RotaTeq Oral Suspension

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.

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.

The vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age. Your doctor will gently squeeze the vaccine into your child’s mouth (see Figure 1). Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your doctor will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your doctor for advice.

RotaTeq 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 RotaTeq 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 RotaTeq is unaffected when OPV is administered two weeks apart from RotaTeq. Effects on ability to drive and use machines- not applicable.

Subjects with history of intussusception. Subjects with Severe Combined Immunodeficiency (SCID) disorder The presence of a minor infection, such as a cold, is not a contraindication for immunisation.

The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection. Call your child's doctor or go to the emergency department right away if your child has any of the following problems after getting RotaTeq, even if it has been several weeks since the last dose because these may be signs of a serious problem called intussusception:

• bad vomiting
• bad diarrhea
• severe stomach pain
• blood in the stool.

Intussusception happens when a part of the intestine gets blocked or twisted.

Other reported side effects include:

• allergic reactions, which may be severe and may include face and mouth swelling, difficulty breathing, wheezing, hives, and/or skin rash; and
• Kawasaki disease (a serious condition that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet and, if not treated, death can occur).

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

It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination. Parents/ guardians should be advised to seek medical advice promptly where these signs/symptoms are evident. There is a potential risk for transmission to non-vaccinated contacts. It should be administered with caution to infants with close contacts who are immunodeficient, such as household members with malignancies or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccinees should be advised to observe personal hygiene

Vaccines, Anti-sera & Immunoglobulin

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