suspension and liquid for injection, suspension in a pre-filled syringe
hepatitis A (inactivated, adsorbed ) and typhoid polysaccharide vaccine
What ViATIM is and what it is used for
ViATIM is a vaccine. Vaccines are used to protect you against infectious diseases. This vaccine helps protect against both typhoid fever and hepatitis A infection in people who are 16 years of age or older.
Typhoid fever is an infectious disease that can be contracted from food and drink containing the bacteria (called Salmonella enterica, subtype Typhi ) that causes the disease. It is a serious infection that can be fatal if not treated immediately.
Hepatitis A infection is caused by a virus that attacks the liver. It can be transmitted through food or drink that contains the virus et. Symptoms include jaundice and general malaise.
When you receive an injection of ViATIM, your body’s natural defenses will produce protection against typhoid fever and hepatitis A infection.
What you need to know before using ViATIM
Do not use ViaTIM
- if you are allergic to active substances or any other ingredient in this vaccine (listed in section 6)
- if you are allergic to neomycin (an antibiotic used in vaccine production and which may be present in the vaccine in small amounts)
- if you have an illness with a fever. Your vaccination should be postponed until you have recovered.
To ensure that ViATIM is suitable for you, you must tell your doctor or nurse if any of the points above apply to you. If there is something you do not understand, ask your doctor or nurse to explain.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ViATIM.
- If you have a reduced immune response due to previous or current treatment that may weaken your immune systems, such as corticosteroids, chemotherapy, or radiation therapy, your doctor or nurse may want to wait until the treatment is finished.
- If you have problems with your immune system due to human immunodeficiency virus ( HIV ) infection, you can receive ViATIM, but the protective effect of the vaccine may not be as good as in those with a normal immune system.
- This vaccine does not protect against other viruses that can infect the liver (such as hepatitis B, hepatitis C, or hepatitis E viruses ). If you are already infected with the hepatitis A virus when you receive ViATIM, it is possible that the vaccination will not have the intended effect.
- This vaccine does not protect you against diseases caused by Salmonella bacteria other than the particular type that causes typhoid fever.
- This vaccine cannot cause the infections it is supposed to protect against.
- As with all vaccines, it is not certain that ViATIM will provide complete protection against hepatitis A and typhoid fever in everyone vaccinated.
Fainting may occur (usually in young people) after or even before the needle stick. Therefore, tell the doctor or nurse if you or your child fainted during a previous needle stick.
Other vaccines or medicines and ViATIM
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
As ViATIM does not contain any live bacteria or viruses, it can usually be given at the same time as other vaccines, but at a different injection site (a different part of the body, eg the other arm or leg). ViATIM must not be mixed with any other vaccines in the same syringe.
The protection obtained when ViATIM is used simultaneously with immunoglobulins ( antibodies obtained from donors) has not been evaluated. If you need an injection of immunoglobulins, it can be given at the same time or within a few weeks of receiving ViATIM. You may then not produce as many antibodies against the hepatitis A virus as you would otherwise have done, but, likely, you will still be protected against infection.
Pregnancy, breastfeeding, and fertility
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.
Although it is not thought that ViATIM could harm an unborn baby, your doctor or nurse should decide whether you should be vaccinated now or after the baby is born.
Driving ability and use of machinery
Dizziness has been reported in some people (less than 1 in 100 but more than 1 in 1,000) after receiving ViATIM, so caution should be exercised when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
ViATIM contains phenylalanine, ethanol, potassium, and sodium
- ViATIM contains 10 micron of phenylalanine per 1 ml, corresponding to 0.17 micron/kg for a 60 kg person.
Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body. - ViATIM contains 2 mg of alcohol ( ethanol ) per 1 ml dose. The small amount of alcohol in this medicine does not produce any noticeable effects.
- This vaccine contains less than 1 mmol (39 mg) per dose of potassium and less than 1 mmol sodium (23 mg) per dose and is almost ‘potassium-free’ and ‘sodium-free’.
How to use ViATIM
Vaccination should be given by health care professionals who are trained in the use of vaccines and who are equipped to deal with any unusual serious allergic reaction after the injection .
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Consult a doctor, pharmacist, or nurse if you are unsure.
Dosage
The recommended dose is one milliliter of the mixed vaccine, for people who are 16 years of age or older. A single dose of the vaccine provides basic protection.
This vaccine starts to protect you against hepatitis A about 14 days after you receive the first dose. You will need a second dose (booster dose) of inactivated hepatitis A vaccine to get long-term protection against hepatitis A. This booster dose will protect you against hepatitis A for more than ten years. The booster dose must be given within 36 months, but preferably within 6 to 12 months after the first dose.
This vaccine can be given to you to provide long-term protection against hepatitis A (if you have already received a first dose of inactivated hepatitis A vaccine 6 to 36 months earlier and if you also need protection against typhoid fever ). If the first dose of a hepatitis A vaccine was given as a combined hepatitis A and typhoid vaccine, the second dose of a combined vaccine should usually be given about 36 months after the first dose of one.
This vaccine starts to protect you against typhoid fever about 14 days after you receive injection one and the protection can last for about 3 years. If after 3 years you are still at risk of getting typhoid fever, you should make sure to get another injection of Vi polysaccharide vaccine against typhoid fever.
The liquids in the two chambers are mixed in the syringe just before an injection is given. Once mixed, the doctor or nurse will shake the syringe and check that the liquid is a cloudy, whitish suspension and that there are no abnormal particles in it.
Mode of administration
This vaccine is given as a slow injection into a muscle in the upper outer part of your arm. Your doctor or nurse will avoid giving you an injection into the skin or a blood vessel. This vaccine should not be given in the buttock.
If you suffer from hemophilia (a condition where you bruise or bleed easily) or any other condition that means you shouldn’t get an injection into the muscle, you can get an injection under the skin.
If you used too much ViATIM
In some cases, more than the recommended dose has been used.
In cases where side effects were reported, they were similar to those described in section 4.
If you have any further questions about the use of this vaccine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines and vaccines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions have been reported:
- Severe allergic reactions ( anaphylactic reaction ) with one or more of the following symptoms:
- hives/rash
- swelling of the face and/or throat, difficulty breathing, blue discoloration of the tongue or lips
- low blood pressure, rapid heartbeat and weak pulse, cold skin, dizziness and which can lead to the collapse
When these reactions do occur, they usually develop very soon after the injection is given and while the affected person is still in the clinic or doctor’s office.
If any of these symptoms occur after you have left the place where the injection was given, you must contact a doctor IMMEDIATELY.
- Serum sickness:
- joint pain, skin rash, enlarged lymph nodes, and a general feeling of malaise.
When these symptoms occur, it is usually 2-4 weeks after the vaccine is taken. If these symptoms occur, you must see a doctor as soon as possible.
Very common reactions (may affect more than 1 in 10 users):
- pain at the injection site, which sometimes lasts more than 3 days. The pain may be intense in up to 1 in 10 people (common)
- redness, swelling, and induration in the area where the vaccine was injected. The swelling and hardening may be severe in up to 1 in 10 people (common)
- headache
- feeling of weakness
- malaise
- muscle pain.
Common reactions (may affect up to 1 in 10 users):
- nausea
- diarrhea
- joint pain
- fever (elevated temperature).
Uncommon reactions (may affect up to 1 in 100 users):
- skin itching
- rash
- dizziness
Very rare reactions (may affect up to 1 in 10,000 users):
- a lump forms at the injection site
Reactions with no known frequency (frequency cannot be calculated from available data).
- worsening of asthma in people who already have asthma
- fainting as a result of needle stick
- a feeling of numbness or tingling in the skin
- rash that is sometimes lumpy and itchy
- vomiting, pain in the stomach
- changes in blood tests that measure how the liver is working
How ViATIM should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the outer carton and the syringe label 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 vaccine in the outer carton. Light sensitive.
The vaccine should not be used if there are abnormal particles in it.
Medicines must not be thrown into 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
The active substances are:
- Hepatitis A virus, GBM strain (inactivated) 1.2 ….160 units
- Cultured on human diploid (MRC-5) cells
- Adsorbed on aluminum hydroxide, hydrated (0.3 mg Al)Aluminum hydroxide is included in the vaccine as an adsorbent. Adsorbents are substances included in some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine
- Vi capsular polysaccharide of Salmonella typhi (Ty 2 strain) 25 micrograms
The other ingredients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, 2-phenoxyethanol, ethanol anhydrous, formaldehyde and Medium 199, Hanks, without phenol red (a mixture of amino acids including phenylalanine (see section 2), mineral salts (including potassium ), vitamins and other substances ) supplemented with polysorbate 80, and water for injections.
Appearance and package sizes of the medicine
The vaccine comes in a pre-filled syringe with two chambers (0.5 ml of inactivated hepatitis A virus in one chamber and 0.5 ml of typhoid polysaccharide vaccine in the other chamber).
Pack size: 1 or 10 syringes with or without a needle.
Not all pack sizes may be marketed.
The inactivated Hepatitis A vaccine is a cloudy, white suspension and the typhoid polysaccharide vaccine is a clear, colorless liquid.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer
| Sanofi PasteurCampus Mérieux1541 avenue Marcel Mérieux,69280 Marcy l’EtoileFrance | or | Sanofi PasteurParc Industriel D’Incarville27100 Val de Reuil,France |
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00
This medicine is approved within the European Economic Area under the names :
| Member State | Name |
| Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, Norway, Portugal, Sweden, Netherlands, United Kingdom, Austria | ViaATIM |
| Belgium | VACCIN COMBINE TYPHOIDIQUE POLYOSIDIQUE VI PURIFIE ET HEPATITE A |
| France, Spain | TYAVAX |