Active immunization of infants from 6 to 24 weeks of age to prevent gastroenteritis caused by rotavirus infection. The use of the vaccine should be based on official recommendations.
Composition:
1 dose (1.5 ml) contains not less than 106 CCID50 human rotavirus, live, attenuated. The product contains sucrose.
Action:
Vaccine for active immunization against rotavirus infections. In clinical trials, efficacy against gastroenteritis caused by rotaviruses like G1P [8], G2P [4], G3P [8], G4P [8] and G9P [8] has been demonstrated. After vaccination, the vaccine virus is excreted in the stool; excretion is most pronounced about the 7th day after vaccination. The vaccine is intended for direct administration.
Contraindications:
Hypersensitivity to the components of the preparation. Hypersensitivity reactions after previous administration of rotavirus vaccines. The presence of intussusception in an interview. Uncorrected congenital gastrointestinal defects that predispose to intussusception. Severe combined immunodeficiency. acute infections with fever (less severe infections are not a contraindication). Do not use in patients with diarrhea or vomiting.
Precautions:
The vaccine must not under any circumstances be injected. There are no data on the safety and efficacy of children with gastro-intestinal disorders or growth retardation; in these children, administration of the vaccine can be considered with caution if unseeding it creates a greater risk. Pay attention to symptoms suggestive of intussusception (acute abdominal pain, persistent vomiting, bloody stools, abdominal distension and / or high fever). It is not expected that asymptomatic or low-grade HIV infection will affect the safety or efficacy of the vaccine. Administration of the vaccine to children with known or suspected immunodeficiency should be preceded by careful consideration of potential benefits and risks. The vaccine should be used with caution in people who are in close contact with immunodeficient patients, such as people with cancer, people with immune deficiencies caused by other factors, and those treated with immunosuppressive therapy. The risk of apnea and the need to monitor respiratory function for 48-72 h should be considered when administering primary immunization doses to very premature premature babies (born ≤28 weeks of gestation), especially for children with symptoms of immaturity of the respiratory system. Due to the significant benefits of vaccinating this group of infants, vaccination should not be withheld or deferred. A protective immune response may not be induced in all vaccinated individuals. There are no data available on the use of the vaccine for prophylaxis after exposure to the virus. Due to the sucrose content, the preparation should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Not applicable - preparation for children.
Side effects:
Common: diarrhea, irritability. Uncommon: flatulence, abdominal pain, dermatitis. Post-marketing adverse reactions: apnea in very premature infants (born ≤28 weeks pregnancies); the presence of blood in the stool; gastroenteritis with excretion of the vaccine virus in children with severe complex immunodeficiency. In addition, cases of intussusception have been reported that have a temporal relationship with the administration of the vaccine, most of these cases have been reported within 7 days of the first dose.
Dosage:
Orally. The vaccination schedule consists of two doses: the first dose can be given from 6 weeks of age, the second best before 16 weeks, at the latest by 24 weeks. The dose interval should be at least 4 weeks. The preparation can be administered according to this scheme to premature babies born not earlier than after 27 weeks of pregnancy.If an incomplete dose is ingested, a replacement dose can be given during the same visit.
(C)
