Storage and Handling For RotaTeq
Storage for RotaTeq
- Store and transport refrigerated at 2°C to 8°C (36°F–46°F). Protect from light.
- RotaTeq should be administered as soon as possible after being removed from refrigeration.
- The product must be used before the expiration date. RotaTeq should be discarded in approved biological waste containers according to local regulations.
- If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).
- Rotate stock so that vaccines with the soonest expiration dates are used first.3
- Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.3
- Never use expired vaccine; immediately remove it from the storage unit.3
- For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
CDC=Centers for Disease Control and Prevention.
Indications and Usage for RotaTeq
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age.
The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent), should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.
Infants with a history of intussusception should not receive RotaTeq.
No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.
In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.
No safety or efficacy data are available for administration of RotaTeq to infants with a history of gastrointestinal disorders.
Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.
In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.
In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.
RotaTeq may not protect all vaccine recipients against rotavirus.