Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Human rotavirus RIX4414 strain live attenuated
GlaxoSmithKline UK Ltd
Human rotavirus RIX4414 strain live attenuated
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF:
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ROTARIX ORAL SUSPENSION IN PRE-FILLED ORAL APPLICATOR 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 allergic reacti Perskaitykite visą dokumentą
OBJECT 1 ROTARIX ORAL APPLICATOR Summary of Product Characteristics Updated 28-Apr-2017 | GlaxoSmithKline UK 1. Name of the medicinal product Rotarix ORAL suspension in pre-filled ORAL applicator Rotavirus vaccine, live 2. Qualitative and quantitative composition 1 dose (1.5 ml) contains: Human rotavirus RIX4414 strain (live, attenuated)* not less than 10 6.0 CCID 50 *Produced on Vero cells Excipient with known effect: This product contains sucrose 1,073 mg (see section 4.4). For the full list of excipients, see section 6.1. 3. Pharmaceutical form ORAL suspension. Rotarix is a clear and colourless liquid. 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 first dose and another rotavirus vaccine is administered for the second dose or vice versa. _Paediatric population_ Rotarix should not be used i Perskaitykite visą dokumentą