Інструкція із застосування VIVOTIF
Зміст інструкції
Vivotif
SalmonellaTyphi Ty21a
Read this leaflet carefully before you take this vaccine, as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This vaccine has been prescribed for you only. Do not pass it on to others.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Vivotifis and what it is used for
- 2. What you need to know before you take Vivotif
- 3. How to take Vivotif
- 4. Possible side effects
- 5. How to store Vivotif
- 6. Contents of the pack and other information
1. What Vivotif is and what it is used for
Vivotifis an oral vaccine that stimulates an immune response against a type of bacteria called
SalmonellaTyphi, which causes typhoid fever. It is used for protection against typhoid fever in adults and
children from 5 years of age.
How Vivotif works
The bacteria contained in the Vivotifvaccine have been modified so that they cannot cause typhoid
fever but can still stimulate the body's natural defense system (immune
system) to fight the bacteria responsible for this disease.
Other types of diseases caused bySalmonella
There are many other types of bacteria of the genus Salmonella, most of which cause diseases
accompanied by diarrhea that differ somewhat from typhoid fever and are also less serious.
Vivotifcannot protect against infections due to these other types of bacteria of the genus
Salmonella.
2. What you need to know before you take Vivotif
Do not take Vivotif
- if you are allergic (hypersensitive) to SalmonellaTyphi Ty21a or to any of the other ingredients of this vaccine (listed in section 6)
- if you have had allergic reactions in the past after taking Vivotif
- if your immune system is weak for any reason, for example, if you have had low immunity to infections since birth. Low immunity may also be due to certain infections or treatments that suppress the immune system such as high-dose corticosteroids, anti-cancer drugs or radiotherapy
- if you currently have a high fever (above 38.5°C) or an intestinal illness (such as diarrhoea)
- do not take Vivotifuntil you have recovered.
Warnings and precautions
Not everyone who takes a complete cycle of Vivotifwill be completely protected against
typhoid fever. It is important to continue to follow hygiene advice and use caution regarding the
consumption of food and water in areas affected by typhoid fever.
Children
This vaccine should not be given to children under 5 years of age, 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, including over-the-counter medicines and herbal remedies, as
Vivotifcan interfere with the mechanism of action of other medicines and vaccines.
In particular, tell your doctor, pharmacist or nurse if you are taking:
- antibiotics - Vivotifmay not be effective if taken at the same time as antibiotics. Take Vivotifat least 3 days after the last dose of an antibiotic.
- medicines for the prevention of malaria - before starting administration, wait 3 days after the last dose of Vivotif, unless otherwise indicated by your doctor, pharmacist or nurse.
If any of the above conditions apply to you, consult your doctor, pharmacist or
nurse before taking Vivotif.
Vivotif with food and drink
Vivotifis taken on an empty stomach and at least one hour before the next meal.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
There are no known effects of Vivotifon the ability to drive or operate machinery. However, if you
do not feel well, do not drive or operate machinery.
Vivotif contains lactose and sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
3. How to take Vivotif
Take this vaccine exactly as your doctor, pharmacist or nurse has told you. If you are unsure, ask your doctor, pharmacist or nurse.
The blister containing the vaccine capsules must be inspected to verify the integrity of the
foil and the capsules.
How much Vivotif to take and when
The recommended dose is three capsules, to be taken individually on alternate days.
- Take the first capsule on a day of your choice. This will be 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 your next meal.
- Do not crush or chew the capsules.
- Swallow the capsules with cold or lukewarm water (at a temperature not exceeding 37°C).
- Swallow the capsules as quickly as possible after placing them in your mouth.
Protection against typhoid fever begins approximately seven to ten days after completing the cycle of
three capsules. Your doctor, pharmacist or nurse will tell you how long before your
trip you need to complete the Vivotifcycle.
After three years you may need to take Vivotifagain, if you continue to travel to areas
where typhoid fever is present. In this case, consult your doctor, pharmacist or nurse.
If you take more Vivotif than you should
If you accidentally take all three doses at once, inform your doctor, pharmacist or
nurse. It is unlikely to make you feel unwell, but you may not be adequately
protected against typhoid fever.
If you forget to take Vivotif
If you forget to take a dose, take it as soon as you remember. Then take the next dose
about 48 hours later.
If you have any doubts about using this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.
Contact a doctor immediately if you develop the following serious side effects:
low blood pressure and fainting.
Other side effects:
Common side effects (may affect up to 1 in 10 people)
- Stomach pain
- Nausea or vomiting
- Diarrhea
- Fever
- Headache
- Skin redness.
Other side effects (frequency cannot be defined based on available data):
- skin irritation, rashes, raised or nodular red rashes, itching
- weakness
- general feeling of discomfort
- chills
- feeling tired
- tingling
- dizziness
- joint or muscle pain
- back pain
- loss of appetite, flatulence, abdominal bloating
- flu-like illness.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Vivotif
Keep this vaccine out of the sight and reach of children.
Do not use Vivotifafter the expiry date which is stated on the label. The expiry date refers
to the last day of that month.
Store in a refrigerator (2 C – 8 C).
Keep the blister in the outer packaging to protect the vaccine from light.
Do not use this vaccine if you notice that the blister or the capsules are damaged.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.
6. Package contents and other information
- Each capsule contains at least 2x10 viable cells of SalmonellaTyphi Ty21a.
- The other components are anhydrous lactose, sucrose, casein hydrolysate, ascorbic acid (E300), magnesium stearate (E470), non-viable cells of SalmonellaTyphi Ty21a. Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172) and red iron oxide (E172). Capsule coating: hydroxypropylmethylcellulose phthalate, ethylene glycol and diethyl phthalate.
Description of the appearance of Vivotif and package contents
The package contains a blister with three enteric-coated capsules of Vivotif. The capsules are
bicoloured, white and salmon.
Marketing Authorisation Holder
Bavarian Nordic A/S
Philip Heymans Alle 3
2900 Hellerup
Denmark
Manufacturer
IL-CSM GmbH
Marie-Curie-Strasse 8
D-79539 Lörrach
Germany
This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) with the following denominations:
Austria, Belgium, Czech Republic, Denmark, Finland, France, Luxembourg, Netherlands,
Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom (Northern Ireland): Vivotif
Germany: Typhoral L
Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency ( http://www.agenziafarmaco.gov.it/ )
- Країна реєстрації
- Лікарська формаEnteric-coated hard capsule
- Код АТХJ07AP01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до VIVOTIFЛікарська форма: Injectable solution, 0.5 MLДіюча речовина: typhoid, purified polysaccharide antigenВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Powder and solvent for injectable solution, 0,5 MLДіюча речовина: haemophilus influenzae B, combinations with toxoidsВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Injectable suspension in pre-filled syringe, 0.5MLДіюча речовина: meningococcus B, multicomponent vaccineВиробник: GLAXOSMITHKLINE VACCINES S.R.L.Рецепт не потрібен
Аналоги VIVOTIF в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог VIVOTIF у Польща
Аналог VIVOTIF у Іспанія
Лікарі онлайн щодо VIVOTIF
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на VIVOTIF онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
VIVOTIF потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у VIVOTIF — typhoid, oral, live attenuated. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
VIVOTIF виробляється компанією BAVARIAN NORDIC A/S. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування VIVOTIF з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати VIVOTIF у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (typhoid, oral, live attenuated) включають TYPIM VI, AKTIB, BEXSERO. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















