suspension, in pre-filled syringe
Influenza vaccine (surface antigen, inactivated). Season 2021/2022
1. What Influvac Tetra is and what it is used for
Influvac Tetra is a vaccine. The vaccine helps protect you or your child from the flu, especially in patients at high risk for complications. Influence Tetra is intended for adults and children from 6 months of age. The use of Influvac Tetra should be based on official recommendations.
When a person receives the vaccine Influvac Tetra, 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 until the spring as there is a risk of contracting the flu until then.
Your doctor may recommend when the best time is to get vaccinated.
Influence Tetra protects you or your baby against the four 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 vaccination, you may still fall ill.
The vaccine does not protect against the common cold, although some of the symptoms are similar to the flu.
2. What you need to know before you or your child receive Influvac Tetra
To ensure that Influvac Tetra is suitable for you or your child, it is important to tell your doctor, pharmacist, or nurse if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor, pharmacist, or nurse to explain.
Do not use Influvac Tetra
– If you or your child are allergic (hypersensitive) to:
- the active substances or
- any of the ingredients of Influvac Tetra (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 or your child should tell your doctor before vaccination if you or your child have:
- poor immune system (weakened immune system or taking drugs that affect the immune system)
- a bleeding disorder or easily get bruises
Your doctor will decide if you or your child should be vaccinated.
Fainting, feeling weak or other stress-related reactions may occur in response to the needle injection. Tell your doctor or nurse if you or your child have had this type of reaction before.
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 Tetra may not provide complete protection to all people who have been vaccinated.
Other medicines and Influvac Tetra
- Tell your doctor, pharmacist or nurse if you or your child are taking or have recently taken or might take any other vaccines or medicines, including over-the-counter ones.
- Influvac Tetra 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 cortisone, chemotherapy or radiation therapy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
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 (3-month period) 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 Tetra can be used during breastfeeding.
Your doctor, pharmacist, or nurse may decide if you should receive Influvac Tetra. Consult a doctor, pharmacist, or nurse before taking any medicine.
Driving and using machines
Influence Tetra has no or negligible influence on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Influvac Tetra contains sodium and potassium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free. is next to “sodium-free”.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, ie essentially ‘potassium’. is almost “potassium-free”.
3. How to get Influvac Tetra
Dosage
Adults receive a dose of 0.5 ml.
Children and young people
Children 6 months – 17 years receive a dose of 0.5 ml.
Children under the age of 9 who have not previously been vaccinated against seasonal flu receive an additional dose when at least 4 weeks have passed.
The safety and efficacy of Influvac Tetra in infants below 6 months of age have not been established.
How Influvac Tetra is given
Your doctor or nurse 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, pharmacist, or nurse.
4. Possible side effects
Like all medicines, Influvac Tetra can cause side effects, although not everybody gets them.
Seek medical attention immediately if you or your child experience any of the following side effects – you or your child may need urgent medical attention:
Severe allergic reactions (occurs in an unknown number of people, has occurred in rare cases during normal use of the trivalent influenza vaccine Influvac)
- which can lead to an acute condition with low blood pressure , fast, shallow breathing, fast heartbeat and weak pulse , cold, moist skin, dizziness, which can lead to collapse ( shock )
- swelling most clearly in the head-neck region, including the face, lips, tongue, throat or any other part of the body and which may cause difficulty swallowing or breathing ( angioedema ).
The following side effects have been observed during clinical trials with Influvac Tetra:
Adults and the elderly
Very common: may affect more than 1 in 10 people:
- headache a
- fatigue
- local reaction: pain after vaccinationa Reported as a common side effect in older adults (≥ 61 years)
Common: may affect up to 1 in 10 people:
- sweating
- muscle pain ( myalgia ), joint pain ( arthralgia )
- general malaise, chills
- local reactions: redness , swelling, bruising ( ecchymosis ), hardening at the injection site ( induration )
Uncommon: may affect up to 1 in 100 people:
- fever.
Children (6 months – 17 years)
Side effects in children 6-35 months:
Very common: may occur in more people is 1 in 10 people:
- drowsiness
- sweating
- reduced appetite
- diarrhea, vomiting
- irritability / trickiness
- fever
- local reactions: pain, redness
Common: may affect up to 1 in 10 people:
- local reactions: swelling, induration , bruising ( ecchymosis )
Side effects in children 3-5 years:
Very common: may affect more than 1 in 10 people:
- drowsiness
- reduced appetite
- irritability / trickiness
- local reactions: vaccination site pain, redness , swelling, induration at the injection site
Common: may affect up to 1 in 10 people:
- sweating
- diarrhea, vomiting
- fever
- local reaction: bruise ( ecchymosis )
Side effects in children 6–17 years:
Very common: may affect more than 1 in 10 people:
- headache
- nausea, abdominal pain, diarrhea, vomiting
- muscle aches ( myalgia )
- fatigue, general malaise
- local reactions: vaccination site pain, redness , swelling, induration at the injection site
Common: may affect up to 1 in 10 people:
- sweating
- joint pain ( arthralgia )
- fever
- overindulge
- local reaction: bruise ( ecchymosis ).
All age groups
In all age groups, most of the reactions mentioned above usually occurred during the first 3 days after vaccination and went away on their own after 1 to 3 days. The reactions were generally mild.
In addition to the above-mentioned side effects, the following side effects have occurred in isolated cases during normal use of the trivalent influenza vaccine Influvac:
Has been reported (occurs in an unknown number of people):
- 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 of parts of or whole body ( encephalomyelitis , neuritis , Guillain-Barré syndrome )
- temporary narrowing of a type of blood cell called platelets , 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 Tetra
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 (inactivated) (hemagglutinin and neuroaminidase) from influenza virus of the following strains *
| A / Victoria / 2570/2019 (H1N1) pdm09-like strain (A / Victoria / 2570/2019, IVR-215) | 15 micrograms HA ** |
| A / Cambodia / e0826360 / 2020 (H3N2) -like strain (A / Cambodia / e0826360 / 2020, IVR-224) | 15 micrograms HA ** |
| B / Washington / 02/2019-like strain (B / Washington / 02/2019, wild type) | 15 micrograms HA ** |
| B / Phuket / 3073/2013-like strain (B / Phuket / 3073/2013, 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 World Health Organization (WHO) recommendations (northern hemisphere) and EU recommendations for the 2021/2022 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 Tetra 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:
| Belgium, France, Luxembourg | Influvac Tetra, injectable suspension and precedent seringue |
| Bulgaria | Influenza Tetra Injection Suspension in Pre-Injured Spray |
| Cyprus, Greece | Influence subunit Tetra |
| Denmark, Iceland | Influvactetra |
| Ireland | Influence Tetra, suspension for injection in pre-filled syringe |
| Italy | Influvac S Tetra suspensible in susceptible pre-riempite |
| Croatia | Influence Tetra suspension for injection into nasal passages, cjepivo protiv influence (površinski antigeni), inactivation |
| Latvia | Influvac Tetra suspension injection pill |
| Lithuania | Influvac Tetra injection suspension is effective |
| Malta, United Kingdom | Influence sub-unit Tetra, suspension for injection in pre-filled syringe |
| Netherlands | Influence Tetra, suspension for pre-injection in pre-filled syringe 0.5 ml |
| Estonia, Finland, Norway, Poland, Portugal, Slovakia, Sweden, Germany | Influence Tetra |
| Romania | Influence Tetra injectable suspension in pre-emptive series |
| Slovenia | Influence Tetra suspension for injection in Naples injection syringe |
| Spain | Influvac Tetra injectable suspension in jeringa precargada |
| Czech Republic | Influence Tetra, injection suspension in previous injection injection |
| Austria | Influence Tetra injection suspension in a ready-to-use syringe |