Influenza vaccine (surface antigen, inactivated) Season 2020/2021
1. What Influvac is and what it is used for
Influence is a vaccine. The vaccine will help protect you or your child against the flu, especially in patients who are at high risk for associated complications. The use of Influvac should be based on official recommendations.
When a person receives the Influvac vaccine, the immune system (the body’s natural defense system) will produce its own protection ( antibodies ) against the disease. None of the ingredients in the vaccine can cause the flu.
Influenza is a disease that can spread quickly and is caused by different strains that can change every year. This is why you or your child may need to be vaccinated every year. The greatest risk of getting the flu is during the cold months between October and March. If you or your child has not been vaccinated during the autumn, there is still reason to vaccinate you or your child until the spring because there is a risk of contracting the flu until then.
Your doctor may recommend when it is best to get vaccinated.
Influence protects you or your baby against the three virus strains included in the vaccine from about 2 to 3 weeks after injection.
It can take a couple of days from the time of infection to becoming ill, so if you or your child has been exposed to the flu immediately before or after your vaccination, you or your child may still fall ill.
The vaccine does not protect you or your child against the common cold, even if the symptoms are similar to the flu.
2. What you need to know before you or your child receive Influvac
To ensure that Influvac is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.
Do not use Influvac
- If you or your child are allergic (hypersensitive) to:
- the active substances or
- any of the ingredients of Influvac (see section 6) or
- any ingredient that may be present in extremely small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic used in the treatment of bacterial infections ).
- If you or your child has a disease with a high fever or acute infection , the vaccination should be postponed until after you or your child has recovered.
Warnings and cautions
You should tell your doctor before vaccination if you or your child has a weakened immune system (weakened immune system or taking medicines that affect the immune system).
Fainting, feeling weak or other stress-related reactions may occur in response to the needle injection. Tell your doctor or nurse if you have had this type of reaction before.
Your doctor will decide if you or your child should be vaccinated.
If for any reason you or your child takes a blood sample within a few days after flu vaccination, tell your doctor. This is because false-positive results have been observed in a few patients who have recently been vaccinated.
As with all vaccines, Influvac may not provide complete protection to all people who have been vaccinated.
Other medicines and Influvac
- 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.
- Influvac can be given at the same time as other vaccines, but in a different extremity (arm or leg). Note that the side effects may be more severe.
- The immune response may be reduced by immunosuppressive therapy, such as corticosteroids , chemotherapy or radiation therapy.
Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Influenza vaccines can be used during all stages of pregnancy. There is a greater amount of safety data available from the second and third trimesters of pregnancy compared to the first trimester. Data from influenza vaccination worldwide do not indicate that the vaccine has harmful effects on pregnancy or the baby.
Influence can be used during breastfeeding.
Your doctor/pharmacist can decide if you should receive Influvac.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Influence has no or negligible influence on the ability to drive and use machines.
3. How to get Influvac
Dosage
Adults receive a dose of 0.5 ml.
Use for children
Children from 36 months and older receive a dose of 0.5 ml.
Children from 6 months to 35 months can receive either a dose of 0.25 ml or a dose of 0.5 ml in accordance with national regulations.
If your child has not been vaccinated against the flu before, a second dose should be given after at least 4 weeks.
How Influvac is given
Your doctor will give the recommended dose of one of the vaccines as an injection into a 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, Influvac can cause side effects, although not everybody gets them.
During clinical trials, the following side effects have been observed. Their frequencies have been calculated as Common: occur in 1 to 10 out of 100 users:
- headache
- sweating
- muscle pain ( myalgia ), joint pain ( arthralgia )
- fever, general malaise, chills, fatigue
- local reactions: redness , swelling, pain, bruising ( ecchymosis ), induration at the injection site ( induration ).
These reactions usually disappear within 1-2 days without treatment.
In addition to the common side effects mentioned above, the following side effects have been reported since the vaccine came on the market:
- allergic reactions:
- which in rare cases can lead to a medical emergency with a failing circulatory system that can not maintain sufficient blood flow to the various organs ( shock ),
- which in very rare cases leads to swelling most evident in the head-neck region, including face, lips, tongue, throat or any other part of the body ( angioedema ).
- skin reactions that can spread throughout the body including itching , ( pruritus , urticaria ), rash.
- vasculitis which can lead to skin rash ( vasculitis ) and in very rare cases to transient renal effects.
- nerve pain ( neuralgia ), abnormal sensations when touching, pain, heat and cold ( paresthesia ), seizures (convulsions) associated with fever, neurological disorders that can lead to stiff neck, confusion, numbness, pain and weakness in arms and legs, worsening balance, impaired reflexes, paralysis in parts of or the whole body ( encephalomyelitis , neuritis , Guillain-Barré syndrome ).
- temporary narrowing of a type of blood cell called platelet , a low number of which can lead to bruising or bleeding (transient thrombocytopenia ), temporary swelling of glands in the throat, armpit or groin (transient lymphadenopathy ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Influvac
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store the syringe in the outer carton. Sensitive to light.
Medicines should not be disposed of via 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 packaging and other information
Content declaration
The active substances are:
Surface antigens (hemagglutinin and neuroaminidase) from influenza virus of the following strains *:
| A / Guangdong-Maonan / SWL1536 / 2019 (H1N1) pdm09-like strain (A / Guangdong-Maonan / SWL1536 / 2019, CNIC-1909) | 15 micrograms HA ** |
| A / Hong Kong / 2671/2019 (H3N2) -like strain (A / Hong Kong / 2671/2019, IVR-208) | 15 micrograms HA ** |
| B / Washington / 02/2019-like strain (B / Washington / 02/2019, wild type) | 15 micrograms HA ** |
| Per 0.5 ml dose | |
| * grown in fertilized chicken eggs from healthy flocks of chickens. ** hemagglutinin |
This vaccine complies with the recommendations of the World Health Organization (WHO) (Northern Hemisphere) and the EU Recommendation for the 2020/2021 season.
The other ingredients are potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and water for injection.
What the medicine looks like and contents of the pack
Influence is a suspension for injection provided in a pre-filled syringe (with/without needle) containing 0.5 ml of colorless clear solution for injection. Each syringe can only be used once.
Packs of 1 or 10 pcs.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
BGP Products AB
Box 23033
104 35 Stockholm
Manufacturer:
Abbott Biologicals BV
Veerweg 12
8121 AA Olst
Netherlands
This medicinal product is authorized under the European Economic Area under the names:
Bulgaria, Denmark, Estonia, Finland, France, Iceland, Croatia, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Romania, Czech Republic, Germany, Austria: Influvac
Belgium, Italy, Luxembourg: Influvac S
Cyprus, Greece, Ireland, Malta, UK: Influvac sub-unit