Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Vivotif® Oral.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having Vivotif® Oral against the benefits expected.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What Vivotif® Oral is used for

Vivotif® Oral is a vaccine used to prevent typhoid fever. Typhoid fever is a severe form of infection caused by a type of Salmonella bacteria.

Vaccination with Vivotif® Oral is recommended for adults and children over 6 years of age who live in or travel through areas where typhoid fever occurs.

How it works

Vivotif® Oral contains live bacteria called Salmonella typhi, which do not cause typhoid fever.

Vivotif® Oral works by causing your body to produce its own protection against the bacteria (germs) which cause typhoid fever. The body makes substances, called antibodies, which destroy the Salmonella typhi bacteria. If you have been vaccinated against Salmonella typhi, your body is able to attack the bacteria if you come in contact with it.

Protection with Vivotif® Oral requires a full course of 3 doses.

After a full course most people will produce enough antibodies to prevent typhoid fever. However, as with all vaccines, 100% protection cannot be guaranteed.

The vaccine cannot give you or your child typhoid fever.

The chance of a severe reaction from Vivotif® Oral is very small, but the risks from not being vaccinated against typhoid fever may be very serious.

Before you take Vivotif® Oral

When you or your child must not take Vivotif® Oral

Do not take Vivotif® Oral if you have an allergy to:

• Vivotif® Oral or any of the ingredients listed at the end of this leaflet.

Tell your doctor if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

Do not take Vivotif® Oral if you have any of the following conditions:

• lowered immunity due to illness including HIV/AIDS or cancer
• lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or treatment for cancer (including radiation therapy)
• illness, with fever
• bowel infection.

Do not give Vivotif® Oral to a child under 6 years. The safety and effectiveness of Vivotif® Oral in children under 6 years has not been established.

Do not take Vivotif® Oral after the expiry date printed on the pack.

Do not take Vivotif® Oral if the packaging is torn or shows signs of tampering.

If you are not sure whether you or your child should take Vivotif® Oral, talk to your doctor, nurse or pharmacist.

Before you or your child start to take Vivotif® Oral.

Tell your doctor if you have reacted to any previous vaccination with an allergic reaction.

Allergic reactions may include:

• an itchy rash (also known as 'hives')
• swelling of lips, face or tongue
• difficulty breathing.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

• leukaemia or any other cancers of the blood, bone marrow or lymph system.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of having Vivotif® Oral during pregnancy.

Tell your doctor if you are breast-feeding. Your doctor will discuss the possible risks and benefits of having Vivotif® Oral during breastfeeding.

Taking other medicines

Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Vivotif® Oral and some medicines may interfere with each other. These include:

• antibiotics
• some antimalarials
• sulphonamides
• other medicines which are active against Salmonella bacteria.

These medicines may be affected by Vivotif® Oral, or may affect how well it works. These medicines should usually be taken after the 3rd (final) dose of Vivotif® Oral. Your doctor, nurse or pharmacist will advise you about the correct timing and decide whether or not you should have this vaccine.

Having other vaccines

Tell your doctor if you have had any vaccines in the last 4 weeks. Your doctor will advise you if Vivotif® Oral may be given at the same time as another vaccine.

Your doctor, nurse and pharmacist may have more information on medicines and vaccines to be careful with or avoid during vaccination with Vivotif® Oral.

How to take Vivotif® Oral

Follow all directions given to you by your doctor, nurse or pharmacist carefully. They may differ from the information contained in this leaflet.

Your doctor, nurse or pharmacist will tell you how many capsules to take and when to take them.

If you do not understand the instructions on the box, ask your doctor, nurse or pharmacist for help.

How much to take

Take one capsule of Vivotif® Oral every second day, that is
Day 1 - 1 capsule
Day 3 - 1 capsule
Day 5 - 1 capsule
until all 3 capsules have been taken.

How to take it

Swallow each Vivotif® Oral capsule whole with a glass of cold or lukewarm water (max. 37°C), one hour before a meal.

Do not chew the capsules. The capsules have a special coating to protect the contents from stomach acid. Chewing destroys this coating and then the capsules will not work.

When to take it

Take Vivotif® Oral on an empty stomach, 1 hour before food. Food can interfere with the absorption of Vivotif® Oral.

If you forget to take it

If you forget to take a dose, tell your doctor.

Your doctor will decide whether you should keep taking your current pack of capsules or whether it would be better for you to start again with another pack.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you or your child do not feel well after having Vivotif® Oral. Vivotif® Oral may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. You or your child may need medical treatment if you get some of the side effects.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

• high temperature
• headache
• itchy rash
• eating and drinking less than usual, loss of appetite
• nausea or vomiting
• constipation
• diarrhoea
• stomach cramps or pain
• joint pain or aching muscles
• tiredness or weakness.

If there are side effects from taking Vivotif® Oral, these are the usual ones. Mostly they are mild and short-lived.

Allergic reaction:
As with all vaccines, there is a very small risk of a serious allergic reaction.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

• skin rash, itchiness, or other severe skin reactions
• raised, itchy swellings on the skin, also called hives or nettlerash
• swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing.

These are serious side effects. If you have them you may have had a serious allergic reaction to Vivotif® Oral. You may need urgent medical attention or hospitalisation. If they do occur, most of these side effects occur within the first few hours of vaccination.

Other side effects not listed above may occur in some patients. Tell your doctor, nurse or pharmacist if you notice anything that is making you or your child feel unwell.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

If you take too much (overdose)

If you think you or anyone else has taken too much Vivotif® Oral immediately telephone your doctor or the Poisons Information Centre (13 11 26 in Australia or 0800 764 766 in New Zealand).

Storing Vivotif® Oral

Keep your capsules in the pack until it is time to take them. If you take the capsules out of the pack they do not store well.

Keep your pack of capsules in the refrigerator, between 2°C and 8°C. Do not freeze Vivotif® Oral.

Do not store Vivotif® Oral or any other medicine in the bathroom or near a sink.

Do not leave it on a windowsill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Vivotif® Oral, the package is damaged or the capsules have passed their expiry date, return the medicine to your pharmacist for disposal.

Product description

What Vivotif® Oral looks like

Each capsule is salmon pink and white in colour. There are 3 capsules in each blister pack.

Ingredients

Active ingredients:

• At least 2000 million live Salmonella typhi.

Inactive ingredients:

• ethylene glycol, sucrose, ascorbic acid, protein hydrolysate, lactose, magnesium stearate, hypromellose phthalate, gelatin (bovine derived), titanium dioxide, erythrosine CI45430, iron oxide yellow CI77492, iron oxide red CI77491, diethyl phthalate.

The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

Further information

This medicine is available only with a doctor's prescription.

Sponsor

Australia:

Biocelect Pty Ltd
ABN 88 168 092 171
Level 29, 66
Goulburn Street,
Sydney, NSW 2000
Australia

New Zealand:

Biocelect New Zealand Ltd
Level 5, Wynn Williams House
47 Hereford Street
Christchurch 8013
New Zealand

Australia: 1300 848 628

New Zealand: +61 1300 848 628

[email protected]

Manufacturer

Bavarian Nordic Berna
GmbH
Oberriedstrasse 68
CH-3174 Thörishaus
Switzerland

Registration number

AUST R 322340

Date of preparation

November 2023

® Vivotif is a registered trademark of Bavarian Nordic A/S, DK.

Published by MIMS March 2024

1 Name of Medicine

Oral Typhoid Vaccine Salmonella typhi (live, attenuated).

2 Qualitative and Quantitative Composition

Vivotif Oral is an oral, live, attenuated typhoid vaccine for active immunisation against typhoid and contains Salmonella typhi. Each capsule enteric contains not fewer than 2 x 10⁹ viable organisms.

Excipients with known effect.

3 Pharmaceutical Form

Vivotif Oral are capsules enteric, salmon-pink and white in colour.

4 Clinical Particulars

4.1 Therapeutic Indications

Vivotif Oral is indicated for active immunisation against typhoid in adults and children above 6 years of age. Effectiveness in children below 6 years of age is not known at present.

4.2 Dose and Method of Administration

The complete immunisation schedule, irrespective of age, for adults and children above 6 years of age, is the ingestion of one capsule on each of days 1, 3 and 5.
The Vivotif Oral Typhoid Vaccine capsule should be swallowed whole and must not be chewed. The capsule should be taken approximately one hour before a meal, with a cold or lukewarm drink (temperature not to exceed body temperature i.e. 37°C).

Re-immunisation.

4.3 Contraindications

Primary and acquired immunodeficiency, including that from treatment with immunosuppressive and antimitotic drugs, acute febrile illness: acute intestinal infection, allergic reaction to a previous dose, and hypersensitivity to the vaccine or to any of the inactive components.

4.4 Special Warnings and Precautions for Use

No data are currently available about the efficacy of Vivotif Oral in individuals with blood dyscrasias, leukaemia, lymphoma or any type of malignant neoplasm affecting the bone marrow or lymphatic system. These individuals may fail to develop protection because of their compromised immune functions.
In the case of acute febrile illnesses and acute gastro-intestinal illness as well as during and up to 3 days after treatment with antibiotics, Vivotif Oral should not be taken due to possible inhibition of the growth of the vaccine organisms.
The capsules must be swallowed whole and not chewed because of the destruction of the organism by gastric acid.

Use in elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The vaccine should not be administered concurrently with antibiotics or other drugs (e.g. sulphonamides) that are active against salmonellae. The vaccine should be administered first and at least 3 days should elapse between the final dose of the vaccine and such drugs.
The simultaneous administration of Vivotif Oral Typhoid Vaccine and parenteral (live attenuated) yellow fever vaccine, or inactivated vaccines, or oral polio vaccines, or parenteral immunoglobulin preparations, has been reported not to interfere with the immune response.

Anti-malaria prophylaxis.

General.

Chloroquine and/or pyrimethamine/sulfadoxine.

Mefloquine.

Atovaquone and proguanil, fixed combination.

Proguanil.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive or use machines have been performed. However, some of the undesirable effects mentioned under Section 4.8 may temporarily affect the ability to drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

Reporting suspected adverse effects.

Post-marketing experience.

4.9 Overdose

Doses five-fold higher than the recommended dose caused only mild, mainly gastro-intestinal adverse reactions which did not require medical treatment. Overdosing can increase the possibility of shedding S. typhi Ty21a organism in the faeces.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: bacterial vaccines (J07AP01).

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No preclinical safety data are available.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each capsule also contains the following excipients: ethylene glycol, sucrose, ascorbic acid, protein hydrolysate, lactose, magnesium stearate, hypromellose phthalate, gelatin (bovine derived), titanium dioxide, erythrosine CI45430, iron oxide yellow CI77492, iron oxide red CI77491, and diethyl phthalate.
The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Store between +2 and +8°C (refrigerate, do not freeze) in a dry place and protected from light.

6.5 Nature and Contents of Container

Each carton contains 3 capsules in a blister pack. Each capsule enteric contains not fewer than 2 x 10⁹ viable organisms of Salmonella typhi.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes