Rotavirus vaccine

Indications & Dose:

Rotavirus vaccine is indicated for the prevention of gastroenteritis caused by Rotavirus, Gl and non Gl serotypes (such as G2, G3, G4, and G9). Rotavirus vaccine may be given to preterm infants with the same posology.

DOSAGE AND ADMINISTRATION: The vaccination course consists of 2 doses. The 1st dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should be completed by the age of 24 weeks. It is strongly recommended that infants who receive a 1st dose of Rotavirus vaccine complete the 2-dose regimen with Rotavirus vaccine.

Method of Administration: Rotavirus vaccine is for oral use only. Rotavirus vaccine should under no circumstances be injected. There are no restrictions on the infant’s consumption of food or liquid, including breast-milk, either before or after vaccination. There is no evidence available to suggest that breast-feeding would reduce the protection against Rotavirus gastro-enteritis afforded by Rotavirus vaccine Therefore, breast-feeding may be continued during the vaccination schedule.

Contraindications:

Rotavirus vaccine should not be administered to subjects with known hypersensitivity after previous administration of Rotavirus vaccine or to any component of the vaccine

Side Effects:

Cautions:

Precautions:

Interaction:

Warnings:

As with other vaccines, administration of Rotavirus vaccine should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. The administration of Rotavirus vaccine should be postponed in subjects suffering from diarrhea or vomiting. . May be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Very common: Irritability and loss of appetite.

Common: Diarrhea, vomiting, flatulence, abdominal pain, regurgitation of food, fever and fatigue.

Uncommon: Constipation , crying, sleep disorder, somnolence.

Rare: Haematochezia, upper respiratory tract infection, hoarsenessn rhinorrhoea, muscle cramp, dermatitis and rash.

Incompatibilities: This medicinal product must not be mixed with other medicinal products.

UNDESIRABLE EFFECTS

Infections and infestations: Rare: upper respiratory tract infection

Psychiatric disorders:Very common: irritability

Uncommon: crying, sleep disorder

Nervous system disorders

Uncommon: somnolence

Respiratory, thoracic and mediastinal disorders:Rare: hoarseness, rhinorrhoea

Gastrointestinal disorders: Very common: loss of appetite

Common: diarrhoea, vomiting, flatulence, abdominal pain, regurgitation of food

Uncommon: constipation

Skin and subcutaneous tissue disorders: Rare: dermatitis, rash

Musculoskeletal and connective tissue disorders:
Rare: muscle cramp

General disorders and administration site conditions: Common: fever, fatigue

Patient And Carer Advice: