Consumer medicine information

Vivaxim

Salmonella typhi Vi polysaccharide vaccine; Hepatitis A vaccine

BRAND INFORMATION

Brand name

Vivaxim

Active ingredient

Salmonella typhi Vi polysaccharide vaccine; Hepatitis A vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vivaxim.

What is in this leaflet

This leaflet answers some common questions about Vivaxim.

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 having Vivaxim against the benefits they expect it will have for you.

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 VIVAXIM is used for

Vivaxim is a vaccine used to help prevent typhoid fever and hepatitis A disease in adults aged 16 years and older who are at risk of these diseases.

How it works

Vivaxim works by causing your body to produce its own protection against typhoid fever and hepatitis A infection. It does this by making substances called antibodies in the blood, which fight the typhoid bacteria and hepatitis A virus. If a vaccinated person comes into contact with the typhoid or hepatitis A organisms, the body is usually ready to destroy them.

Your body usually takes two weeks after vaccination to develop protection against typhoid fever and hepatitis A infection.

Initial protection is provided by one dose of Vivaxim. For long-lasting protection against hepatitis A virus a booster vaccination with a hepatitis A vaccine will be required 6 to 36 months after vaccination with Vivaxim. The body does not develop long-term protection against typhoid fever and repeat vaccinations are required to maintain protection.

Most people will produce enough antibodies against typhoid fever and hepatitis A infection. However, as with all vaccines, 100% protection cannot be guaranteed.

The vaccine will not give you typhoid fever or hepatitis A infection.

The chance of a severe reaction from Vivaxim is very small, but the risks from not being vaccinated against typhoid fever or hepatitis A infection may be very serious.

Before you are given VIVAXIM

When you must not be given it

You have had a severe reaction to a previous injection of this vaccine.

Do not have Vivaxim if you have an allergy to:

  • Vivaxim or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

  • Shortness of breath, wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Skin rash, itching or hives.

Do not have Vivaxim if you have a fever or acute illness. Minor infections are not a reason to delay vaccination.

Do not give Vivaxim to persons younger than 16 years. The safety and effectiveness of Vivaxim in persons under 16 years have not yet been established.

Do not have Vivaxim after the expiry date printed on the pack. Do not have Vivaxim if the packaging is torn or shows signs of tampering.

Talk to your doctor or pharmacist if you are not sure whether you should have Vivaxim.

Before you are given it

Tell your doctor if you have ever had a serious allergic reaction to a vaccine.

Tell your doctor if you have an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.

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

  • Lowered immunity due to diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
  • Lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin, or other medicines used to treat cancer (including radiation therapy)
  • Leukaemia or any other cancers of the blood, bone marrow or lymph system.

If you have lowered immunity then the vaccine may not work as well as it would in healthy individuals.

Tell your doctor if you have allergies to:

  • Any other medicines
  • Any other substances, such as foods, preservatives or dyes
  • Neomycin.

Tell your doctor if you are pregnant or intend to become pregnant. Vivaxim is not recommended for use during pregnancy. If there is a need to consider Vivaxim during your pregnancy, your doctor will discuss with you the benefits and risks of having it.

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

Having other medicines

As Vivaxim does not contain any live bacteria or viruses, it can generally be given at the same time as other inactivated vaccines, but at a different injection site.

Vivaxim can be given at the same time as yellow fever vaccine at different injection sites.

Other medicines should be taken as usual after the vaccination.

How VIVAXIM is given

Vivaxim is given as a slow injection into the muscle of your upper arm.

Vivaxim should not be injected into the veins or into the buttocks.

How much is given

The dose is one millilitre of the mixed vaccine.

When it is given

Vivaxim should be given 14 days before you may be exposed to the typhoid fever and hepatitis A. For long term protection against infection with hepatitis A virus you should obtain a booster dose of hepatitis A vaccine 6-36 months after your initial dose of Vivaxim. If you are at ongoing risk of infection with typhoid fever, you should be revaccinated against typhoid fever, every 3 years.

After having VIVAXIM

Things you must do:

  • Keep an updated record of your vaccinations
  • Attend any other appointments made by your doctor or nurse
  • Report any side effects to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having Vivaxim.

Vivaxim may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have.

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

  • Local reaction around the injection site such as redness, pain, swelling or hardness
  • Headaches
  • Generally feeling unwell
  • Soreness, aching muscles, muscle tenderness or weakness (not caused by exercise)
  • Nausea or diarrhoea
  • Fever
  • Fainting.

These are the more common side effects of Vivaxim. Mostly these are mild and short-lived.

Less common side effects include itchiness of the skin, dizziness and a rash. Very rarely some patients experience fainting, vomiting, abdominal pain and increased liver enzymes.

Tell your doctor immediately if you notice any of the following:

  • Abscess at the injection site
  • Unusual bleeding, bruising or purple spots on the skin
  • Skin rash, itchy spots or red lumps on the skin
  • Painful, swollen joints
  • Swelling of the glands in the neck, armpit or groin
  • Itchiness, hives or rash over the body.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body
  • Pinkish, itchy swellings on the skin, also called hives or nettle rash, shortness of breath, wheezing or trouble breathing.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

All of these side effects are very rare.

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

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

Storing VIVAXIM

Vivaxim is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Vivaxim:

  • Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Vivaxim
  • Keep it where children cannot reach it
  • Keep Vivaxim in the original pack until it is time for it to be given.

Freezing destroys the vaccine.

Product description

What it looks like and contents of the pack

Vivaxim is a combination vaccine contained in a dual chamber syringe. One chamber contains the hepatitis A vaccine, which appears as a white suspension, the other chamber contains the typhoid vaccine, which appears as a clear liquid. The two vaccine components become mixed together when the plunger is depressed.

Ingredients

Active ingredients:

  • 25 micrograms Salmonella typhi Vi Polysaccharide
  • 160 antigen units hepatitis A virus antigen.

Other ingredients:

  • Sodium chloride
  • Dibasic sodium phosphate dihydrate
  • Monobasic sodium phosphate dihydrate
  • Water for injections
  • Aluminium hydroxide hydrate
  • Phenoxyethanol
  • Formaldehyde
  • Medium 199 (Hanks) (including phenylalanine)
  • Polysorbate 80
  • Neomycin (trace)
  • Bovine Serum Albumin (trace).

The hepatitis A virus that this vaccine contains was grown in a cell line derived from human embryonic lung in the 1960s.

The manufacture of this product includes exposure to bovine derived materials. 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.

Name and address of the sponsor

Australia:

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 818 806

New Zealand:

sanofi-aventis new zealand limited
Level 8
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 283 684

AUST R number
AUST R 82745

Date of preparation
05 March 2020

vivaxim-ccdsv9-cmiv4-05mar20

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Vivaxim

Active ingredient

Salmonella typhi Vi polysaccharide vaccine; Hepatitis A vaccine

Schedule

S4

 

1 Name of Medicine

Salmonella typhi Vi polysaccharide and hepatitis A virus antigen.

2 Qualitative and Quantitative Composition

Vivaxim contains a sterile suspension of purified Salmonella typhi Vi polysaccharide and formaldehyde-inactivated hepatitis A virus (HAV) antigen (GBM strain) adsorbed onto aluminium hydroxide. Vivaxim is presented in a dual-chamber by-pass syringe. The contents of both chambers are mixed immediately prior to injection by slowly pressing the plunger.
Each 1.0 mL dose of mixed vaccine contains:

Active ingredients.

Salmonella typhi Vi polysaccharide (Ty 2 strain) 25 micrograms.
Hepatitis A virus antigen* 160 antigen units**.
* GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell line that was derived from human embryonic lung tissue in the 1960s.
** In the absence of an international standardised reference, the antigen content is expressed using an in-house reference.

Excipients with known effects.

Phenylalanine and residual neomycin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The typhoid polysaccharide component is a clear and colourless solution, the hepatitis A component (inactivated, adsorbed) is a cloudy whitish suspension.

4 Clinical Particulars

4.1 Therapeutic Indications

Vivaxim is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subjects aged 16 and older.

4.2 Dose and Method of Administration

The recommended dosage is 1 mL of the mixed vaccine.
Vivaxim should be administered by slow intramuscular injection in the deltoid region.
Vivaxim must not be administered intradermally or intravenously.
Primary immunisation is achieved with a single dose of Vivaxim.
The vaccine should be administered at least 14 days prior to risk of exposure to both typhoid fever and hepatitis A.
A single dose of Vivaxim does not ensure long-term protection against infection with hepatitis A virus. For long-term protection a booster injection of inactivated hepatitis A vaccine is required 6 to 36 months after the first dose. It has been demonstrated that HAV antibodies persist for many years (at least 10 years) after the booster.
In individuals who remain at risk of typhoid fever, revaccination against typhoid fever should be carried out with a single dose of purified Vi polysaccharide typhoid vaccine with an interval of not more than 3 years, unless it is also appropriate to administer a booster dose of hepatitis A vaccine at the same time, in which case Vivaxim may be used.
The HA component of Vivaxim produces an adequate booster response when Vivaxim is given 6-36 months after primary vaccination with either inactivated hepatitis A vaccine or 36 months after primary vaccination with Vivaxim.
All parenteral drugs and vaccine products should be inspected visually prior to administration for discolouration or particulate matter. In the event of either being observed, discard the vaccine.
The two vaccine components must only be mixed immediately prior to injection. The contents of the two compartments are mixed by slowly advancing the plunger. The final volume injected is 1 mL.
Shake before injection to obtain a homogeneous suspension. The mixed vaccine is a whitish opalescent suspension.
Contains no antimicrobial agent. Product is for single use only and must not be used in more than one individual. Discard any remaining unused contents.

4.3 Contraindications

Vivaxim should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or after previous administration of the vaccine or to a vaccine containing the same components or constituents.
Vaccination must be postponed in case of febrile or acute disease.

4.4 Special Warnings and Precautions for Use

Do not administer Vivaxim by intravascular injection. Make sure that the needle does not penetrate a blood vessel.
Subcutaneous administration of Vivaxim may increase the risk of local adverse reaction.
Vivaxim should be administered at least 14 days prior to risk of exposure with S. typhi and hepatitis A virus.

Prior to vaccination.

Anaphylaxis.

As with all injectable vaccines, appropriate medical treatment, such as epinephrine (adrenaline), and supervision should always be readily available in case of a rare anaphylactic reaction following administration of the vaccine (see Section 4.8 Adverse Effects (Undesirable Effects)).

Hypersensitivity.

This vaccine contains formaldehyde as an excipient and it is possible that an allergic reaction may occur. As Vivaxim may contain residual traces of neomycin, caution should be exercised when the vaccine is administered to individuals with hypersensitivity to neomycin (and other antibiotics of the same class). This vaccine contains polysorbate, which may cause local skin reactions.

Syncope.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling injury and manage syncopal reactions.

Special patient groups.

Thrombocytopenia or bleeding disorders.

As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these individuals.

Immunosuppression.

Immunogenicity of Vivaxim could be impaired by immunosuppressive treatment or in immunodeficient individuals. It is recommended to delay vaccination until the completion of any immunosuppressive treatment. Individuals with chronic immunodeficiency such as HIV infection may be vaccinated if the underlying pathology allows the induction of an antibody response, even if limited.

Protection.

Because of the long incubation period of hepatitis A, infection may be present but not clinically apparent at the time of vaccination. It is not known whether Vivaxim will prevent hepatitis A in such cases.
A single dose of Vivaxim does not ensure long-term protection against infection with hepatitis A virus. For long-term protection a booster dose of inactivated hepatitis A virus vaccine is required 6 to 36 months after vaccination with Vivaxim.
Vivaxim provides protection against the risk of infection related to S. typhi, but gives no protection against Salmonella paratyphi A or B or against non-typhoidal Salmonellae.
Vivaxim does not protect against infection caused by other known liver pathogens including hepatitis B, hepatitis C and hepatitis E viruses.
As with other vaccines, vaccination with Vivaxim may not be expected to protect 100% of susceptible individuals.

Use in the elderly.

Immunogenicity and clinical experience with Vivaxim in the elderly is limited.

Paediatric use.

No data on the use of Vivaxim in children and adolescents aged below 16 years are available.

Effects on laboratory tests.

Interference of Vivaxim with laboratory tests has not been studied.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Vivaxim is a combination of purified Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine. Therefore, concomitant administration with other inactivated vaccines using different syringes and at different injection sites may be performed and is unlikely to interfere with the immune response.
Based on data obtained from the concomitant administration of the monovalent vaccines (purified Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine) with yellow fever vaccine, no interference with the immune response is expected when Vivaxim is administered concomitantly at a different site with yellow fever vaccine. However, no specific study has been carried out with Vivaxim.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No fertility data available.
(Category B2)
Animal reproductive studies have not been conducted with Vivaxim.
Data on the use of this vaccine in pregnant women are limited. Therefore, the administration of the vaccine during pregnancy is not recommended.
Vivaxim should be given to pregnant women only if clearly needed, and following an assessment of the risks and benefits.
 It is not known whether this vaccine is excreted in human milk. Caution must be exercised when Vivaxim is administered to a nursing mother.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

Within each system organ class the adverse events are ranked under headings of frequency, most frequent reactions first, using the following convention.
Very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Data from clinical studies.

The safety profile of Vivaxim was evaluated in nearly 1300 subjects during controlled clinical studies. The most commonly reported reactions were those occurring at the injection site.
Pain at the injection site was reported by 89.9% of subjects following administration of Vivaxim compared with 83.2% of subjects who received monovalent Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine concomitantly at separate injection sites.

Local reactogenicity.

The following data show the risk of severe local reactions (or > 5 cm) or reactions lasting more than 72 hours (Table 1).
The adverse reactions observed with Vivaxim were as follows.

Nervous system disorders.

Very common: headache. Uncommon: dizziness.

Gastrointestinal disorders.

Common: nausea, diarrhoea.

Skin and subcutaneous tissue disorders.

Uncommon: pruritus; rash.

Musculoskeletal and connective tissue disorders.

Very common: myalgia. Common: arthralgia.

General disorders and administration site conditions.

Very common: injection site pain, injection site induration, injection site oedema, injection site erythema, asthenia. Common: malaise, pyrexia.

Data from post-marketing experience.

Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of Vivaxim. These events have been very rarely reported; however as exact incidence rates cannot be calculated precisely, their frequency is qualified as "not known".

Immune system disorders.

Anaphylactic/anaphylactoid reactions, including shock; serum sickness.

Nervous system disorders.

Vasovagal syncope.

Gastrointestinal disorders.

Vomiting, abdominal pain.

Skin and subcutaneous tissue disorders.

Urticaria.

Investigations.

Transaminases increased (mild and reversible).
Additional adverse events were not reported with Vivaxim but were reported respectively following use of the monovalent typhoid polysaccharide vaccine or the monovalent inactivated hepatitis A vaccine.

Respiratory, thoracic and mediastinal disorders.

Not known: asthma.

General disorders and administration site condition.

Very rare: injection site nodule.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.9 Overdose

Cases of administration of more than the recommended dose (overdose) have been reported with Vivaxim. When adverse reactions were reported, the information was consistent with the known safety profile of Vivaxim described, see Section 4.8 Adverse Effects (Undesirable Effects).
For general advice on overdose management, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: J: Antiinfectives for systemic use; J07 (vaccines) CA (Bacterial and viral vaccines, combined) 10 (typhoid-hepatitis A).

Mechanism of action.

A minimum of fourteen days after vaccination is necessary to allow development of an adequate immune response prior to a potential exposure.
Typhoid fever seroprotection threshold is not known and estimates vary between 0.6 microgram/mL and 1.5 microgram/mL. Seroprotection level of ≥ 1 microgram/mL has been used in the studies supporting immunogenicity of Vivaxim. There is a consensus on the 4-fold increase as a criterion for seroconversion and this is used in all clinical trials.
By consensus hepatitis A seroprotection level is ≥ 20 mIU/mL.
The efficacy of the combined vaccine has not been demonstrated in field studies.

Clinical trials.

Immunogenicity. The combined vaccine, Vivaxim, produced immune responses for primary vaccination and for booster vaccination that were non-inferior to those of the two monovalent vaccines Typhim Vi and Avaxim.

Study 1.

The immunogenicity and safety of Vivaxim have been determined by this pivotal study designed to compare the immunogenicity of S. typhi Vi and hepatitis A antigens administered either together, using a dual chamber syringe (Vivaxim), or separately at two different sites (Typhim Vi and Avaxim vaccines). The study was open label and randomised and included 360 adult subjects; 179 in the Vivaxim group and 181 in the Typhim Vi + Avaxim group.
Forty subjects, 17 in the Vivaxim group and 32 in the separately administered vaccine group, were found to be seropositive at inclusion and were excluded from the analysis of immunogenicity. Consequently the per protocol population evaluated 28 days after vaccination consisted of:
Vivaxim - 172 subjects in the typhoid Vi analysis and 157 for the hepatitis A analysis;
Typhim Vi and Avaxim - 173 in the typhoid Vi analysis and 149 in the hepatitis A analysis.
Twenty eight days after the Vivaxim injection, the anti-typhoid Vi seroconversion rate (≥ four-fold rise in titre) was 84.7% and the anti-hepatitis A seroprotection rate (≥ 20 mIU/mL) was 98.7%. (Table 2 and Table 3.)

Study 1 follow-up.

A follow-up study examined residual antibody levels 3 years after the primary vaccination. At this time, a subset of the original subjects underwent revaccination with the combined vaccine: antibody response was recorded 28 days later.
Three years after primary vaccination with Vivaxim, the typhoid Vi seroprotection rate (percent ≥ 1 microgram/mL) was 32.1%. One month following re-vaccination with Vivaxim the seroprotection rate for typhoid Vi increased to 69.6%; the seroconversion rate for typhoid Vi was 26.1%.
Three years after primary vaccination with Vivaxim the hepatitis A seroprotection rate (percent ≥ 20 mIU/mL) was 99.1%. The seroprotection rate for hepatitis A increased to 100% 28 days after re-vaccination.
Results of the follow-up study are shown in Table 4 and Table 5.

Study 2.

The batch consistency of Vivaxim was demonstrated in a multicentric double blind randomised study of adult subjects, using 3 batches of the combined vaccine. The seroconversion rate for typhoid antibody was 92.1% and for hepatitis A antibody was 100% (Tables 1 and 2).

Combined studies 1 and 2.

The two studies combined included a total of 789 subjects. The combined seroconversion rate for anti-Vi antibody was 90.3% and seroprotection rate for anti-HAV antibody was 99.7% (Table 2 and Table 3).

Study 3.

A single centre, open, randomised study of adult subjects demonstrated noninferiority of the hepatitis booster response of the combined vaccine Vivaxim compared with the single component inactivated hepatitis A vaccine, Avaxim. The primary vaccination of all subjects was Avaxim. Six months after initial vaccination subjects underwent booster vaccination and antibody levels were measured 28 days later (Table 6).

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Vivaxim has not been evaluated for genotoxicity.

Carcinogenicity.

Vivaxim has not been evaluated for carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each 1.0 mL dose of mixed vaccine contains:

Other components.

Salmonella typhi Vi polysaccharide typhoid vaccine components.

Phosphate buffer solution containing: sodium chloride 4.150 mg, dibasic sodium phosphate dihydrate 0.065 mg, monobasic sodium phosphate dihydrate 0.023 mg, water for injections up to 0.5 mL.

Inactivated hepatitis A virus vaccine component.

Aluminum hydroxide hydrate (quantity expressed as aluminium) 0.3 mg, phenoxyethanol (preservative) 2.5 microlitres, formaldehyde (preservative) 12.5 micrograms, medium 199 (Hanks)* up to 0.5 mL.
* Supplemented with polysorbate 80. Medium 199 (Hanks) without phenol red, is a complex mixture of amino acids including phenylalanine, mineral salts, vitamins and other components such as glucose, diluted in water for injections and with a pH adjusted with hydrochloric acid or sodium hydroxide.
Neomycin (≤ 5 microgram/mL) and bovine serum albumin (< 10 nanograms) may be present as residual traces.
The manufacture of this product includes exposure to bovine derived materials. 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

This vaccine must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store between 2°C and 8°C (Refrigerate. Do not freeze). Product that has been exposed to freezing should not be used. Do not use after expiration date. Protect from light.

6.5 Nature and Contents of Container

Vivaxim is contained in a type I glass, dual chamber, by-pass syringe (1 mL) with an elastomer (chlorobromobutyl) plunger stopper, elastomer (chlorobromobutyl) tip cap and elastomer (chlorobromobutyl) by-pass stopper.
The purified Vi polysaccharide typhoid vaccine (solution for injection) is contained in the chamber of the syringe closest to the needle, and the inactivated hepatitis A vaccine (suspension for injection) in the chamber closest to the plunger-stopper.

6.6 Special Precautions for Disposal

Any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Not relevant to vaccines.

CAS number.

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes