ROTATEQ

It is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). Itis approved for use in infants 6 weeks to 24 weeks of age

Vaccines, Anti-sera & Immunoglobulin

Rotavirus Vaccine is an oral vaccine used to help prevent rotavirus infection in children. Rotavirus infection can cause fever, vomiting, and diarrhea that can be severe and can lead to loss of body fluids (dehydration), hospitalization and even death in some children. Rotavirus Vaccine may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them. Rotavirus is one of the important causes of severe acute gastroenteritis in infants and young children. There are 2 commercially available forms of rotavirus vaccine. Rotavirus is a live, attenuated monovalent vaccine derived from human strain indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4 and G9 serotypes; Rotavirus as a live, pentavalent human-bovine reassortant vaccine indicated for prevention of gastreoenteritis caused by rotavirus serotypes G1, G2, G3 and G4. Although presence of porcine cirovirus (PCV1 and PCV2) DNA have been detected in the rotavirus vaccine, current available information shows that there is no evidence that PCV1 or PCV2 poses a safety risk to humans. Exact immunologic mechanism of action is not fully understood although it is known that vaccine viruses replicate in the small intestine and promote active immunity.

FOR ORAL USE ONLY. ? Each dose is 1 mL administered orally. ? Administer first dose to infants beginning at 6 weeks of age. ? Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age

Rotavirus vaccine can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: Diphtheria-tetanus-whole cell pertussis vaccine (DTPw), Diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib). inactivated Polio vaccine (IPV), Hepatitis B vaccine and Pneumococcal vaccine. Concomitant administration of Rotavirus vaccine and oral polio vaccine (OPV) does not affect the immune response to the polio antigens. Although concomitant administration of OPV may slightly reduce the immune response to rota virus vaccine there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected. The immune response to Rotavirus vaccine is unaffected when OPV is administered two weeks apart from Rotavirus vaccine. Effects on ability to drive and use machines- not applicable.

A demonstrated history of hypersensitivity to the vaccine or any component of the vaccine. ? History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. ? History of intussusception. ? History of Severe Combined Immunodeficiency Disease (SCID).

Very common areirritability, loss of appetite; common arediarrhoea, vomiting, flatulence, abdominal pain, regurgitation of food, fever, fatigue; uncommon are- crying, sleep disorder, somnolence, constipation rare; upper respiratory tract infection hoarseness, rhinorrhoea, dermatitis, rash, muscle cramp; very rare- gastro-enteritis. In a large safety trial, subjects vaccinated with Rotavirus vaccine gave evidence of no increased risk of intussusception when compared with subjects receiving a placebo.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Store refrigerated at 2° to 8°C. Protect vials from light.

Rotavirus vaccine containing- 5 live rotavirus strains (G1, G2, G3, G4, and P1). Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.