Stamaril Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch name of the administered product should be clearly registered.
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 Contraindications and as follows).
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 Adverse Reactions). 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 breast-feeding), although cases have been also reported in other age groups. Congenital or acquired immunodeficiency has also been recognised as a predisposing factor (see Contraindication). However, YEL-AND cases have also been reported in persons without identified risk factors. The vaccinated persons must be informed of the need to request a medical opinion if the patient feels, after vaccination, any symptoms indicative of YEL-AND such as high fever together with headache or confusion, personality change, or if the patient feels extreme fatigue, neck stiffness, seizures, loss of movement or feeling in part or all of the body. Vaccinated persons should also be reminded to inform their health care provider that they received a yellow fever vaccine (see Adverse Reactions).
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 Adverse Reactions). 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 has also been recognised as a predisposing factor (see Contraindications). However, YEL-AVD cases have also been reported in persons without identified risk factors.
The vaccinated persons must be informed of the need to request a medical opinion if the patient feels after vaccination, any symptoms indicative of YEL-AVD such as fever, myalgia, fatigue, headache or hypotension, because these symptoms can potentially rapidly progress to liver dysfunction with jaundice, muscle cytolysis, thrombocytopenia and acute respiratory and renal failure. Vaccinated persons should also be reminded to inform their health care provider that the patient received a yellow fever vaccine (see Adverse Reactions).
Immunosuppressed persons: STAMARIL must not be administered to immunosuppressed persons (see Contraindications).
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 administered to persons with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function (see Contraindications). 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 Dosage & Administration and Contraindications and as follows) 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 Contraindications).
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 visit areas where there is a risk of yellow fever transmission at the time of travel. The countries designated by WHO, where vaccination is not recommended generally, or not recommended, should be considered as not presenting an inevitable significant risk (refer to the list of countries with yellow fever infection risk updated by WHO) (see as previously mentioned and Adverse Reactions).
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 Use in Pregnancy & Lactation).
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 latex derivative that could cause allergic reaction in people sensitive to latex.
Excipients with a known effect: STAMARIL contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free."
STAMARIL contains less than 1 mmol (39 mg) of potassium per dose, i.e. it is essentially "potassium-free".
STAMARIL contains about 8 mg of sorbitol (E420) per dose.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive or use machines have been performed.
Use in Pregnancy & Lactation: 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 Use in Pregnancy & Lactation).