Stamaril

/ Medici

Primary vaccination: 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.
Adults: a single dose of 0.5 ml of the reconstituted vaccine.
Paediatric population:
– Children aged 9 months and older: a single dose of 0.5 ml of the reconstituted vaccine.
– Children from 6 to 9 months of age: Vaccination against yellow fever is not 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.
– Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age.
Older people: The dose is the same as for adults. However due to a potentially 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 significant and unavoidable risk of acquiring yellow fever infection.
Re-vaccination: The duration of protection following administration of one single 0.5 ml dose of STAMARIL is expected to be at least 10 years and may be life-long.
Re-vaccination with one dose of 0.5 ml.
Re-vaccination may be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.
Method of administration: It is preferable that the vaccine is injected by the subcutaneous route.
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 children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age, or the deltoid muscle in children from 36 months of age onwards and adults.
DO NOT INJECT INTRAVASCULARLY.

STAMARIL is indicated for active immunization against yellow fever in 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).
See sections 4.2, 4.3 and 4.4 at the attached doctor’s leaflet regarding the minimum age for vaccination of children under special circumstances and guidance for vaccination of other specific patient populations.
In order to comply with vaccine regulations and to be officially recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination center and registered on an International Certificate of Vaccination. The validity period of this certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination.

Hypersensitivity to the active substance or to any of the excipients or to eggs or chicken proteins.
Severe hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any yellow fever vaccine.
Age less than 6 months.
Immunosuppression, whether congenital, idiopathic or as a result of treatment with systemic steroids (greater than the standard dose of topical or inhaled steroids), radiotherapy or cytotoxic drugs.
History of thymus dysfunction (including myasthenia gravis, thymoma, thymectomy).
Symptomatic HIV infection.
Asymptomatic HIV infection when accompanied by evidence of impaired immune function.
Moderate or severe febrile illness or acute illness.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylaxis or other severe hypersensitivity reaction following administration of the vaccine.
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 injury from faints and manage syncopal reactions.
DO NOT INJECT INTRAVASCULARLY.
Because intramuscular injection can cause injection site haematoma, STAMARIL should not be given by the intramuscular route to persons with any bleeding disorder, such as haemophilia or thrombocytopenia, or to persons on anticoagulant therapy. The subcutaneous route of administration should be used instead.
STAMARIL should be administered only to persons who are/will be at risk of infection with yellow fever virus or who must be vaccinated to comply with international health regulations. Before considering administration of yellow fever vaccine, care should be taken to identify those who might be at increased risk of adverse reactions following vaccination.
Yellow Fever Vaccine-Associated Neurotropic Disease (YEL-AND): Very rarely, YEL-AND has been reported following vaccination, with sequelae or with fatal outcome in some cases. 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 infants exposed to vaccine through breastfeeding) although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognized as a potential risk factor.
Yellow Fever Vaccine-Associated Viscerotropic Disease (YEL-AVD): Very rarely, YEL-AVD resembling fulminant infection by wild-type virus has been reported following vaccination. 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. History of thymus dysfunction has also been recognized as a potential risk factor.
Immunosuppressed persons: 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.
HIV infection: STAMARIL must not be administrated 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.
Children born to HIV positive mothers: 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.
Age
Paediatric population: children less than 9 months of age: Children aged from 6 months up to 9 months should only be vaccinated under special circumstances (e.g. during major outbreaks) and on the basis of current official advice. STAMARIL is contraindicated in children less than 6 months of age.
Older people: persons aged 60 years and older: Persons aged 60 years and older may have an increased risk of serious and potentially fatal adverse reactions (including systemic and neurological reactions persisting more than 48 hours, YEL-AVD and YEL-AND) when compared to other age groups. Therefore, the vaccine should only be given to those who have a significant risk of acquiring yellow fever.
Pregnant and breast-feeding women: STAMARIL should not be used in pregnant and breast-feeding woman unless when clearly needed and following an assessment of the risks and benefits.
Transmission: 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 infant. Following transmission the infants may develop YEL-AND from which the infants recover.
As with any vaccine, vaccination with STAMARIL may not protect 100% of vaccinated individuals.

In the most representative study in general population, the most frequently reported reactions (between 12% and 18% of subjects) were headache, asthenia, injection site pain and myalgia.
In the most representative study in toddler population, the most frequently reported reactions (between 32% and 35% of toddlers) were irritability, crying and appetite loss.
Adverse reactions usually occurred within the first three days following vaccination except pyrexia, which occurred between Day 4 and Day 14.
These reactions usually lasted for not more than 3 days.
Both local and systemic reactions were usually of mild intensity; however at least one severe injection site reaction was reported in 0.8% of subject in general population and in 0.3% of toddlers and at least one severe systemic reaction was reported in 1.4% of subjects in general population and 4.9% in toddlers.
See prescribing information for full details.

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).
This vaccine may be administered at the same time as measles vaccine if this is in accordance with official recommendations.
It may be administered at the same time as vaccines containing typhoid Vi capsular polysaccharide and/or inactivated hepatitis A virus.
It 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).
It can induce false positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis.

Pregnancy: No animal developmental and reproductive studies have been conducted with STAMARIL and the potential risk for humans is unknown. Data on a limited number of exposed pregnancies indicate no adverse effects of STAMARIL on pregnancy or the health of the fetus/newborn child. Nevertheless, STAMARIL should be given to pregnant women only when clearly needed and only after careful consideration of the potential risks and benefits.
Lactation: As there is a probable risk of transmission of the vaccine virus strain to the infants from breast-feeding mothers, STAMARIL 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.

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 described in Section 4.8 at the attached doctor’s leaflet.

Incompatibilities: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Shelf life: The expiry date of the product is indicated on the packaging materials. After reconstitution, the medicinal product must be used immediately.
Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial of powder and the syringe of solvent in the outer carton in order to protect from light.