hard enteric capsules
Salmonella Typhi Ty21a
What Vivotif is and what it is used for
Vivotif is a vaccine to be swallowed. It stimulates a reaction of the immune system against a type of bacteria called Salmonella Typhi, which causes typhoid fever. The vaccine is used to protect against typhoid fever in adults and children 5 years of age and older.
How Vivotif works
The vaccine bacteria in Vivotif have been altered so that they cannot cause typhoid fever but can still stimulate the body’s natural defense system (the immune system) to fight bacteria that cause typhoid fever.
Other types of Salmonella – disease
There are many other types of Salmonella bacteria. Most of these cause diarrheal diseases that are quite different from typhoid fever. They are also less serious. Vivotif cannot protect you against infection caused by these other types of Salmonella bacteria.
What you need to know before using Vivotif
Do not use Vivotif
- if you are allergic (hypersensitive) to Salmonella Typhi Ty21a or any of the other ingredients of this vaccine (listed in section 6).
- if you have had allergic reactions when you have previously taken Vivotif.
- if for some reason you have a weakened immune system if you e.g. have had reduced immunity to infection since birth. You may also have reduced immunity due to certain infections or treatments that inhibit the immune system, e.g. high doses of corticosteroids, cancer drugs, or radiation.
- if you have a high fever (above 38.5ºC) or an illness affecting the bowels (such as diarrhea) at the moment; in that case, wait to take Vivotif until you have recovered.
Warnings and precautions
Not everyone who takes a full treatment with Vivotif will be completely protected against typhoid fever. It is important to continue to follow hygiene advice and to be careful when consuming food and water in areas affected by typhoid fever.
Children and young people
Do not give this vaccine to children younger than 5 years, as the capsule is not suitable for this age group.
Other medicines and Vivotif
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines or vaccines. This also applies to over-the-counter medicines including (traditional) herbal medicines. This is because Vivotif can affect the way other medicines and vaccines work.
You must tell your doctor, pharmacist, or nurse if you are taking:
- Antibiotics – Vivotif may not work if you take it at the same time as antibiotics. Do not take Vivotif earlier than 3 days after the last dose of an antibiotic.
- Medicines to prevent malaria – do not start these until 3 days after the last dose of Vivotif, unless your doctor, pharmacist, or nurse has told you otherwise.
If any of the above apply to you, talk to your doctor, pharmacist, or nurse before taking Vivotif.
Vivotif with food and drink
Vivotif should be taken on an empty stomach and at least one hour before the next meal.
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 medicine.
Driving ability and use of machinery
Vivotif is not expected to affect the ability to drive or use machines. However, do not drive or use machinery if you feel unwell.
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 your doctor or pharmacist if you are unsure.
Vivotif contains lactose and sucrose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Vivotif
Always take this vaccine exactly as your doctor, pharmacist, or nurse has told you. Consult a doctor, pharmacist, or nurse if you are unsure.
Check the blister pack containing the vaccine capsules to ensure that the foil seal and capsules are intact.
How much and when to take Vivotif
The recommended dose is three capsules. Take one capsule every other day.
- Take the first capsule on a selected day. This is day 1.
- Take the second capsule on day 3.
- Take the third capsule on day 5.
How to take the capsules
- Take the capsules on an empty stomach and at least one hour before the next meal.
- Do not crush or chew the capsules.
- Swallow the capsules with cold or lukewarm water (temperature no more than 37 °C).
- Swallow the capsules as quickly as possible after placing them in your mouth.
Protection against typhoid fever starts about seven to ten days after you take the three-capsule treatment. Your doctor, pharmacist, or nurse will advise you on how close to the trip you should take Vivotif.
After three years, you may need to take Vivotif again, if you continue to visit areas where typhoid fever occurs. In this case, contact a doctor, pharmacist, or nurse.
If you have taken too much Vivotif
If you accidentally take all three doses at the same time or if e.g. a child accidentally ingested the vaccine, contact a doctor or hospital for an assessment of the risk and advice. You probably won’t get sick, but you might not get good protection against typhoid fever.
If you forget to take Vivotif
If you forget a dose, take it as soon as you remember. Then take the next dose about 48 hours later.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all vaccines, this vaccine can cause side effects, but not all users will get them.
Contact your doctor immediately if you experience any of the following serious side effects:
- severe allergic reaction causing swelling of the face or throat and shortness of breath and/or drop in blood pressure and fainting.
Other side effects:
Common side effects (may affect up to 1 in 10 users):
- stomach pain
- nausea or vomiting
- diarrhea
- fever
- headache
- skin redness
Other side effects (frequency cannot be estimated from available data):
- skin irritation, rash, red or bumpy raised rash, and itching
- weakness
- general malaise
- overindulge
- fatigue
- tingling and numbness
- dizziness
- pain in joints or muscles
- back pain
- decreased appetite, flatulence, distended abdomen
- flu-like illness
How to store Vivotif
Keep this vaccine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C – 8 °C).
Store the blister pack in the outer carton. Light sensitive.
Do not use this vaccine if you notice that the blister pack or capsules are not whole.
Medicines should not be thrown down the drain. 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
- Each capsule contains at least 2 x 10 9 live cells of Salmonella Typhi Ty21a.
- Other ingredients are anhydrous lactose, sucrose, casein hydrolyzate, ascorbic acid (E300), magnesium stearate (E470), and non-viable cells of Salmonella Typhi Ty21a.Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), and red iron oxide (E172). Capsule coating: hypromellose phthalate, ethylene glycol, and diethyl phthalate.
Appearance and package sizes of the medicine
The package contains a blister pack with three enteric-coated capsules. The capsules are two-colored; white and salmon-colored.
Marketing Authorisation Holder
Emergent Netherlands BV
Stravinskylaan 411
1077XX Amsterdam
Netherlands
Manufacturer
IL-CSM GmbH
Marie-Curie-Strasse 8
D-79539 Lörrach
Germany
or
Emergent BioSolutions UK Ltd.
Building 3, Chiswick Park
566 Chiswick High Road
London, W4 5YA
UK
This medicine is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
Austria, Belgium, Czech Republic, Denmark, Finland, France, Italy, Luxembourg, Netherlands, Norway, Portugal, Slovakia, Spain, United Kingdom (Northern Ireland): Vivotif
Germany: Typhoral L