MedPath
HSA Product

STAMARIL VACCINE

Product approved by Health Sciences Authority (SG)

Basic Information

STAMARIL VACCINE

INJECTION

Regulatory Information

SIN08682P

April 30, 1996

Prescription Only

Therapeutic

SUBCUTANEOUS, INTRAMUSCULAR

August 10, 2023

May 30, 2025

XJ07BL01

Company Information

Active Ingredients

LIVE ATTENUATED YELLOW FEVER VIRUS STRAIN 17 D

Strength: Not less than 1000 IU

Detailed Information

Contraindications

**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.

Indication Information

**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).

© Copyright 2025. All Rights Reserved by MedPath