Leaflet ROTARIX oral suspension

Product code:
W53550001
Quantity:
1
Indicated for:
prevention of rotavirus gastroenteritis
Route of administration:
oral
Substance:
rotavirus vaccine (vaccine)
ATC
J07BH01 — Antiinfectives for systemic use | Viral vaccines | Rotavirus diarrhea vaccines

Precautions:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light

Store protected from light.

The rotavirus vaccine is used to prevent severe gastroenteritis caused by rotavirus infection, a common illness in infants and young children. Rotavirus is a leading cause of severe diarrhea, which can result in severe dehydration and hospitalization, especially in the first years of life.

The vaccine is administered orally and is included in the vaccination schedule for infants. It is given in two or three doses, depending on the type of vaccine, usually starting at 6 weeks of age. It is important that all doses are completed before the age of 8 months.

The vaccine is highly effective in preventing severe forms of rotavirus gastroenteritis and significantly reduces the risk of hospitalization. It is well-tolerated, with side effects being rare and generally mild, such as irritability or minor gastrointestinal disturbances.

Rotavirus vaccination is an essential preventive measure to protect infant health and reduce the burden of the disease in the community. It is recommended by international health organizations and is widely available in many countries.

Official documents

Added to database:
05/10/2009
Source record updated:
22/04/2026

General data about ROTARIX

Substance:
rotavirus vaccine
Date of latest medicines list:
01-06-2026
Product code:
W53550001
Pharmaceutical form:
oral suspension
Packing volume:
15ml
Product type:
Original
Price:
287.45 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
GLAXO SMITHKLINE BIOLOGICALS SA - BELGIA
Holder:
GLAXO SMITHKLINE BIOLOGICALS SA - BELGIA
Number:
330/2008/09
Shelf life:
3 years

Pharmaceutical forms available for rotavirus vaccine