Vepacel
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated,prepared in cell culture)
Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What VEPACEL is and what it is used for
What you need to know before you receive VEPACEL
How VEPACEL is given
Possible side effects
How to store VEPACEL
Contents of the pack and other information
Medicinal product no longer authorised
VEPACEL is a vaccine for use in individuals aged 6 months and older. It is intended to be given before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms of pandemic flu are similar to those of an 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 ingredients in the vaccine can cause flu.
As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated.
if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet – section 6) or to any substances that may be present in trace (very low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein.
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, it may be appropriate for you to have the
vaccine, provided that appropriate medical treatment is immediately available in case of an
allergic reaction.
If you are not sure, talk to your doctor or nurse before having this 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 problem, but your doctor should advise whether you could still be vaccinated with VEPACEL.
if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been
reported following use of a similar vaccine for H1N1 influenza during a pandemic period. Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
if you have a weakened immune system as for example because of immunosuppressive therapy,
e.g. taking of corticosteroids or treatment for cancer.
if you have a bleeding problem or bruise easily.
If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with VEPACEL, the result of the test may not be correct. Tell the doctor requesting the test that you have recently received VEPACEL.
The vaccine should never be given into a blood vessel.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Medicinal product no longer authorised
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or if you have recently received any other vaccine.
There is no information on administration of VEPACEL with other vaccines. However, if this cannot be avoided, the other vaccine should not be injected into the same arm used for VEPACEL.
You should be aware that side effects may be intensified.
If you take any medicines that reduce immunity to infections or have any other type of treatment that affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to the vaccine may be poor.
VEPACEL should not be given at the same time as immunoglobulins. However, if this cannot be avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL.
If you 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 VEPACEL.
VEPACEL may affect your ability to drive and use machines.
Your doctor or nurse will administer the vaccine in accordance with official recommendations. The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass. The vaccine should never be given into a vein.
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years:
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the clinical studies conducted in adults and older people most side effects were mild in nature and short term. The side effects are generally similar to those related to the flu 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 (affects more than 1 user in 10):
pain at the injection site
fatigue (feeling tired)
Medicinal product no longer authorised
headache
Common (affects 1 to 10 users in 100):
runny nose and sore throat
vertigo (a spinning sensation)
pain in mouth and throat
cough
diarrhoea
increased sweating
itching
pain in joint or muscle
fever
chills
malaise (generally feeling unwell)
hardness, redness, swelling or bruising at the injection site
abnormal, reduced sensation
Uncommon (affects 1 to 10 users in 1,000):
swollen glands
insomnia (difficulty sleeping)
dizziness
sleepiness
conjunctivitis (an inflammation of the eye), eye irritation
ear pain
reduced blood pressure, feeling faint (syncope)
shortness of breath
stuffy or runny nose
dry throat
vomiting
feeling sick
stomach pain, upset stomach
rash, hives
chest discomfort
flu-like illness
injection-site reaction such as irritation, itching, bruising or stiff arm
sudden hearing loss
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 user in 10):
sleepiness
pain at the injection site
fever
irritability
Common (affects 1 to 10 users in 100):
runny nose and sore throat
decreased appetite
sleep disorder
crying
feeling sick
Medicinal product no longer authorised
vomiting
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 users in 100):
runny nose and sore throat
headache
pain in mouth and throat
feeling sick
vomiting
pain in joint or muscle
hardness, redness, swelling or bruising at the injection site
fatigue (feeling tired)
fever
malaise
Uncommon (affects 1 to 10 users in 1,000):
decreased appetite
eye irritation
cough
runny nose
diarrhoea
increased sweating
itching where the injection was given
pain in the armpit
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 user in 10):
headache
pain at the injection site
Common (affects 1 to 10 users in 100):
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 users in 1,000):
decreased appetite
insomnia (difficulty sleeping)
Medicinal product no longer authorised
dizziness
abnormal, reduced sensation
vertigo (a spinning sensation)
cough
runny nose
diarrhoea
itching
pain in extremity
bruising at the injection site
itching where the injection was given
pain in the armpit
fever
feeling cold
There are no post-marketing data available for VEPACEL.
Side effects observed with a similar influenza vaccine (Celvapan)
The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock
fits due to fever
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
Side effects observed with flu vaccines given routinely every year
In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side effects listed below have occurred. These side effects may occur with VEPACEL.
Uncommon (affects 1 to 10 users in 1,000):
generalised skin reactions including urticaria (hives)
Rare (affects 1 to 10 users in 10,000):
allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated,
may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
severe stabbing or throbbing pain along one or more nerves
low blood platelet count which can result in bleeding or bruising
Very rare (affects less than 1 user in 10,000):
vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems)
neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
If you get any side effects talk to your doctor or nurse. 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.
Medicinal product no longer authorised
Do not use this medicine after the expiry date which is stated on the carton and the label. 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.
After first opening, the vaccine should be used immediately (within a maximum period of 3 hours). 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 to protect the environment.
The active substance is: 1 dose (0.5 ml) contains:
Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**
* produced in Vero cells
** haemagglutinin
The other ingredients are Trometamol
Sodium chloride Water for injections Polysorbate 80.
VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials.
The suspension is clear to opalescent.
Ology Bioservices Ireland LTD Wilton Park House
Wilton Place Dublin 2
D02P447
Ireland
Baxter AG Uferstrasse 15
A-2304 Orth/Donau Austria
Medicinal product no longer authorised
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The following information is intended for healthcare professionals only:
Multidose vial (10 doses of 0.5 ml per vial)
The vaccine should be allowed to reach room temperature before use. Shake before use. After shaking, the vaccine is a clear to opalescent 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.