STAMARIL VACCINE [SIN08682P]

Product Info

STAMARIL VACCINE

[SIN08682P]

4.1 Therapeutic indications

STAMARIL is indicated for active immunization against yellow fever in persons:

• travelling to, passing through or living in an area where there is a current or periodic risk of yellow fever transmission.

• 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 regarding the minimum age for vaccination of children under special circumstances and guidance for vaccination of other specific patient populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

For updated yellow fever vaccination requirements and recommendations consult the WHO dedicated website or refer to resources provided by national health authorities.

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 centre by a qualified and trained health care professional 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 (see Section 4.2).

4.2 Posology and method of administration

Posology
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 (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), in which case the dose is the same as in children aged 9 months and older.

• Children under 6 months of age: STAMARIL is contraindicated in children less than 6 months of age (see Section 4.3).

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 such as travel to an area where there is current or periodic risk of yellow fever transmission (see Sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

In accordance with WHO advice and International Health Regulations, the validity of a certificate of vaccination against yellow fever shall extend for the life of the person vaccinated. However, re-vaccination with one dose of 0.5 mL may be needed in individuals who had an insufficient immune response after their primary vaccination if they continue to be at risk for yellow fever virus infection. Re-vaccination may also be required, depending on official recommendations of local Health Authorities.

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.

Precautions to be taken before handling or administering the medicinal product.
For instructions on reconstitution of the medicinal product before administration, see Section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 or to eggs or chicken proteins – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Severe hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any yellow fever vaccine.

• Age less than 6 months (see Sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Immunosuppression, whether congenital, or acquired. This includes individuals receiving immunosuppressive therapies such as treatment with high-dose systemic corticosteroids (e.g. daily dose of 20 mg or 2 mg/kg body weight of prednisone or equivalent for 2 weeks or more or daily dose of 40 mg or more of prednisone for more than one week), any other medicinal products including biologicals with known immunosuppressive properties, radiotherapy, cytotoxic drugs or any other condition which may result in immunocompromised status.

• History of thymus dysfunction (including myasthenia gravis, thymoma).

• Thymectomy (for any reason).

• Symptomatic HIV infection.

• Asymptomatic HIV infection when accompanied by evidence of impaired immune function (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Moderate or severe febrile illness or acute illness.