Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
SUSPENSION
**Dosage and Administration** **Posology** The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is recommended that infants who receive a first dose of _**Rotarix**_ complete the 2-dose regimen with _**Rotarix**_. There are no data on safety, immunogenicity or efficacy when _**Rotarix**_ is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa. **Method of administration** _**Rotarix**_ is for **oral** use only. Administer the entire content (1.5 mL) of the tube **ORALLY** on the inside of the cheek. _**ROTARIX**_ SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. There are no restrictions on the infant’s consumption of food or liquid, including breast-milk, either before or after vaccination. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by _**Rotarix**_. Therefore, breast-feeding may be continued during the vaccination schedule. For information on instructions for administration, see section _Use and Handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
ORAL
Medical 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_).
**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_).
J07BH01
rota virus, live attenuated
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals s.a.
Active Ingredients
HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN
Not less than 10⁶ CCID₅₀/dose (1.5 ml)
Documents
Package Inserts
Rotarix Oral Suspension (Tube) PI.pdf
Approved: November 15, 2022