Consumer medicine information

Stamaril

Yellow fever vaccine

BRAND INFORMATION

Brand name

Stamaril

Active ingredient

Yellow fever vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Stamaril.

What is in this leaflet

Read all of this leaflet carefully before you or your child is vaccinated.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This vaccine has been prescribed for you or your child. Do not pass it on to others.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • What STAMARIL is and what it is used for
  • Before you or your child is given STAMARIL
  • How STAMARIL is given
  • Possible side effects
  • Storing STAMARIL
  • Further Information

What STAMARIL is and what it is used for

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:

  • are travelling to, passing through or living in an area where yellow fever is present or may be present,
  • 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,
  • 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.

Before you or your child is given STAMARIL

STAMARIL should not be given if you or your child:

  • women who are pregnant or breast-feeding,
  • children under 6 months of age,
  • is allergic to eggs, chicken proteins or any other ingredient of STAMARIL,
  • has experienced a serious reaction after an injection of a yellow fever vaccine,
  • has an illness with a fever or acute infection. The vaccination will be postponed until you have recovered,
  • has a poor or weakened immune system for any reason, such as illness or medical treatments (for example corticosteroids or chemotherapy),
  • has a weakened immune system due to HIV infection. Your doctor will tell you if you can still receive STAMARIL based on your blood tests,
  • is infected with HIV and has active symptoms due to the infection,
  • has a history of problems with thymus gland or has had thymus gland removed for any reason.

Take special care with STAMARIL if:

  • 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,
  • STAMARIL contains a small amount of sorbitol. The vaccine should not be given to people who have rare hereditary problems of fructose intolerance.

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, 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.

Having other vaccines

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.

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. In case vaccination is needed you will need to interrupt breastfeeding for at least 2 weeks following vaccination. Your doctor or nurse can advise you on whether it is essential that you are vaccinated while pregnant or breastfeeding.

How STAMARIL is given

STAMARIL is given as a single 0.5 mL dose injection by a doctor or nurse. It is usually injected under the skin but it can be given into a muscle.

It must not be injected into a blood vessel.

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 revaccinated if they continue to be at risk for yellow fever virus infection.

Possible Side effects

Like all medicines, STAMARIL can cause side effects, although not everybody gets them.

Serious side effects

The following serious side effects have sometimes been reported:

Allergic reactions

  • Rash, itching or hives on the skin.
  • Swelling of the face, lips, tongue or other parts of the body.
  • Difficulty swallowing or breathing.
  • Loss of consciousness.

Reactions affecting the brain and nerves

These may occur within one month of the vaccination and have sometimes been fatal.

Symptoms include:

  • High fever with headache and confusion.
  • Extreme tiredness.
  • Stiff neck.
  • Inflammation of brain and nerve tissues.
  • Fits.
  • Loss of movement or feeling affecting certain parts or all of the body.

Serious reaction affecting vital organs

This may occur within 10 days of the vaccination and may have a fatal outcome. The reaction can resemble an infection with the yellow fever virus.

It generally begins with feeling tired, fever, headache, muscle pain and sometimes low blood pressure.

It may then go on to a severe muscle and liver disorders, drops in number of some types of blood cells resulting in unusual bruising or bleeding and increased risk of infections, and loss of normal functioning of the kidneys and lungs.

If you experience ANY of the above symptoms contact your doctor IMMEDIATELY.

Other side effects

Very common side effects (reported by more than 1 in 10 people)

  • Injection site pain or discomfort
  • Unusual weakness
  • Muscle tenderness or weakness not caused by exercise
  • Headache
  • Fever, crying, irritability, drowsiness, vomiting, or appetite loss in children

Common side effects (reported by less than 1 in 10 people)

  • Injection site redness, bruising, swelling or appearance of a hard lump
  • Fever
  • Painful joints
  • Rash
  • Feeling sick
  • Vomiting
  • Stomach pain

Uncommon side effects (reported by less than 1 in 100 people)

  • Dizziness
  • Itching

Rare side effects (reported by less than 1 in 1000 people)

  • Diarrhoea
  • Runny or blocked nose, sneezing, facial pressure or pain

Other possible side effects include:

  • Swollen glands in the neck, armpit or groin
  • Temporary lack of white blood cells, symptoms for which include frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • Itchy rash
  • Fainting
  • Tingling or numbness of the hands or feet
  • Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills

Storing STAMARIL

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

  • Keep out of reach and sight of children.
  • 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.

Do not use STAMARIL after the expiry date which is stated on the carton after EXP.

Do not have STAMARIL if the packaging is torn or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What STAMARIL contains

Active substance:

Yellow fever virus (produced in specified pathogen-free chick embryos), 17D strain (live, attenuated): not less than 1000 IU

Other ingredients:

Lactose monohydrate, sorbitol, histidine hydrochloride, alanine, sodium chloride, potassium chloride, sodium phosphate dihydrate, monobasic potassium phosphate, calcium chloride dihydrate, magnesium sulfate heptahydrate and water for injections.

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.

Name and Address of Australian 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 58571

Date of preparation

16 September 2020

sta-ccdsv11-cmiv4-16sep20

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Stamaril

Active ingredient

Yellow fever vaccine

Schedule

S4

 

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.

A single 0.5 mL dose given by intramuscular or subcutaneous injection.
Do not administer by intravascular injection.
Stamaril must not be mixed with any other injectable vaccine(s) or medical product(s).
The freeze dried powder is reconstituted with the accompanying 0.4% sodium chloride diluent contained in the syringe. The vial is shaken and, after complete dissolution, the suspension obtained is withdrawn into a separate syringe for injection.
Before administration, the reconstituted vaccine should be shaken vigorously.
Use immediately after reconstitution.
Product is for single use in one patient only. Discard any residue.
Use a separate, sterile syringe and needle for each patient to prevent transmission of blood borne infectious agents. Do not recap needles. Dispose of needles and syringes according to biohazard waste guidelines.
The duration of protection is expected to be at least 10 years and may be a lifelong. However, re-vaccination may be needed in individuals who had an insufficient immune response after their primary vaccination if they continue to be at risk for yellow fever virus infection.
Re-vaccination may also be required, depending on official recommendations of local health authorities.
For updated yellow fever vaccination requirements and recommendations consult the WHO dedicated website or refer to resources provided by national health authorities.

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.

Individuals with rare hereditary problems of fructose intolerance should not take this vaccine.
As with any vaccine, vaccination with Stamaril may not protect 100% of vaccinated individuals.
Do not administer by intravascular injection.
In individuals with thrombocytopenia or a bleeding disorder, the vaccine should be administered by subcutaneous route since bleeding may occur following an intramuscular administration to these individuals.
As with other injectable vaccines, appropriate medical treatment and supervision should always be available in cases of anaphylactic reactions. Adrenaline (epinephrine) should always be readily available whenever the injection is given.
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.
Before considering administration of yellow fever vaccine, care should be taken to identify individuals who might be at increased risk of adverse reactions following vaccination.

Yellow fever vaccine associated neurotropic disease.

Very rarely, yellow fever vaccine-associated neurotropic disease (YEL-AND) has been reported following vaccination, with sequelae or with fatal outcome in some cases (see Section 4.8 Adverse Effects (Undesirable Effects)). Other neurological complications have included Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM), and bulbar palsy. To date, most of cases of YEL-AND have been reported in primary vaccinees with an onset within 30 days of vaccination. The risk appears to be higher in those aged over 60 years, and below 9 months of age (including transmission from nursing mothers to the infants) although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognised as a predisposing condition (see Section 4.3 Contraindications). However, cases of YEL-AND have also been reported in individuals with no identified risk factors. Vaccinees should be instructed to seek medical attention if they experience after vaccination any symptoms suggestive of YEL-AND such as high fever with headache or confusion, personality change or if they experience extreme tiredness, stiff neck, fits, loss of movement or feeling in part or all of the body and they should also be reminded to inform their health care professional that they received yellow fever vaccine (see Section 4.8 Adverse Effects (Undesirable Effects)).

Yellow fever vaccine associated viscerotropic disease.

Very rarely, yellow fever vaccine-associated viscerotropic disease (YEL-AVD), which may present as non-specific multi-organ system failure or can be similar to fulminant infection by wild-type virus, with liver failure and internal bleeding leading to death, has been reported following vaccination (see Section 4.8 Adverse Effects (Undesirable Effects)). The clinical presentation may include fever, fatigue, myalgia, headache, hypotension, progressing to one or more of metabolic acidosis, muscle and liver cytolysis, lymphocytopenia and thrombocytopenia, renal failure and respiratory failure. The mortality rate has been around 60%. To date, most of cases of YEL-AVD have been reported in primary vaccinees with an onset within 10 days of vaccination. The risk appears to be higher in those aged over 60 years although cases have also been reported in other age groups. Thymectomy or history of thymus dysfunction have also been recognised as predisposing conditions (see Section 4.3 Contraindications). However, cases of YEL-AVD have also been reported in individuals with no identified risk factors. Vaccinees should be instructed to seek medical attention if they experience after vaccination any symptoms suggestive of a YEL-AVD such as pyrexia, myalgia, fatigue, headache or hypotension, as these can potentially progress quickly to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia and acute respiratory and renal failure and they should also be reminded to inform their health care professional that they received yellow fever vaccine (see Section 4.8 Adverse Effects (Undesirable Effects)).

Persons with altered immune status.

Children born to HIV positive mothers.

It is necessary to obtain information of the child's HIV status (see Section 4.3 Contraindications; Section 4.2 Dose and Method of Administration):
If the child is not infected with HIV: Stamaril can be administered as routinely advised.
If the child is infected with HIV: the advice of specialist paediatric team must be sought.

Individuals under immunosuppressive treatments.

For individuals following an immunosuppressive treatment, it is recommended to delay the vaccination until the immune function has recovered. In individuals taking high doses of systemic corticosteroids, it is advisable to wait for at least one month. Individuals following other immunosuppressive treatments should seek advice from a specialist.

HIV infection.

Stamaril must not be administered to persons with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function. However, there are insufficient data at present to determine the immunological parameters that might differentiate persons who could be safely vaccinated and who might mount a protective immune response from those in whom vaccination could be both hazardous and ineffective. Therefore, if an asymptomatic HIV-infected person cannot avoid travel to an endemic area, available official guidance should be taken into account when considering the potential risks and benefits of vaccination.

Use in the elderly.

Individuals aged 60 years and older may have an increased risk of serious adverse events (systemic or neurological reactions persisting more than 48 hours), including YEL-AVD and YEL-AND, compared to other age groups. In this population, the risk of a rare serious reaction to yellow fever vaccine must be balanced against the risk of yellow fever infection. Individuals should not receive the vaccine if they travel to a country without an ongoing risk of yellow fever transmission at the time of travel. Refer to the WHO list of countries with risk of yellow fever transmission or to resources provided by national health authorities.

Paediatric use.

Routinely, only children aged 9 months and above should be vaccinated. However, during outbreak control when mass vaccination campaigns are needed in order to interrupt the circulation of yellow fever virus, vaccination of children aged 6 to 9 months could be considered.

Effects on laboratory tests.

Stamaril can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis.

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.

Stamaril has not been evaluated for the effects on fertility.
(Category B2)
As with all live attenuated vaccines, pregnancy constitutes a contraindication. No animal developmental and reproductive studies have been conducted with Stamaril. Data from post marketing surveillance and literature are not sufficient to demonstrate whether Stamaril can adversely affect pregnancy and embryo-fetal development, parturition and postnatal development. The potential risk is unknown.
Stamaril should be given to pregnant women only when clearly needed, and following an assessment of the risks and benefit.
 No data exists on the use of Stamaril during lactation. As there is a probable risk of transmission of vaccine components to the infants from breast-feeding mothers, Stamaril should not be given to nursing mothers unless when clearly needed and only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child. In case vaccination is needed, it is recommended to interrupt breastfeeding for at least 2 weeks following vaccination.
There are very few reports suggesting that transmission of yellow fever vaccine virus may occur from nursing mothers, who received yellow fever vaccine postpartum, to the infants. Following transmission the infants may develop YEL-AND from which the infants recover.

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.

Data from the 2 most representative studies for safety profile of Stamaril are presented below.
General population. Safety data of Stamaril were collected in 1,252 subjects during a blind observer, randomised safety study conducted on 2,514 subjects from 1 to 85 years old with a median age of 21 years receiving either Stamaril or another yellow fever vaccine.
The safety profile was assessed during the first 3 weeks following vaccination as follows:
Solicited injection site and local reactions within 8 days (D0-7) post-vaccination.
Unsolicited and serious adverse events and reactions within 21 days from vaccination.

Solicited reactions.

Headache, asthenia and injection site pain were the most frequently reported adverse reactions in the Stamaril group.
Solicited local reactions usually occurred within the first 3 days following vaccination, and usually lasted for not more than 3 days. Solicited systemic reactions usually occurred within the first 3 days following vaccination, except pyrexia, which occurred between day 4 and day 7. These events usually lasted for not more than 3 days.
The percentage of subjects experiencing at least one solicited local or systemic reaction was 15.3% and 30.4% respectively. Both local and systemic reactions were usually of mild intensity; only 0.8% of subjects had at least one severe solicited injection site reaction and 1.4% of subjects had at least one severe solicited systemic reaction.
The summary of adverse reactions from this study is available in Table 1.
Paediatric population: toddlers aged 12-13 months. The safety of Stamaril in paediatric population has been recently studied through a clinical study performed in 393 toddlers aged 12 to 13 months. They received Stamaril and placebo concomitantly at different sites.
The safety profile was assessed during the first 4 weeks following vaccination as follows:
Solicited injection site and local reactions within 8 days (D0-7) and 15 days (D0-14) post-vaccination respectively.
Unsolicited and serious adverse events and reactions within 28 days from vaccination.

Solicited reactions.

Irritability, appetite loss and crying were the most frequently reported adverse reactions.
Solicited local reactions usually occurred within the first 3 days following vaccination, and usually lasted for not more than 3 days. Solicited systemic reactions usually occurred within the first 3 days following vaccination, except pyrexia, which occurred with similar rates from day 0 to day 3 as from day 4 to day 7 and day 8 to day 14. These events usually lasted for not more than 3 days.
The percentage of subjects experiencing at least one solicited local or systemic reaction was 30.6% and 63.5% respectively. Both local and systemic reactions were usually of mild intensity; only one toddler (0.3%) experienced a severe solicited injection site reaction (at both Stamaril and placebo administration sites) and 19 toddlers (4.9%) had at least 1 severe solicited systemic reaction.
The summary of adverse reactions to Stamaril from this study is available in Table 2.

Post-marketing experience.

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

Skin and subcutaneous tissue disorders.

Urticaria.

Blood and lymphatic system disorders.

Lymphadenopathy, transient moderate leucopenia.

Immune system disorders.

Anaphylactoid reaction including angioedema.

Nervous system disorders.

Neurotropic disease, described as Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND), sometimes fatal, has been reported to occur within 30 days following vaccination with Stamaril, and also with other Yellow Fever vaccines. The clinical presentation has varied, and includes either encephalitis (with or without demyelination), or a neurologic disease with peripheral nervous system involvement (e.g. Guillain-Barré syndrome). Encephalitis usually starts with high fever with headache that may progress to include encephalopathy (e.g. confusion, lethargy, personality change lasting more than 24 hours), aseptic meningitis, focal neurologic deficits, cerebellar dysfunction or seizures. YEL-AND with peripheral nervous system involvement usually manifests as bilateral limb weakness or peripheral cranial nerve paresis with decreased or absent tendon reflexes. See Section 4.4 Special Warnings and Precautions for Use).
Neurologic diseases and neurologic manifestations not meeting the criteria for YEL-AND have been reported. These include aseptic meningitis, Guillain-Barré Syndrome, convulsions, focal neurological deficits, and seizures with no associated focal neurologic deficit.
Syncope and paresthesia.

Infections and infestations.

Yellow fever vaccine associated viscerotropic disease (YEL-AVD, formerly described as "febrile multiple organ system failure").
YEL-AVD, sometimes fatal, has been reported following Stamaril and also following administration of yellow fever vaccines from other manufacturers. In the majority of cases reported, the onset of signs and symptoms was within 10 days after the vaccination.
Initial signs and symptoms are non-specific and may include pyrexia, myalgia, fatigue, headache and hypotension, potentially progressing quickly to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia and acute respiratory and renal failure.

General disorders and administration site conditions.

Influenza-like illness.

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.

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.

Stamaril is a live stabilised vaccine for active immunisation against yellow fever. Immunity appears 10 days after injection, lasts at least 10 years and may be life-long.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Stamaril has not been evaluated for the genotoxic potential.

Carcinogenicity.

Stamaril has not been evaluated for the carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Other ingredients.

Stabilising medium.

16.0 mg lactose monohydrate, 8.0 mg sorbitol, 833 microgram histidine hydrochloride, 362 microgram alanine, 1.6 mg sodium chloride, 54 microgram potassium chloride, 298 microgram dibasic sodium phosphate dihydrate, 63 microgram monobasic potassium phosphate, 39 microgram calcium chloride dihydrate, 29 microgram magnesium sulfate heptahydrate.

Diluent.

0.4% sodium chloride solution.

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