Patient leaflet - Vepacel
1. What VEPACEL is and what it is used for
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.
¿CT
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.
2. What you need to know before you receive VEPACEL
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You should not receive VEPACEL
-
– 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.
Warnings and precautions
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 immunosuppressiv e.g. taking of corticosteroids or treatment for cancer.
y,
if you have a bleeding problem or bruise easily.
ew weeks ctor requesting
If you need a blood test to look for evidence of infection with certain viruses in after vaccination with VEPACEL, the result of the test may not be correct. Tel the test that you have recently received VEPACEL.
The vaccine should never be given into a blood vessel.
tion may not be recommended,
In any of these cases, TELL YOUR DOCTOR OR NURSE, as or may need to be delayed.
Other medicines and VEPACEL
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained witho other vaccine.
, or if you have recently received any
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 affects the immune s the vaccine may be p
duce immunity to infections or have any other type of treatment that as radiotherapy), VEPACEL can still be given but your response to
VEPACEL should not be given at the same time as immunoglobulins. However, if this cannot be avoided, the i munoglobulins should not be injected into the same arm used for VEPACEL.
Pregn
reast-feeding
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.
Driving and using machines
VEPACEL may affect your ability to drive and use machines.
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3. How VEPACEL is given
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets the
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)
- 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
- fever
- chills
- malaise
- hardness, redness, swelling or bruising at the injection site
- abnormal, reduced sensation (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.
a) The following side effects have been reported in a clinical study in infants aged 6 to 35
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
- vomiting
- diarrhoea
- increased sweating
- hardness, redness, swelling or bruisi
Very common (affects more thanHjser in 10):
Common (affects 1 to
sers in 100): throat
- pain at the injection site
runny nose a headache pain in fee
and throat
in in joint or muscle
rdness, 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 c) 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)
- 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
- feeling cold
There are no post-marketing data available for VEPACEL.
Sidyeffects observed with a similar influenza vaccine (Celvapan)
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 an problems)
- neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barre syndrome
Reporting of side effects
If you get any side effects talk to your doctor or nurse. This includes any possibe^ideWfects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more informationonthe safety of this medicine.
5. How to store VEPACEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date w date refers to the last day of that month.
tated on the carton and the label. The expiry
Store in a refrigerator (2°C – 8°C).
Store in the original package in order to Do not freeze.
After first opening, the vaccine
e 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.
What V
6. Conten
pack and other information
L contains
active substance is:
se (0.5 ml) contains:
Influenza virus (whole virion, inactivated), containing antigen of*strain:
A/Vietnam/1203/2004 (H5N1) 7.5 micrograms**
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* produced in Vero cells
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* * haemagglutinin
What VEPACEL looks like and contents of the pack
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.
Marketing Authorisation Holder
Ology Bioservices Ireland LTD
Wilton Park House
Wilton Place
Dublin 2
D02P447
Ireland
Manufacturer
Baxter AG
Uferstrasse 15
A-2304 Orth/Donau
Austria
This leaflet was last revised in
Detailed information on this medicine is web site:.
pean Medicines Agency (EMA)
icare professionals only:
The following information is in
Multidose vial (10 doses of 0.5 ml
The vaccine should be allowe
ch room temperature before use. Shake before use.
After shaking, the vaccine lear to opalescent suspension.
Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physica arance. In the event of either being observed, discard the vaccine.
The vaccine
not be administered intravascularly.
accine or waste material should be disposed of in accordance with local requirements.
st 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.