SUMMARY CMI

STAMARIL^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about receiving this vaccine, speak to your doctor or pharmacist.

1. Why am I or my child receiving Stamaril?

Stamaril contains the active ingredient attenuated (weakened) yellow fever virus. Stamaril is a vaccine that provides protection against the serious infectious disease, yellow fever. Yellow fever occurs in certain areas of the world and is spread to people through the bites of infected mosquitoes.

For more information, see Section 1. Why am I or my child receiving Stamaril? in the full CMI.

2. What should I know before my child or I receive Stamaril?

Do not use if you or your child have ever had a severe allergic reaction to Stamaril or a similar vaccine, the active ingredient, eggs, chicken proteins, or any of the ingredients listed at the end of the CMI. Talk to your doctor if you or your child have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before my child or I receive Stamaril? In the full CMI.

3. What if I or my child is taking other medicines?

Some medicines may interfere with Stamaril and affect how it works.

A list of these medicines is in Section 3. What if I or my child is taking other medicines? in the full CMI.

4. How is Stamaril given?

• Stamaril is given as a 0.5mL injection, usually under the skin but can be given into a muscle by a doctor or nurse.
• The injection should be given at least 10 days before being at risk of infection with yellow fever.

More instructions can be found in Section 4. How is Stamaril given? in the full CMI.

5. What should I know while being given Stamaril?

For more information, see Section 5. What should I know while being given Stamaril? in the full CMI.

6. Are there any side effects?

The most common side effects of Stamaril are injection site redness, pain or discomfort, unusual weakness, muscle tenderness or weakness not caused by exercise, headaches, fever, crying and irritability in children, painful joints, rash, feeling sick, vomiting or stomach pain.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

STAMARIL^®

Active ingredient: yellow fever virus (live, attenuated)

Consumer Medicine Information (CMI)

This leaflet provides important information about receiving Stamaril. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Stamaril.

Where to find information in this leaflet:

1. Why am I or my child receiving Stamaril?
2. What should I know before my child or I receive Stamaril?
3. What if I or my child is taking other medicines?
4. How is Stamaril given?
5. What should I know while being given Stamaril?
6. Are there any side effects?
7. Product details

1. Why am I or my child receiving Stamaril?

Stamaril contains the active ingredient attenuated (weakened) yellow fever virus. Stamaril is a vaccine that provides protection against a serious infectious disease called yellow fever.

Yellow fever occurs in certain areas of the world and is spread to people through the bites of infected mosquitoes.

Stamaril is given to people who:

1. are travelling to, passing through or living in an area where yellow fever is present or may be present.
2. are travelling to any country that requires an International Certificate of Vaccination for entry, this may depend on the countries previously visited during the same trip.
3. may handle infectious materials such as laboratory workers.

To obtain a vaccination certificate against yellow fever it is necessary to be vaccinated in an approved vaccination centre by a qualified and trained health care professional so that an International Certificate of Vaccination can be issued. This certificate is valid from the 10th day after the vaccination.

2. What should I know before my child or I receive Stamaril?

Warnings

Stamaril must not be given to:

• women who are pregnant or breast-feeding,
• children under 6 months of age.

Stamaril should not be given if you or your child:

• have ever had a severe allergic reaction to the active ingredient, eggs, chicken proteins or any other ingredient of Stamaril,
• have experienced a severe allergic reaction after an injection of a yellow fever vaccine,
• have an illness with a fever or acute infection. The vaccination will be postponed until you have recovered,
• have a poor or weakened immune system for any reason, such as illness or medical treatments (for example corticosteroids or chemotherapy),
• have a weakened immune system due to HIV infection. Your doctor will tell you if you can still receive Stamaril based on your blood tests,
• are infected with HIV and have active symptoms due to the infection,
• have a history of problems with thymus gland or has had thymus gland removed for any reason.

Always check the ingredients to make sure you can be given this vaccine.

Check with your doctor if:

• you are taking any medicines for any other condition,
• you are over 60 years old as you have an increased risk of certain types of severe but rare reactions to vaccines (including serious reactions that affect the brain and nerves, as well as vital organs). You will only be given the vaccine if the risk of infection with the virus is well established in countries where you are going to stay,
• your child is aged 6 to 9 months. Stamaril may be given to children aged between 6 and 9 months only in special situations and on the basis of current official recommendations,
• you are infected with the HIV but do not present with any HIV infection related symptoms, your doctor will specify whether Stamaril can be given based on your blood tests,
• your child is infected with the HIV (AIDS). The doctor may need to perform specific exams and seek advice from a specialist before telling you whether your child may receive Stamaril,
• you have bleeding disorders (such as haemophilia or a low level of platelets) or are taking medicines that reduce blood circulation. You can still receive Stamaril provided that it is injected under the skin and not into a muscle,
• you or your child have rare hereditary problems of fructose intolerance. Stamaril contains a small amount of sorbitol and should not be given to people who have fructose intolerance.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor or nurse if you are pregnant, think you might be pregnant or are breastfeeding. You should not receive Stamaril unless this cannot be avoided.

If Stamaril is needed, you will need to stop breastfeeding for at least 2 weeks after receiving Stamaril.

Your doctor or nurse can advise you on whether it is essential that you receive Stamaril while pregnant or breastfeeding.

3. What if I or my child is taking other medicines?

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you have recently been receiving any treatment which may have weakened your immune system (such as chemotherapy or high doses of corticosteroids), vaccination against yellow fever should be postponed until your laboratory results show that your immune system has recovered. Your doctor will advise you when it is safe for you to be vaccinated.

Stamaril can be given at the same time as vaccines against typhoid (those containing the Vi capsular polysaccharide).

In adults, Stamaril can be given at the same time as IMOJEV (live attenuated vaccine against Japanese encephalitis).

Your doctor will advise you if Stamaril can be given with another vaccine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Stamaril.

4. How is Stamaril given?

How much is given

• Stamaril is given as a single 0.5mL dose by your doctor or nurse.
• Stamaril is given as an injection, usually under the skin, but it can be given into a muscle. It must not be injected into a blood vessel.

When Stamaril is given

• The injection should be given at least 10 days before being at risk of infection with yellow fever, because it takes 10 days for the vaccine to work and provide good protection against the yellow fever virus.
• The protection will last at least 10 years and may be a life-long protection. Some people may need to be re-vaccinated if they continue to be at risk for yellow fever virus infection.

If you are given too much Stamaril

Overdose is most unlikely because your doctor or nurse gives the injections. If you have any concerns, ask your doctor.

5. What should I know while being given Stamaril?

Call your doctor straight away if you:

• Do not feel well after receiving Stamaril

Remind any doctor, dentist or pharmacist you visit that you have received Stamaril.

Looking after your medicine

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

• Keep Stamaril in the original pack until it is time for it to be given.
• Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Stamaril. Protect from light.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this vaccine after the expiry date.

6. Are there any side effects?

All vaccines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems in Australia or in New Zealand at pophealth.my.site.com/carmreportnz/s/.

By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What Stamaril contains

Do not receive this vaccine if you are allergic to any of these ingredients.

The manufacture of this vaccine includes exposure to bovine 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.

What Stamaril looks like

Stamaril is a beige to orange beige homogenous powder, which after reconstitution with sodium chloride solution (a clear and colourless solution) forms a beige to pinked beige suspension, which is more or less opalescent.

AUST R 58571

Who distributes Stamaril

Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]

Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Email: [email protected]

This leaflet was prepared in July 2024.

sta-ccdsv11-cmiv5-09nov23

Published by MIMS September 2024

1 Name of Medicine

Yellow Fever Vaccine (Live).

2 Qualitative and Quantitative Composition

Each 0.5 mL dose of reconstituted vaccine from the freeze dried product contains an injectable suspension in stabiliser of the attenuated 17D strain of yellow fever virus. The virus has been propagated in specific pathogen-free chick embryos, in particular free from avian leucosis viruses. Each dose contains not less than 1000 IU.
Stamaril meets the World Health Organization (WHO) requirements for manufacture of biological substances.
The manufacture of this product includes exposure to bovine 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.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and diluent for suspension for injection.
Stamaril is a beige to orange beige and homogenous powder, which after reconstitution with sodium chloride solution (a clear and colourless solution) forms a beige to pinked beige suspension, more or less opalescent.

4 Clinical Particulars

4.1 Therapeutic Indications

Prevention of yellow fever. Vaccination is recommended for:
Every individual aged 9 months and over living or travelling through an endemic area with a current or periodic risk of yellow fever transmission.
Non-vaccinated individual moving from an endemic area with a current or periodic risk of yellow fever transmission to a potentially receptive non-endemic area with a current or periodic risk of yellow fever transmission.
Laboratory workers handling potentially infectious materials.
In order to be officially recognised, the yellow fever vaccination must be administered in an approved vaccination centre by a qualified and trained health care professional and registered on an international certificate. The validity period of the certificate is established according to International Health Regulations recommendations and starts 10 days after primary vaccination and immediately after re-vaccination.

4.2 Dose and Method of Administration

For adults and children aged 9 months and over.

4.3 Contraindications

Stamaril should not be administered to individuals with a history of severe allergic reaction to eggs or chicken proteins or to any component of the vaccine or a history of severe allergic reaction after previous administration of the vaccine or a vaccine containing the same components.
Administration of Stamaril should be postponed in individuals suffering from moderate or severe febrile or acute illness.
Stamaril should not be used in pregnant and breast-feeding women, unless when clearly needed and following an assessment of the risks and benefits.
Stamaril should not be administered to children less than 6 months of age due to the risk of encephalitis.
Stamaril should not be administered to individuals with a congenital or acquired immune deficiency that impairs cellular immunity. This includes individuals receiving immunosuppressive therapies, such as chemotherapy or high doses of systemic corticosteroids or any other medicinal products including biologicals with known immunosuppressive or immunomodulating properties.
Stamaril should not be administered to symptomatic HIV-infected individuals.
Stamaril should not be administered to HIV-infected individuals who are asymptomatic when accompanied by evidence of impaired immune function.
Stamaril should not be administered to individuals with a history of thymus dysfunction (including myasthenia gravis, thymoma or thymectomy for any reasons).
Thymectomy and thymus disease have been identified as potentially influencing the development of yellow fever vaccine-associated viscerotropic disease. Healthcare providers are advised to ask for a history of thymus dysfunction prior to administering yellow fever vaccine. Alternative means of prevention in such individuals are to be considered.

4.4 Special Warnings and Precautions for Use

General.

Yellow fever vaccine associated neurotropic disease.

Yellow fever vaccine associated viscerotropic disease.

Persons with altered immune status.

Children born to HIV positive mothers.

Individuals under immunosuppressive treatments.

HIV infection.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

To avoid reduction in serological responses, another live vaccine, if not given concurrently with Stamaril, should be given after four weeks have elapsed.
Available data supports concomitant use of Stamaril with polysaccharide typhoid vaccine in separate syringes at separate sites.
Stamaril may be administered in adults at the same time as Imojev but with separate syringes, into separate sites.
Data concerning other vaccines is limited. However, no interaction is anticipated when vaccines are given at separate sites using separate syringes.
In the case of immunosuppressive therapies, such as chemotherapy or high doses of systemic corticosteroids, or any other medicinal products including biologicals with known immunosuppressive or immunomodulating properties, see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use.

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.

4.8 Adverse Effects (Undesirable Effects)

The reactions are listed within body systems and categorised by frequency according to the following definitions: very common: ≥ 1/10 (≥ 10%); common: < 1/10 and ≥ 1/100 (< 10% and ≥ 1%); uncommon: < 1/100 and ≥ 1/1000 (< 1% and ≥ 0.1%); rare: < 1/1000 and ≥ 1/10,000 (< 0.1% and ≥ 0.01%); very rare: < 1/10,000 (< 0.01%); not known: cannot be estimated from available data.

Clinical trial experience.

Solicited reactions.

Solicited reactions.

Post-marketing experience.

Skin and subcutaneous tissue disorders.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Infections and infestations.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

Cases of administration of more than the recommended dose (overdose) have been reported with Stamaril. When adverse reactions were reported, the information was consistent with the known safety profile of Stamaril.
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: Yellow Fever Vaccine (Live), ATC code: J07BL01.

Mechanism of action.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Other ingredients.

Stabilising medium.

Diluent.

6.2 Incompatibilities

In the absence of compatibility studies, Stamaril must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

36 months.
Use immediately after reconstitution.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (Refrigerate. Do not freeze.) Protect from light.
For storage conditions after reconstitution of the medicine, see Section 6.3 Shelf Life.

6.5 Nature and Contents of Container

1 single dose lyophilised vaccine vial + (0.5 mL) diluent syringe.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

6.7 Physicochemical Properties

No data available.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes