solution for injection, suspension, pre-filled syringe
hepatitis A vaccine inactivated, adsorbed
1. What Avaxim is and what it is used for
Avaxim is a vaccine. Vaccines are used to protect against infectious diseases. This vaccine helps protect against hepatitis A infection in people who are 16 years or older.
Hepatitis A infection is caused by a virus that attacks the liver. It can be transmitted through food or drink that contains the virus. Symptoms are yellow skin (jaundice) and general malaise.
When you are vaccinated with Avaxim, your body’s natural defenses will begin to produce protection against the virus that causes hepatitis A infection.
2. What you need to know before using Avaxim
Do not use Avaxim
- if you are allergic (hypersensitive) to
- active substance or any other ingredient of Avaxim (listed in section 6), or
- neomycin, an antibiotic used during vaccine production, which may be present in small amounts in the vaccine, or
- Avaxim
- if you have a high fever infection, your vaccination may need to be postponed until you have recovered
Warnings and cautions
Talk to your doctor or nurse before taking Avaxim if you have:
- a liver disease.
- a weakened or weakened immune system due to any of the following:
- corticosteroids, cytotoxic drugs, radiation therapy, or any other treatment that weakens the immune system. Your doctor or nurse may want to wait with the vaccination until the treatment is over.
- HIV (human immunodeficiency virus) or any other disease that weakens the immune system. It is recommended that you be vaccinated, but the protective effect of the vaccine may not be as good as for people with a normal immune system.
- hemophilia or another condition that makes it easy for you to get bruises or bleeding
Fainting can occur (mainly in adolescents) after or even before needle sticking. Therefore, tell your doctor or nurse if you or your child have fainted from a previous injection.
This vaccine does not protect against other viruses that attack the liver (such as hepatitis B, hepatitis C or hepatitis E virus ).
If you already have the hepatitis A virus when you receive Avaxim, the vaccination may not work properly.
The vaccine cannot cause infection as it protects against it.
As with all vaccines, it is not certain that everyone vaccinated with Avaxim will have complete protection against hepatitis A infection.
Other medicines and Avaxim
This vaccine can be given at the same time as the following, provided that it is given in different parts of the body (eg the other arm or leg) and not mixed in the same syringe:
- polysaccharide vaccine against typhoid fever
- the vaccine against yellow fever
- immunoglobulin ( antibodies obtained from blood donors)
Avaxim may not work as well if given at the same time as immunoglobulin. However, it is likely that you are still protected against hepatitis A infection.
Tell your doctor, nurse, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
If you are pregnant or think you may be pregnant, tell your doctor or nurse. They will decide whether the vaccination should be postponed.
This vaccine can be used during breast-feeding.
Driving and using machines
Avaxim is unlikely to affect your ability to drive or use machines. However, no studies have been done regarding this.
Avaxim contains ethanol, phenylalanine, potassium and sodium
Avaxim contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Avaxim contains 10 micrograms of phenylalanine per 0.5 ml corresponding to 0.17 micrograms / 60 kg. Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Avaxim contains less than 1 mmol (39 mg) per dose of potassium and less than 1 mmol (23 mg) sodium per dose, ie essentially ‘potassium-free’ and ‘sodium-free’.
3. How to use Avaxim
The vaccine should be administered by a doctor or nurse who is trained in the use of vaccines and who know how to handle the rare serious allergic reaction to the injection one.
Dosage
Avaxim is given as an injection of 0.5 ml to people who are 16 years or older.
Avaxim will start protecting against hepatitis A infection approximately 14 days after you receive the first dose of Avaxim. This provides protection for up to 36 months.
If you need longer-term protection against hepatitis A, you will need a second dose(refill dose) of an inactivated hepatitis A vaccine. This is usually given between 6 and 12 months after the first dose but can be given up to 36 months later. This refill dose protects you against hepatitis A for more than 10 years.
Avaxim can be given as a booster dose even if your first dose was another hepatitis A vaccine (including vaccines that protect you against hepatitis A and typhoid fever ).
How the vaccine is given
The doctor or nurse shakes the syringe immediately before use and checks that the liquid is white and cloudy and that there are no unexpected particles in it.
Avaxim should be injected into a muscle in the upper outer part of the arm.
If you suffer from a bleeding disorder, you can get an injection under the skin. The doctor or nurse must not inject the vaccine into the skin or into a blood vessel.
Avaxim is not given in the buttocks.
4. Possible side effects
Like all medicines, Avaxim can cause side effects, although not everybody gets them.
Possible severe allergic reactions
Severe allergic reactions are possible but very rare after vaccination. These reactions may include:
- difficulty breathing, blue discoloration of the tongue or lips
- dizziness (low blood pressure ) and collapse
- swelling of the face and neck.
If severe allergic reactions occur, this usually occurs immediately after injection while you are still in the hospital or doctor’s office. If any of these symptoms occur after leaving the injection site, you must contact a doctor IMMEDIATELY.
Very common side effect is (can occur in more than 1 in 10):
- mild pain at the injection site
- the general feeling of weakness ( asthenia ).
Common side effects are (may affect up to 1 in 10):
- headache
- nausea or vomiting
- loss of appetite
- diarrhea and/or abdominal pain
- pain in muscles and joints ( myalgia, arthralgia )
- mild fever.
Less common side effects are (may affect up to 1 in 100):
- redness ( erythema ) at the injection site.
Rare side effects are (may affect up to 1 in 1000):
- hardening at the injection site
- mild and transient changes in blood tests that measure liver function (increase in transaminases).
Very rare side effects are (may affect up to 1 in 10 000 users):
- fainting due to injection
- rash that has sometimes been hardened and itchy (including hives ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Avaxim
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label on the syringe after EXP. The expiration date is the last day of the specified month.
Do not use Avaxim if it contains unexpected particles.
The vaccine should be stored in a refrigerator (2 ° C-8 ° C). Do not freeze. If it has been frozen, it should be discarded.
Store in the original package. Sensitive to light.
Vaccines should not be disposed of via wastewater or household waste. Ask the pharmacy staff how to deal with vaccines that are no longer used. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is:
- Hepatitis A virus GBM strain (inactivated) 1,2, 160 EU1 grown on human diploid (MRC-5) cells2 adsorbed on aluminum hydroxide, hydrated (0.3 milligrams Al)
Other ingredients are:
- 2-phenoxyethanol
- ethanol, anhydrous
- formaldehyde
- Medium 199 Hanks *
- water for injections
- polysorbate 80
- hydrochloric acid and sodium hydroxide for pH adjustment
* Medium 199 Hanks (utanphenolsulfonphthalein) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components.
What the medicine looks like and the contents of the pack
The inactivated hepatitis A vaccine is a cloudy, white suspension.
The vaccine is available as a suspension for injection in a pre-filled syringe (0.5 ml inactivated hepatitis A virus ) with or without a fixed needle (pack size of 1, 5, 10, or 20) or with 1 or 2 separate needles (pack size of 1 or 10 ). Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Henry Vallée Space
69007 Lyon
France
Manufacturer:
| Sanofi PasteurCampus Mérieux1541 avenue Marcel Mérieux69280 Marcy l’EtoileFrance | or | Sanofi PasteurParc Industriel D’Incarville27100 Val de ReuilFrance |
| Local representative:Sanofi ABBox 30052104 25 StockholmTel: +46 8-634 50 00 |
This medicinal product is authorized under the European Economic Area under the names:
AVAXIM – Austria, Belgium, Germany, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxembourg, Netherlands, Portugal, , UK.