This vaccine helps to protect you or your child against influenza (flu), particularly in subjects at high risk of associated complications. VAXIGRIP use should be based on official recommendations.
When a person is given the vaccine VAXIGRIP, the immune system (the body's natural sewn) will produce its own protection (antibodies) against the disease. None of the components in the vaccine can cause flu.
Influenza is a disease which can spread rapidly and is caused by different types of strains that can change every year. Therefore, because this may have you or your child are vaccinated each year.
The greatest risk of catching flu is during the cold months between October and March. If you or your child have not been vaccinated in the autumn, it is still wise to be vaccinated until spring, because until then you and your child's risk of catching flu.
Your doctor may recommend what is the best time for vaccination.
VAXIGRIP will protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection.
The incubation period for flu is a few days, because if you or your child has been infected with flu immediately before or after vaccination, you or your child you could still develop the disease.
This vaccine will not protect you or your child from common cold, although some of the symptoms are similar to those of influenza.
2. BEFORE YOU OR YOUR CHILD TO USE VAXIGRIP
To make sure that VAXIGRIP is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child.
If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use VAXIGRIP
if you or your child is allergic (hypersensitive) to:
any of the other ingredients of VAXIGRIP, see section 6 "Further information";
each component which may be present in very small amounts such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde, octoxynol-9;
If you or your child has an illness with fever or acute infection, the vaccination should be delayed until recovery.
Take special precautions when using VAXIGRIP
Before vaccination, you should inform your doctor if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system).
Your doctor will decide whether you or your child to be vaccinated.
If for some reason you or your child have a blood test within a few days following an influenza vaccination, please tell your doctor.
This is due to the fact that several patients were false positive blood test results shortly after vaccination.
As with all vaccines, VAXIGRIP may not fully protect all persons who are vaccinated.
Administration of the vaccine with other drugs
Please tell your doctor or pharmacist if you or your child is taking or have recently taken any other vaccines or other medicines, including medicines obtained without a prescription;
VAXIGRIP may be administered concurrently with other vaccines, using different extremities. It should be noted that the side effects may be stronger;
The immune response may be reduced in the case of immunosuppressive therapy, such as corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and lactation
Tell your doctor or pharmacist if you are pregnant or suspect that you are pregnant.
Influenza vaccines can be applied at all stages of bremennostta.
Extensive safety data are available for the second and third trimesters of pregnancy compared with those for the first trimester. However, data from the use of inactivated influenza vaccines worldwide, have shown no deleterious effect on the pregnancy or the baby, attributable to the vaccine.
VAXIGRIP can be used during breastfeeding.
Your doctor / pharmacist will be able to assess whether you should be vaccinated with VAXIGRIP.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
VAXIGRIP no or negligible influence on the ability to drive and use machines.
3. HOW TO USE VAXIGRIP
Adults receive one dose of 0,5 ml.
Use in children
Children 36 months and older received a single dose of 0,5 ml.
Children from 6 months to 35 months may receive one dose of 0,25 ml or one dose of 0,5 ml in accordance with existing national recommendations.
If your child has not previously been vaccinated, should be given a second dose after at least 4-week intervals.
Method and / or routes of administration
Your doctor will administer the recommended dose of vaccine as an injection into the muscle or deep under the skin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VAXIGRIP can cause side effects, although not everybody gets them.
In clinical trials, the following adverse reactions were observed.
Their frequency has been evaluated as:
Common: affects 1 to 10 of 100 vaccinated:
muscle pain (myalgia), joint pain (arthralgia);
fever, malaise (feeling unwell), shivering, fatigue;
Local reactions: redness, swelling, pain, bruising (ecchymosis), induration (hardening) around the injection site.
These reactions usually disappear within 1-2 days without treatment.
Addition to the above common side effects after the vaccine market, have been reported following side effects:
medical emergency resulting in impaired circulatory system while maintaining sufficient blood flow to the different organs (shock) in rare cases;
swelling mainly of the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases;
skin reactions that may spread throughout the body, including skin itching (pruritus, urticaria), rash;
inflammation of blood vessels, which can lead to skin rashes (vasculitis) and in very rare cases in temporary kidney;
pain situated on the nerve route (neuralgia), anomalies in the perception affecting the sensitivity of touch, pain, heat and cold (paraesthesia), seizures (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness in the limbs, loss of balance, loss of reflexes, paralysis of the body or part of it (encephalomyelitis, neuritis, Guillain-Barré syndrome);
temporary reduction in the number of certain blood components called platelets; low number of these can lead to highly bruising or bleeding (transient thrombocytopenia), temporary swelling of the lymph nodes in the neck, armpit and groin (transient lymphadenopathy).
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE VAXIGRIP
Keep out of reach of children.
VAXIGRIP not use after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Keep the syringe in the outer carton to protect from light.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What contain VAXIGRIP
The active substances are:
Influenza virus (inactivated, split) of the following strains *:
A / California / 7/2009 (H1N1) rdm09-derived strain (NYMC X-179a): 15 micrograms **;
A / Texas / 50/2012 (H3N2) strain -derivative (NYMC X-223A): 15 micrograms **;
B / Massachusetts / 2/2012: 15 micrograms **.
For a dose of 0,5 ml.
* propagated in fertilized hens' eggs from healthy chicken flocks
The vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2014/2015 season.
The other ingredients are a buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, water for injections.
VAXIGRIP looks like and contents of the pack
VAXIGRIP is presented suspension for injection in pre-filled syringe 0,5 ml in box of 1, 10, 20 or 50.
Not all pack sizes may be marketed.
After careful shaking, the vaccine is a slightly whitish and opalescent liquid.