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ABRIDGED PRESCRIBING INFORMATIONSTAMARIL® Powder and solvent for
suspension for injection in a pre-filled syringe.
Yellow fever vaccine (Live)
Refer to Summary of Product Characteristics for full product information before
prescribing.
Active ingredients: One dose (0.5ml) of the reconstituted vaccine contains the live,
attenuated 17D-204 strain of the yellow fever virus, not less than 1000 IU.
Indication: Active immunisation against yellow fever in adults and children aged
≥9months, for persons travelling to, passing through or living in an endemic area.
Travelling to any country that requires an International Certificate of Vaccination for
entry (which may or may not depend on the previous itinerary). Handling potentially
infectious materials (e.g. laboratory personnel).
Dosage: STAMARIL® is to be used on the basis of official recommendations. Adults
and children aged 9 months and over: A single dose of 0.5 ml of reconstituted
vaccine. The vaccine must not be given to children less than 6 months old.
Vaccination against yellow fever is not usually recommended in children aged from 6
months up to 9 months except in specific circumstances and in accordance with
available official recommendations, in which case the dose is the same as in older
children and adults. The vaccine should be given at least 10 days before entering an
endemic area since protective immunity may not be achieved until at least this time
has elapsed. In the elderly the dose is the same as for adults. However due to a
higher risk of yellow fever vaccine-associated severe and potentially fatal disease in
persons from 60 years of age, the vaccine should only be given when it is considered
that there is a considerable and unavoidable risk of acquiring yellow fever infection.
Administration: It is preferable to give the reconstituted vaccine by subcutaneous
injection. Intramuscular injection may be performed if this is in accordance with
applicable official recommendations. For intramuscular use the recommended
injection sites are the anterolateral aspect of the thigh in infants and toddlers (6
months up to 2 years of age) and the deltoid muscle in older children and adults. DO
NOT INJECT INTRAVASCULARLY. STAMARIL® may be administered at the same
time as vaccines containing typhoid Vi capsular polysaccharide and/or inactivated
hepatitis A virus and measles vaccine if this is in accordance with official
recommendations. STAMARIL® must not be mixed with any other vaccine or
medicinal product in the same syringe. If there is a need to administer another
injectable vaccine(s) at the same time as STAMARIL® each vaccine should be
injected into a separate site (and preferably a separate limb). STAMARIL® must not
be administered to persons who are receiving immunosuppressant therapy (e.g.,
cytotoxic agents, systemic steroids, greater than standard dose of topical or inhaled
steroids or other agents). Revaccination with one 0.5ml dose every 10 years is
recommended for persons at risk of infection or if required by International Health
Regulations to retain a valid vaccination certificate.
Contraindications: Hypersensitivity reactions to eggs, chicken proteins or any
component of STAMARIL®; previous serious hypersensitivity reaction to any yellow
fever vaccine; immunosuppression (congenital, idiopathic or caused by treatment
with systemic steroids, radiotherapy or cytotoxic drugs); history of thymus dysfunction
(including thymoma, thymectomy); symptomatic HIV infection; asymptomatic HIV
infection when accompanied by evidence of impaired immune function; current
severe febrile illness. Age less than 6 months of age.
Warnings and precautions: Appropriate treatment and supervision should be
readily available in case of anaphylaxis or other severe hypersensitivity reaction
following vaccine administration. Yellow fever vaccine should only be given to
persons who are at risk of infection or in cases to comply with International Health
Regulations. Very rarely, yellow fever vaccine-associated neurotropic disease (YEL-
AND) has been reported following vaccination, with sequelae or with fatal outcome in
some cases. Clinical features have appeared within one month of vaccination and
include high fever with headache that may progress to include one or more of the
following: confusion, encephalitis/encephalopathy, meningitis, focal neurological
deficits, or Guillain Barré syndrome. To date, those affected have been primary
vaccinees. The risk appears to be higher in those aged over 60 years, although
cases have been also reported in younger persons or following transmission from
nursing mothers to the infants. Very rarely, yellow fever vaccine-associated
viscerotropic disease (YEL-AVD) resembling fulminant infection by wild-type virus
has been reported following vaccination. 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, all
cases of YEL-AVD have been in primary vaccinees with 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 younger persons. Disease of the thymus gland has
also been recognised as a potential risk factor. As some adverse reactions appear to
occur at higher frequencies after the age of 60 years, therefore the vaccines should
only be given to those who have considerable risk of acquiring yellow fever in this
age group. STAMARIL® must not be administered to immunosuppressed persons. If
the immunosuppression is temporary, vaccination should be delayed until the
immune function has recovered. In patients who have received systemic
corticosteroids for 14 days or more, it is advisable to delay vaccination until at least
one month after completing the course. STAMARIL® must not be administrated to
persons with symptomatic HIV infection or with asymptomatic HIV infection when
accompanied by evidence of impaired immune function. Official guidance should be
taken into account when considering the risks and benefits of vaccinating an
asymptomatic HIV-infected person travelling to an endemic area. Children aged at
least 6 months may be vaccinated if it is confirmed that they are not infected with
HIV. HIV infected children aged at least 6 months who are potentially in need of
protection against yellow fever should be referred to a specialist paediatric team for
advice on whether or not to vaccinate. Children aged 6-9 months should only be
vaccinated under special circumstances (e.g. during major outbreaks) and on the
basis of current official advice. The potential risk of administration of STAMARIL®
during pregnancy is unknown. Vaccine should only be administered in pregnancy if
clearly needed and after careful risk/benefit analysis. Vaccine should not be given to
nursing mothers unless when clearly needed such as during an outbreak control, and
following an assessment of the risks and benefits. Patients with hereditary fructose
intolerance should not be given this vaccine.
Undesirable effects: Very common side effects include: headache and injection site
reactions (pain, redness, haematoma, induration, swelling). Common side effects
include: nausea, diarrhoea, vomiting, myalgia, pyrexia and asthenia. Post-marketing
studies have reported serious side effects including anaphylaxis, angioedema,
Guillain-Barré syndrome and focal neurological deficits. Cases of neurotropic
disease (YEL-AND) have been reported which may manifest as encephalitis,
encephalopathy and meningitis and may be fatal. Viscerotropic disease (YEL-AVD)
has been reported which may manifest as fever, fatigue, myalgia, headache and
hypotension progressing to one or more of metabolic acidosis, muscle and liver
cytolysis, lymphocytopenia, thrombocytopenia, renal and respiratory failure and may
be fatal. Immunodeficiency and age (>60 years) are risk factors for YEL-AND. A
history of thymic disease and age (> 60 years) are risk factors for YEL-AVD.
For a complete list of undesirable effects please refer to the Summary of Product
Characteristics.
Package quantities: Single pack containing vial of lyophilised powder with 0.5 millilitre
diluent in a syringe with 2 separate needles. Basic NHS cost £33.10.
Marketing authorisation holder: Sanofi Pasteur MSD Limited, Mallards Reach,
Bridge Avenue, Maidenhead, Berkshire SL6 1QP.
Marketing authorisation number: PL6745/0087
Legal category: POM
® Registered trademark
Date of last review: October 2013

Source: http://www.areyouready2go.co.uk/media/69300/105_Stamaril_II18_10-2013_UK_API.pdf