Stamaril Special Precautions

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.
STAMARIL PASTEUR 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).
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 PASTEUR 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.
Yellow fever vaccine associated neurotropic disease (YEL-AND): Very rarely, yellow fever vaccine-associated neutropic disease (YEL-AND) has been reported following vaccination, with sequel 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 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 recognised as a predisposing factor (see CONTRAINDICATIONS). 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 they feel, after vaccination, any symptoms indicative of YEL-AND such as high fever together with headache or confusion, personality change, or if they feel 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, yellow fever vaccine-associated viscerotropic disease (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 vaccines 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 recognized as a predisposing factor (see CONTRAINDICATIONS and ADVERSE REACTIONS). 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 they feel, 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 they received a yellow fever vaccine (see ADVERSE REACTIONS).
Immunosuppressed persons: STAMARIL PASTEUR 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 PASTEUR must not 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) may be vaccinated if it is confirmed that they are not infected with HIV.
HIV infected children aged at least 6 months who are potentials in need of protection against yellow fever should be referred to a specialist paediatric team for advice on whether or not to vaccinate.
Age: 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 ADVERSE REACTIONS).
Transmission: There are 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 yellow fever vaccine associated neurotropic disease (TEL-AND) from which the infants recover (see USE IN PREGNANCY AND LACTATION).
As with any vaccine, vaccination with STAMARIL PASTEUR may not protect 100% of vaccinated individuals.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly registered.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: No studies on the effects on the ability to drive or use machine have been performed.