Vaccine, rotavirus


Concise Prescribing Info
Dosage Details
Oral
Prevention of rotavirus gastroenteritis
Child: As live attenuated monovalent rotavirus vaccine: 6-24 weeks 1 mL or 1.5 mL (based on product used) for 2 doses, with an interval of at least 4 weeks. 1st dose must be given between 6-14 weeks of age; course should be completed before 24 weeks of age (preferably before 16 weeks of age). As live pentavalent human-bovine reassortant rotavirus vaccine: 6-32 weeks 2 mL for 3 doses. 1st dose given at 6-12 weeks of age, followed by subsequent doses at 4- to 10-week intervals; the 3rd dose should not be given after 32 weeks of age.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of intussusception, uncorrected congenital malformations of the gastrointestinal tract (e.g. Meckel’s diverticulum) that would predispose to intussusception, severe combined immunodeficiency (SCID) disorder. Children born to mothers who received immunosuppressive biological therapy during pregnancy.
Special Precautions
Patient with or with history of gastrointestinal illnesses, chronic diarrhoea, congenital abdominal disorders, failure to thrive, abdominal surgery, immunodeficiency, growth retardation, minor illnesses, personal or family history of febrile convulsions. Postpone vaccination in patients with diarrhoea, vomiting or acute severe febrile illness. Children. Pregnancy.
Adverse Reactions
Ear and labyrinth disorders: Otitis media.
Gastrointestinal disorders: Diarrhoea, flatulence, vomiting, haematochezia.
General disorders and administration site conditions: Irritability, fever.
Metabolism and nutrition disorders: Loss of appetite.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough, runny nose.
Vascular disorders: Kawasaki disease.
Potentially Fatal: Anaphylactoid or hypersensitivity reactions, intussusception.
Drug Interactions
Reduced immune response or risk of generalised infection when used concomitantly with immunosuppressants (e.g. corticosteroids).
Lab Interference
May interfere with tuberculin tests.
Action
Description: Rotavirus is one of the important causes of severe acute gastroenteritis in infants and young children. There are 2 commercially available forms of rotavirus vaccine, including, a) live, attenuated monovalent vaccine derived from human strain indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4 and G9 serotypes; and b) live, pentavalent human-bovine reassortant vaccine indicated for prevention of gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and G9. Although presence of porcine circoviruses (PCV1 and PCV2) DNA have been detected in the rotavirus vaccine, current available information shows that there is no evidence that PCV1 or PCV2 poses a safety risk to humans. The exact immunologic mechanism by which the vaccine protects against rotavirus gastroenteritis is unknown. However, studies suggest a combination of factors is important in rotavirus immunity including neutralising antibodies to the outer capsid G proteins, serum and secretory IgA, and other local mucosal responses.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.
References
Anon. Rotavirus Vaccine Live Oral. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 26/06/2018.

Anon. Rotavirus Vaccine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/06/2018.

Buckingham R (ed). Rotavirus Vaccine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2018.

Joint Formulary Committee. Rotavirus Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2018.

Rotarix (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

RotaTeq (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 26/06/2018.

Disclaimer: This information is independently developed by MIMS based on Vaccine, rotavirus from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Rotarix
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