ROTARIX ORAL SUSPENSION (ORAL APPLICATOR)

GLAXOSMITHKLINE BIOLOGICALS S.A. (BELGIUM)🇸🇬 Health Sciences Authority

Approval Date: Dec 4, 2009
Approval ID: f0512a782149117a
Company: GLAXOSMITHKLINE BIOLOGICALS S.A. (BELGIUM)
Type: Therapeutic

Approval Details

Approval Id: f0512a782149117a
Drug Name: ROTARIX ORAL SUSPENSION (ORAL APPLICATOR)
Product Name: ROTARIX ORAL SUSPENSION (ORAL APPLICATOR)
Approval Number: SIN13743P
Approval Date: 2009-12-04
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: SUSPENSION
Dosage: 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. Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age (see sections Adverse Reactions and Pharmacodynamics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 oral applicator 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.
Route Of Administration: ORAL
Indication Info: 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: 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. 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).
Atc Code: J07BH01
Atc Item Name: rota virus, live attenuated
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN

Not less than 10⁶ CCID₅₀/dose (1.5 ml)

HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX4414 STRAIN

NOT LESS THAN 106 CCID50/DOSE (1.5 ML)

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 4, 2009

Approval ID

f0512a782149117a

Type

Therapeutic

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