Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
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 (see Section 4.3 and below).
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 (see Section 4.8). 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 predisposing condition (see Section 4.3). 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).
Yellow Fever Vaccine-Associated Viscerotropic Disease (YEL-AVD)
Very rarely, YEL-AVD resembling fulminant infection by wild-type virus has been reported following vaccination (see Section 4.8). 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 recognized as predisposing conditions (see Section 4.3). 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).
Immunosuppressed persons
STAMARIL must not be administered to immunosuppressed persons (see Section 4.3).
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 (see Section 4.3). 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 (see Sections 4.2 and 4.3 and below) 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 (see Section 4.3).
•     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 are visiting areas where there is an ongoing risk of yellow fever transmission at the time of travel.
Countries designated by WHO as where vaccination is not generally recommended, or not recommended, should be considered as not representing a significant and unavoidable risk (refer to updated WHO list of countries with risk of yellow fever transmission) (see above and Section 4.8).
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 (see Section 4.6).
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 (see Section 4.6).

As with any vaccine, vaccination with STAMARIL may not protect 100% of vaccinated individuals.
Latex
The tip caps of the prefilled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.

Excipients with known effect
STAMARIL contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
STAMARIL contains less than 1 mmol potassium (39 mg) per dose that is to say essentially “potassium free”.
STAMARIL contains approximately 8 mg of sorbitol (E420) per dose.

Effects on Driving

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.