Tuesday, April 11, 2017 by Gregory Van Dyke
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RotaTeq safely and effectively. See full prescribing information for RotaTeq.
See full insert sheet at this link at the Natural News Reference website.
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
Initial U.S. Approval: 2006
INGREDIENTS AND EXCIPIENTS
RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P), herein referred to as type P1A, from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain.
The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents.
The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives.
In the manufacturing process for RotaTeq, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans
RotaTeq is a pale yellow clear liquid that may have a pink tint.
The plastic dosing tube and cap do not contain latex.
INDICATIONS AND USAGE
RotaTeq is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9. (1)
RotaTeq is approved for use in infants 6 weeks to 32 weeks of age. (1)
DOSAGE AND ADMINISTRATION
FOR ORAL USE ONLY. NOT FOR INJECTION. (2)
The vaccination series consists of three 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. (2)
DOSAGE FORMS AND STRENGTHS
2 mL solution for oral administration of 5 live human-bovine reassortant rotaviruses which contains a minimum of 2.0 – 2.8 x 106 infectious units (IU) per reassortant dose, depending on the reassortant, and not greater than 116 x 106 IU per aggregate dose. (3)
A demonstrated history of hypersensitivity to the vaccine or any component of the vaccine. (4.1)
History of Severe Combined Immunodeficiency Disease (SCID). (4.2, 6.2)
History of intussusception. (4.3)
WARNINGS AND PRECAUTIONS
No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised (e.g., HIV/AIDS). (5.2)
In a post-marketing study, 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. (5.3, 6.2)
No safety or efficacy data are available for the administration of RotaTeq to infants with a history of gastrointestinal disorders (e.g., active acute gastrointestinal illness, chronic diarrhea, failure to thrive, history of congenital abdominal disorders, and abdominal surgery). (5.4)
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. (5.5)
Most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov4.
USE IN SPECIFIC POPULATIONS
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.
No human or animal data are available to assess the impact of RotaTeq on milk production, its presence in breast milk, or its effect on the breastfed infant.
Safety and effectiveness of RotaTeq have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.
Data are available from clinical studies to support the use of RotaTeq in pre-term infants according to their age in weeks since birth [see Adverse Reactions (6.1)].
Data are available from clinical studies to support the use of RotaTeq in infants with controlled gastroesophageal reflux disease.
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