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Live oral pentavalent rotavirus vaccine (RotaTeq, MSD) for infants: 2 ml oral solution in a single-dose squeezable tube; given as a 3-dose course from 6 to 32 weeks of age.

• Active immunisation of infants from 6 to 32 weeks of age for prevention of gastroenteritis due to rotavirus infectionPopulation: Infants 6-32 weeks of ageEgyptian Drug Authority (EDA), Technical Assessment Unit
• Active immunisation of infants from 6 to 32 weeks of age for prevention of rotavirus gastroenteritis, on the basis of official recommendationsPopulation: Infants 6-32 weeks of ageEuropean Medicines Agency (EMA)
• Prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4 and G9 when given as a 3-dose series to infants 6 to 32 weeks of agePopulation: Infants 6-32 weeks of ageDailyMed (U.S. National Library of Medicine)

• Very common: pyrexia, diarrhoea, vomiting. Common: upper respiratory tract infection. Uncommon: nasopharyngitis, otitis media, haematochezia, upper abdominal pain, rash. Rare: bronchospasm, urticaria. Very rare: intussusception. Not known (post-marketing): anaphylactic reaction, angioedema, gastroenteritis (including with vaccine viral shedding), irritability.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to the active substance or any excipient; hypersensitivity after previous administration of rotavirus vaccines; previous history of intussusception; congenital malformation of the gastrointestinal tract that could predispose to intussusception; known or suspected immunodeficiency. Postpone in acute severe febrile illness and in acute diarrhoea or vomiting (minor infection is not a contraindication).International label, same product · European Medicines Agency (EMA)
• US label: contraindicated after a severe allergic reaction (e.g. anaphylaxis) to any component or a previous dose, in infants with Severe Combined Immunodeficiency Disease (SCID), and in infants with a history of intussusception.International label, same product · DailyMed (U.S. National Library of Medicine)

• Observational studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (up to 6 additional cases per 100,000 infants); follow up symptoms such as severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating or high fever, and advise parents to report them promptly.International label, same product · European Medicines Agency (EMA)
• Vaccine virus is shed in stools (8.9% after dose 1, mostly within the first week) and transmission to non-vaccinated contacts has been observed; use with caution when close contacts are immunodeficient, and carers should observe careful hygiene when handling excreta. No data in immunocompromised or HIV-infected infants, or after blood transfusion/immunoglobulins within 42 days.International label, same product · European Medicines Agency (EMA)
• Very premature infants (born at or before 28 weeks of gestation): consider the potential risk of apnoea and the need for respiratory monitoring for 48-72 hours after primary immunisation; vaccination should not be withheld or delayed.International label, same product · European Medicines Agency (EMA)

• Routine infant vaccines (DTaP, Hib, IPV, hepatitis B, pneumococcal conjugate, MenC conjugate; DTaP-IPV-HBV-Hib hexavalent)Co-administration did not affect the immune responses or safety profiles of the co-administered vaccines; RotaTeq can be given concomitantly with these infant vaccines.European Medicines Agency (EMA)
• Oral poliomyelitis vaccine (OPV)Concomitant OPV slightly reduced the immune response to rotavirus vaccine without current evidence of reduced clinical protection; the response to RotaTeq was unaffected when OPV was given two weeks after RotaTeq.European Medicines Agency (EMA)

• RotaTeq is intended for use in infants only; human data on use during pregnancy or lactation are not available and animal fertility or reproduction studies have not been performed.International label, same product · European Medicines Agency (EMA)
• US label: RotaTeq is not approved for individuals 32 weeks of age and older; no human or animal data are available to assess vaccine-associated risks in pregnancy.International label, same product · DailyMed (U.S. National Library of Medicine)

• Rotavirus type G1 (human-bovine reassortant, live): Oral live reassortant rotaviruses replicate in the gut and induce serum neutralising antibodies and anti-rotavirus IgA, protecting against rotavirus gastroenteritis.
• Rotavirus type G2 (human-bovine reassortant, live): Oral live reassortant rotaviruses replicate in the gut and induce serum neutralising antibodies and anti-rotavirus IgA, protecting against rotavirus gastroenteritis.
• Rotavirus type G3 (human-bovine reassortant, live): Oral live reassortant rotaviruses replicate in the gut and induce serum neutralising antibodies and anti-rotavirus IgA, protecting against rotavirus gastroenteritis.
• Rotavirus type G4 (human-bovine reassortant, live): Oral live reassortant rotaviruses replicate in the gut and induce serum neutralising antibodies and anti-rotavirus IgA, protecting against rotavirus gastroenteritis.
• Rotavirus type P1A[8] (human-bovine reassortant, live): Oral live reassortant rotaviruses replicate in the gut and induce serum neutralising antibodies and anti-rotavirus IgA, protecting against rotavirus gastroenteritis.