Rotarix

Rotarix

rotavirus vaccine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Human rotavirus RIX4414 strain (live, attenuated) vaccine
Indications/Uses
Active immunisation of infant 6-24 wk of age for prevention of gastroenteritis due to rotavirus infection.
Dosage/Direction for Use
PO 2-dose vaccination course: 1st dose may be administered from age of 6 wk w/ at least 4-wk interval between doses. The vaccination course should preferably be given before 16 wk of age & must be completed by 24 wk of age.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to any component of the vaccine. Hypersensitivity after previous administration of rotavirus vaccines. History of intussusception; uncorrected congenital malformation of the GIT that would predispose for intussusception; severe combined immunodeficiency disorder. Postpone vaccination in acute severe febrile illness, diarrhoea or vomiting.
Special Precautions
Do not inj. Follow-up on any symptom indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating &/or high fever). Carefully consider potential benefits & risks before administration in infants who have known or suspected immunodeficiency. Caution to individuals w/ immunodeficient close contacts. Contacts of recent vaccinees should observe personal hygiene. Consider potential risk of apnoea & the need for resp monitoring for 48-72 hr when administering primary immunisation series to very premature infants & those w/ history of resp immaturity. Protective immune response may not be elicited in all vaccinees. Does not protect against gastro-enteritis due to other pathogens than rotavirus. Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine. Not for use in adults. Should not be used in childn >24 wk of age. No data on safety & efficacy in infants w/ GI illnesses or growth retardation.
Adverse Reactions
Drug Interactions
Can be given concomitantly w/ diphtheria-tetanus-whole cell pertussis vaccine, diphtheria-tetanus-acellular pertussis vaccine, Hib vaccine, inactivated polio vaccine, HBV vaccine, pneumococcal conjugate vaccine & meningococcal serogroup C conjugate 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
1's
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