Rotarix Oral Suspension (Tube)

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).

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.