البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
human rotavirus, live attenuated
GlaxoSmithKline Biologicals S.A.
J07BH01
rotavirus vaccine, live
Vaccines
Immunization; Rotavirus Infections
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.The use of Rotarix should be based on official recommendation.
Revision: 41
Authorised
2006-02-21
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE USER ROTARIX POWDER AND SOLVENT FOR ORAL SUSPENSION rotavirus vaccine, live READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS VACCINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This vaccine has been prescribed for your child only. Do not pass it on to others. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rotarix is and what it is used for 2. What you need to know before your child receives Rotarix 3. How Rotarix is given 4. Possible side effects 5. How to store Rotarix 6. Contents of the pack and other information 1. WHAT ROTARIX IS AND WHAT IT IS USED FOR Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection. HOW ROTARIX WORKS Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. Most children with rotavirus diarrhoea recover on their own. However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation. When a person is given the vaccine, the immune system (the body’s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies protect against disease caused by these types of rotavirus. As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent. 2. WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES ROTARIX ROTARIX SHOULD NOT BE GIVEN • if your child has previously had any a اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rotarix powder and solvent for ORAL suspension Rotavirus vaccine, live 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1 mL) contains: Human rotavirus RIX4414 strain (live, attenuated)* not less than 10 6.0 CCID 50 *Produced on Vero cells Excipients with known effect: This product contains 13.5 mg of sorbitol, 9 mg of sucrose, 10 micrograms of glucose and 0.15 microgram of phenylalanine per dose (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for ORAL suspension. The powder is white. The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastro- enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). The use of Rotarix should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age (see sections 4.8 and 5.1). In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix. There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the fir اقرأ الوثيقة كاملة