Active immunization of infants from the age of six weeks to prevent gastroenteritis caused by rotavirus infection. The preparation should be used in accordance with official recommendations.
Composition:
1 dose (2 ml) contains not less than 2.2 x 106 IU rotavirus serum G1, 2.8 x 106 IU rotavirus serotype G2, 2.2 x 106 IU rotavirus G3 serum, 2.0 x 106 IU rotavirus serotype G4 and 2.3 x 106 IU of the P1 serotype rotavirus [8]. The product contains sucrose.
Action:
Vaccine for active immunization against rotavirus infections. After administration of 3 doses, the level of IgA directed against rotaviruses is significantly increased in the serum. After vaccination, the vaccine virus is excreted in the stool; excretion is most pronounced about the 7th day after vaccination.
Contraindications:
Hypersensitivity to the components of the preparation. Hypersensitivity after previous administration of a rotavirus vaccine. Occurrence of intussusception in the past. Congenital gastrointestinal defects that predispose to intussusception. Children with known or suspected immunodeficiency. Asymptomatic HIV infection does not affect the safety and efficacy of the vaccine, however, due to the lack of sufficient data, administration of the vaccine to infants with asymptomatic HIV infection is not recommended. The date of vaccine administration should be postponed in children who have a severe disease with high fever. The presence of a small infection is not a contraindication to vaccination. The timing of the vaccine should be postponed in children with acute diarrhea or vomiting.
Precautions:
The safety and efficacy of the vaccine in HIV-infected children or children who have been transfused with blood or given immunoglobulins within 42 days before or after the vaccine has not been established. Theoretically, it is possible to transfer the vaccine virus to non-vaccinated people. Caution should be exercised when administering the vaccine to people who are in close contact with immunodeficient persons. People dealing with the care of recently vaccinated people should observe careful hygiene, especially dealing with excreta. No data are available on the safety and efficacy of the vaccine in infants with active gastrointestinal disease (including chronic diarrhea) or growth retardation - these infants may be considered to be administered with caution if refraining from vaccination is associated with greater risk. There are no data on the use of the vaccine in prophylaxis after exposure to infection. Due to the sucrose content, patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not be given this vaccine. The potential risk of apnea and the need to monitor respiratory function for 48-72 hours should be considered for the first vaccination course of premature infants (at 28 weeks gestation or earlier), especially for those with a history of immaturity in the respiratory system due to the benefits of vaccinations should not be neglected or postponed.
Pregnancy and lactation:
Not applicable - preparation for children.
Side effects:
Very common: diarrhea, vomiting, fever. Common: infection of the upper respiratory tract. Uncommon: rhinitis, epigastric pain, rash. In addition, fecal blood, urticaria and gastroenteritis associated with vaccine virus have been observed in infants with severe combined immunodeficiency.
Dosage:
Orally. The vaccination schedule consists of three doses: the first dose can be given from 6 weeks of age, but no later than 12 weeks of age. The vaccine may be given to premature infants, provided that the period of pregnancy was at least 25 weeks, the first dose should be given at least 6 weeks after birth. Subsequent doses should be administered at least 4 weeks apart. All doses should be administered before 20-22 weeks, at the latest before 26 weeks.life. If an incomplete dose is ingested, an additional dose can be given during the same visit, however this has not been studied in clinical trials. If the problem recurs, do not administer an additional dose. The vaccine can be administered independently of food, liquids or breast milk. Due to the lack of data on the substitution of RotaTeq with another rotavirus vaccine, it is recommended that infants who receive the first dose of RotaTeq receive the Next dose of the same vaccine. It is not recommended to administer further doses of the vaccine after completing the 3-dose vaccination course.
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