Vivotif
Oral Typhoid Vaccine
Read all of this leaflet carefully before you start taking this medicine
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This vaccine has been prescribed only for you and you should not pass it on to others.
In this leaflet
- 1. What Vivotif is and what it is used for
- 2. Before you take Vivotif
- 3. How to take Vivotif
- 4. Possible side effects
- 5. Storing Vivotif
- 6. Further information
The name of this vaccine is Vivotif.
The active ingredient of Vivotif consists of live bacteria called Salmonella enterica serovar Typhi (abbr. S. typhi) (strain Ty21a).
The bacteria have been freeze-dried and enclosed in a capsule. Each enteric coated capsule (the coating protects the bacteria in the capsules from the stomach acids that could kill them) of Vivotif contains at least 2x109 live S. typhi (strain Ty21a).
The other ingredients of Vivotif are lactose, sucrose, amino acid-peptide mixture (Hy-Case SF), ascorbic acid (E300), magnesium stearate (E470), inactivated S. typhi (strain Ty21a).
Capsule: gelatin, titanium dioxide (E171), erythrosine red No. 3 (E127), ferric oxide (E172).
Capsule coating: hydroxypropylmethyl-cellulose-phthalate (HP-MCP) – 50, ethylene glycol, dibutyl phthalate, diethyl phthalate.
The company responsible for placing the vaccine on the market is
The vaccine is manufactured by
What Vivotif is and what it is used for
The pack contains three enteric-coated casules of Vivotif. One capsule is one dose.
Vivotif is a vaccine that provides protection against typhoid fever for children who are at least 6 years of age and adults. The vaccine is intended for persons travelling to or staying in countries where there is a risk of catching typhoid fever. Your doctor will advise you if you need to be vaccinated against typhoid and when you should be vaccinated. See also section 3 of this leaflet.
Typhoid fever is caused by an infection with bacteria called S. typhi. You can catch typhoid fever from food or water that contains these bacteria. Without special antibiotic treatment, typhoid fever can be fatal.
The bacteria in Vivotif have been altered so that they cannot cause typhoid fever but they can still stimulate the immune system so that it may protect vaccinated persons against the bacteria that cause typhoid fever.
However, not all vaccinated persons will be fully protected against typhoid even after a full course of Vivotif and protection only lasts for at most three years. Therefore, even if you have been vaccinated, you should still take all the precautions necessary to avoid food or water that may contain the bacteria that cause typhoid.
There are many other types of Salmonella bacteria that can infect humans. Most of these cause diarrhoeal illnesses that are quite different to and less serious than typhoid fever. Vivotif cannot protect you against infections due to types of salmonella bacteria other than S. typhi.
Before you take Vivotif
This vaccine helps to protect against typhoid fever and is only for people 6 years of age or older. To make sure that Vivotif is suitable for you, it is important to tell your doctor or nurse if any of the points below apply to you. If there is anything you do not understand, ask your doctor or nurse to explain.
Vivotif should not be given to you if you:
- Have ever had an allergic reaction to any of the ingredients contained in Vivotif.
- Have a poor immune system for any reason. For example, if you have had poor immunity to infections since birth or have since developed poor immunity due to treatment with drugs that depress the immune system (such as high dose corticosteroids or drugs used to treat cancers) or radiotherapy.
- Have an infection with a high temperature or an illness affecting your gut (such as a diarrhoeal illness) at the moment. Vaccination should be delayed until you have recovered.
Pregnancy and breast-feeding
Vivotif should only be given to pregnant women if it is clearly necessary. If you are or think you may be pregnant, you should discuss this with your doctor or nurse before having Vivotif.
It is not known if the live bacteria or any other component of Vivotif can pass into breast milk. If you are breast-feeding, you should discuss this with your doctor or nurse before having Vivotif.
Driving and using machines
Vivotif is not known to affect your ability to drive or use machines.
Taking other medicines and having other vaccines
Vivotif may not work if it is given while you are also taking medicines to treat bacterial infections (antibiotics). Vivotif should not be given until at least three days after the last dose of the antibiotic and, if possible, antibiotics should not be started within three days of the last dose of Vivotif. If you also need to take tablets to prevent malaria, these should not usually be started within 3 days of the last dose of Vivotif. However, tablets that contain atovaquone plus proguanil can be taken on the same days as Vivotif. Also, mefloquine can be taken on the same days as Vivotif provided that you leave at least 12 hours between doses of mefloquine and of Vivotif.
If you need to have yellow fever vaccine or oral polio vaccine before you travel, these can be given while you are taking Vivotif.
How to take Vivotif
For adults and children of 6 years of age or older, 3 capsules have to be taken. The first capsule should be taken on a chosen day (Day 1). The second should be taken on Day 3 and the third on Day 5.
Each capsule should be taken with cold or lukewarm water (max. 37 °C) about one hour before a meal. The capsules should not be chewed and should be swallowed as quickly as possible after placing in the mouth.
After taking the course of three capsules, protection against typhoid fever starts at about 7–10 days later. Your doctor or nurse will advise you when you should take Vivotif in relation to your travel plans.
If you are living under conditions in which you are likely exposed to the bacteria that cause typhoid fever, you may be protected for up to 3 years after vaccination. Otherwise, a repeat course of three capsules of Vivotif is recommended every year if you travel intermittently to areas where you are at particular risk of catching typhoid fever.
If you should take all three doses accidentally at once, it is not expected that there would be serious consequences but you may not be well protected against typhoid fever. Therefore, you should tell your doctor or nurse about the error.
If you forget to take a dose, take it as soon as you remember. Then take the next dose about 48 hours later.
Vivotif Side Effects
Like all vaccines, Vivotif can have side effects.
The following side effects were reported commonly (in less than one in ten but more than one in a hundred persons) in clinical studies:
Stomach pains, feeling or being sick, diarrhoea, fever, flu-like illness, headache and rash.
Side effects that have been reported very rarely (in less than one in ten thousand persons) during normal use include:
Skin irritation rashes, red or lumpy raised rashes and itching.
Severe allergic reactions with drops in blood pressure and loss of consciousness.
Weakness, generally feeling unwell, shivering, tiredness, pins and needles, dizziness, joint and muscle pain.
If you notice any side effects not mentioned in this leaflet, please tell your doctor, nurse or pharmacist.
Storing Vivotif
Keep Vivotif out of the reach and sight of children.
Store the package at 2 °C to 8 °C, in the refrigerator, as the vaccine is not stable at normal room temperatures. It is essential to replace the capsules back in the refrigerator between doses.
The package should be kept dry and out of the light.
DO NOT USE AFTER EXPIRY DATE SHOWN ON THE LABEL.
Further information
If you want more information about Vivotif please ask your doctor, nurse or pharmacist or contact:
This leaflet was last approved on March 2005.
Berna Biotech Ltd
82315gbpr.100
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