OralPrevention of rotavirus gastroenteritisChild: As live attenuated monovalent rotavirus vaccine: 6-24 weeks 1 mL (using vial for reconstitution formulation) or 1.5 mL (using the ready-to-administer formulation) for 2 doses. 1st dose may be given beginning 6 weeks of age. The interval of the 2 doses must be at least 4 weeks and should be completed before 24 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.
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May be taken with or without food.
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Hypersensitivity. History of intussusception; severe combined immunodeficiency disorder (SCID). History of uncorrected congenital malformations of the gastrointestinal tract (e.g. Meckel’s diverticulum) that would predispose to intussusception. Children born to mothers who received immunosuppressive biological therapy during pregnancy including exposure via breastfeeding.
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Patient with history or active gastrointestinal illnesses (e.g. chronic diarrhoea, failure to thrive, congenital abdominal disorders, abdominal surgery); known or suspected immunodeficiency (e.g. infants with HIV, cancer involving bone marrow or lymphatic system; receiving immunosuppressive therapy, blood transfusion or blood products); growth retardation; very premature infants or with history of respiratory immaturity. Presence of immunocompromised family members or closed contacts (e.g. patients with cancer, receiving immunosuppressive therapy). Postpone vaccination in patients with diarrhoea, vomiting or acute severe febrile illness. Children.
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Ear and labyrinth disorders: Otitis media.
Gastrointestinal disorders: Vomiting, diarrhoea, flatulence, abdominal pain.
General disorders and administration site conditions: Fussiness or irritability, fever.
Metabolism and nutrition disorders: Loss of appetite.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough, runny nose, bronchospasm.
Skin and subcutaneous tissue disorders: Dermatitis.
Vascular disorders: Kawasaki disease.
Potentially Fatal: Intussusception.
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Assess for sign and symptoms of intussusception (e.g. high fever, persistent vomiting, severe abdominal pain, abdominal bloating, bloody stools) and hypersensitivity or anaphylactoid reactions.
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Reduced immune response or increased risk of generalised infection when used concomitantly with immunosuppressants (e.g. corticosteroids, antimetabolites, alkylating agents, cytotoxic drugs).
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May decrease the diagnostic effect of tuberculin tests.
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Description:
Mechanism of Action: Rotavirus vaccine is an oral, live vaccine which replicates in the small intestine and provides active immunity against rotavirus gastroenteritis. It has 2 commercially available forms used for prophylaxis of rotavirus gastroenteritis: a) live, attenuated monovalent vaccine derived from human rotavirus strain indicated for rotavirus serotypes G1, G3, G4 and G9; and b) live, pentavalent vaccine with 5 live reassortant rotaviruses isolated from human and bovine hosts indicated for rotavirus serotypes G1, G2, G3, G4 and G9. The exact immunologic mechanism is still unknown and the relationship between antibody response and protection against gastroenteritis was not yet established.
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Store between 2-8°C. Do not freeze. Protect from light. Any unused portions should be disposed of in accordance with local requirements.
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J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.
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Anon. Rotavirus Vaccine Live Oral. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 09/11/2023. Anon. Rotavirus Vaccine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/11/2023. Buckingham R (ed). Rotavirus Vaccine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/11/2023. GlaxoSmithKline NZ Limited. Rotarix Live Attenuated Vaccine Oral Liquid data sheet 09 March 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 09/11/2023. Joint Formulary Committee. Rotavirus Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/11/2023. Paediatric Formulary Committee. Rotavirus Vaccine. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 09/11/2023. Rotarix Oral Suspension (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/11/2023. Rotarix Vaccine Oral Suspension (GlaxoSmithKline Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/11/2023. Rotarix Vaccine, Live, Oral Solution (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/11/2023. Rotateq Vaccine, Live, Oral, Pentavalent Solution (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/11/2023.
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