Rotarix

Rotarix

rotavirus vaccine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Live attenuated human rotavirus RIX4414 strain not <106 CCID50
Indications/Uses
Prevention of gastroenteritis caused by rotavirus.
Dosage/Direction for Use
Oral vaccination consists of 2 doses: 1st dose to be given from 6 wk of age w/ at least 4-wk interval between doses. Vaccination must be completed by 24 wk of age (may be given to preterm infant w/ same posology).
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of intussusception; uncorrected congenital malformation (eg, Meckel's diverticulum) of the GIT. Severe combined immunodeficiency disorder (SCID).
Special Precautions
For oral use only. Postpone vaccination in patients w/ acute severe febrile illness, diarrhea or vomiting. Symptoms indicative of intussusception (eg, severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating &/or high fever). Infants w/ GI illness; individuals w/ immunodeficient close contacts eg, those w/ malignancies, immunocompromised or on immunosuppressive therapy. Observe careful hygiene after contact w/ recent vaccinee. Not for protection against gastroenteritis due to other pathogens than rotavirus. Do not administer through inj. Not intended for use in adults.
Adverse Reactions
Drug Interactions
May slightly reduce the immune response w/ oral polio vaccine.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.
Presentation/Packing
Form
Rotarix vaccine oral susp
Packing/Price
(pre-filled syringe) 1.5 mL x 10 × 1's (P1,800/oral susp); (pre-filled syringe) 1.5 mL x 1's (P1,800/oral susp)
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