Liquid for injection, solution
Quadrivalent influenza vaccine ( recombinant, produced in cell culture)
What Supemtek is and what it is used for
Supreme is a vaccine for adults who are 18 years of age or older. This vaccine helps protect you against the flu. Supemtek is egg-free due to the technology used to produce it.
How Supemtek works
When a person receives Supemtek, the body’s natural defenses (the immune system) produce protection against the flu virus. None of the vaccine’s ingredients can cause influenza.
As with all vaccines, Supemtek may not provide complete protection to everyone who is vaccinated.
When should you get the flu vaccine?
Influenza can spread very quickly
- Influenza is caused by different types of influenza viruses that can change every year. Therefore, you may need to be vaccinated every year.
- During the cold months between October and March, the risk of getting the flu is greatest.
- If you haven’t been vaccinated in the fall, it’s still wise to get vaccinated right up until spring, because until then you’re at risk of getting the flu.
Your doctor can recommend the best time for vaccination.
What you need to know before receiving Supemtek
Do not use Supemtek
- if you are allergic to the active substances or any other ingredient of this medicine (listed in section 6)
- if you are allergic to octylphenol ethoxylate, a residue from the manufacturing process.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Supemtek.
As with all vaccines, Supemtek may not provide complete protection to everyone who is vaccinated.
Talk to your doctor, pharmacist, or nurse before getting the vaccine
- if you have a short illness with fever – the vaccination may need to be postponed until the fever has disappeared
- if you have a weakened immune system (due to immunodeficiency disease or if you take medicines that affect the immune system, for example, cytostatics or corticosteroids )
- if you have problems with bleeding or bruise easily
- if you have previously fainted in connection with an injection. Fainting can occur after – or even before – an injection.
Talk to your doctor, pharmacist, or nurse before receiving Supemtek if any of the above apply to you (or if you are not sure).
Other medicines and Supemtek
Tell the doctor or nurse if you are using, have recently used, or might be using other medicines. This also applies to over-the-counter medicines or if you have recently received another vaccine. Supemtek can be given at the same time as other vaccines if the vaccine is given at different places on the body.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine. The doctor or pharmacist will help you decide whether you should be vaccinated with Supemtek.
Driving ability and use of machinery
Supemtek has no or negligible effect on the ability to drive and use machines.
Supemtek contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. is next to “sodium-free”.
How Supemtek is given
September is given to you by a doctor, nurse, or pharmacist as an injection into the muscle at the top of your upper arm (deltoid muscle).
Adults aged 18 and over:
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
Contact a doctor or healthcare professional immediately or go to the nearest emergency room immediately if you experience an allergic reaction. It can be life-threatening.
The symptoms include
- difficulty breathing, shortness of breath
- swelling of the face, throat, lips, or tongue
- cold, cold sweaty skin
- palpitation
- dizziness, feeling weak, fainting
- skin rash or itching.
The following side effects have been reported with Supemtek:
Other side effects are
Very common (may affect more than 1 in 10 users):
- pain at the injection site
- fatigue
- headache
- muscle pain and joint pain.
Muscle pain and joint pain are common in adults aged 50 and older.
Common (may affect up to 1 in 10 users):
- nausea
- redness, swelling, induration in the area where the vaccine is injected
- fever chills.
Fever is rare in adults age 50 and older.
Uncommon (may affect up to 1 in 100 users):
- diarrhea
- itching, skin irritation, skin rash
- flu-like symptoms
- cough, pain in the mouth and throat
- itching where the vaccine was injected
Itching is rare in adults age 50 and older.
Skin irritation and rash have not been reported in adults 50 years of age and older.
Flu-like symptoms have not been reported in adults aged 18-49.
Rare (may affect up to 1 in 1,000 people):
- dizziness
- hives
Dizziness and hives have not been reported in adults aged 18-49.
Frequency not known (cannot be estimated from available data):
- disorders of the nervous system that may result in neck stiffness, confusion, numbness, pain and weakness in arms and legs, inability to maintain balance, lack of reflexes, and paralysis of all or part of the body ( Guillain-Barré syndrome ).
How to store Supemtek
Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store the pre-filled syringe in the outer carton. Light sensitive.
Use before the expiry date stated on the label and carton after “EXP”.
Medicines must not be thrown down the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
One dose (0.5 ml) contains :
The active substances are hemagglutinin proteins from influenza viruses (HA), of the following strains*:
An (xxxxxx) (H1N1)-like virus …………………..45 micrograms HA
An (xxxxxx) (H3N2)-like virus …………………..45 micrograms HA
B/xxxxxx-like virus ……………………………….45 micrograms HA
B/xxxxxx-like virus ……………………………….45 micrograms HA
*produced by recombinant DNA technology using a baculovirus expression system in a continuous insect cell line derived from Sf9 cells of the corn fly, Spodoptera frugiperda.
This vaccine follows the Northern Hemisphere recommendation of the World Health Organization (WHO) as well as the EU recommendation for the season {year/year}.
Other ingredients are polysorbate 20 (E432), sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, and water for injections.
Appearance and package sizes of the medicine
Supemtek is an injection solution in a pre-filled syringe (ready-to-use syringe ).
Supemtek is a clear and colorless solution.
One syringe contains 0.5 ml solution for injection.
Supemtek is available in packs containing 1, 5, or 10 pre-filled syringes without a needle or with a separate needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Pasteur
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer
Sanofi Pasteur
Incarville Industrial Park
27100 Val de Reuil
France