IDflu 9 mcg
IDflu is a vaccine. This vaccine is recommended to prevent flu.
The vaccine may be administered to adults 59 years of age, especially in individuals with increased risk of developing complications associated with influenza.
When IDflu be injected, the immune system (the body's natural defenses) will develop protection against flu infection.
IDflu will help to protect you against the three strains of virus contained in the vaccine or other strains closely related to the vaccine strains. The full effect of the vaccine is generally achieved 2-3 weeks after vaccination.
2. What you need to know before taking IDflu
Do not take IDflu:
If you are allergic to:
All other ingredients in this vaccine (listed in section 6);
Component which may be present in very small amounts such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxynol 9;
If you have an illness with fever or acute infection, the vaccination should be postponed until after you have recovered.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking IDflu:
Before vaccination should tell your doctor if you have a poor immune response (immunosuppression) due to disease or medicines, as in this case, the vaccine may not work very well;
This vaccine under no circumstances be administered into a vein (intravascularly);
If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor. This can affect the results of tests for the presence of HIV-1, hepatitis C virus and HTLV-1.
Children and adolescents
Not recommended for use of IDflu in children and adolescents under 18 years.
Other vaccines or medicines and IDflu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other vaccines: IDflu can be given simultaneously with other vaccines by using separate limbs. It should be noted that the adverse reactions may be intensified;
Tell your doctor if you are taking medicines that may weaken your immune response such as corticosteroids (for example cortisone), medicines to treat cancer (chemotherapy), radiotherapy or other medicines that affect the immune system.
In this case, the vaccine may not work very well.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Vaccines against influenza can be applied during all stages of pregnancy. Larger set of safety data are available for the second and third trimester of pregnancy, compared to the first trimester. Data from the use of influenza vaccines worldwide showed no harmful effects of the vaccine on pregnancy or the baby.
Your doctor will decide whether you should receive this vaccine.
This vaccine can be used during breastfeeding.
Driving and using machines
This vaccine or negligible influence on the ability to drive and use machines.
3. How to use IDflu
Always take this vaccine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 0,1 ml for adults 18 to 59 years of age.
IDflu is administered to you by your doctor or nurse.
IDflu is injected into the top layer of the skin (preferably the muscle of the upper arm).
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
You should immediately visit your doctor if you experience symptoms of angioedema, such as:
Swelling of the face, tongue or throat;
Rash and difficulty breathing.
During clinical trials and after the vaccine is marketed, reported the following adverse reactions of Idflu.
Very common reactions (may affect more than 1 in 10 people):
Injection site: redness, swelling, hardness, itching and pain;
Malaise, headache, and muscle aches.
Common reactions (may affect up to 1 in 10 people):
Bruising at the injection site;
Chills, fever (38,0 ° C or higher).
Uncommon (may affect up to 1 in 100 people):
Fatigue, swelling of the glands in the neck, armpit or groin, tingling or numbness, joint pain, itching and rash.
Rare reactions (may affect up to 1 in 1000 people):
Reactions known (from the available data can not be estimated frequency):
Allergic reactions, including skin reactions that may spread throughout the body, such as hives, severe allergic reactions (anaphylaxis), swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema), failure of circulation (shock) leading to medical emergency.
Most of the side effects listed above resolved without treatment within 1 to 3 days after onset. In some cases, redness at the injection continues up to 7 days.
The following adverse reactions have been reported with other vaccines given to prevent flu. These side effects may occur with IDflu:
A transient reduction in the number of blood cells, called platelets which can result in bruising or bleeding;
Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré syndrome which causes extreme weakness and paralysis;
Inflammation of blood vessels, which may result in very rare cases in temporary kidney.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. How to store IDflu
Keep out of the reach and sight of children.
Do not use this vaccine 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. Contents of the pack and other information
The active substances are Influenza virus (inactivated, split) of the following strains *:
A / California / 7/2009 (H1N1) pdm 09 - derivative strain (NYMC X-179A): 9 micrograms **;
A / Texas / 50/2012 (H3N2) - derived strain (NYMC X-223A): 9 micrograms **;
B / Massachusetts / 2/2012: 9 micrograms **.
a dose of 0,1 ml
* Propagated in fertilized hens' eggs from healthy chickens.
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2014/2015 season.
The other ingredients are sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injection.
What IDflu looks like and contents of the pack
The vaccine is a colorless and opalescent suspension.
IDflu is a suspension for injection in pre-filled syringe of 0,1 ml with a Micro-Injection System in packs of 1, 10 or 20.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Pasteur SA, France.
Sanofi Pasteur, France.
The following information is intended for healthcare professionals only:
As with all injectable vaccines should always be provided with appropriate medical treatment and supervision in case of anaphylactic reactions following the administration of the vaccine.
Before use, the vaccine should be allowed to reach room temperature.
The vaccine should not be used if the slurry has any foreign particulate matter.
It is not necessary to shake the vaccine before use.
Micro-Injection System for intradermal injection consists of a pre-filled syringe with a microneedle (1,5 mm) and a needle shielding system.
The needle shielding system is designed to cover the micro after use.