Influvac vaccine. This vaccine helps you or your child to protect yourself from the flu (influenza). It is particularly recommended for patients at high risk of complications of the disease related to influenza.
Use of Influvak must be on the basis of official recommendations. Vaccination with Influvak, the immune system (body's natural defense system) will produce its own protection (antibodies) against the flu. None of the ingredients in the vaccine can cause flu.
Influenza is a disease that spreads quickly and is caused by the different virus strains, which may change every year. So you and your child should be vaccinated every year. The greatest risk to get flu is during the cold months between October and March. If you and your child are not vaccinated in the autumn, it is prudent to be vaccinated until the spring, as you and your child is still a risk of getting sick by then.
Your doctor will recommend the best time for vaccination.
Influvak will protect you or your child against the three virus strains contained in the vaccine.
The incubation period for flu is a few days, so if you or your child are exposed to flu immediately before or after vaccination with Influvak, you or your child you can still get sick.
Vaccine would not protect against the common cold, although some of its symptoms are similar to those of influenza.
2. BEFORE YOU OR YOUR CHILD TAKE INFLUVAC
To make sure that Influvak is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the following things affect you. If something you are unclear, ask them to explain.
Do not take Influvac:
If you or your child are allergic (hypersensitive) to the active substances:
to any of the excipients of Influvak;
to certain ingredients that may be present in very small amounts such as eggs (or chicken proteins ovalbumin), formaldehyde, tsetriltrimetilamoniev bromide, polysorbate 80, or gentamicin (antibiotic used to treat bacterial infections).
If you or your child are sick, have a fever or acute infection, the vaccination should be delayed until you or your child recover.
Take special care with Influvak:
Before vaccination tell your doctor or pharmacist if you or your child have a weak immune response (suffering from immunodeficiency or taking medicines affecting the immune system). Your doctor will decide whether you or your child are vaccinated.
If for some reason have you or your child should have blood samples a few days following an influenza vaccination, tell your doctor. This is necessary because after vaccination, may produce false positive results for some recently vaccinated patients.
As with all vaccines, Influvak may not completely protect all persons who are vaccinated.
Using other medicines
Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Influvak can be administered simultaneously with other vaccines. In these cases, the vaccines should be placed on separate limbs. Co-administration with other vaccines may increase side effects.
The immune response may be weak in case of immunosuppressant treatment, such as treatment with corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and lactation
Tell your doctor if you are pregnant or think you are.
Influenza vaccine can be given in all periods of pregnancy. There are extensive data on safety during the second and third trimester compared with the first trimester; however, data from the use of influenza vaccine worldwide do not indicate harmful effects on pregnancy or the baby.
Influvak can be used during breastfeeding.
Your doctor / pharmacist will decide if you should be vaccinated with Influvak.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Influvak no or negligible influence on the ability to drive and use machines.
3. HOW TO TAKE INFLUVAC
Adults: 0,5 ml.
Use in children
Children over 36 months should get a dose of 0,5 ml.
Children from 6 months to 35 months may receive either a single dose of 0,25 ml or one dose of 0,5 ml in accordance with existing national recommendations.
If your child has not been vaccinated against flu so far, it is recommended that a second dose after an interval of not less than 4 weeks.
Method for administration
Your doctor will administer the vaccine as an injection into a muscle or deep under the skin.
If you have any questions regarding the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Influvak can cause side effects, although not everybody gets them.
During clinical trials, the following adverse reactions. They are defined as common if affects 1 to 10 of 100 vaccinated:
muscle pain (myalgia), joint pain (arthralgia);
fever, malaise, shivering, fatigue;
Local reactions: redness, swelling, pain, ecchymosis (bruising), hardness (induration) around the injection site.
These reactions usually disappear within 1 -2 days without treatment.
Than those common, putting the vaccine market are observed:
rare cases leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock);
Very rare cases of swelling most common head and neck, including the face, lips, tongue, throat and other parts of the body (angioedema);
Skin reactions that may spread throughout the body, including itching (pruritus and urticaria) and rash;
Inflammation of blood vessels, which can lead to skin rash (vasculitis) and in very rare cases in temporary kidney problems;
Pain along the nerves (neuralgia); abnormalities in the perception of touch, pain, burning or cold (paraesthesia); convulsions associated with fever; neurological disorders that can lead to stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance and reflexes, paralysis of body parts or the whole body (encephalomyelitis, neuritis and Guillain-Barré syndrome);
Temporary reduction in the number of certain blood cells called platelets, which in rare cases can cause bleeding and bruising (transient thrombocytopenia); transient swelling of the glands in the neck, armpit or groin (transient lymphadenopathy).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE INFLUVAC
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (+2 to +8 ° C).
Do not freeze!
Store in the original package in order to protect from light.
Medicines should not be disposed of in household waste or sewage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substances are:
Virus surface antigens (hemagglutinin and neuraminidase) of these influenza strains of influenza virus *:
A / California / 7/2009 (H1N1) pdm09 - derived strain NYMC X-181: 15 micrograms **;
A / Victoria / 361/2011 (H3N2) - derived strain IVR-165: 15 micrograms **;
B / Wisconsin / 1/2010 - similar strain NYMC VC-39 derived from B / Hubei-Wujiagang / 158/2009: 15 micrograms **.
For a dose of 0.5 ml.
* Propagated in fertilized hens' eggs from healthy bird populations.
The composition of Influvak is in line with the recommendations of the World Health Organization for the Northern Hemisphere and the decision of the European Union for the 2012/2013 season.
The other ingredients are potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate and water for injections.
Looks Influvak and contents of container
Influvak is a suspension for injection in a pre-filled glass syringe (with or without attached needles) containing 0,5 ml clear, colorless liquid. Each syringe should be used only once.
1 syringe in a carton.