickness)
pain in mouth and throat
cough
diarrhoea
increased sweating
itching
joint or muscle pain
fever
chills
malaise (generally feeling unwell),
hardness, redness, swelling or minor bleeding at the injection site
abnormal, reduced sensation
Uncommon (may affect more than 1 in 100 vaccinees):
swollen glands
insomnia (difficulty sleeping)
dizziness
sleepiness
conjunctivitis (an inflammation of the eye), eye irritation
sudden hearing loss, ear pain
reduced blood pressure, feeling faint (syncope)
shortness of breath
dry throat
stuffy or runny nose
feeling sick
vomiting
stomach pain, indigestion
rash, hives
irritation or itching at the injection site, bruising or stiff arm
chest discomfort
flu-like illness
In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
The following side effects have been reported in a clinical study in infants aged 6 to 35 months. Very common (affects more than 1 in 10 vaccinees):
sleepiness
fever
irritability
pain at the injection site
Common (affects 1 to 10 in 100 vaccinees):
runny nose and sore throat
decreased appetite
sleep disorder
crying
vomiting
feeling sick
diarrhoea
increased sweating
hardness, redness, swelling or bruising at the injection site
The following side effects have been reported in clinical studies in children aged 3 to 8 years. Very common (affects more than 1 user in 10):
pain at the injection site
Common (affects 1 to 10 in 100 vaccinees):
runny nose and sore throat
headache
pain in mouth and throat
vomiting
feeling sick
pain in joint or muscle
hardness, redness, swelling or bruising at the injection site
fatigue (feeling tired)
fever
malaise
Uncommon (affects 1 to 10 in 1,000 vaccinees):
decreased appetite
eye irritation
cough
runny nose
diarrhoea
increased sweating
pain in the armpit
itching where the injection was given
feeling cold
The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Very common (affects more than 1 in 10 vaccinees):
headache
pain at the injection site
Common (affects 1 to 10 in 100 vaccinees):
runny nose and sore throat
pain in mouth and throat
stomach pain
feeling sick
vomiting
increased sweating
pain in joint or muscle
hardness, redness or swelling at the injection site
fatigue (feeling tired)
chills
malaise
Uncommon (affects 1 to 10 in 1,000 vaccinees):
decreased appetite
insomnia (difficulty sleeping)
dizziness
abnormal, reduced sensation
vertigo (a spinning sensation)
cough
runny nose
diarrhoea
itching
pain in extremity
pain in the armpit
bruising at the injection site
itching where the injection was given
fever
feeling cold
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme. The frequency cannot be estimated from the available data.
allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
fits
pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
swelling of tissue just below the skin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light. Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Active substance:
Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*:
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** per 0.5 ml dose
* produced in Vero cells
** haemagglutinin
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
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This leaflet was last revised in {MM/YYYY}.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional circumstances”. This means that for scientific reasons, it has been impossible to get complete information on this medicine. The European Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
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The following information is intended for health care professionals only:
The vaccine should be allowed to reach room temperature before use. Shake before use. After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.
The vaccine should not be administered intravascularly.
Any unused vaccine or waste material should be disposed of in accordance with local requirements. After first opening, the vial is to be used within a maximum of 3 hours.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.