Rotasiil Ampoule
Rotasiil Ampoule Uses, Dosage, Side Effects, Food Interaction and all others data.
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. Rotarix®: 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.
Rotarix and Rotateq contain live attenuated and live virus respectively. The virus replicates in the intesine and interacts with the patient's immune system to produce immunity . Seroconversion has been defined as the appearance of anti-rotavirus IgA antibodies at concentrations greater than 20 U/mL post-vaccination in the serum of infants previously negative for rotavirus .
| Trade Name | Rotasiil Ampoule |
| Generic | Rotavirus vaccine |
| Rotavirus vaccine Other Names | Rota virus, live attenuated, Rotavirus vaccine, live, oral |
| Weight | 100000iu |
| Type | Liquid |
| Groups | Approved |
| Therapeutic Class | Vaccines, Anti-sera & Immunoglobulin |
| Manufacturer | Serum Institute Of India Private Limited |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Rotasiil Ampoule containing live attenuated human rotavirus RIX4414 strain. This vaccine is presented as 1 ml vial for oral administration.
Rotasiil Ampoule is used for the prevention of gastro-enteritis caused by rotavims, GI and non GI serotypes (such as G2, G3, G4, G9).
Rotasiil Ampoule is also used to associated treatment for these conditions: Rotavirus Gastroenteritis caused by rotavirus G1, Rotavirus Gastroenteritis caused by rotavirus G2, Rotavirus Gastroenteritis caused by rotavirus G3, Rotavirus Gastroenteritis caused by rotavirus G4, Rotavirus Gastroenteritis caused by rotavirus G9
How Rotasiil Ampoule works
The exact mechanism specific to the rotavirus vaccines' interaction with the immune system is uncharacterized .
Dosage
Rotasiil Ampoule dosage
The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between the dosages. The vaccination course should be completed by the age of 24 weeks. Lyophilised vaccine to be recostituted with a liquid diluent before oral administration. After reconstitution, 1 dose (1 ml) contains- live attenuated human rotavirus RIX4414 strain not less than 106 CCID50. Repeat dosing is not indicated if an infant should spit out, regurgitate or vomit during or after the administration of the vaccine. The vaccination course should be completed as recommended above. There are no restrictions on the infant's consumption of food or liquid, including breast-milk, either before or after vaccination.
Side Effects
In controlled clinical studies, the adverse reaction profile observed in the subjects receiving Rotasiil Ampoule was similar to the adverse reaction profile observed in subjects receiving placebo. No increase in the incidence or severity of these reactions was seen with the second dose.
However, some adverse reactions considered as being at least possibly related to Rotasiil Ampoule vaccination were reported. 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 Rotasiil Ampoule gave evidence of no increased risk of intussusception when compared with subjects receiving a placebo.
Toxicity
Rotasiil Ampoule may produce severe diarrhea and vomiting as a result of rotavirus infection . Post marketing reports suggest an increased risk of intussusception with rotavirus vaccine but this is unsupported by clinical data.
Precaution
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
Interaction
Rotasiil Ampoule 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 Rotasiil Ampoule 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 Rotasiil Ampoule is unaffected when OPV is administered two weeks apart from Rotasiil Ampoule. Effects on ability to drive and use machines- not applicable.
Half Life
The median duration of viral shedding was observed to be 10 days .
Pregnancy & Breastfeeding use
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
Contraindication
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.
Innovators Monograph
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FAQ
What is Rotasiil Ampoule used for?
Rotasiil Ampoule used to prevent rotavirus disease.
How safe is Rotasiil Ampoule?
The Rotasiil Ampoule is very safe, and it is effective at preventing rotavirus disease.Rotasiil Ampoule like any medicine, can have side effects. Most babies who get Rotasiil Ampoule do not have any problems with it.
How does Rotasiil Ampoule work?
The Rotasiil Ampoule contains a weakened version of rotavirus. This helps your baby build up immunity, so that the next time they come into contact with rotavirus they will not get the infection.
What are the common side effects of Rotasiil Ampoule?
Common side effects of Rotasiil Ampoule include:
- crying,
- mild irritability,
- fever,
- diarrhea, or.
- vomiting.
Is Rotasiil Ampoule safe during pregnancy?
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.
This product is not indicated for women of childbearing age and should not be administered to pregnant females.
Is Rotasiil Ampoule safe during breastfeeding?
Breastfeeding does not reduce the protection against rotavirus gastroenteritis.
The child being Rotasiil Ampoule may continue to be breastfed during taking Rotasiil Ampoule.
Can I drink alcohol with Rotasiil Ampoule?
There should be no problem drinking alcohol the day after the regular publicly funded taking Rotasiil Ampoule.
When should I take Rotasiil Ampoule?
The first dose of Rotasiil Ampoule should be given before a child is 15 weeks of age. Children should receive all doses of Rotasiil Ampoule before they turn 8 months of age.
How quickly does Rotasiil Ampoule work?
Your baby needs 2 Rotasiil Ampoule at least 4 weeks apart to be fully protected. If they miss the 1st dose, they can have it at up to 15 weeks. If they miss the 2nd dose, they can have it at up to 24 weeks.
How long does Rotasiil Ampoule stay in system?
The infection typically lasts for 3-8 days, but it can lead to problems such as severe lack of fluid in the body in younger children.
Why is Rotasiil Ampoule given orally?
Infection with Rotasiil Ampoule can affect the digestive system of babies and young children, causing severe stomach or intestinal illness. The Rotasiil Ampoule is used to help prevent this disease in children.
Can I skip Rotasiil Ampoule?
If they miss one of the Rotasiil Ampoule, the first one can be given a month later, at 12 weeks, and the second dose a month later, at 16 weeks.
Who should not take Rotasiil Ampoule?
Your child should not receive Rotasiil Ampoule if he or she has severe combined immunodeficiency disease (SCID).Rotasiil Ampoule should not be given if the child has a history of an intestinal problem called intussusception.
What happens if I miss a dose?
Contact your doctor if you miss a booster dose or if you get behind schedule. Your child may not be protected from rotavirus if the doses aren't given within 10 weeks of each other. Be sure your child receives all recommended doses of Rotasiil Ampoule.
