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VIVAXIM SUSPENSION AND SOLUTION FOR SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): HEPATITIS A VIRUS INACTIVATED / SALMONELLA TYPHI TY2 VI CAPSULAR POLYSACCHARIDE PURIFIED

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Package leaflet: Information for the user
ViVAXIM, Suspension and solution for suspension for injection in pre-filled syringe
Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine

Read all of this leaflet carefully before using this vaccine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This vaccine has been prescribed for you only. Do not pass it on to others.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What ViVAXIM is and what it is used for
What you need to know before you use ViVAXIM
How to use ViVAXIM
Possible side effects
How to store ViVAXIM
Contents of the pack and other information

1.

What ViVAXIM is and what it is used for

ViVAXIM is a vaccine. Vaccines are used to protect you against infectious diseases. This
vaccine helps to protect against both typhoid fever and hepatitis A infection in people 16
years of age and older.
Typhoid fever is an infectious disease that may be caught from food and drink that contain the
bacteria (called Salmonella enterica, subtype typhi) that cause the illness. It is a serious
infection that may be fatal if not treated promptly.
Hepatitis A infection is due to a virus that attacks the liver. It may be caught from food or
drink that contains the virus. Symptoms include jaundice and feeling generally unwell.
When you are given an injection of ViVAXIM, your body’s natural defences will produce
protection against typhoid fever and hepatitis A infection.

2.

What you need to know before you use ViVAXIM

To make sure that ViVAXIM 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.
Do not use ViVAXIM




If you are allergic to the active substances or to any of the other ingredients of this
vaccine (listed in section 6)
If you are allergic to neomycin (an antibiotic used during vaccine production which
may be present in the vaccine in small amounts)
If you have an illness with a high temperature. Your vaccination should be delayed
until you have recovered.

1

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ViVAXIM.








If you have a poor immune response because you have had, or are having a course of
treatment that can weaken your immune system such as corticosteroids, cytotoxic drugs
or radiotherapy, your doctor or nurse may want to wait until the course of treatment has
finished.
If you have problems with your immune system due to human immunodeficiency virus
(HIV) infection, you may be given ViVAXIM but the vaccine may not protect you as
well as it protects people with normal immune systems.
This vaccine will not protect against other viruses known to infect the liver (such as
hepatitis B, hepatitis C or hepatitis E viruses). Also, if you are already infected with
hepatitis A virus when you are given ViVAXIM, the vaccination may not work properly.
This vaccine will not protect you against disease caused by Salmonella bacteria other than
the particular type that causes typhoid fever.
This vaccine cannot cause the infections against which it protects.
As with any vaccine, not everyone who receives ViVAXIM will definitely be protected
against hepatitis A and typhoid fever.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Therefore tell your doctor or nurse if you or your child fainted with a previous injection.
Other vaccines or medicines and ViVAXIM
Tell your doctor or pharmacist if you are using, have recently used or might use any other
medicines.
As ViVAXIM does not contain any live bacteria or viruses, it can generally be given at the
same time as other vaccines, but at a different injection site (another part of your body, e.g.
the other arm or leg). ViVAXIM must not be mixed with any other vaccine in the same
syringe.
The protection obtained when using ViVAXIM at the same time as immunoglobulins
(antibodies obtained from blood donors), has not been assessed. If you need an injection of
immunoglobulins, this may be given at the same time or within a few weeks of having
ViVAXIM. However, you may not produce as much antibody to the hepatitis A virus as you
would otherwise but it is likely that you will still be protected against infection.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 ViVAXIM could harm an unborn baby, your doctor or nurse
will decide if you should be vaccinated now or after the baby has been born.
Driving and using machines
This vaccine has a minor influence on the ability to drive and use machines.
Dizziness has been reported in some people (less than 1 in 100 but more than 1 in 1000) after
receiving ViVAXIM, so care should be taken when driving or using machines.
ViVAXIM contains phenylalanine and sodium
As this product contains phenylalanine, it may be harmful for people with phenylketonuria.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree’.

2

3.

How to use ViVAXIM

The vaccination should be given by medical or healthcare professionals who are trained in the
use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to
the injection.
Always use this vaccine exactly as your doctor, pharmacist or nurse have told you. Check
with your doctor, pharmacist or nurse if you are not sure.
Dosage
The recommended dose is one millilitre of the mixed vaccine to people 16 years of age and
older. Initial protection is achieved with one single dose of the vaccine.
This vaccine will start to protect you against hepatitis A from about 14 days after you have
the first dose. You will need a second dose (booster) injection of inactivated hepatitis A
vaccine to give you long-term protection against hepatitis A. This booster will protect you
against hepatitis A beyond ten years. The booster dose should be given within 36 months and
preferably within 6 to12 months after the first dose.
This vaccine can be given to you to boost your immunity to hepatitis A if you have already
received a first dose of inactivated hepatitis A vaccine 6 to 36 months ago, provided that you
also require protection against typhoid fever. However, if the first dose of hepatitis A vaccine
was given as a combined typhoid and hepatitis A vaccine, then the second dose of combined
vaccine should usually be given approximately 36 months after the first dose.
This vaccine will start to protect you against typhoid fever from about 14 days after having
the injection and protection may last for about 3 years. If, after 3 years, you carry on being at
risk from catching typhoid fever, you should arrange to receive another injection of typhoid
Vi polysaccharide vaccine.
The liquids in the two chambers will be mixed in the syringe just before the injection is given
to you. Once mixed, your doctor or nurse will shake the syringe and check that the liquid is a
cloudy whitish suspension and that there are no unexpected particles in it.
Method and route of administration
This vaccine will be given as a slow injection into a muscle (intramuscular (IM) use) in the
upper outer part of your arm. Your doctor or nurse will avoid giving you the injection either
into the skin or into a blood vessel. This vaccine should not be given into your buttock.
If you suffer from haemophilia (a condition where you bruise or bleed easily) or any other
condition which means you should not receive an injection into the muscle, you may be given
the injection under the skin.
If you use more ViVAXIM than you should
In some cases, more than the recommended dose was used.
In these cases, when side effects were reported, they were of the same nature as those
described in section 4.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or
nurse.

4.

Possible side effects

Like all medicines and vaccines, ViVAXIM can cause side effects, although not everybody
gets them.

3

Serious allergic reactions have been reported:
- Severe allergic reaction (anaphylaxis), which may include one or more of the following
symptoms:
• urticaria/skin rashes
• swelling of the face and/or throat, difficulty in breathing, blue discolouration of
the tongue or lips
• low blood pressure, rapid heart rate and weak pulse, coldness of the skin,
dizziness and potentially collapse.
When these signs or symptoms occur they usually develop very quickly after the injection is
given and while the person affected is still in the clinic or doctor’s surgery.
If any of these symptoms occur after leaving the place where your injection was given,
you must consult a doctor IMMEDIATELY.
- Serum sickness:
• joint pains, skin rashes, enlarged lymph glands and generally feeling unwell
When these symptoms occur, they usually develop 2-4 weeks after receiving the vaccine.
If these symptoms occur you must consult a doctor as soon as possible.
Very common reactions (may affect more than 1 in 10 people)
• pain where the vaccine was injected, sometimes lasting more than 3 days. Pain may
be severe in up to 1 in 10 people (common)
• redness, swelling and hardness where the vaccine was injected. Swelling and
hardness may be severe in up to 1 in 10 people (common)
• headache
• feeling weak
• feeling generally unwell
• aching muscles
Common reactions (may affect up to 1 in 10 people)

feeling sick

diarrhoea

aching in the joints

fever (a high temperature)
Uncommon reactions (may affect up to 1 in 100 people)

itchiness of the skin

rashes

dizziness
Very rare reactions (may affect up to 1 in 10,000 people)

a lump formed at the site of injection
Reactions of not known frequency (frequency cannot be estimated from the available data)
• worsening of asthma in people who already have asthma
• fainting in response to injection
• sensation of numbness or tingling on the skin
• rashes that are sometimes lumpy and itchy
• vomiting, stomach pains
• changes in blood tests that measure how the liver is working
Reporting of side effects in the UK
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

4

5.

How to store ViVAXIM

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the carton and syringe label
after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vaccine in the outer carton in order
to protect from light.
This vaccine should not be used in case of unexpected particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What ViVAXIM contains
The active substances are:


Hepatitis A virus GBM strain (inactivated)1,2………………..160 antigen units
produced in human diploid (MRC-5) cells
2
adsorbed on aluminium hydroxide hydrated (0.3 milligram Al)
Aluminium hydroxide is included in this vaccine as an adsorbent. Adsorbents are
substances included in certain vaccines to accelerate, improve and/or prolong the
protective effects of the vaccine.
• Salmonella typhi (Ty 2 strain) capsular Vi polysaccharide ……25 micrograms
1

The other ingredients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen
phosphate dihydrate, 2-phenoxyethanol solution, formaldehyde, Medium 199 Hanks without
phenol red (a mixture of aminoacids including phenylalanine (see section 2), mineral salts,
vitamins and other components) supplemented with polysorbate 80, and water for injections.
What ViVAXIM looks like and contents of the pack
The vaccine is presented as a suspension and solution for suspension for injection in a prefilled dual chamber syringe (0.5 ml of inactivated hepatitis A virus in one chamber and 0.5 ml
of typhoid polysaccharide antigen in the other chamber) with or without a needle – pack size
of 1 or 10. Not all pack sizes are marketed.
The inactivated hepatitis A vaccine is a cloudy, white suspension, and the typhoid
polysaccharide vaccine is a clear, colourless solution.
Marketing Authorisation Holder
Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
FRANCE
Manufacturer
The manufacturer responsible for batch release is Sanofi Pasteur S.A. at one of the following
manufacturing sites:
Sanofi Pasteur S.A.,
Sanofi Pasteur S.A.,
Campus Mérieux,
or
Parc Industriel D’Incarville,

5

1541 avenue Marcel Mérieux,
69280 Marcy l’Etoile,
France

27100 Val de Reuil,
France

This medicinal product is authorised in the Member States of the EEA under the
following names:
Member State

Name

United Kingdom

ViVAXIM

France

VIVAXIM

This leaflet was last revised in 01/2015.
-----------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Instructions for use – Dual chamber syringe (See diagram overleaf)
ViVAXIM, Suspension and solution for suspension for injection in pre-filled syringe
Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine
1.
2.
3.
4.

Remove the tip-cap (A).
Attach needle and needle shield (B) to the syringe.
Screw the plunger rod (C) into the plunger stopper (Stopper 2).
Shake the syringe; then mix the vaccine components by slowly pushing the plunger,
keeping the needle upwards. The vaccine in the lower chamber moves into the upper
chamber by means of the by-pass channel.
5. Shake vigorously until a homogeneous suspension is achieved.
6. Holding the needle shield at the tip, remove by pulling upwards without twisting.
7. Proceed immediately with the injection. A vein test may be carried out by pulling
slightly on the plunger. The stoppers may separate but ensure that Stopper 2 does not
reach the by-pass channel in order to avoid any leakage of liquid. If a blood vessel
has been penetrated, blood will be pulled back into the syringe.

See also section 3. How to use ViVAXIM

6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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