Basic Information
Rotarix Oral Suspension (Tube)
SUSPENSION
Regulatory Information
SIN13813P
June 1, 2010
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XJ07BH01
Company Information
Active Ingredients
Strength: Not less than 10⁶ CCID₅₀/dose (1.5 ml)
Detailed Information
Contraindications
**Contraindications** _**Rotarix**_ should not be administered to subjects who have on-going diarrhoea or vomiting. _**Rotarix**_ should not be administered to subjects with known hypersensitivity after previous administration of _**Rotarix**_ vaccine or to any component of the vaccine ( _see sections Qualitative and Quantitative Composition and List of Excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Subjects with history of intussusception. Subjects with uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose to intussusception. _**Rotarix**_ should not be administered to subjects with known or suspected immune deficiency diseases and conditions such as combined immunodeficiency, hypogammaglobulinemia, agammaglobulinemia, human immunodeficiency virus (HIV) infection, thymic abnormalities, malignancy, leukemia, lymphoma, or advanced debilitating conditions. _**Rotarix**_ should not be administered to subjects who may be immunosuppressed or have an altered or compromised immune status, such as those who are being treated with systemic corticosteroids, alkylating drugs, antimetabolites, radiation, or other immunosuppressive therapies. Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section Adverse Reactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**Indications** **_Rotarix_** is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection ( _see sections Dosage and Administration, Warnings and Precautions and Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).